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The Ion Facet Screw System is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:
• Spondylolisthesis

• · Spondylolysis
  · Pseudoarthrosis or failed previous fusions which are symptomatic
  · Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
  The system is intended for use with bone graft material.

The Ion Facet Screw System contains various sized facet screws for bilateral stabilization of the facet joints from levels C2 through S1, inclusive. The system is supplied with various orthopedic instruments that assist the user in implanting a titanium facet screw into the facets to fixate the facet joint. There are various facet screw sizes available for implanting to accommodate a range of facet joint sizes and geometries.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Ion Facet Screw System. This document clears the device for market based on substantial equivalence to existing predicate devices.

**Crucially, this document does not contain information about acceptance criteria for device performance studies or the studies themselves for a new device. Instead, it demonstrates substantial equivalence to previously cleared devices through non-clinical performance data and a comparison of technological characteristics. **

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies in the way you might expect for a novel device undergoing clinical trials or rigorous standalone algorithm evaluation.

Here's what I can extract based on the provided text, and where I must state that the information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) clearance. The document asserts substantial equivalence based on a comparison to predicate devices, rather than establishing new acceptance criteria for a novel device's clinical performance. The "performance data" listed are for non-clinical aspects.

Note: These are non-clinical performance data points demonstrating the device's fundamental characteristics and safety, not clinical efficacy or diagnostic accuracy.

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

Not provided. This document does not describe a clinical test set in the traditional sense for evaluating device performance against a ground truth. The "test set" here refers to the materials and conditions used in the non-clinical tests listed above.

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

Not provided. This information would be relevant for studies involving expert consensus on medical image interpretation or clinical outcomes, which is not the type of study described in this 510(k) clearance document.

4. Adjudication Method

Not provided. Adjudication methods are typically used when multiple experts review cases to establish a ground truth, which is not applicable to the non-clinical tests mentioned.

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

Not performed/Not applicable. The document focuses on demonstrating substantial equivalence to predicate devices, not on showing human readers improve with AI assistance. The Ion Facet Screw System is a physical medical device, not an AI or diagnostic software.

6. Standalone Performance Study (Algorithm Only)

Not performed/Not applicable. As a physical medical device (facet screws), there is no 'algorithm-only' standalone performance study.

7. Type of Ground Truth Used

For the non-clinical performance data:

• Biocompatibility: Reference standards from ISO 10993-1.
• Sterilization: Reference standards from ISO 17665-1.
• Mechanical Testing: Reference standards from ASTM F543, ASTM F1264, and ASTM F2193.
• V/V Mechanical and Safety Testing: Implied internal company safety and mechanical specifications.

There is no clinical ground truth established or used in this document for the device's efficacy, as this is a 510(k) clearance for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set of data.

9. How Ground Truth for the Training Set Was Established

Not applicable. (See point 8).

Summary Explanation:

The provided document, an FDA 510(k) clearance letter, states that the Ion Facet Screw System is "substantially equivalent" to legally marketed predicate devices. This means that new clinical studies demonstrating the device's performance against specific acceptance criteria (as you might expect for a novel drug or a truly new device with an unknown risk profile) were not required or performed for this clearance. Instead, the manufacturer provided non-clinical performance data (biocompatibility, sterilization, mechanical testing) and compared the technological characteristics and indications for use to existing, cleared devices. The FDA then determined that these comparisons sufficiently demonstrate that the new device is as safe and effective as the predicate devices.

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The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic. Jumbar, and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the following instabilities or deformities:

• Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

• • Spinal Stenosis (indicated for L1-S1 only);
• • Spondylolisthesis;
• • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• • Trauma (i.e., fracture, dislocation, or subluxation);
• • Spondylolysis;
• • Tumor;
• • Pseudoarthrosis: and/or
• • Failed previous fusion

The Epic Anterior Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.

The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laninoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following:

• • Pseudoarthrosis and failed previous fusions;
• • Spondylolisthesis;
• • Spondylolysis;

• Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;

• • Degeneration of the facets with instability and;
• • Trauma including spinal fractures and/or dislocations.

The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.

