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The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

The SpineNet SSP System is an anterior cervical plate and screw system which includes fixed and variable self-tapping screws and one- through four level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided document is a 510(k) Premarket Notification from the FDA regarding the SpineNet SSP System. It confirms the device's clearance and substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML powered device.

The document primarily focuses on the mechanical testing of the implant device itself (spinal intervertebral body fixation orthosis), confirming its mechanical performance is substantially equivalent to predicate devices.

Therefore, it is not possible to complete the requested table or answer the questions related to AI/ML device performance and validation based on the provided text. The document refers to "Performance Data" which states: "Mechanical testing of the worst case SpineNet SSP System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. The mechanical test results demonstrate that the SpineNet SSP System device performance is substantially equivalent to the predicate devices." This clearly indicates a physical device, not a software or AI/ML product that would require the type of performance evaluation outlined in your request.

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PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondy lolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System consists of plates (1-5 levels) and screws (self-tapping and self-starting) made of titanium in accordance with ASTM F1472 and F136 and CP titanium per ASTM F67. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds additional Mono screws to the system. The Pyrenees system components are provided non-sterile.

Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.

The provided text is a 510(k) summary for a medical device, the Pyrenees Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices based on technological comparison and non-clinical performance evaluation.

However, the document does not contain information related to a study that proves the device meets specific acceptance criteria based on clinical performance, human-in-the-loop studies (such as MRMC), or AI/algorithm performance. The assessment is based on non-clinical performance (mechanical testing) and demonstrates substantial equivalence to predicate devices, not on the kind of clinical or AI-driven performance metrics requested in the prompt.

Therefore, I cannot provide the detailed information requested in your prompt (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth details for AI/algorithm validation, etc.) because this information is not present in the provided text.

The document focuses on:

• Device Description: Plates and screws for cervical spine fixation.
• Materials: Titanium alloys.
• Intended Use: Anterior screw fixation to the cervical spine (C2-T1) for conditions like DDD, spondylolisthesis, trauma, stenosis, tumors, failed fusions, and deformity.
• Non-clinical Performance Evaluation: Static compression, static torsion, and dynamic compression testing in accordance with ASTM F1717 for the predicate plates, with engineering rationales for subject screws.
• Conclusion: Substantial equivalence to other marketed devices in design, function, material, and intended use.

This is typical for a 510(k) submission for a spinal implant, which primarily relies on mechanical testing and comparison to legally marketed predicate devices, rather than clinical efficacy studies or performance metrics derived from AI/algorithm evaluations.

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The VELOX Anterior Cervical Plate System is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fision of the cervical spine (C2 to C7). 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 discogenion of the disc confirmed by patient history and radiographic studies),

• · spondylolisthesis,
  · trauma (i.e. fractures or dislocations),

• tumors,

· deformity,

· pseudarthrosis.

· failed previous fusion,

· spinal stenosis.

The VELOX Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The VELOX anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The VELOX plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the VELOX Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths.

The VELOX Anterior Cervical Plate is a medical device and is not subject to acceptance criteria in the same way an AI/ML diagnostic or prognostic device would be. Instead, its approval is based on demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical performance testing.

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

Acceptance Criteria and Device Performance (Derived from Substantial Equivalence Claim)

The "acceptance criteria" for a medical device like this are primarily demonstrating that its design, materials, and mechanical performance are equivalent or superior to predicate devices. The performance is reported in comparison to these predicates.

Explanation: In the context of a 510(k) submission for a traditional medical device, "acceptance criteria" are implied by the chosen predicate device's established safety and effectiveness. The manufacturer must demonstrate that the new device meets or exceeds the performance of these predicates.

Study Details (Non-Clinical)

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

   • Test Set Sample Size: Not explicitly stated in terms of the number of specific test articles. However, the study references "testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests" according to ASTM F1717-12. The ASTM standard itself would specify the number of samples required for each test.
   • Data Provenance: The testing was conducted by the manufacturer, SpineCraft, LLC, likely in a laboratory setting. The country of origin for the testing is implied to be within the USA, given the submitter's location in Westmont, IL, USA. This is a prospective non-clinical study designed for regulatory submission.

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

   • Not Applicable. This is a non-clinical mechanical performance study, not a clinical study involving human patients or expert interpretation of data. "Ground truth" in this context refers to the measured physical properties and performance characteristics determined by the mechanical tests, not expert consensus on medical conditions.

3. Adjudication method for the test set:

   • Not Applicable. As a non-clinical mechanical test, there is no expert adjudication process. The results are quantitative measurements against established engineering 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:

   • Not Applicable. This is a mechanical device, not an AI/ML algorithm. No human readers or AI assistance are involved in its primary function or testing for regulatory approval.

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

   • Not Applicable. This is a mechanical device, not an algorithm.

6. The type of ground truth used:

   • Mechanical Test Results against ASTM Standards. The "ground truth" for this device's performance is derived from the objective measurements obtained through standardized mechanical testing (ASTM F1717-12). These results are then compared to the known performance of predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set. The design of the device is based on engineering principles and potentially prior experience with similar devices, but not a data-driven training set in the AI sense.

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

   • Not Applicable. No training set was used.

