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Ventris anterior cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Ventris anterior cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Ventris 2-screw anterior cages may be used as a stand alone device only when two (2) vertebral body bone screws are used. Ventris 4-screw anterior cages may be used as a stand alone device only when at least two (2) vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use Ventris anterior cages with fewer than two (2) screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used. Ventris anterior cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. When used to treat ASD, or when cages with more than 20° of lordosis are used, Ventris anterior cages must be used with a supplemental spinal fixation system cleared for use in the lumbosacral spine and cannot be used as a stand alone.

Ventris anterolateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Ventris anterolateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. Ventris anterolateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Ventris anterolateral cages are intended to be used with a supplemental spinal fixation system cleared for use in the lumbosacral spine.

Ventris lateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Ventris lateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. Ventris lateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Ventris lateral cages are intended to be used with a supplemental spinal fixation system cleared for use in the lumbosacral spine.

The Ventris system consists of intervertebral body fusion devices intended for lumbar interbody fusion using an anterior lumbar interbody fusion surgical approach (ALIF), anterolateral (i.e., oblique) lumbar interbody fusion surgical approach (AOLIF), or a lateral lumbar interbody fusion surgical approach (LLIF). The devices are intended to improve stability of the spine while supporting fusion. The Ventris constructs are intended for use at one or two contiguous levels in the lumbar spine (L2-S1). The components are offered in different shapes and sizes to meet the requirements of the individual patient's anatomy and are provided sterile.

Ventris cages are available in six configurations: Ventris Ti Interbody anterior four-hole constructs for ALIF approach, Ventris Ti FRA Interbody anterior fully round ALIF (FRA) constructs for ALIF approach, Ventris Ti Open Interbody anterior two-hole constructs for ALIF approach, Ventris Ti AL Interbody anterolateral (i.e., oblique) constructs for OLIF approach, Ventris Ti Lateral FX two-screw lateral constructs for LLIF approach, and Ventris Ti Lateral Interbody lateral constructs for LLIF approach. All cages are also available with increased surface area options that provide additional endplate surface area. For the increased surface area cages, the outer footprint remains the same, but the volume of the internal graft window is reduced, creating more endplate surface area.

Ventris cages are secured on the vertebral bodies using bone screws. A cover plate assembly prevents the screws from backing out after insertion. The cages and cover plates are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. The bone screw and cover plate screws are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. All anterior and anterolateral constructs are zero profile, reducing potential for vessel interference with the anterior column.

All Ventris cages and cover plates are manufactured using the L-PBF (laser powder bed fusion) additive manufacturing method. L-PBF allows for the formation of solid, non-porous cages with a layered porous lattice structure on the surfaces of the components, including the surfaces of the interior graft window. This intricate structure facilitates bone in-growth by providing a larger surface of implant/bone contact than a buffed surface. Interbody cages and bone screws may also be titanium anodized to allow for identification of various heights/sizes by color.

Ventris Ti Interbody cages, Ventris Ti FRA Interbody cages, Ventris Ti Open Interbody cages, Ventris Ti AL Interbody cages, Ventris Ti Lateral FX Interbody cages, Ventris Ti Lateral Interbody cages, and Ventris bone screws are also available with a Proximal HA Surface (hydroxyapatite) coating. Cages and bone screws are coated with 20mm HA layer composed of crystalline hydroxyapatite particles that mimic human bone tissue through shape, composition, and structure. This surface treatment increases implant anchoring by facilitating osseointegration and enhancing early bone growth. All Ventris devices are only available sterile packaged.

Non-sterile, reusable surgical instruments to support implantation of the system are provided for use with Ventris devices are provided in steam sterilization trays.

The provided FDA 510(k) clearance letter and summary for the Ventris IBFD focuses primarily on demonstrating substantial equivalence to predicate devices through non-clinical performance testing (mechanical, biocompatibility, sterilization, and packaging validation), rather than outlining specific clinical acceptance criteria for a diagnostic AI device or a direct human observational study.