The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/illum) pedicle and nonpedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Alpine XC Adjustable MIS Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. The Alpine XC Adjustable MIS Fusion System is intended for use with bone graft material, not intended for stand-alone use.

The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); and/or tumor. The Aspendevice is intended for use with bone graft material, not intended for stand-alone use.

The LPlate device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The LPlate device is intended for use with bone graft material, not intended for stand-alone use.

The Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems referred to in this submission include the following systems: Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate. These subject Miscellaneous Spinal Fixation Systems are identical to the predicate Miscellaneous Spinal Fixation Systems, Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate, currently marketed. As defined within the product-specific Indications for Use, the subject Miscellaneous Spinal Fixation Systems are intended for the stabilization and immobilization of spinal segments as an adjunct to fusion in the cervical, thoracic, lumbar and/or sacral spine.

The provided text is a 510(k) summary for several Zimmer Biomet Spine fixation systems. It explicitly states that "Performance testing is not necessary" for this particular submission because the systems themselves are identical to already marketed predicate devices. The purpose of this submission is solely to obtain clearance for modified product labeling establishing the safety and compatibility of these existing passive implants in the magnetic resonance (MR) environment.

Therefore, the document does not contain information about acceptance criteria or a study demonstrating device performance in the traditional sense of evaluating efficacy or accuracy against a pre-defined standard. It's a regulatory filing based on demonstrating substantial equivalence to already cleared devices.

Based on the provided text, I can extract the following information:

1. Table of acceptance criteria and the reported device performance: This information is not present in the document. The document states "Performance testing is not necessary to evaluate the effects within magnetic fields during Magnetic Resonance Imaging (MRI) on the subject Miscellaneous Spinal Fixation Systems." The submission is for modified labeling regarding MRI safety of existing devices, which are substantially equivalent to their predicates.

2. Sample size used for the test set and the data provenance: Not applicable. No performance testing was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established for performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication was involved.

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 document is about spinal fixation systems, not AI-powered medical imaging devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about spinal fixation systems, not standalone algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for performance testing.

8. The sample size for the training set: Not applicable. This document is about physical medical devices, not machine learning models with training sets.

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth was established.

In summary, the provided FDA 510(k) summary (K202309) primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices for the purpose of clarifying MRI safety labeling. It explicitly states that performance testing is not necessary because the devices themselves are identical to their predicates, and the changes are limited to labeling regarding MRI compatibility. Therefore, the details requested about acceptance criteria, study design, and performance metrics are not present in this specific document.

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The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical treatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability. The system is intended for use with only autogenous bone graft material.

The SS Fenestrated Facet Screw System (FFS) is a permanent implant device made from Cobalt Chrome Alloy Per ASTM 1537. It is to be implanted from the posterior approach. The device is provided in one diameter and multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The SS Fenestrated Facet Screw System is cannulated and fenestrated which allows it to be used as a delivery system for bone graft. The system is not to be used with bone cement.

The provided text describes the regulatory submission for a medical device called the "SS Fenestrated Facet Screw System." It does not contain information about a study involving software or AI. Therefore, I cannot extract details about acceptance criteria or a study proving device performance in the context of AI.

The document discusses the substantial equivalence of the SS Fenestrated Facet Screw System to predicate devices based on performance testing for mechanical properties. However, this is for a physical implantable device, not an AI software.

Here's a breakdown of what is present in the document related to performance and testing for the physical device:

Device: SS Fenestrated Facet Screw System (FFS)

Acceptance Criteria and Reported Device Performance (for the physical device):

The document states:

• "Testing of the FFS to demonstrate substantial equivalence included static and dynamic 3-point bending, screw axial pullout, and torque to failure."
• "The testing standards utilized were, ASTM F543-07 'Standard Specification and Test Methods for Metallic Medical Bone Screws', F2193-02, 'Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System,' and ASTM F1264-03 'Standard Specification and Test Methods for Intrameduliary Fixation Devices.'"

While the specific numerical acceptance criteria and reported performance values are not detailed in the provided text, the successful 510(k) clearance implies that the device met the requirements outlined in these ASTM standards and was deemed substantially equivalent to its predicate devices in terms of safety and effectiveness.

