Search Results

The Stabilis SA Cervical Stand-Alone System is 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 system is 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.

The Stabilis SA Cervical Stand-Alone System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, 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.

Stabilis SA Cervical Stand-Alone System cages may be used as a stand-alone device when two (2) vertebral body bone screws are used. Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may be used as a stand-alone device when at least two (2) vertebral body bone screws are utilized with one inferior and one superior screw trajectory on opposite sides of the cage. If the physician chooses to use Stabilis SA Cervical Stand-Alone System cages with fewer than two (2) screws, then an additional supplemental spinal fixation system cleared for use in the cervical spine must be used.

Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may only be used at contiguous levels if at least two (2) vertebral body bone screws are utilized in each cage with one inferior and one superior screw trajectory on opposite sides of the cage, such that no more than two (2) vertebral body bone screws are implanted at the shared vertebral body with one inferior and one superior screw trajectory on opposite sides of the cages. Additionally, a cage with four (4) screw holes and a cage with two (2) screw holes can be implanted contiguously only if the cage with four (4) screw holes uses at least (2) vertebral body bone screws with one inferior screw on the left side of the cage and one superior screw on the right side of the cage.

The Stabilis SA cages are intervertebral body fusion devices intended for cervical interbody fusion using an anterior approach. The devices are intended to improve stability of the spine while supporting fusion. Stabilis SA constructs are intended for use at one or two contiguous levels in the cervical spine (C2-T1). The components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy.

Stabilis SA Cervical Stand-Alone System cages 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. All cages 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. The cages are also titanium anodized to allow for identification of various heights by color. The Stabilis SA Cervical Stand-Alone System cages are secured on the vertebral bodies using bone screws. The bone screws are machined 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 and passivated according to ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants.

Stabilis Ti SA 2 Interbody, Stabilis Ti SA 2 Interbody, Curved, Stabilis Ti SA 4 Interbody, Stabilis Ti SA 4 Interbody, Curved, Stabilis Ti ZP Interbody, Stabilis Ti ZP Interbody, Curved cages, and bone screws are also available with a hydroxyapatite coating to increase implant anchoring by facilitating osseointegration and enhancing early bone growth. All Stabilis SA Cervical Stand-Alone implants are only available sterile packaged.

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

Here's an analysis of the provided FDA 510(k) clearance letter for the Stabilis SA Cervical Stand-Alone System, focusing on the acceptance criteria and study information:

This document describes the mechanical testing performed on an intervertebral body fusion device and does not involve AI. Therefore, many of the typical questions regarding AI device studies are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

Device: Stabilis SA Cervical Stand-Alone System (Intervertebral Body Fusion Device)

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

The document does not specify the exact sample size for the mechanical performance testing (e.g., number of devices tested for each mechanical test). It refers to the tests as being conducted on "the worst-case subject device" and "new implant sizes and configurations."

The data provenance is from non-clinical (mechanical and material) testing performed on the physical device, not patient data. Therefore, concepts like country of origin or retrospective/prospective do not apply in the typical sense for clinical studies.

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

This question is not applicable as this is a non-clinical device clearance for an intervertebral body fusion device, not an AI/software device requiring "ground truth" derived from expert interpretation of clinical data. The "ground truth" here is the adherence to established mechanical and material standards and the performance equivalence to predicate devices.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to how expert disagreements are resolved when establishing ground truth in clinical data interpretation studies. This document describes mechanical and material testing, not clinical data assessment.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or prognostic AI/software devices where human reader performance is being evaluated with and without AI assistance. This document pertains to the mechanical and material safety and effectiveness of a physical implant.

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

Not Applicable. This device is a physical implant, not an algorithm. Standalone performance typically refers to the diagnostic or predictive capability of an AI algorithm without human input or modification of the output.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Adherence to recognized industry standards: ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices), ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Compression), ASTM F3001 (Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI), ASTM F136 (Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy), and ASTM F86 (Practice for Surface Preparation and Marking of Metallic Surgical Implants).
• Performance equivalence to previously cleared predicate devices, as demonstrated through mechanical and material testing.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the device's design is based on engineering principles, material science, and the performance characteristics of previously cleared predicate devices.

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

Not Applicable. As there is no training set in the context of AI/ML, there is no ground truth established for it. The standards and predicate devices guide the design and manufacturing, but this is a different concept than ground truth for machine learning.

