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The Sacrix® Sacroillac Joint Fusion Device System is intended for fusion of the sacroillac joint for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

The InSpan® ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.

The Invue® MAX™ + Invue Inset Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma; (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudloarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and reoperation for failed fusion or instability following surgery for above indications.

The FacetFuse® Screw Fixation System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1) Trauma, including spinal fractures and/ or dislocations: 2) Spondylolisthesis: 3) Spondylolysis: 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) 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.

The Sacrix® Sacroiliac Joint Fusion Device System implants consist of Solid and Fenestrated Screws. Solid and Fenestrated Screws are available in varying diameters and lengths. Solid and Fenestrated Screws are fabricated from medical grade titanium alloy, Ti-6AI-4V ELI per ASTM F136. Solid and Fenestrated Screws have a cannulated core to allow packing of allograft or autograft material. Solid Screws have a solid outer wall, while Fenestrated Screws have fenestrations on the outer wall.

The Inspan® ScrewLES Fusion System consists of a variety of sizes of plates, set screws, and associated instruments. The plates are offered in five hub diameters (8 mm in 2 mm increments) and five wing length configurations (35 mm to 47 mm increments). The device height (measured from the base of the central hub to the top of the wing) is fixed across all configurations at 18.85 mm for InSpan® and 13.89 mm for InSpan® Slim. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating post-operatively. The components of the Inpan® ScrewLES Fusion System are fabricated from medical grade titanium alloy Ti-6AI-4V ELI per ASTM F136.

The Invue® MAX™ + Invue Inset Anterior Cervical Plate System consists of a variety of shapes and sizes of plates, screws, and the associated instruments. The plates are available in four levels to accommodate one to four levels of fixation. The one level plates have lengths ranging from 17 mm in 2 mm increments, two level plates range from 33 mm in 2 mm increments, three level plates range from 48 mm to 78 mm in 3 mm increments, and the four-level plates range from 61 mm in 4 mm increments. A lock is integrated in the plate and screw to secure the screw from backout. Ø4.2 mm self-drilling screws and Ø4.5 mm self-tapping screws are offered. All screws are offered in lengths of 12 mm, 16 mm, 18 mm, and 20 mm. The Invue® MAX™ + Invue Inset Anterior Cervical Plate System components are single use and are fabricated from titanium alloy Ti-6AI-4V ELI per ASTM F136.

The FacetFuse® Screw Fixation System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. The FacetFuse® Screw Fixation System offers partially threaded screws. The partially threaded screws are available in Ø4.5 mm diameter screw (in 0.5 mm increments) offered in lengths of 25 mm to 50 mm (in 5 mm increments). The fully threaded screws are available in diameters Ø4.5 mm and Ø5.0 mm in lengths from 20 mm in 5 mm increments. The device is fabricated from titanium alloy Ti-6Al-4V ELI per ASTM F136. The devices are offered with a built in washer or without a washer. The washers are intended to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories.

The purpose of this submission is to offer sterile packaged options of each implant.

The provided text is a 510(k) summary for several medical devices (Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System). It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily due to changes in sterilization and packaging.

The document does not contain information about an AI/ML-based device or a study involving human readers and AI assistance. Therefore, I cannot provide details regarding acceptance criteria, performance data, ground truth establishment, or multi-reader multi-case studies for an AI/ML device from this text.

The "Performance Data" section explicitly states that "The results of these non-clinical tests showed that each system is substantially equivalent to legally marketed predicate devices. The changes in sterilization and packaging do not affect mechanical performance and require no additional bench testing for this submission." This indicates that the performance evaluation was based on previously conducted mechanical and physical testing of the devices, not on data from clinical studies or AI/ML evaluations.

In summary, the provided document does not contain the information required to answer your questions regarding acceptance criteria and study proving device performance for an AI/ML component.

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The Facet FixxTM System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following: Degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies, Degenerative disease of the facets with instability, Trauma (i.e. fracture or dislocation), Spondylolisthesis, Spondylolysis, Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity.

The Facet FixxTM System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.

This device is a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance and study design are not applicable. The provided text describes the device, its intended use, materials, and a comparison to predicate devices, focusing on mechanical performance.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of an algorithm. For mechanical testing, the number of samples tested for static/dynamic cantilever bending and axial pullout is not specified.
• Data Provenance: The mechanical testing was likely conducted in a laboratory setting, not with human patient data.

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

• Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. Mechanical testing involves objective measurements rather than expert adjudication.

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

• Not applicable. This is not an AI/ML device.

6. Standalone Performance Study:

• Not applicable. This is not an AI/ML algorithm. The performance established is the mechanical performance of the device itself.

7. Type of Ground Truth Used:

• Mechanical Testing Results: The "ground truth" here is the objective measurement of the device's mechanical properties (static and dynamic cantilever bending, axial pullout strength) against established ASTM standards (F2193 and F543) and comparable predicate devices.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that uses a training set.

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

• Not applicable.

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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 VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:

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

This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The screws and washers that are the subject components of this submission are modified DISCOVERY® System screws and washers that are available in various geometries and sizes. Manufactured from ASTM F 136 implant grade titanium alloy.