Regarding your specific questions related to AI/Software:

1. A table of acceptance criteria and the reported device performance: This information is not present for an AI/software device. The document describes mechanical testing of a physical implant.
2. Sample sized used for the test set and the data provenance: Not applicable for an AI/software study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/software study.
4. Adjudication method: Not applicable for an AI/software study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for an AI/software study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/software study.
7. The type of ground truth used: Not applicable for an AI/software study.
8. The sample size for the training set: Not applicable for an AI/software study.
9. How the ground truth for the training set was established: Not applicable for an AI/software study.

In summary, the provided text is a 510(k) summary for a physical medical implant (a facet screw system) and does not describe an AI or software device, nor does it contain the type of study data you are asking for regarding AI acceptance criteria and performance.

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The Spinal USA Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous which are symptomatic: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

The Spinal USA Facet Screw System consists of a assortment of screws. Each are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3. The screws will be provided non-sterile.

The provided text describes a medical device, the "Spinal USA Facet Screw System," and its mechanical testing to demonstrate substantial equivalence to a predicate device. It is a 510(k) premarket notification summary.

Here's a breakdown of the requested information based on the provided text, while noting that many of the requested items are not applicable to this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "test set" sample size for mechanical testing in the way that would apply to clinical performance studies (e.g., number of patients or images). For mechanical testing, the "sample size" would refer to the number of individual screws and/or constructs tested for each mechanical test condition (Axial Pullout, Torque to Failure, Static 3-Point Bending, Dynamic 3-Point Bending). This specific number is not provided in the summary.
• Data Provenance: The mechanical testing was "performed per ASTM F1264." This indicates it was laboratory testing conducted according to a recognized standard, not data from human subjects or clinical trials. Therefore, concepts like "country of origin" or "retrospective/prospective" are not applicable here.

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

• N/A. This information is not relevant for a mechanical testing study of a medical implant and is not provided in the document. Ground truth as typically defined in AI/clinical studies (e.g., expert consensus on medical images or patient outcomes) does not apply to this type of engineering performance evaluation.

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or for establishing ground truth for AI model training/testing. This is not applicable to mechanical testing data.

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

• No. This was not a MRMC comparative effectiveness study. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The submission describes mechanical testing of a surgical implant.

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

• N/A. This does not involve an algorithm or AI. It is a physical medical device (facet screw system) undergoing mechanical performance testing.

7. Type of Ground Truth Used

• The "ground truth" for this engineering study is defined by the measured mechanical properties of the device when subjected to standardized tests (ASTM F1264) and compared against pre-defined acceptance criteria, as well as against the mechanical performance of a predicate device. It's an objective measurement against engineering standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

• N/A. This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles and standards, not data training.

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

• N/A. As there is no training set for an AI model, this question is not applicable.

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The X-spine Systems, Inc. Zygafix Spinal Facet Screw System is intended for posterior fixation to the lumbar spine (L1 to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system is intended for use with only autogenous bone graft material. The system is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

• . Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
• . Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
• Trauma (i.e., fractures and/or dislocations), .
• Spondylolisthesis, .
• Spondylolysis, ●
• Pseudoarthrosis and/or failed previous fusions. .

The X-spine Zygafix Spinal Facet Screw System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. The system consists of titanium alloy, cannulated bone screws that are available in various lengths and thread configurations to account for variations in patient anatomy. Each screw option contains axial fenestrations to allow the optional packing of bone graft. The screws are manufactured of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136.

This system is not to be used with bone cement. The safety and efficacy of using bone cement with this system has not been established.

The implant components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the Autoclave.

The Zygafix™ Spinal Facet Screw System is a medical device for posterior fixation to the lumbar spine. Its acceptance criteria and performance are based on biomechanical testing and comparison to predicate devices, rather than a clinical study involving human readers or AI.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Zygafix™ Spinal Facet Screw System are based on its performance in biomechanical tests, demonstrating substantial equivalence to its predicate devices. The system was tested against various aspects of ASTM F543 and ASTM F2193 standards, designed for metallic bone screws and spinal skeletal system components, respectively. While specific numerical acceptance thresholds are not explicitly stated in the provided text, the overall acceptance criterion is that the device's performance must be "substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use."

