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PISCES™-SA ALIF Spacers (Standalone Use, With Integrated Fixation)

The PISCES™ SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

PISCES™-SA Used with Screws and/or Anchors:

When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation.

When used with three (3) screws, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation.

Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels.

PISCES™ ALIF Spacers (Without Integrated Fixation)

PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>= 20 lordosis) must be used with at least anterior supplemental fixation.

PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws and/or anchors, these devices are standalone interbody fusion devices. The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior plate, posterior pedicle screws) may be needed. When used without screws and/or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES™ SA interbodies are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.

The provided text is related to a 510(k) premarket notification for a medical device called the "PISCES™-SA STANDALONE ALIF Interbody System". This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML device evaluations. As such, many of the requested elements (like sample size for test sets, data provenance, ground truth establishment, expert qualifications, MRMC studies, standalone performance for AI, and training set details) are not applicable or available in this document because it describes a traditional hardware medical device clearance, not an AI/ML software device.

However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose to meeting acceptance criteria for this type of device.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that would be directly comparable to the reported device performance in the way you might expect for an AI/ML model. Instead, it refers to a battery of non-clinical mechanical tests and cadaveric studies. The "reported device performance" is implicitly that the device performs equivalently to the predicate and meets the requirements of the standards cited.

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

• Sample Size for Test Set: Not explicitly stated for each test. For cadaveric studies, the sample size (number of cadavers or specimens) is not provided. For mechanical tests, the number of samples tested is not given but would typically follow the requirements of the ASTM standards or internal protocols.
• Data Provenance: The cadaveric studies originate from cadaveric specimens. Mechanical testing data comes from laboratory experiments. There is no mention of country of origin or whether the data is retrospective or prospective, as this is typically not relevant for this type of non-clinical device testing.

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

• Ground truth as typically understood for AI/ML (e.g., expert consensus) is not applicable here. The "ground truth" for this device comes from the physical and mechanical properties measured in the laboratory and cadaveric settings, compared against established standards (like ASTM) and the performance of a predicate device.

4. Adjudication method for the test set

• Adjudication methods like 2+1 or 3+1 are not applicable for this type of non-clinical testing. Performance is determined by direct physical measurement and comparison to predefined acceptance criteria within engineering and anatomical studies.

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

• A Multi Reader Multi Case (MRMC) comparative effectiveness study is not applicable as this is a physical interbody fusion device, not an AI-powered diagnostic or assistive tool for human readers.

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

• "Standalone performance" in the context of an algorithm is not applicable. This is a physical implant, not an algorithm. Its performance is inherent to its design and material properties.

7. The type of ground truth used

• The "ground truth" for justifying substantial equivalence is based on engineering standards (ASTM F2077, ASTM F2267) and direct experimental measurements (mechanical tests, cadaveric studies) demonstrating that the device performs functionally and safely in a manner equivalent to its predicate device. This is a form of empirical ground truth based on physical and biomechanical properties, rather than expert consensus or pathology reports.

8. The sample size for the training set

• A "training set" as defined for AI/ML models is not applicable. This device is a physical product, not a software algorithm that undergoes a training phase.

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

• As a training set is not applicable, the method of establishing its ground truth is also not applicable.

In conclusion, this FDA 510(k) clearance document is for a traditional medical device (an interbody fusion system). The "acceptance criteria" and "study" described are primarily non-clinical evaluations to confirm the device's mechanical and functional equivalence to a legally marketed predicate device, rather than a clinical trial or AI/ML performance study.

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The Black Diamond™ POCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (Cl to C7) and the upper thoracic spine (TI-T3); traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin, as confirmed by radiographic studies, and degenerative disease with instability. The Black Diamond™ POCT Spinal System is also intended to restore the integrity of the spinal column even in the absences of fusion for a limited time period in patients with advanced stage tumors in whom if e expectancy is of insufficient duration to permit achievement of fusion. To achieve additional levels offixation, the Black Diamond™ POCT Spinal System may be comected to the Osseus Black Diamond™ Pedicle Screw System using transition rods or anatomically-bent rods.

The Black Diamond™ POCT Spinal System is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and upper thoracic spine. The Black Diamond™ system contains rods in multiple shapes and sizes, polyaxial screws, set screws, rod connectors and transverse connectors. Connecting components can be locked to the rod in various configurations to accommodate individual patient anatomy.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Black Diamond™ POCT Spinal System," which is a posterior cervical screw system.