The provided text describes the 510(k) summary for the VIPER® F2 Facet Fixation System. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical mechanical testing, rather than device performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from this document in the typical sense of AI/medical device performance evaluation.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way a diagnostic AI device summary would. Instead, the "device performance" is demonstrated through nonclinical mechanical testing and comparison to predicate devices, implying that if the device performs comparably to legally marketed devices, it meets the unstated "acceptance criteria" for safety and effectiveness.

Nonclinical Test Summary and Implied Performance:

2. Sample size 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 study did not involve a test set of data points (e.g., medical images, patient records) for evaluation of the device's diagnostic or predictive performance. The "testing" involved mechanical benchmarks of the physical device.

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. The device is an implantable medical device, not an AI or diagnostic tool requiring ground truth established by medical experts for performance evaluation. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1798).

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

This information is not applicable. There was no clinical test set or human interpretation involved that would require an adjudication method.

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

There was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical implant, not an algorithm.

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

The "ground truth" for the nonclinical mechanical testing was based on engineering standards (ASTM F1798) for evaluating spinal arthrodesis implants.

8. The sample size for the training set

This information is not applicable. There was no training set involved as this is not an AI/machine learning device.

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

This information is not applicable. There was no training set.

Summary of the Study:

The study proving the device meets acceptance criteria was a nonclinical mechanical testing program involving static and dynamic compression bending, and static and dynamic three-point bending, all conducted in accordance with ASTM F1798. The intent was to demonstrate that the modified components of the VIPER® F2 Facet Fixation System perform mechanically comparably to its predicate devices. No clinical tests were performed. The FDA's substantial equivalence determination was based on this nonclinical testing and comparison of intended use, design, materials, manufacturing methods, performance, sterility, biocompatibility, safety, and packaging design to legally marketed predicate devices.

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The Spartan S2 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;

2. Spondylolisthesis;

3. Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;

4. Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.

The Spartan S Facet System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in 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 provided text describes a 510(k) summary for the Spartan S2 Facet System, a medical device. This document focuses on establishing substantial equivalence for market clearance, rather than presenting a study demonstrating the device meets a predetermined set of acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, training set size, ground truth establishment for training) cannot be answered from the provided text.

The document states: "The pre-clinical testing performed indicates that the Spartan S2 Facet System is substantially equivalent to the predicate devices and is adequate for the intended use." This implies that the 'acceptance criteria' for this clearance process was the demonstration of substantial equivalence through pre-clinical testing, likely mechanical or material testing as is common for implants. However, the specific details of these tests and their results are not provided.

Here is what can be inferred or explicitly stated from the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Provided. The document refers to "pre-clinical testing," which typically involves mechanical and material testing, not human subject data or a "test set" in the context of AI performance evaluation. The type of data provenance would likely be laboratory test results, not country of origin for patient data.

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

• Not Applicable / Not Provided. Ground truth establishment by experts for a test set is relevant for diagnostic or AI-driven devices. This document refers to a physical implant.

4. Adjudication method for the test set:

• Not Applicable / Not Provided. Adjudication methods are typically used in clinical studies involving observer interpretation, not for mechanical device testing.

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

• No. This is a 510(k) summary for a physical implant, not an AI-assisted diagnostic device. Therefore, an MRMC study related to AI assistance would not be performed.

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

• No. This is a physical implant, not an algorithm.

7. The type of ground truth used:

• Not Applicable / Not Provided for typical AI/diagnostic ground truth. For a physical implant, "ground truth" would relate to material properties and mechanical performance meeting engineering specifications, rather than expert consensus, pathology, or outcomes data in a clinical sense for diagnostic accuracy.

8. The sample size for the training set:

• Not Applicable / Not Provided. Training sets are relevant for machine learning algorithms.

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

• Not Applicable / Not Provided.

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The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.

The US Spine Facet Fixation System consists of two implantable components, the screw in various lengths and an optional washer. Both components are made from implant grade wrought Titanium 6-Aluminum 4-Vanadium (Ti6Al4V) alloy.

The provided text describes a medical device, the "US Spine Facet Fixation System," and its 510(k) submission. However, it does not include information about a study based on AI/ML.

Here's a breakdown of the requested information based on the provided text, with "N/A" indicating information not present:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific quantitative acceptance criteria (e.g., "withstanding X N of force for Y cycles") and the actual quantitative results achieved by the device are not provided in this summary. It only states that testing was performed.

Study Details (Focusing on AI/ML, which is not present)

2. Sample size used for the test set and the data provenance
N/A - The document describes biomechanical testing, not a study involving a test set of data for an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This is not an AI/ML study.

4. Adjudication method for the test set
N/A - This is not an AI/ML study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A - This is not an AI/ML study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI/ML study.

7. The type of ground truth used
N/A - The performance data is based on biomechanical testing of the physical device. For a physical device, the "ground truth" would be objective measurements from these tests and observation of the device's physical integrity and stability under load.

8. The sample size for the training set
N/A - This is not an AI/ML study.

9. How the ground truth for the training set was established
N/A - This is not an AI/ML study.

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