Ask a specific question about this device

The Tera Lumbar Interbody Fusion System is 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.

The Tera Lumbar Interbody Fusion System is 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.

The Tera Lumbar Interbody Fusion System is intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

The Tera Lumbar Interbody Fusion System consists of intervertebral body fusion devices intended for lumbar interbody fusion using a transforaminal lumbar interbody fusion surgical approach (TLIF), an oblique transforaminal interbody fusion surgical approach (Oblique TLIF), or a posterior lumbar interbody fusion surgical approach (PLIF). The devices are intended to improve stability of the spine while supporting fusion. The Tera Lumbar Interbody Fusion System cages 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.

Tera Lumbar Interbody Fusion System cages 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. All cages 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. The cages are also titanium anodized to allow for identification of various heights by color.

Tera-T Ti Interbody cages, Tera-O Ti Interbody cages, and Tera-P Ti Interbody cages are also available with a Promimic HAnano Surface (hydroxyapatite (HA) coating). Cages are coated with a 20nm 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 Tera Lumbar Interbody Fusion System implants are only available sterile packaged.

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

The provided text describes a 510(k) clearance for a medical device called the "Tera Lumbar Interbody Fusion System." This document is a regulatory approval for a physical medical device (an implant used in spinal fusion surgery), not a software or AI-driven diagnostic device.

Therefore, the requested information about acceptance criteria for AI/software performance, such as MRMC studies, ground truth establishment, training set details, or expert adjudication, is not applicable to this document. The clearance is based on mechanical performance testing and substantial equivalence to a predicate device.

Here's a breakdown of the relevant information provided in the document regarding the device's acceptance and testing:

Acceptance Criteria and Device Performance for Tera Lumbar Interbody Fusion System

The Tera Lumbar Interbody Fusion System is a physical medical device. Its acceptance criteria and performance are based on mechanical testing to demonstrate substantial equivalence to previously cleared predicate devices, rather than AI or software performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and reported values. Instead, it states that the device was tested against recognized ASTM standards, and its performance met the acceptance criteria of these standards.

Note: The document states, "Performance equivalence demonstrated that the subject device met the acceptance criteria of the standards and is substantially equivalent to the predicate devices." This indicates that the established acceptance criteria were the thresholds defined by the respective ASTM standards for intervertebral body fusion devices.

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

The document refers to "mechanical performance testing" and "worst-case analysis and resulting worst-case configuration mechanical testing." It doesn't specify a precise numerical sample size for the physical devices tested (e.g., "N units were tested"). However, typically, mechanical performance testing of medical implants involves a statistically sufficient number of samples to ensure robust results, often following specific sample size recommendations within the testing standards.

• Test Set Sample Size: Not explicitly stated as a number of devices (e.g., "10 units"). However, "worst-case configuration mechanical testing" implies selected configurations representative of the most challenging conditions.
• Data Provenance: The data is generated from in-vitro (laboratory) mechanical testing of the manufactured device. It is not patient or clinical data. No country of origin for data or retrospective/prospective status is applicable as it's not a clinical study.

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

This question is not applicable for this type of device clearance. Ground truth, in the context of AI/software, refers to human expert annotations or pathological diagnoses. For mechanical devices, "ground truth" is defined by the performance requirements of the relevant engineering standards (e.g., ASTM F2077, ASTM F2267, ASTM F3001). The "experts" in this context would be the engineers and technicians performing the tests and validating the results against the standard requirements.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in human expert annotations for AI ground truth. For mechanical testing, the results are quantitative measurements against predefined thresholds in the standards.

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

No, a MRMC study was NOT done. MRMC studies are specific to evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical implant, not a diagnostic AI tool.

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

This question is not applicable. This device is not an algorithm. The "standalone" performance here refers to the device's mechanical integrity on its own without human interaction during the test (other than setting up the test). The mechanical tests performed (static/dynamic compression, shear, subsidence) are essentially "standalone" evaluations of the device's physical properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance validation is defined by the acceptance criteria specified in the relevant ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices and titanium alloys. These standards define the mechanical properties and performance thresholds that the device must meet.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical implant, not an AI model, so there is no "training set."

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

This question is not applicable as there is no training set for a physical medical device.

Ask a specific question about this device

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.

