(21 days)
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:
- 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.
- Sample sized used for the test set and the data provenance: Not provided. No clinical test set is described.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided. No test set requiring adjudication is described.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implantable device.
- 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.
- The sample size for the training set: Not provided. No training set is described (this is not a machine learning device).
- 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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.