Therefore, the requested information regarding human reader studies, training data, and ground truth establishment, which are typical for AI/diagnostic device clearances, is not present in the provided document. The Ventris IBFD is a physical intervertebral body fusion device, not a diagnostic AI or imaging analysis tool.

However, I can extract the acceptance criteria and performance related to the mechanical and physical properties of the device as described in the non-clinical testing.

Here's the information based on the provided text, with the understanding that this is for a physical medical implant and not a diagnostic AI system:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of devices or test articles for each mechanical test. The text mentions "worst-case subject device" and "all process steps, including HIP and Non-HIP test articles" were taken into account. This implies a selection of devices representing various configurations and manufacturing processes were tested.
• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer, Acuity Surgical Devices LLC, or a contract lab. The provenance is internal testing to establish product performance against industry standards. There is no mention of country of origin for test data, as it's not a clinical study. It's not retrospective or prospective in the clinical sense, but rather pre-market engineering validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. For mechanical testing of a medical device, "ground truth" is established by adherence to recognized ASTM standards and validated testing methodologies. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the standard's specifications. The document does not specify their number or qualifications but implies standard engineering and regulatory expertise would be involved in such validation.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving multiple human readers for diagnostic interpretation. For mechanical testing, the "adjudication" is inherently built into the pass/fail criteria of the ASTM standards and the rigorous interpretation of raw data against these predefined limits.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is not relevant for this type of device (an intervertebral body fusion device) which is a physical implant, not a diagnostic or AI-assisted system. No human readers or AI assistance are mentioned in the context of device performance improvement for an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical implant. There is no "algorithm only" performance to evaluate. Its "performance" is its mechanical integrity and biological compatibility when implanted.

7. Type of Ground Truth Used

• The "ground truth" for the non-clinical tests is based on established industry standards (ASTM F2077, ASTM F2267, ASTM F3001) for the mechanical, material, and performance characteristics of intervertebral body fusion devices. These standards define the acceptable range of performance for such devices.

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI model. There is no concept of a "training set" in the context of its validation for FDA clearance. The design and manufacturing processes are developed based on engineering principles and existing knowledge, not through machine learning training data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI model, there is no ground truth, in that sense, to establish.

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DZ-Tabone Intervertebral Body Fusion Device can be divided into two types, CIF-PTA and LIF-PTA.

The CIF-PTA is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-Tl. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The CIF-PTA is intended for use with supplemental fixation systems and with autogenous bone graft. The CIF-PTA is implanted via an anterior approach.

The LIF-PTA is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic pam with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The LIF-PTA is implanted using a posterior approach and is intended to be used in pairs with supplemental fixation.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios.

DZ-Tabone Intervertebral Body Fusion Device is a single device manufactured wholly from tantalum metallic material. It has a convex structure on the upper and lower surfaces, and a block structure as a whole. The device has a trabecular porous structure with a central bone graft window, facilitating vertebral fusion through bone ingrowth and providing stable support between vertebrae to maintain intervertebral space height.

The device intends to be used for spinal fusion surgery for patients with degenerative disc diseases, vertebral slippage, and instability of vertebrae. The surgery involves fusing one or two adjacent vertebral segments, with the option to implant in the cervical spine (C2-T1) or lumbar spine (L2-S1) vertebral gaps. It aims to restore the lost height due to vertebral lesions and is used in conjunction with an internal fixation system.

The Device is sterilized by irradiation and provided in a sterile form. These implants are intended for single use only and must not be reused under any circumstances.