It discusses:

• The FDA's review and determination of substantial equivalence to predicate devices.
• The device's indications for use.
• A summary of its technological characteristics.
• Non-clinical testing performed (mechanical testing per ASTM F1717).

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, or ground truth establishment for software/AI performance evaluation.
• Information on expert panels, adjudication methods, or multi-reader multi-case studies, as these are typically applicable to diagnostic imaging or AI/ML-based medical devices, not to mechanical spinal implants.
• Information about a standalone (algorithm only) performance study.
• Ground truth types for software performance.
• Training set sample sizes or how training set ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

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PISCESTM-SA ALIF Spacers (Standalone Use. With Integrated Fixation)

The PISCES™ SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

· PISCESTM-SA Used With Screws:

When used with three (3) screws, interbody devices with a lordotic angle 20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.

· PISCESTM_SA Used With Anchors

When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation.

PISCESTM ALIF Spacers (Without Integrated Fixation)

PISCESTM ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudatthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (200 lordosis) must be used with at least anterior supplemental fixation.

PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are standalone interbody fusion devices. When used with anchors or without screws, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES" -SA interbodies are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, anchors, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.

The provided text does not contain information about specific acceptance criteria, study details, or performance results from a clinical or analytical study. The document is primarily a 510(k) submission summary for a medical device (PISCES™-SA Standalone ALIF Interbody System), demonstrating substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies. The text explicitly states "Substantial equivalence is supported by the results of mechanical testing," and "Substantial equivalence is also supported by performing cadaveric implantation and cadaveric Range of Motion (ROM) studies." This indicates that the safety and effectiveness determination for this device was based on non-clinical data rather than human clinical trials.

The information I can extract about the testing performed is:

Non-clinical Testing Performed:

• Static and dynamic compression per ASTM F2077
• Static and dynamic compression shear per ASTM F2077
• Subsidence per ASTM F2267
• Expulsion testing
• Cantilever anchor bending
• Anchor impaction testing
• Cadaveric implantation
• Cadaveric Range of Motion (ROM) studies

Since the request asks for details that are typically associated with clinical or analytical studies involving human data or expert review for AI/ML devices, and this document pertains to a spinal implant cleared through substantial equivalence based on non-clinical data, the majority of the requested fields cannot be filled.

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The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Blue Topaz Sacroiliac Screw System consists of cannulated, fully threaded screws intended to facilitate fusion of the sacroiliac joint. The Blue Topaz Sacroiliac Screw System is fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Blue Topaz System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.

The provided document is a 510(k) summary for the "Blue Topaz Sacroiliac Screw System" which is a medical device. It does not describe an AI/ML powered device, nor does it contain information about clinical studies with human readers or AI-assistance. Therefore, I cannot provide details on most of the requested points, as they are specific to AI/ML device evaluations.

However, I can extract information related to the device's performance data based on non-clinical testing.

Here's what can be extracted from the provided text:

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

The document mentions that the device was tested to demonstrate its strength for its intended use and substantial equivalence to predicate devices. However, specific numerical acceptance criteria and reported performance values are not explicitly stated in the provided text. It only lists the types of tests performed.

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

This information is not applicable as the document describes non-clinical mechanical testing of a physical medical device, not a study involving a test set of data or human subjects.

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 information is not applicable as the document describes non-clinical mechanical testing of a physical medical device. Ground truth, in the context of expert review, is not relevant for this type of evaluation.

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

This information is not applicable as the document describes non-clinical mechanical testing of a physical medical device. Adjudication methods are typically used in clinical studies or expert reviews.

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 information is not applicable as the document describes a physical medical device (sacroiliac screw system) and its non-clinical mechanical testing. There is no mention of AI assistance or human readers.

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

This information is not applicable as the document describes a physical medical device and its mechanical performance, not an algorithm or AI system.

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

This information is not applicable as the document describes non-clinical mechanical testing. The "ground truth" for mechanical performance would be the direct measurement outcomes from the specified ASTM standards.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device and its non-clinical mechanical testing. There is no training set involved.

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

This information is not applicable as the document describes a physical medical device and its non-clinical mechanical testing. There is no training set or ground truth in that context.