2. Sample Size for the Test Set and Data Provenance

The provided document describes biomechanical testing of the device components, not a clinical study involving a "test set" of patients or data in the typical sense of a diagnostic or AI device. Therefore, the concept of sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) as it applies to medical imaging or diagnostics is not applicable here. The "sample" in this context refers to the number of physical devices or components subjected to the mechanical tests. The document does not specify the number of devices or components used for each biomechanical test.

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

This information is not applicable as the study is a biomechanical engineering study focusing on mechanical properties of an implant, not a study requiring expert interpretation or ground truth establishment in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a biomechanical engineering study and does not involve clinical data adjudication.

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

This information is not applicable. The provided document describes a premarket notification for a spinal implant, which relies on biomechanical testing for substantial equivalence, not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone Performance Study

This information is not applicable. The device is an implantable medical device, not a software algorithm or diagnostic tool. Its "performance" is assessed through biomechanical testing of its physical properties.

7. Type of Ground Truth Used

The ground truth for this device is based on accepted engineering standards and physical mechanical properties. The "ground truth" for the performance of the Zygafix™ Spinal Facet Screw System is its ability to meet the performance characteristics specified in the ASTM F543 and ASTM F2193 standards, demonstrated through direct physical testing. The goal is to show it performs comparably to legally marketed predicate devices under these rigorous engineering standards.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not a machine learning model, and therefore does not involve a "training set" in the computational sense.

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

This information is not applicable for the same reasons as above; there is no "training set" for a physical medical implant.

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The Facet-Link Facet Screw System is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The methods of fixation are:

Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.

Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle.

The Facet-Link Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 (inclusive). The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:

(a) pseudoarthrosis and failed previous fusion;

(b) spondylolisthesis: and

(c) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.

The Facet-Link Facet Screw System is intended for conventional surgical placement.

The Facet-Link Facet Screw System consists of a conical and threaded head, partially threaded lag screws and fully threaded screws designed to compact or fixate juxtaposed facet articular processes to enhance spinal fusion and stability. The screws and washers are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes.

The Facet-Link Facet Screw System requires accessory general instruments for implantation. Instruments required for implantation may include a variety of k-wires, cannulae, drills, taps, and drivers.

The provided text describes a medical device, the Facet-Link Facet Screw System, and its performance testing to demonstrate substantial equivalence for 510(k) clearance. However, it does not include information about AI/algorithm performance, ground truth establishment for AI, expert consensus for AI, or multi-reader multi-case studies related to AI. The information provided is solely for the mechanical testing of a physical medical device.

Therefore, many of the requested sections related to AI/algorithm performance cannot be filled from the given text.

Here's a breakdown of the available information:

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 for each test, but it refers to "in vitro bench tests." This implies a set of physical samples of the device were tested.
• Data Provenance: In vitro bench tests. No country of origin is specified for the data itself as it's mechanical testing of a manufactured product. The manufacturing location is Facet-Link, Inc. in Rockaway, NJ, USA.
• Retrospective/Prospective: Not applicable, as this refers to physical device testing, not data analysis on patient outcomes.

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

• This question is not applicable as the study describes mechanical bench testing of a physical device, not an AI algorithm requiring expert ground truth.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as above.

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

• No. An MRMC study was not done. This type of study is relevant for evaluating human performance, often with AI assistance, which is not described here.

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

• No. This is not an algorithm; it is a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical tests would be the established engineering standards (ASTM F1717, ASTM F2193, and ASTM F543) and the performance of the predicate devices. The device's performance was compared against these standards and predicates to determine substantial equivalence.

8. The Sample Size for the Training Set

• This question is not applicable as there is no mention of a training set for an AI algorithm.

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

• This question is not applicable as there is no mention of a training set for an AI algorithm.

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The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

The Resolute Facet Screw System is comprised of various sized single-use, non-sterile facet screws that are designed to provide bilateral transfacet fixation of the lumbar facet joints. The system consists of titanium alloy (6AL-4v-EU per ASTM F136) screws in fully threaded and partially threaded designs, both of which are cannulated.