This document describes the premarket notification (510(k)) for the DZ-Tabone™ Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing a new, independent set of acceptance criteria based on a clinical study of the device's performance. Therefore, the information requested can only be partially provided based on the content of this FDA clearance letter.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific quantitative acceptance criteria in terms of clinical performance (e.g., fusion rates, pain reduction scores) or report the device's performance against such criteria. Instead, the "acceptance criteria" are related to non-clinical testing designed to demonstrate substantial equivalence to predicate devices. The reported device performance is therefore in terms of meeting these non-clinical standards and demonstrating comparable characteristics.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of clinical performance. The "tests" mentioned are non-clinical (mechanical, biocompatibility, sterilization, endotoxin) performed on samples of the device itself. Specific sample sizes for these engineering and lab tests are not provided in this summary but would have been part of the full 510(k) submission.
• Data Provenance: The data provenance for the non-clinical tests is the manufacturer, Shenzhen Dazhou Medical Technology Co., Ltd. The document refers to "test results," implying these were prospective tests specifically conducted for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable as no clinical test set requiring expert ground truth establishment is described for this 510(k) submission. The FDA clearance is based on non-clinical data demonstrating substantial equivalence.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication is described in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is an intervertebral body fusion device, not an AI or imaging diagnostic tool. Therefore, a MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a physical implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO) and regulatory guidance (e.g., FDA guidance for sterility).

8. The Sample Size for the Training Set:

Not applicable, as there is no specific "training set" in the context of this 510(k) submission for a physical medical device. Device design and validation processes rely on engineering principles, materials science, and testing against known standards, not machine learning training sets.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reasons as above.

In summary:

This FDA 510(k) clearance is based on demonstrating that the DZ-Tabone™ Intervertebral Body Fusion Device is substantially equivalent to legally marketed predicate devices. This is primarily achieved through non-clinical testing that confirms the new device's material properties, mechanical performance, biocompatibility, and sterility meet established standards and are comparable to those of the predicate devices. The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." Therefore, information related to clinical studies, expert-established ground truths, or AI performance metrics requested in your prompt is not found within this clearance letter.

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The Nu Vasive Cohere ALF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Interverebird Body Fusion Device 10-200 lordotic cages may be used as a standalone system. The System Intervetebral Body Fusion Device 25-30° lordotic cages may be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneis bone graft, intervertebral hody fraise to corticocancellous bone graft, or a bone void filler as cleared by FDA, for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had alleast sim onths of non-operative treatment.

The NuVasive Cohere ALLF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectory in the trestment of symptomatic degenerative disc disease (DD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disconfirmed by history and radiographic studies. The Cohere ALFE System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative spondylolisthanis as saind the used in these patients at multiple levels at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervetebrah Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the internal spillal fixal.

The Cohere ALIF System Intervertebral Body Fusion Device is inclusive of sterile, single use interbody implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights. Each device within the Cohere ALIF System Intervertebral Body Fusion Devce is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. In addition to PEEK, the device assembly contains radiolucent markets to enable visibility under x-ray in vivo. The implants are available in a variety of sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

This document describes the NuVasive® Cohere® ALIF System Intervertebral Body Fusion Device, which is an implant made of PEEK material for spinal fusion procedures. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each mechanical test. The tests were non-clinical, implying in-vitro or bench testing. The data provenance is implied to be from the manufacturer's internal testing facilities, as no external data sources (e.g., country of origin, retrospective/prospective) are mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a non-clinical, mechanical testing study to assess device performance against established standards and predicate devices, not a study involving human expert judgment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation or subjective assessments. This study involved objective mechanical testing against defined ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states that "No clinical studies were conducted." This study focuses on the physical and mechanical properties of the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical intervertebral body fusion device and does not involve any algorithms or software that would have standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is established by:

• ASTM Standards: Specifically ASTM F2077, F1714, and F1877, which provide benchmark performance requirements for intervertebral body fusion devices and material properties.
• Predicate Device Performance: The subject device's performance was compared to that of legally marketed predicate devices to demonstrate substantial equivalence, meaning the predicate devices' established performance serves as a comparative "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth, and hence no establishment process for it relevant to this context.

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The aprevo™ anterior lumbar interbody fusion and aprevo™M lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo™ anterior lumbar interbody fusion and aprevo™ lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo™ ALIF and LLIF devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo™ devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient. The individualized surgical correction plan and device configurations are developed using patient CT scans. Aprevo™ devices are additively manufactured and made from Titanium Alloy (Ti-6Al-4V) per ASTM F3001, and have a cavity intended for the packing of bone graft.

The provided text describes a 510(k) premarket notification for the "aprevo™ Intervertebral Body Fusion Device." This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through mechanical performance testing, rather than a study evaluating device performance against pre-defined clinical acceptance criteria.