Summary of available information regarding the device itself (not AI/ML related):

The Blue Topaz Sacroiliac Screw System underwent the following non-clinical (mechanical) tests:

• Static and Dynamic Cantilever Bending per ASTM F2193
• Driving Torque per ASTM F543
• Static Torsion per ASTM F543
• Pullout per ASTM F543

The conclusion from this testing was that the device's strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

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The Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Black Diamond Navigation Instruments are non-sterile, reusable instruments; including probes, bone taps, and inserters that are operated manually. These instruments are intended to be used within the context and limitations of the indications for use for Osseus Fusion System's FDA-cleared Black Diamond system and the Medtronic Synergy Experience StealthStation System S7 (v2.1.0). Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.

The Black Diamond Navigation Instruments are non-sterile, reusable instruments (probes, bone taps, and inserters) intended for use during the preparation and placement of Black Diamond pedicle screws in spinal surgery. The device aims to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures, specifically designed for use with the Medtronic Stealth Station System.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a table format. It mentions that "nonclinical testing was performed to show that the subject Black Diamond Navigation Instruments are substantially equivalent to the predicate device" and lists the types of testing: Accuracy testing, Compatibility testing, and Performance testing. It concludes that "The results of these evaluations indicate that the Black Diamond Navigation Instruments are equivalent to predicate devices."

Without specific numerical thresholds or performance metrics for acceptance, a table cannot be fully constructed.

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

The document states: "Nonclinical testing was performed to show that the subject Black Diamond Navigation Instruments are substantially equivalent to the predicate device." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The testing mentioned is non-clinical, suggesting that expert human assessment in a clinical context for ground truth may not have been the primary method.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set.

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

The document explicitly states: "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted.

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

The device is a set of "Navigation Instruments" used with the Medtronic Stealth Station System. This implies it's a tool for surgeons, not a standalone AI algorithm. The document mentions "Accuracy testing" and "Performance testing" among the non-clinical tests. While these tests evaluate the device's inherent capabilities (e.g., how accurately it tracks, how it performs mechanically), they are likely evaluating the instrument's standalone performance within the context of the navigation system, rather than an AI algorithm's standalone performance. The text does not explicitly refer to an "algorithm only" standalone performance study.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the non-clinical testing. Given that the device is a navigation instrument for surgery, "Accuracy testing" would likely compare the instrument's reported position/orientation against a known, precise physical reference (e.g., measured by a coordinate measuring machine or similar highly accurate metrology equipment). Such a ground truth would be objective, physical measurements rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This further supports the interpretation that the device is a physical instrument rather than a machine learning algorithm that undergoes a training phase.

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

Since no training set is mentioned (as the device is not an AI algorithm requiring one in the traditional sense), this information is not applicable and not provided.

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The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intent patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and cross links. All the components are available in a variety of sizes to match more closely the patient's anatomy

The provided text describes a 510(k) premarket notification for a medical device called the "Black Diamond Pedicle Screw System." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, primarily through non-clinical mechanical testing, rather than a clinical study involving human patients or complex AI algorithms. Therefore, much of the information requested about acceptance criteria for AI/ML performance, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this specific submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" presented in this submission are not expressed as specific performance metrics and thresholds (e.g., accuracy > X%, AUC > Y%) typical for AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various comparisons, primarily mechanical testing.

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

• Test Set Sample Size: Not applicable in the context of human data or image data for AI/ML. The "test set" here refers to the Black Diamond Pedicle Screw System components themselves undergoing non-clinical mechanical testing. The specific number of physical components tested is not detailed, but standard mechanical testing involves multiple samples to ensure statistical validity.
• Data Provenance: Not applicable in the context of human data. The "data" comes from mechanical testing of the device components.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not human expert interpretation.

4. Adjudication Method:

Not applicable.

5. MRMC Comparative Effectiveness Study:

Not applicable. No clinical studies involving human readers or AI assistance were performed.

6. Standalone Performance Study:

Not applicable. This is a physical medical device, not an AI algorithm. The performance evaluation is based on mechanical testing of the device itself.

7. Type of Ground Truth Used:

Ground truth for this submission is based on engineering standards and direct physical measurements derived from non-clinical mechanical testing (e.g., static and dynamic compression per ASTM F1717, static torsion per ASTM F1717).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model and does not have a "training set" in that context.

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

Not applicable.

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The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are interbody fusion devices intended 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 to 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 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Aries® Lumbar Interbodies are interbody fusion devices used to provide structural stability in skeletally mature patients. The implants were developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The system is comprised of interbodies of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients and multiple surgical approaches. Each interbody has an axial hole to allow grafting material to be placed inside of the interbody. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

This document describes Aries® Lumbar Interbodies, an intervertebral body fusion device, and its acceptance criteria for FDA clearance.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not include information on sample size for a test set or data provenance for any clinical studies. It explicitly states, "No clinical studies were performed." The testing conducted was non-clinical (mechanical and pyrogenicity).