Ask a specific question about this device

The sagAlign Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

sagAlign Lumbar Cage implants are to be used with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open posterior approach. saqAlian Lumbar Cage implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The sagAlign Lumbar Cage System is an interbody expandable lumbar cage. It is implanted by a posterior approach and supported by posterior fixation which is required to achieve fusion. The lumbar cages can be gradually expanded to reach the height chosen by the surgeon, allowing restoration of disc height and the ideal lordosis.

The sagAlign Lumbar Cages are delivered non-sterile packaged. The cages are available in several sizes in different heights, widths, and lengths. One or two cages may be implanted for each treated level. The sagAlign Lumbar Cages will be composed of titanium alloy and may have a surface treating of Promimic HAnano Surface (hydroxyapatite (HA) coating). The Promimic HAnano Surface coated cages are only available sterile.

Reusable instruments to support implantation of the subject device are provided with non-sterilization trays.

This document is a 510(k) premarket notification for a medical device called the "sagAlign Lumbar Cage System." It is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than an AI/ML powered device that would typically have the detailed types of studies you are asking for.

Therefore, the information you requested regarding acceptance criteria, study details for an AI/ML device, and performance metrics like sensitivity, specificity, or MRMC studies for AI assistance, is not present in this document.

This document describes a spinal implant (intervertebral body fusion device) and focuses on the following to demonstrate substantial equivalence:

• Indications for Use Comparison: Showing the new device has similar indications to existing ones.
• Technological Comparison: Detailing how the design, materials, surgical approach, and mechanisms are similar to predicate devices.
• Non-Clinical Tests Summary & Conclusions: This section mentions mechanical testing (static compression, static compression-shear, dynamic compression-shear, and subsidence testing) performed according to ASTM standards (ASTM F2077, ASTM F2267). These tests are to ensure the mechanical strength and fatigue endurance of the lumbar cage are comparable to predicate devices.

In summary, as this document pertains to a physical medical implant and not an AI-powered diagnostic or assistive tool, it does not include the detailed AI/ML study information you are asking for (e.g., sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance, or specific AI acceptance criteria).

Ask a specific question about this device

The Align Cervical Interbody Fusion is 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. The Align Cervical Interbody Fusion System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, 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. The Align Cervical Interbody Fusion is intended to be used with supplemental spinal fixation system cleared for use in the cervical spine.

The Align Cervical Interbody Fusion System consists of intervertebral body fusion devices that are implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. Align cervical cages will be manufactured from titanium alloy per ASTM F3001 and will be offered with an optional hydroxyapatite (HA) coating. Implants will be provided sterile by gamma irradiation.

The provided text is a 510(k) summary for the "Align Cervical Interbody Fusion System," a medical device, and not an AI/ML device. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML device.

The document discusses:

• Device Type: Intervertebral body fusion device
• Regulatory Classification: Class II
• Intended Use: Intervertebral body fusion of the cervical spine for degenerative disc disease.
• Materials: Titanium alloy with optional hydroxyapatite (HA) coating.
• Performance Testing: Confirmatory fatigue testing (dynamic compression shear, and dynamic torsion per ASTM F2077) – this is mechanical testing for an implant, not AI/ML performance.
• Substantial Equivalence: Comparison to predicate devices based on indications for use, materials, and geometry.

There is no mention of:

• Acceptance criteria for an AI/ML algorithm.
• Performance metrics like sensitivity, specificity, AUC, etc.
• Sample sizes for test or training sets related to AI/ML data.
• Experts establishing ground truth for AI/ML.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI assistance.
• Standalone algorithm performance.
• Provenance of data (country, retrospective/prospective).
• Ground truth methods (pathology, outcomes data).

Therefore, I cannot populate the requested table or answer the questions related to AI/ML device acceptance criteria and study details based on the provided text.

Ask a specific question about this device

Align 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. Align anterior cages are intended for use at ether 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 radios. Align 2-screw anterior cages may be used as a stand alone device only when two (2) vertebral body bone screws are used. Align 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 superior screw trajectory. If the physician chooses to use Align 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 spinal fixation system cleared for use in the lumbosacral spine must be used.