Therefore, many of the requested elements for a study proving device performance (such as sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) are not applicable or cannot be extracted from this document, as it pertains to a mechanical device and not an AI/diagnostic software.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical outcomes or performance metrics for the device in a clinical setting. Instead, it relies on demonstrating mechanical properties that are sufficient for its intended use and comparable to predicate devices. The "reported device performance" refers to the results of various mechanical tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This information is not explicitly provided in the document. Mechanical tests typically use a certain number of device samples, but the specific quantity is not stated here. For the "Cadaver Accuracy Validation and Usability Study" and "Inter- and Intradesigner Variability Testing," the sample size (e.g., number of cadavers or number of designers/cases) is not detailed.
• Data Provenance: Not specified, as the data predominantly refers to mechanical testing of the physical device samples. It is not clinical data from patients or countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes mechanical testing of an intervertebral body fusion device, not an AI/diagnostic software that requires expert ground truth for image interpretation or diagnosis. The "Cadaver Accuracy Validation" likely involved medical professionals, but their number and specific qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of mechanical device testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical implant, not an algorithm. The "patient-specific adaptable features" and "individualized surgical correction plan" are developed using patient CT scans, which implies a human-in-the-loop design process based on AI/software, but the core device performance evaluation is mechanical.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" is typically defined by engineering standards (e.g., ASTM standards) and the physical properties of the material and design. For the "Cadaver Accuracy Validation," anatomical landmarks or surgical measurements would serve as the "ground truth." For the "Inter- and Intradesigner Variability Testing," consistency and deviation from a "gold standard" design or a human expert's optimal design would be evaluated. Detailed specifics are not provided in the document.

8. The sample size for the training set

This is not applicable as the document is about a manufactured medical device and its mechanical properties, not an AI/machine learning model that requires a "training set." While the device design process involves patient CT scans to create patient-specific implants, these likely serve as input data for design software (which may incorporate AI), rather than a training set for algorithm development that is being evaluated in this 510(k).

9. How the ground truth for the training set was established

This is not applicable for the same reasons as #8.

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The DualX™ PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DualX™ PLIF is indicated for unilateral implantation.

The DualX™ LLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to L5, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The DualX™ TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The DualX™ Lumbar Intervertebral Body Fusion Device implants are an expanding family of interbody fusion devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery and, in the collapsed configuration, are between 12.3 mm wide (TLIF and PLIF) and 13.3mm wide (LLIF).

After entering the joint space, the implants expand laterally to maximize the contact area around the cortical rim of the vertebral bodies. The implants then expand vertically to maintain distraction of the vertebral bodies and maximize clearance for exiting nerve roots. The implants are binary, and each implant can only be locked out in the fully expanded state. Specific sizes are included in the system with various expanded heights to optimize the fit for the patient.

The DualX™ Lumbar Intervertebral Body Fusion Device is made from titanium that conforms to ASTM F136.

This looks like a 510(k) premarket notification for a medical device called the DualX™ Lumbar Intervertebral Body Fusion Device. The provided document does not contain information typically found in a study proving a device meets acceptance criteria, especially not for an AI/algorithm-based device.

The document describes a modification to the sterilization trays of the device, allowing for non-sterile implants to be sterilized by the end user. It explicitly states: "mechanical testing was not required to demonstrate substantial equivalent mechanical strength since there are no modifications to the implants and instruments. The substantial equivalence of mechanical strength for the DualX™ Lumbar Intervertebral Body Fusion Device was established in the clearance of K181397."

This means the submission is not about proving the initial performance of the device itself (the implant), but rather about a change in how it is processed (sterilization trays), and relies on the previously established substantial equivalence of the device's mechanical strength under K181397.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI-based device, as this is a physical medical implant called an "intervertebral body fusion device" and the submission is for a minor modification to its packaging/sterilization.

If you have a document related to K181397 or a different type of medical device (like an AI/algorithm-based one) that includes performance study data, I would be happy to analyze that.