This document describes the Resolute™ Facet Screw System, a medical device designed for spinal stabilization, and its regulatory submission (510(k)). The provided text does not describe an AI/ML powered medical device, an imaging device, or a study that uses acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).

Instead, this is a 510(k) summary for a traditional medical implant (facet screw system) where "acceptance criteria" and "performance data" refer to mechanical and material testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested fields regarding AI/ML device performance, reader studies, ground truth establishment, and training sets are not applicable.

Here's an analysis of the provided information in the context of the device:

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

The document states: "Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System." and "No new technical characteristics are being introduced with this product."

This implies that the acceptance criteria for the Resolute™ Facet Screw System would be to meet or exceed the mechanical performance (e.g., stiffness, strength) of the predicate devices (Spineology® Capture™ Facet Screw System (K092464) and NuVasive® Triad® Facet Screw System (K020411)) as demonstrated through cantilever testing and engineering analysis. The specific numerical acceptance criteria (e.g., minimum loads, deflections, fatigue cycles) are not provided in this summary but would have been part of the full submission.

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

For a mechanical device like this, the "test set" would refer to the number of screws or test constructs used in the mechanical testing. This information is not provided in the given 510(k) summary. Data provenance is not applicable for this type of mechanical testing, as it's performed in a laboratory setting.

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 question is not applicable. The "ground truth" for a mechanical device is established by physical laws and engineering standards, not expert clinical consensus. The testing would be conducted by engineers in a lab.

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

This question is not applicable. Adjudication methods are used for clinical or diagnostic data, not for mechanical testing of an orthopedic implant.

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 question is not applicable. This device is a surgical implant, not an imaging or diagnostic AI device. No reader studies would be performed.

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

This question is not applicable as this is a mechanical medical device, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is based on engineering principles, material science, and relevant ASTM standards for mechanical testing of spinal implants. It's not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This question is not applicable. There is no "training set" for a mechanical medical device in the context of the provided information.

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

This question is not applicable for the same reason as above.

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The Apollo Spine Venus Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 4.5mm and 5.5 mm screws. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Apollo Venus Facet System is indicated for treatment of any or all of the following:

• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity
• Spondylolisthesis
• Spondylolysis
• Degenerative disk disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
• Degeneration of the facets with instability
• Trauma including spinal fractures and/or dislocations

The Venus Facet Screw System consists of two separate diameter screws and is provided in variable lengths for cervical and lumbar use. The screws have small fenestration in the threaded portion. The system includes a cervical and lumbar facet screws. The system screws provide fixation and are designed to connect vertebral facets, resulting from such causes as degenerative disease and/or trauma. These screw kits are considered a 'family' product line with sizes based on the anatomical variations of the patient's facets. The materials contained in the device include implant grade titanium alloy, Ti-6AI-4V (ELI) per ASTM F-136. The device is sold non-sterile and is to be sterilized at the end use facility by steam sterilization. The Venus Facet Screw System is a single use device.

The provided text is a 510(k) Premarket Notification for the Apollo Spine Venus Facet Screw System. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of a software or AI device.

The document details the mechanical properties and materials of the Venus Facet Screw System through performance testing, which is standard for implantable medical devices. However, it does not involve any AI, software, or imaging analysis that would require the typical components of device performance studies (like sample size for test/training sets, expert ground truth, adjudication methods, or MRMC studies) that you've listed.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI/software.
• Sample sizes for test sets or data provenance for AI/software.
• Number/qualifications of experts for AI/software ground truth.
• Adjudication method for AI/software test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone (algorithm only) performance information.
• Type of ground truth used for AI/software.
• Sample size or ground truth establishment for a training set (AI/software).

The study mentioned in the document focuses on mechanical performance standards for the physical screw system:

• Performance Standards: Performance testing and engineering analysis were conducted to characterize the performance of the Apollo Spine Venus Facet Screw System.
• Testing Performed: Dynamic and static three-point bend per ASTM F1264-03, cantilever bend per ASTM F2193, torsion and axial pull-out testing per ASTM F543.
• Device Performance: "The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices."
• Conclusion: "Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices. Equivalency of this device to the predicate devices is based on similarities in intended use, materials and design in combination with acceptable mechanical performance properties."

