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The TOMCAT™ Cervical Spinal System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients. The interbody is used with bone screws provided and requires no additional supplementary fixation. The interbody is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies. The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, to facilitate fusion. The device is implanted by an anterior approach. The TOMCAT™ implant must be used with the screws included in the TOMCAT™ system. This device is to be used in patients who have had six weeks of non-operative treatment.

The TOMCAT™ Cervical Spinal System is an anterior cervical spinal fixation system for an effective means of stabilizing the cervical vertebral column (C2-T1) as an adjunct to fusion of vertebral bodies. The TOMCAT™ System will provide an alternative to the more common cervical plate and cervical interbody spacer Anterior Cervical Discectomy & Fusion (ACDF) surgical procedure. The TOMCAT™ Cervical Spinal System is a radiolucent and radiopaque intervertebral body fusion device. The interbody is made from PEEK per ASTM F2026 with titanium alloy (Ti-6Al-4V ELI) per ASTM F136, tantalum radiopaque markers per ASTM F560, and nitinol clips per ASTM F2063. This device accepts titanium (Ti-6Al-4V ELI) bone screws that are available in two diameters and multiple lengths.

The system will be composed of a cervical interbody spacer with a zero profile and a hybrid profile design. The hybrid device is implanted anteriorly by inserting two screws, one screw into the anterior face of vertebral body and the other diagonally though the end plate. The zero profile device implants are implanted anteriorly and stabilized by two diagonally placed screws.

This document is a 510(k) summary for the TOMCAT™ Cervical Spinal System, primarily focused on gaining clearance for an additional sterilization method. As such, it does not contain the detailed performance data, acceptance criteria, or study design information typically found in a clinical study report or a 510(k) summary for a novel device requiring extensive performance testing.

The document explicitly states:

• "The device design remains unchanged from the original 510(k) submission (K152515)."
• "The purpose of this submission is to gain clearance for an additional method of sterilization for the TOMCAT™ Interbodies of the TOMCAT™ Cervical Spinal System. The indications for use and design characteristics of the system devices have not changed."
• "Therefore, it can be concluded that the subject device is substantially equivalent to the predicate."

Given this, the document only lists the following performance data:

• Sterilization validation performed in accordance with ISO 11137
• Pyrogenicity testing performed in accordance with USP Bacterial Endotoxin Test (BET) and ANSI/AAMI ST72.

Therefore, it is impossible to provide the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The provided text focuses on demonstrating substantial equivalence to a predicate device (K152515) for a change in sterilization method, rather than proving the device meets clinical performance acceptance criteria for a new, unproven technology. Such clinical performance data would have been part of the original K152515 submission if required.

Here's a breakdown of why each specific point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The performance data is limited to sterilization and pyrogenicity testing, which have pass/fail criteria, but these are not clinical performance acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not provided. No clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. This is a medical device (spinal interbody fusion system), not an AI/imaging diagnostic device. MRMC studies are not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implantable device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance study requiring ground truth is described in this submission.
8. The sample size for the training set: Not provided. No training set is described (this is not a machine learning device).
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document does not contain the type of clinical performance study data that would allow for an answer to almost all of the questions posed.

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The TOMCAT™ Cervical Spinal System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients. The interbody is used with bone screws provided and requires no additional supplementary fixation. The interbody is inserted between the vertebral bodies into the disc space at one level from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies. The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, to facilitate fusion. The device is implanted by an anterior approach. The TOMCAT™ implant must be used with the screws included in the TOMCAT™ system. This device is to be used in patients who have had six weeks of non-operative treatment.

The TOMCAT™ Cervical Spinal System is an anterior cervical spinal fixation system for an effective means of stabilizing the cervical vertebral column (C2-T1) as an adjunct to fusion of vertebral bodies. The TOMCAT™ System will provide an alternative to the more common cervical interbody spacer Anterior Cervical Discectomy & Fusion (ACDF) surgical procedure. The TOMCAT™ Cervical Spinal System is a radiolucent and radiopaque intervertebral body fusion device. The interbody is made from PEEK-OPTIMA® HA, PEEK per ASTM F2026 with Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136, Tantalum radiopaque markers per ASTM F560. This device accepts titanium (Ti-6Al-4V ELI) bone screws that are available in two diameters and multiple lengths.

The system will be composed of a cervical interbody spacer with a zero profile and a hybrid device is implanted anteriorly by inserting two screws, one screw into the anterior face of vertebral body and the other diagonally through the end plate. The zero profile device is implanted anteriorly and stabilized by two diagonally placed screws.

This document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria for a new medical device. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which would typically be found in a clinical or standalone performance study report, is not present in this document.

The document describes the regulatory process for the TOMCAT™ Cervical Spinal System, highlighting its indications for use and outlining performance standards it was tested against. However, it does not provide specific acceptance criteria values or detailed results of those tests.

Here's an analysis based on the provided text, indicating what information is available and what is not:

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

• Acceptance Criteria: Not explicitly stated in terms of pass/fail values for each test. The document mentions that the device "has been tested by an independent laboratory in accordance to the following standard," implying that the testing met the requirements within those standards, but specific numerical acceptance criteria (e.g., "must withstand X MPa of compression") and the device's actual performance values against those criteria are not provided.
• Reported Device Performance: No specific numerical performance metrics are reported. The document states that "The performance testing required is the equivalent for the predicate devices," which confirms that testing was done but omits the results.

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

• Sample Size: Not specified. The document refers to "testing" against various ASTM standards, but does not state how many devices were tested for each.
• Data Provenance: The document states that testing was done by "an independent laboratory," but does not specify the country of origin or if the tests were retrospective or prospective studies. Given the nature of mechanical testing, it would generally be prospective lab testing.

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

• This information is not applicable to this document. This typically applies to clinical studies or studies involving interpretations (e.g., imaging diagnosis). The testing performed here (mechanical and material characterization) does not involve expert ground truth establishment in the same way. The "ground truth" for these tests are the physical measurements and material properties themselves.

4. Adjudication method for the test set

• This information is not applicable for the same reasons as point 3. Mechanical testing results are objective measurements and do not require expert adjudication in the typical sense.

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

• This information is not applicable. An MRMC study is relevant for AI/imaging interpretation devices. This device is an intervertebral body fusion device, not related to AI or diagnostic interpretation.

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

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

7. The type of ground truth used

• The "ground truth" for the tests mentioned (Static/Dynamic Axial Compression, Torsion, Compression Shear, Subsidence, Expulsion) would be the physical properties and mechanical behavior of the device itself, measured objectively according to the specified ASTM standards. There is no expert consensus, pathology, or outcomes data used as "ground truth" in this context.

8. The sample size for the training set

• This information is not applicable as this is a physical medical device, not a machine learning model that requires a training set.

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

• This information is not applicable for the same reason as point 8.

Summary of available information regarding the study:

• Study Type: Mechanical and material performance testing (physical device testing).
• Standards Followed: ASTM F2077 (Static Axial Compression, Static Torsion, Static Compression Shear, Dynamic Axial Compression, Dynamic Torsion, Dynamic Compression Shear), ASTM F2267 (Static Testing in Subsidence), and ASTM Draft Standard F-04.25.02.02 (Static Testing in Expulsion).
• Testing Body: An independent laboratory.
• Purpose: To demonstrate that the device performs equivalently to predicate devices according to recognized performance standards, supporting a claim of substantial equivalence for regulatory clearance.

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