(253 days)
PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
The PMT Cervical Cage is an intervertebral fusion device intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and has the following design features:
- Devices are single use and supplied sterile. .
- . Rectangular box shape with fenestrations (graft windows).
- Superior and inferior surfaces feature teeth that provide bony contact with the endplates. .
- Manufactured from Titanium-6AL-4V ELI alloy, conforming to ASTM F136 .
- Available in various footprints and heights. .
Here's an analysis of the provided text regarding the PMT Cervical Cage's acceptance criteria and studies:
Summary of Device Performance Test and Acceptance Criteria for PMT Cervical Cage
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Static Compression Testing (ASTM F2077-11) | Met or exceeded the performance of predicate devices. |
| Dynamic Compression Testing (ASTM F2077-11) | Met or exceeded the performance of predicate devices. |
| Static Torsion Testing (ASTM F2077-11) | Met or exceeded the performance of predicate devices. |
| Dynamic Torsion Testing (ASTM F2077-11) | Met or exceeded the performance of predicate devices. |
| Subsidence Testing (ASTM F2267-04) | Met or exceeded the performance of predicate devices. |
| Expulsion Testing (ASTM Draft Standard F-04.25.02.02, 2000) | Met or exceeded the performance of predicate devices. |
Study Details
-
Sample size used for the test set and the data provenance:
The document does not specify the sample sizes (number of devices, or specific conditions/replicates) used for each non-clinical test. It only states that the tests were conducted. The provenance of the "data" in terms of geography or whether it was retrospective/prospective is not applicable as these are laboratory-based mechanical tests on the device itself, not studies involving human or animal data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to the non-clinical mechanical testing described. "Ground truth" in this context would refer to established ASTM standards and best practices for mechanical testing, not expert consensus on medical images or patient outcomes. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in AI/imaging assessments. This document describes mechanical device testing against established engineering standards. -
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 MRMC comparative effectiveness study was mentioned. The document focuses solely on the mechanical substantial equivalence of the device. This type of study would be relevant for AI-powered diagnostic devices, not for a cervical cage. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The PMT Cervical Cage is a physical medical device, not a software algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical mechanical tests, the "ground truth" (or basis for comparison) was the performance envelopes and characteristics defined by the specified ASTM standards (F2077-11, F2267-04, and Draft Standard F-04.25.02.02) and the performance of previously cleared predicate devices. -
The sample size for the training set:
Not applicable. There is no mention of a "training set" as this document describes the regulatory submission for a physical medical device based on mechanical testing, not a machine learning model. -
How the ground truth for the training set was established:
Not applicable, as there is no training set involved.
§ 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.