This information speaks to the physical integrity and strength of the implant, not the diagnostic or analytical performance of an AI or software device.

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The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Lanx Facet Screw System is indicated for treatment of any or all of the following:

• pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
• spondylolisthesis;
• spondylolysis;
• degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
• degeneration of the facets with instability and;
• trauma including spinal fractures and/or dislocations.

The Lanx Facet Screw System consists of various screws and washers designed to compact juxtaposed facet articular processes to enhance spinal fusion and stability. The screws are available partially threaded or fully threaded, cannulated or non-cannulated, and in various diameters and lengths to accommodate patient anatomy. Lanx Facet Screw System implants are fabricated from medical grade titanium alloy (per ASTM F-136).

The provided text describes a 510(k) premarket notification for the Lanx Facet Screw System and not a study assessing the performance of a device against acceptance criteria in the context of AI or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical testing.

Therefore, many of the requested categories are not applicable to this document. I will fill in the available information and indicate where data is not present or relevant for this type of submission.

Acceptance Criteria and Device Performance Study for Lanx Facet Screw System

This 510(k) submission for the Lanx Facet Screw System focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific clinical performance acceptance criteria for diagnostic accuracy or AI-assisted decision-making. The "performance data" presented relates to mechanical testing to ensure the device is physically robust and comparable to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Ability to withstand cantilever bend (per ASTM F2193).
• Ability to withstand torsion.
• Ability to withstand axial pull-out (per ASTM F543).
• Comparable mechanical properties to predicate devices (NuVasive Facet Screw and Globus Corridor Fixation System). | - Testing performed included dynamic and static three-point bend per ASTM F1264-03, cantilever bend per ASTM F2193, torsion, and axial pull-out testing per ASTM F543.
• "The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices."
• Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices. |
  | Intended Use/Indications | - Stabilize the spine as an aid to fusion through bilateral immobilization of facet joints.
• Used from C2 to S1 (for 3.5mm and 4.0mm screws) and L1 to S1 (for 4.5mm screws).
• Indicated for conditions such as pseudoarthrosis, spondylolisthesis, DDD, degeneration of facets with instability, and trauma. | - The system is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws.
• The system is indicated for the specified conditions. |
  | Material Composition | - Fabricated from medical grade titanium alloy. | - Implants are fabricated from medical grade titanium alloy (per ASTM F-136). |

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

• Sample Size for Test Set: This is a mechanical testing submission, not a clinical study involving patients. The "test set" refers to the number of screws and components subjected to mechanical testing. The document does not specify the exact number of units tested for each mechanical test, but references standard ASTM methods which typically define sample size requirements.
• Data Provenance: The data originates from laboratory mechanical testing and engineering analysis conducted by Lanx, Inc. (the manufacturer). It is not patient or clinical data, retrospective or prospective.

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

• Not Applicable. This is a mechanical testing submission for substantial equivalence. "Ground truth" in the diagnostic or AI context (e.g., expert consensus on medical images or pathology) is not relevant here. The "truth" is established by adherence to ASTM standards and engineering principles for mechanical performance.

4. Adjudication Method for the Test Set

• Not Applicable. As this is mechanical testing, there is no "adjudication" in the sense of reconciling divergent expert opinions or labeling for diagnostic accuracy. The performance is objectively measured against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This document describes a medical device (surgical implant) and its mechanical performance evaluation for substantial equivalence, not a diagnostic device or AI system. Therefore, MRMC studies improving human reader performance with AI assistance are irrelevant to this submission.

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

• No. This is not an AI algorithm or software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Engineering Standards: The "ground truth" or reference for evaluating the device's performance is adherence to established ASTM mechanical testing standards (e.g., ASTM F1264-03, ASTM F2193, ASTM F543) and engineering principles, demonstrating comparable mechanical properties to predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI system that requires a "training set" of data.

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

• Not Applicable. As above, no training set is involved.

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