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

This information is not applicable as no clinical studies were performed, and thus no expert-established ground truth for a test set was required in this submission. The "ground truth" for the non-clinical tests was established through adherence to recognized ASTM standards.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical studies requiring human adjudication were performed.

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. The submission explicitly states "No clinical studies were performed."

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

This information is not applicable. The device is an intervertebral body fusion device, which is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was based on established industry standards and specifications (ASTM F2077, ASTM F2267, ASTM F3001, and pyrogenicity limits). The goal was to demonstrate equivalence to predicate devices, meaning the device performed within the acceptable parameters defined by these standards, similar to already cleared devices.

8. The Sample Size for the Training Set

This information is not applicable as there was no algorithm or AI component requiring a training set. The device is a physical medical implant.

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

This information is not applicable as there was no algorithm or AI component requiring a training set or its associated ground truth.

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The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

The Osseus Fusion Systems' Gemini-C Hybrid Cervical Interbody System is used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. This system includes three design configurations: 1) PEEK, 2) Titanium alloy (Ti-6Al-4V ELI), and 3) Hybrid PEEK/Titanium alloy. The implants are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of bone graft.

This document is a 510(k) premarket notification for a medical device and therefore describes a medical device (intervertebral body fusion device) rather than an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of mechanical and material performance standards and non-clinical testing, rather than AI/ML performance metrics, ground truth, or reader studies.

Here's an analysis based on the provided document, addressing the closest equivalents to your prompts for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices through a series of standardized non-clinical mechanical tests. The performance is deemed acceptable if the device meets or exceeds the requirements of these ASTM standards, indicating similar mechanical safety and performance to the legally marketed predicate devices.

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: Not explicitly stated in terms of the number of device units tested. For mechanical testing, samples are typically device prototypes or finished products. ASTM standards dictate the number of samples required for each test.
• Data Provenance: The document does not specify the country of origin of the data beyond the fact that the testing was conducted for a device seeking approval in the United States. The testing is prospective in the sense that physical devices were manufactured and subjected to controlled laboratory tests, rather than analyzing historical patient data.

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

This question is not applicable to a non-AI/ML medical device. Ground truth, in the context of device performance, is established by adherence to engineering principles, material science, and the relevant ASTM (American Society for Testing and Materials) standards. The "experts" would be the engineers and technicians skilled in conducting the mechanical tests and interpreting the results according to the specified standards.

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

Not applicable. Mechanical testing involves quantitative measurements against defined standards, not subjective interpretations requiring adjudication among human observers.

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 is a traditional medical device, not an AI-powered diagnostic or assistive tool. No human reader studies were conducted or are relevant to its approval.

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

Not applicable. This is a physical intervertebral body fusion device, not an algorithm.

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

The "ground truth" for this device's performance is established by validated mechanical testing standards (ASTM standards). These standards define the expected physical properties and responses of materials and devices under simulated conditions relevant to their intended use. For example, the "ground truth" for compression strength is the maximum force the device can withstand before failure, measured according to ASTM F2077.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable.

Summary of Relevant Information from the Document:

The provided document describes the Gemini-C Hybrid Cervical Interbody System, an intervertebral body fusion device.

• Acceptance Criteria for Device Type: Substantial equivalence to predicate devices regarding intended use, design, materials, mechanical safety, and performance, demonstrated through non-clinical testing.
• Study Proving Acceptance: A series of non-clinical, mechanical tests were conducted per established ASTM standards:
  • Static and dynamic compression (ASTM F2077)
  • Static and dynamic compression shear (ASTM F2077)
  • Static and dynamic torsion (ASTM F2077)
  • Subsidence (ASTM F2267)
  • Expulsion testing (ASTM Draft Standard F-04.25.02.02)
• Conclusion: The results of these evaluations indicated that the Gemini-C Hybrid Cervical Interbody System is equivalent to predicate devices, thus meeting the acceptance criteria for market clearance.
• Clinical Studies: "No clinical studies were performed." This is common for 510(k) devices when substantial equivalence can be demonstrated through non-clinical means.