Align 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. Align 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. Align anterolateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Align 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. Align lateral cages are intended for use at either one level 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. Align lateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Align implants are 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 (OLIF), or a lateral lumbar interbody fusion surgical approach (LLIF). The devices are intended to improve stability of the spine while supporting fusion. The Align constructs are intended for use at one or two contiguous levels in the lumbar spine (L2-S1). Components are offered in different shapes and sizes to meet the requirements of the individual patient's anatomy and are provided sterile. Align devices are available in six configurations: modular constructs, standard constructs, fully round ALIF (FRA) constructs, and open constructs for ALIF approach, anterolateral (i.e., oblique) constructs for OLIF approach, and lateral constructs for LLIF approach. Align 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 Alulminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. The bone screws 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 constructs are zero profile, reducing potential for vessel interference with the anterior column. With the exception of the modular constructs, all cages and bone screws are also available with a hydroxyapatite coating.

The provided text is related to a 510(k) premarket notification for a medical device called "Align" by Acuity Surgical Devices, LLC. It describes the device, its indications for use, and a comparison to a predicate device. However, it explicitly states that no clinical data was provided to demonstrate substantial equivalence. This means there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study is not part of this 510(k submission. The submission relies on non-clinical testing and substantial equivalence to a predicate device and reference devices to demonstrate safety and effectiveness.

Here’s what I can extract based on the document:

1. A table of acceptance criteria and the reported device performance:
Not applicable as no clinical acceptance criteria or performance study results are provided. The submission focuses on demonstrating substantial equivalence through non-clinical testing.

2. Sample size used for the test set and the data provenance:
Not applicable as no clinical study with a test set is described. Non-clinical testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical study requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical study with adjudication is 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:
Not applicable. The device is an intervertebral body fusion device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable as no clinical study requiring a ground truth is described.

8. The sample size for the training set:
Not applicable as no clinical study or AI model with a training set is described.

9. How the ground truth for the training set was established:
Not applicable as no clinical study or AI model with a training set and ground truth establishment is described.

Summary of Non-Clinical Testing (as provided in the document):

The device's substantial equivalence is supported by non-clinical testing, which includes:

• Performance testing per ASTM F2077 for Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, and Dynamic Compression Shear.
• Performance testing per ASTM F2267 for Subsidence and Expulsion testing.
  • Note: These tests performed on the predicate device (K201671) are deemed applicable to the modified devices because there is no difference in size, dimension, raw material, or manufacturing method/equipment, except for a nanometer-thin layer of hydroxyapatite applied to the surface.
• Performance testing of HA®® Surface integrity was conducted per the Promimic protocol, which was accepted by FDA for the clearance of reference devices K201614, K170392, and K101225.
• Performance testing of the break-off cover plate screw per the protocol accepted by FDA for the clearance of the reference device K130958.

The document concludes that these non-clinical tests indicate that "Align" is substantially equivalent to the predicate and reference devices.

Ask a specific question about this device

The Align Lumbar Interbody Fusion System is 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 with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Align Lumbar Interbody Fusion System is 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 radios.

The Align Lumbar Interbody Fusion System is intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

The Align Lumbar Interbody Fusion System consists of several models of intervertebral body fusion devices. The Align ALIF unitary cages and Align fully round ALIF (FRA) cages are intended for anterior approaches. The Align AOLIF cages are intended for anterolateral approaches. The Align Lateral cages are intended for lateral approaches. The Align TLIF cages and Align Oblique TLIF cages are intended for transforaminal approaches. The Align PLIF cages are intended for posterior approaches.

Align Lumbar Interbody Fusion System devices are made from titanium alloy (Ti-6A1-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. Align Lumbar Interbody Fusion System devices are also made from polyetheretherketone (Zeniva ZA-500 PEEK®) per ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. The PEEK devices contain radiopaque markers constructed from Tantalum per ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications to assist with intraoperative placement. The radiopaque markers are positioned so the implant can be visualized from an Anterior-Posterior (AP) and Lateral x-ray view.

Reusable instruments to support implantation of the subject device are provided with non-sterile implants in sterilization trays. Implants are also available sterile packaged.

This document is a 510(k) premarket notification for a medical device, the "Align Lumbar Interbody Fusion System." Within this specific type of regulatory submission to the FDA, detailed information regarding acceptance criteria and the study that proves the device meets those criteria, especially in the context of AI/ML performance, is generally not present.

