(29 days)
The COUGAR System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation.
The COUGAR System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The COUGAR System is also indicated for treating fractures of the thoracic and lumbar spine. The COUGAR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, the COUGAR System is intended for use with DePuy Spine supplemental internal fixation.
The Cougar® System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of autogenous bone graft materials.
Here's an analysis of the provided text regarding the Cougar® Implant System, focusing on acceptance criteria and the supporting study:
The provided document is a 510(k) Summary for the DePuy Spine Cougar® Implant System, specifically for a modification (increase in lordotic angle) to an existing device. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria for a novel device or AI performance. Therefore, many of the requested points related to AI/algorithm performance, ground truth, and expert adjudication are not applicable to this document.
Understanding the Context:
This is a regulatory submission for a medical device. The "acceptance criteria" here refer to demonstrating that the modified device (with increased lordotic angle) is as safe and effective as previously cleared predicate devices. The "study" is a series of performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a physical medical device (spinal implant) and not an AI/software device, the "acceptance criteria" are related to mechanical and material performance. The document doesn't explicitly state numerical acceptance criteria, but rather implies meeting the performance established by the predicate devices through standardized testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain strength and performance comparable to predicate devices | Passed static and dynamic compression testing per ASTM standards |
| Maintain open architecture for bone graft materials | Consistent with predicate design |
| Utilize carbon-fiber reinforced PEEK Optima material | Identical to predicate device material |
| Demonstrate no new questions of safety and effectiveness | Data presented demonstrates safety and effectiveness |
| Maintain intended use (spinal fusion, vertebral body replacement) | Intended use remains unchanged |
2. Sample Size Used for the Test Set and Data Provenance
The document describes performance testing of the physical implant, not a "test set" in the context of AI models evaluating data.
- Sample Size: The document does not specify the exact number of implants or test specimens used for the performance tests (static compression, dynamic compression, subsidence, expulsion). It simply states "This testing was comprised of static and dynamic compression testing on the proposed device as well as subsidence and expulsion testing."
- Data Provenance: Not applicable in the context of an AI model's data. This is laboratory-based mechanical testing of manufactured devices.
- Retrospective or Prospective: Not applicable. These are physical tests conducted on manufactured prototypes or samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. There is no concept of "ground truth" established by human experts for mechanical performance testing of a physical implant. The "ground truth" for mechanical testing is typically defined by engineering specifications and material properties, validated by standardized tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations of data, particularly in medical image analysis or clinical diagnosis. This is not relevant for mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to compare the diagnostic performance of different readers or systems (often involving AI) on multiple cases. This document concerns the mechanical safety and efficacy of a spinal implant, not diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical implant, not a software algorithm or AI.
7. Type of Ground Truth Used
For the performance testing mentioned:
- Type of Ground Truth: The "ground truth" for physical device performance is based on established engineering standards and material science principles, verified through standardized mechanical and material tests. The relevant ASTM standards are cited (ASTM F2077-11, ASTM-F2267-04), which define how such tests should be conducted and how performance characteristics are measured. The "ground truth" is that the device, when subjected to these tests, performs within acceptable parameters (usually implied to be similar to or better than the predicate devices).
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or "ground truth" in the AI/ML sense for this type of device submission.
§ 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.