(91 days)
K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) 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), spondylolisthesis, 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 level) and screws (self-tapping and self-starting) made of titanium alloy per ASTM F1472 and F136 and CP titanium per ASTM F67. The plates range in length from 18-110mm and the screws from 10-22mm. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds plates and 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.
This document is a 510(k) premarket notification for a medical device called the "Pyrenees Cervical Plate System". It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information in the context of your request:
Analysis of Acceptance Criteria and Study Information
The document describes a medical device, the "Pyrenees Cervical Plate System," and its submission for FDA 510(k) clearance. A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than fulfilling specific acceptance criteria in the way a new drug trial or an AI algorithm validation might.
The "study" described here is a non-clinical performance evaluation focusing on mechanical testing, a common requirement for orthopedic implants.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a mechanical device like this, "acceptance criteria" are typically related to meeting specific performance benchmarks established by recognized ASTM standards or demonstrating equivalence to predicate devices. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance equal to or better than predicate devices in static compression per ASTM F1717 | Performed equally to or better than predicate systems in static compression |
| Performance equal to or better than predicate devices in static torsion per ASTM F1717 | Performed equally to or better than predicate systems in static torsion |
| Performance equal to or better than predicate devices in dynamic compression per ASTM F1717 | Performed equally to or better than predicate systems in dynamic compression |
Note: The document doesn't explicitly state quantitative acceptance values (e.g., minimum load strength). Instead, the performance is reported relative to the predicate devices, which is typical for 510(k) mechanical testing. The ASTM F1717 standard itself establishes methodologies for such testing.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact number of plates or screws tested. It refers to "the Pyrenees plates" being "mechanically tested," implying a representative sample.
- Data Provenance: Not explicitly stated, but mechanical testing of medical devices is typically conducted in controlled laboratory settings, often by the manufacturer or a third-party testing facility. This is a non-clinical, prospective test in a laboratory environment. There is no patient data involved.
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)
- Experts: Not applicable. For mechanical testing of an orthopedic implant, "ground truth" is established through physical measurement and adherence to engineering standards (like ASTM F1717). No human experts are involved in "diagnosing" or "interpreting" the mechanical performance, beyond engineers conducting and analyzing the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is mechanical testing, not a clinical trial involving human interpretation.
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
- MRMC Study: No. This document is for a physical medical device (cervical plate system), not an AI/software as a medical device. Therefore, MRMC studies and concepts of human readers or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" here is the physical mechanical properties of the device, measured quantitatively according to established engineering standards (ASTM F1717) and compared against the mechanical properties of predicate devices. There is no biological, clinical, or consensus-based ground truth in this context.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device. There is no concept of a "training set" for a physical implant.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As above, there is no training set.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.