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When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

When used with the SpinPlate, the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.

The Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand-alone device. If the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

When used with the bone screws, the SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

When used with the SpinPlate, the Vu a•POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a POD Prime Intervertebral Body Fusion Device is intended for use with supplemental fixation.

The Vu a POD Prime Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand-alone device. If the Vu a•POD Prime Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine Vu aºPOD Prime Intervertebral Body Fusion Devices are anterior intervertebral body fusion devices (IBD) which can be used in combination with two Bone Screws, a SpinPlate, or both Bone Screws and SpinPlate together. When used with Bone Screws or Bone Screws and SpinPlate, the system is a stand-alone device. When used with the SpinPlate alone, the system is intended for use with supplemental fixation. The spacer is intended to be used at one or two contiguous levels from L2 to S1 in the ALIF approach. Implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). The Bone Screws and SpinPlate are manufactured from Ti-6A1-4V ELI per ASTM F136.

The Vu a•POD Prime IBD spacers are comprised of PEEK-OPTIMA LT1 polymer and include large central graft windows, which are packed with bone graft prior to implantation. The spacers include toothed spikes/knurls on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The spacers are offered in all PEEK or with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM). Tantalum pins (i.e. radiopaque markers) are press fit into each end of the radiolucent spacer to allow easier radiological assessment of the position and orientation.

The Vu aºPOD Prime IBD NanoMetalene implants are provided in gamma sterilized packaging; the Vu a•POD Prime IBD PEEK spacer, Bone Screws, and SpinPlate are provided non-sterile for subsequent sterilization at the healthcare facility. The instruments included with the Vu a•POD Prime IBD facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device" and "SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device".

This document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any performance data related to AI/algorithm performance.

Instead, it's a submission to demonstrate substantial equivalence to legally marketed predicate devices. The section explicitly states:

• Clinical Testing: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
• Non-Clinical Testing: Mentions that previous analyses verified "no new worst cases were created for Static Axial and Shear Compression, Dynamic Axial and Shear Compression per ASTM F2077, and Subsidence per ASTM F2267," and "the subject devices have equivalent mechanical strength to the predicates." It also refers to packaging, shipping, sterility, and bacterial endotoxin testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and AI/algorithm study results based on this document. The device in question is an intervertebral body fusion device, which is a physical implant, not an AI-driven diagnostic or assistive tool.

To answer your request, a document detailing the clinical trials or performance studies for an AI/algorithm-driven medical device would be necessary.

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When used with the bone screws, the SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

When used with the SpinPlate™, the Vu aªPOD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate™, the Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is intended for use with supplemental fixation.

The Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate™, is a stand-alone device. If the Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is used only with the SpinPlate™ then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine® Vu a•POD™ Prime NanoMetalene® is an anterior intervertebral body fusion device (IBD) which can be used in combination with two titanium Bone Screws, a titanium SpinPlate™, or both Bone Screws and SpinPlate™ together. When used with Bone Screws or Bone Screws and SpinPlate™, the system is a stand-alone device. When used with the SpinPlate™ alone, the system is intended for use with supplemental fixation. The spacer is intended to be used at one or two contiguous levels from L2 to S1 in the ALIF approach. Implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems).

The Vu a•POD™ Prime NanoMetalene® IBD spacers are comprised of PEEK-OPTIMA® LT1 polymer and include large central graft windows, which are packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacers include toothed spikes/knurls on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The spacers have a one-micrometer thick layer of commercially pure (CP) titanium. NanoMetalene® (NM), that is molecularly bonded to the surface. Tantalum pins (i.e. radiopaque markers) are press fit into each end of the radiolucent spacer to allow easier radiological assessment of the position and orientation. The spacer will be provided in sterile packaging; the Bone Screws and SpinPlate™ will be provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with the Vu a•POD™ Prime NanoMetalene® IBD system facilitate the placement, adjustment, and final locking of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any clinical study details for a device that detects or diagnoses a condition using AI.

The document is a 510(k) premarket notification for an orthopedic intervertebral body fusion device (SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device). It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing (mechanical safety, sterilization, etc.), rather than an AI-powered diagnostic device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, or AI performance metrics.