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The White Pearl Preferred Angle Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis

The White Pearl Preferred Angle Anterior Cervical Plate consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6Al-4V ELI). The White Pearl Preferred Angle Anterior Cervical Plate is intended to provide stabilization of the cervical vertebrae for various indications. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screws using an anterior approach. Bone screws are available for fixed angle or variable angle implantation. The White Pearl Preferred Angle Anterior Cervical Plate is intended to be removed after solid fusion has occurred.

This document is a 510(k) Pre-Market Notification for a medical device called the "White Pearl Preferred Angle Anterior Cervical Plate." It outlines the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Acceptance Criteria and Reported Device Performance

This document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance acceptance criteria for a novel device with clinical endpoints like sensitivity or specificity. Instead, the acceptance criteria are based on mechanical performance standards to demonstrate that the new device performs as safely and effectively as existing, legally marketed devices.

Study Details:

The provided document describes non-clinical testing to support the substantial equivalence claim.

1. Sample Size used for the test set and the data provenance:

   • The document does not specify the sample size (number of constructs or units) used for the mechanical "test set." It only mentions the types of tests performed.
   • Data provenance is not explicitly stated in terms of country of origin. The tests are described as non-clinical (laboratory-based mechanical testing), not involving patient data.

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

   • This question is not applicable to this type of submission. Mechanical testing of a medical device does not typically involve expert review to establish "ground truth" in the way clinical studies or diagnostic AI algorithms do. The "ground truth" for mechanical testing is defined by the physical loads and deformation measurements under established ASTM standards (ASTM F1717).

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used in clinical studies or for diagnostic image interpretation where there's variability in expert opinion. For mechanical testing, the results are quantitative measurements against predefined standards.

4. 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 MRMC comparative effectiveness study was done. This document is for a spinal implant, which is a physical medical device, not a diagnostic imaging AI algorithm. Therefore, "human readers" and "AI assistance" are irrelevant in this context.

5. 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.

6. The type of ground truth used:

   • For the non-clinical mechanical testing, the "ground truth" is established by the definitions and requirements of the ASTM F1717 standard for static and dynamic compression and static torsion testing. This standard specifies how to conduct the tests and how to measure the mechanical properties of the device.

7. The sample size for the training set:

   • Not applicable. This document describes the testing of a physical medical device. There is no concept of a "training set" as would be used for machine learning.

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

   • Not applicable, as there is no training set for this type of device submission.

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The Osseus Black Diamond Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

This is a 510(k) summary for a spinal implant system and as such, it does not involve AI/ML device performance testing. The 'acceptance criteria' and 'device performance' in this context refer to mechanical and material performance rather than diagnostic accuracy or classification metrics.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The results of this testing indicate that the Osseus Black Diamond Pedicle Screw System is equivalent to predicate devices." This implies that the device met the performance standards established by the predicate devices through these ASTM tests. The specific numerical acceptance criteria (e.g., maximum load, fatigue life) are not detailed in this summary document but would have been part of the full submission.

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

Given this is a mechanical engineering test of a physical device, not an AI/ML system:

• Sample Size for Test Set: The document does not specify the exact number of units or replicates tested for each static and dynamic test. These would typically be defined by the ASTM F1717 standard and the test protocol.
• Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting on manufactured devices, not on human patients or data derived from them. The data is generated from physical mechanical testing.

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

• This question is not applicable to this type of device submission. Ground truth, in the context of device performance described here, is established by adherence to ASTM standards for mechanical testing, not by expert interpretation of data or images.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical tests according to ASTM standards do not involve adjudication by multiple experts in the same way clinical or AI/ML studies do. The results are quantitative measurements against predefined engineering specifications.

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. This type of study is relevant to diagnostic imaging devices or AI systems where human readers interpret medical images. This submission is for a physical orthopedic implant.
• Effect Size: Not applicable as no such study was performed.

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

• This question is not applicable. This device is a physical pedicle screw system, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering standards and specifications (specifically ASTM F136 for materials and ASTM F1717 for mechanical performance). The device's performance is compared against the known performance of legally marketed predicate devices through these standardized mechanical tests.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a pedicle screw system's mechanical testing. This concept applies to AI/ML devices.

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

• This question is not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided 510(k) summary describes a traditional medical device (a spinal implant) and its non-clinical mechanical testing, not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of the questions related to AI/ML study design, readers, and ground truth are not relevant to this specific document. The "study" referenced is a series of mechanical tests to demonstrate substantial equivalence to predicate devices.

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