(329 days)
The COMET Lumbar Interbody Fusion Cage is indicated for use in intervertebral body fusion of the Spine. The COMET Lumbar Interbody Fusion Cage is inserted via a transforaminal posterior lumbar fusion procedures in skeletally mature patients with degenerative disc disease (DDD defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) and intended for use with autogenous bone graft at one or two contiguous levels of the lumbosacral spine (L2-S1). The COMET Lumbar Interbody Fusion Cage is intended to be used with supplemental fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
The COMET Lumbar Interbody Fusion Cage is a hollow, bullet-shaped PEEK cage (per ASTM F2026) with three Tantalum marker pins (per ASTM F560). It is indicated for use in skeletally mature patients for the lumbar spine intervertebral fusion. It is angulated 4°to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle.) The Cage devices are offered in a variety of different sizes with varying footprint dimensions to accommodate a multitude of anatomical needs. The implant has serrations on the top and bottom for fixation and the hollow space of the implant is intended to hold autogenous bone graft for fusion purposes. The COMET Lumbar Interbody Fusion Cage is supplied "Sterile".
The document describes a 510(k) premarket notification for the "COMET Lumbar Interbody Fusion Cage" and references a predicate device, the "SYNTHES T-PAL SPACER" (K100089). This type of submission is for medical devices and typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness or extensive AI performance studies.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies, does not directly apply in the context of this 510(k) submission.
Instead of clinical performance, the approval hinges on demonstrating:
- Identical Indications for Use.
- Similar technological characteristics, materials, and operational principles.
- Non-clinical testing to ensure the device meets established mechanical performance standards as outlined in relevant ASTM standards.
Here's a breakdown of the information that is available in the document, mapped against your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical targets and the device's reported performance against them in the way clinical studies for AI algorithms might. Instead, it refers to non-clinical mechanical testing performed in accordance with specific ASTM standards. The "acceptance criteria" here are implied by compliance with these standards, meaning the device must withstand the forces outlined in the tests without failure.
The reported device "performance" is implicitly stated as having "provided in support of substantial equivalence," meaning it passed these tests.
The following non-clinical tests were performed:
- Static Compression per ASTM F2077
- Static Compression Shear per ASTM F2077
- Subsidence per ASTM F2267
- Expulsion
- Dynamic Compression per ASTM F2077
- Dynamic Compression Shear per ASTM F2077
2. Sample sized 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 this is a non-clinical, mechanical device submission, not an AI or diagnostic tool clinical study. The "test set" refers to physical samples of the device used for mechanical testing. The document states "The worst-case size for the COMET Lumbar Interbody Fusion Cage was conducted" for these tests, implying specific configurations of the device were tested. No data provenance in the context of patient data is relevant here.
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. Ground truth, in the sense of expert radiological or pathological labels, is not relevant for a mechanical device submission. The "ground truth" for mechanical testing is defined by the ASTM standard test methods and the physical properties observed during testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, which are not part of this device submission.
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. No MRMC comparative effectiveness study was conducted as this is a mechanical interbody fusion cage, not an AI or imaging diagnostic device intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, in the context of its safety and effectiveness, is established through compliance with recognized mechanical testing standards (ASTM F2077, ASTM F2267). This demonstrates that the device has appropriate structural integrity and performance characteristics for its intended physical function.
8. The sample size for the training set
This information is not applicable. This is not an AI algorithm submission, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" or ground truth for it as this is a mechanical device.
§ 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.