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Lucent intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The Lucent® XP device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The Lucent® XP device is comprised of two PEEK endplates with teeth for engaging the vertebral body endplates on the outside of the device and an internal titanium mechanism for expanding the PEEK endplates of the device. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device is made from PEEK-Optima® grade LT1 conforming to ASTM F2026 with or without a coating of commercially pure titanium conforming to ASTM F1580. The internal mechanism is made from titanium alloy conforming to ASTM F136.

This document describes the Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®). However, it does not contain detailed acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-based medical devices.

Instead, this is a 510(k) Premarket Notification for a spinal implant, which relies on demonstrating substantial equivalence to a predicate device. The "performance data" section focuses on mechanical and physical testing rather than clinical performance or comparisons of human readers with and without AI assistance.

Therefore, I cannot provide all the requested information, specifically regarding AI-related aspects (like MRMC studies, standalone algorithm performance, AI training/test sets, expert qualifications for ground truth in an AI context).

Here's an breakdown of the available information based on your request, explicitly noting what is not applicable (N/A) or not provided (N/P) in this document for the requested AI-centric details:

Device Name: Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®)

Device Type: Intervertebral Body Fusion Device (Spinal Implant)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For this type of device (spinal implant), acceptance criteria are primarily based on meeting the performance specifications outlined in relevant ASTM standards for mechanical integrity, rather than clinical efficacy metrics like sensitivity/specificity for an AI algorithm. The document states that "All data indicates that the device will perform as intended," implying successful adherence to these standards, but does not provide quantitative results or detailed pass/fail thresholds within this summary.

Regarding AI/ML-specific Study Information:

This document is for a physical medical device (spinal implant), not an AI/ML algorithm. Therefore, the following points are not applicable (N/A) or not provided (N/P) as they pertain to AI/ML device evaluations.

2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML device)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML device)
4. Adjudication method for the test set: N/A (Not an AI/ML device)
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (Not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Not an AI/ML device; for spinal implants, "ground truth" would be related to physical properties and functionality confirmed by engineering tests and potentially predicate device history / clinical literature)
8. The sample size for the training set: N/A (Not an AI/ML device)
9. How the ground truth for the training set was established: N/A (Not an AI/ML device)

Summary of this Document's Approach:

This 510(k) submission leverages the concept of substantial equivalence. The manufacturer demonstrates that the Lucent® XP and Lucent XP Ti-Bond® device has the same indications for use, manufacturing method, raw materials, and operating principles as several legally marketed predicate devices. The "Performance Data" section confirms that the device has undergone standard mechanical tests (Static Compression, Dynamic Compression, Subsidence, Compression Shear) according to specific ASTM standards, and the results indicate it performs as intended. This type of testing is standard for implantable devices to ensure structural integrity and biocompatibility, rather than diagnostic accuracy as would be required for an AI/ML system.

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Talos® Intervertebral Body Fusion Devices:

The Talos® IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos® IBF Devices are intended to be used with autograft comprised of cancellous and/or corticocancellous bone graft.

The Talos® IBF Device is to be used in patients who have had six months of non-operative treatment. Talos® IBF devices are to be implanted via a direct posterior, transforaminal, lateral, or anterior approach in the lumbosacral spine. The Talos®-A, Talos®-L, Talos®-T are intended to be used with supplemental fixation.

Talos®-C Cervical Intervertebral Body Fusion Devices:

The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in sketally mature patients with Degenerative Disc (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.

Talos®-C (HA) Cervical Intervertebral Body Fusion Devices:

Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Non-operative treatment prior to treatment with Talos@-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.

Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation.

The Talos® IBF Device is made of polymer, polyetheretherketone (PEEK). The Talos® IBF Device is available in four configurations: Talos®-P, Talos®-L, and Talos®-A. The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos® –P and Talos® –L are rectangular devices and the Talos® – A have curved lateral walls and rounded edges. The implants are available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allow the Talos® IBF radiological confirmation for proper positioning.

The Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning.

