(20 days)
The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
The PERIMETER® Interbody Fusion Device consists of interbody cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.
This 510(k) premarket notification for the PERIMETER® Interbody Fusion Device primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through material and design similarity, and an engineering rationale. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, which would be typical for an AI-powered diagnostic device.
However, I can extract the information relevant to performance data as presented in the document, which in this case pertains to biocompatibility and mechanical testing for a physical medical device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description of Acceptance Criteria | Reported Device Performance and How it Meets Criteria |
|---|---|---|
| Biocompatibility | The materials used in the device (implants and instruments) must be biocompatible for long-term implantation in the human body. (Implied criterion based on general medical device regulations and the "safe and effective use" claim). | Device Performance: The implants are made from Titanium alloy. The non-sterile instruments are manufactured from stainless steel. |
Meets Criteria: The document states: "The titanium alloy and stainless steel material used for the subject PERIMETER® Interbody Fusion Devices implants and instruments (trials) have a long clinical history of safe and effective use in similar commercially available medical devices. Therefore, no additional biocompatibility testing is required." This indicates that the materials themselves, based on prior use and regulatory acceptance, are deemed biocompatible, and no new testing was necessary to prove this. |
| Mechanical Testing | The device must demonstrate mechanical equivalence to predicate devices, ensuring it can withstand the intended physical stresses in the spinal environment without new worst-case scenarios. (Implied criterion for interbody fusion devices, often aligned with FDA guidance for spinal systems). | Device Performance: The subject devices (new PERIMETER® Interbody Fusion Devices) incorporate additional interbody cages manufactured from medical grade titanium alloy (Ti-6Al-4V ELI) that are packaged sterile, and new instruments (trials).
Meets Criteria: The document states: "In accordance with, Guidance for Industry and FDA Staff - Spinal System - 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. It was determined that subject devices do not represent a new worst case. Therefore, an engineering rationale was used to demonstrate substantial equivalence. As a new worst case has not been indicated and an engineering rationale was deemed adequate to prove equivalence to the predicate device, no additional mechanical testing is required." This indicates that through an engineering rationale, rather than new physical testing, the device was determined to be mechanically equivalent to existing, cleared devices and did not introduce new safety concerns. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a spinal implant (interbody fusion device), not an AI-powered diagnostic device or a system that uses test sets in the traditional sense of AI/software validation. Therefore, there is no information provided about:
- Sample size used for a "test set."
- Data provenance (country of origin, retrospective/prospective).
The "performance data" provided refers to material characteristics and mechanical equivalence reasoning, not data from patient studies.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. This device is a physical implant, and its regulatory submission is based on material science, mechanical properties, and equivalence to predicate devices, not on the interpretation of medical images or patient data by experts for establishing ground truth in an AI context.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of an AI algorithm or diagnostic performance being evaluated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI device or a diagnostic tool that would typically undergo an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical implant, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this type of device is established through:
- Established Material Standards: Compliance with ASTM F136 for Titanium Alloy and the "long clinical history of safe and effective use" for both titanium alloy and stainless steel.
- FDA Guidance Documents: Adherence to "Guidance for Industry and FDA Staff - Spinal System - 510(k)'s" for mechanical evaluation.
- Predicate Device Performance: The safety and effectiveness of the existing predicate devices (K111525 and K090353) serve as the established "ground truth" or benchmark for demonstrating substantial equivalence. The claim is that the new device is "as safe and effective" as the predicates.
8. Sample Size for the Training Set
Not applicable, as this is not an AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI 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.