(28 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 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. The PERIMETER® Interbody Device is to be used with supplemental instrumentation. The device is offered in Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) or PEEK Optima LT1 (Polyetheretherketone). This interbody device is offered in sterile (PEEK) or non-sterile (PEEK and Titanium Alloy) forms. The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 21mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum-4 Vanadium EL.I) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone graft.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, though it's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for a device that relies on an AI algorithm.
This document describes a medical device (Interbody Fusion Device) that does not involve an AI algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation will not be applicable. The study performed here is a non-clinical validation for a labeling change.
Therefore, for aspects related to AI (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies), the answer will be "Not applicable" or "No AI component in this device."
Acceptance Criteria and Device Performance for PERIMETER® Interbody Fusion Device (K132700)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description | Reported Device Performance/Evidence |
|---|---|---|
| Substantial Equivalence | The device must be demonstrated to be substantially equivalent to previously legally marketed predicate devices in terms of indications for use, intended use, fundamental scientific technology, design, and material. | The PERIMETER® Interbody Fusion Device is stated to have the "same indications, intended use, fundamental scientific technology, design and material as the previously FDA cleared predicates; PERIMETER® Interbody Fusion Device K111525 (S.E. 08/24/2011) and K090353 (S.E. 09/29/2009)." The only change in the application is a modification to the labeling. |
| Labeling Modification | The modified labeling must be confirmed as appropriate and supported by validation. This implies that the changes in labeling accurately reflect the device's capabilities and do not introduce new risks or alter the intended use. | "This modified labeling has been confirmed for the subject device by surgeons performing the procedure on cadavers. Data from this confirmatory validation supports the labeling modification." "Validation and risk analysis were completed for the labeling change." |
| Device Integrity/Function | While not explicitly stated as "acceptance criteria" but implied for any medical device, the device must be able to perform its intended function of providing support and correction during lumbar interbody fusion surgeries, maintaining grip on end plates, and being compatible with autogenous bone graft. Its physical properties (sizes, materials, lordosis options) must be suitable for the indications for use. | The device is offered in various sizes (8-20mm height, 21-28mm length, 19-38mm width, 4-15 degrees lordosis), made of Titanium Alloy or PEEK Optima LT1, and designed with teeth for expulsion resistance. The hollow geometry allows for bone graft. The device is intended for interbody fusion with autogenous bone graft in patients with DDD at L2-S1. These functionalities are assumed to be met due to substantial equivalence to predicates. |
| Safety and Effectiveness | The device must be safe and effective for its indicated use, not posing unacceptable risks to patients. For a 510(k), this is largely established by demonstrating substantial equivalence to a predicate device that has already been deemed safe and effective. The minor labeling change should not negatively impact safety or effectiveness. | The FDA's issuance of a substantial equivalence determination letter indicates that the device is deemed safe and effective for its intended use, based on its comparison to predicate devices and the validation of the labeling change. "Medtronic believes that the subject device is substantially equivalent to the predicate device." |
Study Information (Pertaining to non-clinical validation for labeling change)
Since this document describes a conventional medical device (an interbody fusion implant) and not an AI/ML-driven device, many of the AI-specific questions are not applicable.
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Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a number of "samples" in the context of an AI test set. The validation involved "surgeons performing the procedure on cadavers." The number of cadavers or procedures is not specified.
- Data provenance: Cadaveric testing. The country of origin is not specified, but the applicant is based in Memphis, Tennessee, USA. This was a non-clinical, prospective evaluation of the labeling change using cadavers.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: "Surgeons" (plural) were involved. The exact number is not specified.
- Qualifications of experts: Implied to be medical professionals qualified to perform spinal fusion procedures. No specific years of experience or sub-specialty are explicitly stated in this summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of an AI-driven "test set" and ground truth adjudication. The validation appears to be a direct confirmation by surgeons that the modified labeling aligns with their practical experience during cadaveric procedures. There's no indication of a consensus-based adjudication process for a binary or categorical ground truth.
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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. This was not an AI-assisted device, and therefore no MRMC study comparing human readers with and without AI assistance was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device does not have an algorithm component.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the practical confirmation by surgeons during cadaveric procedures that the modified labeling accurately reflects how the device is used and its features. It's a pragmatic validation against expert surgical practice rather than a diagnostic "truth" like pathology.
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The sample size for the training set:
- Not applicable. There is no AI algorithm being developed or trained for this device.
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How the ground truth for the training set was established:
- Not applicable. There is no AI algorithm being developed or trained for this 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.