The 510(k) pathway focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, primarily through non-clinical testing (bench testing, biocompatibility) and comparisons of technological characteristics. Clinical data is often not required for 510(k) submissions unless the device has new indications for use, different technological characteristics that raise new safety or effectiveness questions, or if the predicate device itself required clinical data.

Based on the provided document, I can primarily address the information regarding non-clinical testing acceptance criteria and studies. The questions related to AI/ML specific performance, such as MRMC studies, expert ground truth adjudication, and training/test set details, are not applicable to this specific submission as there is no mention of AI/ML components in the "Align Lumbar Interbody Fusion System."

Here's an analysis of what is available in the document regarding acceptance criteria and studies:

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

The document broadly states that the device met acceptance criteria, especially for bench testing. However, it does not provide a specific table detailing numerical acceptance criteria and corresponding reported performance values. This level of detail is typically found in the full submission, not in the publicly available 510(k) summary.

2. Sample size used for the test set and the data provenance:

• Test Set (for physical device testing): Not explicitly stated in terms of a "sample size" like one would for a clinical study. For bench testing, typically a certain number of samples per configuration are tested (e.g., 6 or 12 per test type). This detail is not provided in a summary.
• Data Provenance: The studies are laboratory-based bench tests and biocompatibility tests, not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

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: This submission relies on engineering and material science standards (ASTM, ISO), not expert clinical reviews for "ground truth". The "ground truth" for these tests is generally defined by the parameters and methodologies outlined in the referenced standards.

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

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for imaging interpretation, to resolve discrepancies between readers. This is not relevant for bench testing.

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: The document states, "No clinical data was provided to demonstrate substantial equivalence." This implies no human reader studies of any kind were performed for this submission, negating the possibility of an MRMC study related to AI assistance.

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

• Not Applicable: This device is an implantable medical device (intervertebral body fusion system), not a software algorithm or AI-powered system. No standalone algorithm performance was assessed.

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

• Bench Testing Standards & Specifications: For the non-clinical tests, the "ground truth" is adherence to the specified engineering standards (e.g., ASTM F2077, ASTM F2267) and biocompatibility standards (ISO 10993 series), and comparison to the performance of the predicate device. The goal is to show that the device performs mechanically as intended and is biocompatible, similar to existing devices.

8. The sample size for the training set:

• Not Applicable: As this is a physical medical device and not an AI/ML system, there is no "training set."

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

• Not Applicable: No training set exists for this device.

In summary: The provided document describes a 510(k) submission for a physical implantable device. The "acceptance criteria" and "proof" primarily stem from meeting established international and national standards for biocompatibility and mechanical performance, and demonstrating equivalence to predicate devices through laboratory bench testing. The questions related to AI/ML performance, clinical studies, and expert ground truth are not applicable to the information contained within this specific 510(k) summary.

Ask a specific question about this device

A-Link Z 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. A-Link Z 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. A-Link Z 2-screw anterior cages may be used as a stand alone device only when two (2) vertebral body bone screws are used. A-Link Z 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 A-Link Z 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.

A-Link Z 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. A-Link Z 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. A-Link Z anterolateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

A-Link Z 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. A-Link Z 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. A-Link Z lateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

A-Link Z consists of six models of intervertebral body fusion devices intended for anterior, anterolateral, or lateral lumbar interbody fusion. The A-Link Z Modular Cages, A-Link Z Standard Cages, A-Link Z FRA Cages, and A-Link Z Open Cages are intended for anterior approach. A-Link Z AL Cages are intended for anterolateral approach. A-Link Z Lateral Cages are intended for lateral approach. The devices are intended to improve stability of the spine while supporting fusion. The A-Link Z constructs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. A-Link Z devices 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 and ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI 5Extra Low Interstitial) with Powder Bed Fusion, and an optional interbody component composed of polyetheretherketone (PEEK) per ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications with tantalum markers per ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

This FDA 510(k) summary (K201671) describes a spinal intervertebral body fusion device (A-Link Z), not an AI-powered medical device. Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details for AI performance, sample sizes for training/test sets, expert adjudication, MRMC studies, or ground truth establishment for an AI algorithm.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (biocompatibility and mechanical performance testing), as is typical for traditional medical device clearances under the 510(k) pathway. There is no mention of an algorithm, image analysis, or any form of AI component.

Therefore, I cannot provide the requested table and study details as the input document does not pertain to an AI device.

Ask a specific question about this device