The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.

This document is a 510(k) premarket notification for Meditech Spine, LLC's Talos® Intervertebral Body Fusion Devices. It focuses on changes to previously cleared devices, specifically the addition of allograft bone options and a change in marker material for cervical devices.

Based on the provided text, the device itself (hardware) has not undergone changes, but the submission is for modifications to the indications for use concerning bone graft material and material change for radiopaque markers. Therefore, the acceptance criteria and study information relate to demonstrating that these proposed changes do not introduce new safety or effectiveness concerns, and that the device remains substantially equivalent to its predicate devices.

Here's the breakdown of the requested information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative table format for device performance (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are implicitly that the modified indications and marker material do not increase risk and maintain substantial equivalence to the predicate devices. The "reported device performance" is framed in terms of clinical outcomes from published literature for similar devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated as a specific number of patients or cases. The document refers to "Published retrospective clinical data" rather than a newly conducted study by the submitter.
• Data Provenance: "Published retrospective clinical data for lumbar and cervical intervertebral body fusion devices similar to the Talos® Intervertebral Body Fusion Devices..." No specific country of origin is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. As the clinical data referenced is "published retrospective clinical data," details about expert review for ground truth within those studies would not typically be part of this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document, as it refers to existing published literature rather than a new study with a specific adjudication protocol.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC study done? No. This document is for intervertebral body fusion devices, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.
• Effect size of human reader improvement with AI? Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone study done? No. This document is for intervertebral body fusion devices, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document references "published clinical outcomes" for similar devices. This implies that the "ground truth" for the effectiveness of allograft in fusion procedures would be based on clinical outcomes data (e.g., fusion rates, patient reported outcomes, absence of complications) from those retrospective studies.

8. The sample size for the training set

The concept of a "training set" is not applicable here as this is not an AI/ML device being developed or validated. The document refers to existing published clinical literature.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/ML device, and no "training set" in that context is referenced. The "ground truth" in the context of the referenced clinical literature would have been established through standard clinical follow-up and evaluation methods of the respective studies.

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When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device cispine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. Additionally, the clspine implants are to be used with autogenous bone graft and supplemental fixation via an open, anterior approach.

When used as a lumbar intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device tispine implants are indicated for spinal fusion procedures in skeletally mature patients. Lumbar interbody fusion implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for treatment of lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The tlspine implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implanted via a transforaminal approach. These implants are to be used with autogenous bone graft and supplemental fixation.

Ackermann Intervertebral Body Fusion Device c|spine and t|spine is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from implant grade PEEK (polyetheretherketone, VESTAKEEP® i4 R bv Evonik).

The provided document is a 510(k) summary for a medical device called the "Ackermann Intervertebral Body Fusion Device." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results to establish acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested points regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, and expert ground truth establishment are not applicable to this document as it describes a physical implant device, not an AI or algorithmic diagnostic tool.

However, I can extract the relevant "performance data" which refers to mechanical testing as opposed to clinical or algorithmic performance.

Here's the information that can be extracted from the document:

1. A table of acceptance criteria and the reported device performance
The document refers to adherence to ASTM standards for mechanical testing, which implies the acceptance criteria were defined by these standards. Specific numerical acceptance criteria or reported performance values (e.g., specific load resistance in Newtons) are not detailed in this summary. Instead, it states that the device was "tested in accordance with" specific ASTM standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes mechanical testing of a physical device, not an AI/algorithmic device with a "test set" of patient data. The "test set" would refer to the number of physical devices or components tested. This detail is not provided. The manufacturer is Ackermann Instrumente GmbH, located in Rietheim-Weilheim, Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of AI/algorithms, refers to expert-validated labels. For mechanical testing, the "ground truth" is adherence to ISO/ASTM standards and physical measurements, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/algorithm ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is a physical medical device, not an AI algorithm. Therefore, an MRMC study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a physical device's performance is objective measurement based on mechanical testing standards (ASTM F2077, ASTM F2267).

8. The sample size for the training set
Not applicable. This is not an AI/algorithmic device, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this physical device.

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