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The CoreLink ANODYNE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scollosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

The Anodyne™ Anterior Cervical Plate System is comprised of an assortment of cervical plates and screws that act to stabilize the spine during the intervertebral fusion process. The cervical plate has a rotatable anti-backout "lock" for each screw position to prevent back-out of the screw.

The plate is available in single and double plate configurations with multiple lengths ranging from 13 mm – 22 mm (1 level) and 26 mm – 40 mm (2 level) for the single plates. The double plates include 1 level (13 mm - 30 mm), 2 level (26 mm - 46 mm), 3 level (46 mm - 70 mm), and 4 level (60 mm -100 mm). The screws are available in various lengths from 12 mm - 20 mm, with major thread diameter options of 4.6 mm or 5.2 mm.

The Anodyne™ Anterior Cervical Plate System is a medical device intended for anterior fixation of the cervical spine. The device's acceptance criteria and the study proving it meets these criteria are outlined in the 510(k) summary.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Anodyne™ Anterior Cervical Plate System are based on the mechanical performance of the device, specifically its ability to withstand static and dynamic loads and torsion, as compared to predicate devices. The study demonstrates that the device performs equivalently to previously cleared devices.

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

• Sample Size: Not explicitly stated as a number of devices tested. Instead, the testing refers to "the ANODYNE™ Anterior Cervical Plate System" as the subject of the tests, implying a representative sample of its components (plates and screws across various sizes and configurations).
• Data Provenance: The tests are described as "Non-Clinical Test Summary" and were likely conducted in a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, as these are non-clinical (mechanical) tests rather than clinical studies on human subjects.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

Not applicable. This device underwent non-clinical mechanical testing, not clinical studies involving human patients or expert interpretation of medical images. Therefore, no medical experts were involved in establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. As described above, there was no clinical test set requiring adjudication. The assessment was based on objective mechanical testing results against industry standards.

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

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. Standalone Performance Study:

No. Since no clinical studies were performed, there was no standalone algorithm performance study (the device is a physical medical implant, not an AI or digital diagnostic tool). The "standalone performance" in this context refers to the device's mechanical integrity as tested in a lab setting, independent of human interaction during real-world use, which was indeed evaluated through the non-clinical tests.

7. Type of Ground Truth Used:

The ground truth for the non-clinical tests was established by recognized industry standards (ASTM F1717) for mechanical testing of spinal implants. The performance of the Anodyne™ system was compared against the established mechanical properties and performance of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. The device is a physical medical implant, not an AI algorithm. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a physical medical implant.

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The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

This document describes the Zavation Cervical Plate System, a medical device. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does not contain information typically found in a study for an AI/ML diagnostic device, such as acceptance criteria based on metrics like sensitivity/specificity, nor does it discuss ground truth establishment, expert adjudication, or reader studies.

Therefore, many of the requested categories related to AI/ML device studies are not applicable to this submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The submission refers to "a worst-case, cervical plate construct" being tested, implying a limited number of constructs rather than a large clinical test set.
• Data provenance: Mechanical testing was performed according to ASTM F1717. This is laboratory-based testing, not human data.

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

Not applicable. Ground truth for mechanical performance is established by standardized testing protocols (ASTM F1717) and engineering measurements, not by expert medical review.

4. Adjudication method for the test set

Not applicable. See point 3.

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 spinal implant device, not an AI/ML diagnostic device requiring a reader study.

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

Not applicable. This is a spinal implant device, not an AI/ML diagnostic device.

7. The type of ground truth used

"Ground truth" was established through standardized mechanical testing (ASTM F1717) on physical device constructs, measuring parameters like bending strength, torsion stability, and fatigue resistance.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML system that requires a training set. Development and validation rely on engineering design principles and physical testing.

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

Not applicable. See point 8.

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The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, turnor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws. The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F 136 implant grade titanium Materials: alloy.

The provided text describes a 510(k) submission for a medical device and does not contain information about a study proving the device meets acceptance criteria or details about AI/algorithm performance. It is a regulatory submission for a spinal implant, which typically relies on mechanical testing and comparison to predicate devices, rather than AI performance studies or human reader studies.

Therefore, I cannot fulfill the request as it asks for information not present in the provided context. The document focuses on regulatory approval based on substantial equivalence and mechanical performance data, not a study evaluating algorithm performance or human reader improvement with AI.

To directly answer the prompt based on the absence of information:

1. Table of acceptance criteria and reported device performance: Not applicable. The document refers to "Performance data per ASTM F 1717" being submitted to characterize the device but does not provide specific acceptance criteria or detailed results of those tests.
2. Sample size used for the test set and the data provenance: Not applicable. This document is for a spinal implant, not an AI/algorithm-based device. "Test set" in this context would refer to mechanical testing of the implant, not a data set for an algorithm. Data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/algorithm studies (e.g., expert consensus on medical images) is not relevant to the regulatory submission for this physical medical device.
4. Adjudication method: Not applicable.
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, an MRMC study was not done, as this is a physical medical device (spinal plate) and not an AI or imaging diagnosis device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, a standalone algorithm performance study was not done, as this is a physical medical device.
7. The type of ground truth used: Not applicable in the context of AI/algorithm ground truth. The "ground truth" for this device would be its mechanical properties, established through standardized ASTM testing.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm device.

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