(147 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 I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc contirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These 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.
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. PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.
The device is offered in both Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) and Polyetheretherketone (PEEK). The PEEK implants include tantalum markers for imaging purposes. This interbody device is offered in both sterile (by gamma irradiation) and non-sterile forms.
PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm 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 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 version of this device offers lateral windows for visibility of the autogenous bone graft.
The PERIMETER® Interbody Fusion Device system includes instrumentation that enables the surgeon to implant the devices via either an open or a minimallyinvasive approach (including anterior, lateral, and oblique).
The purpose of this submission is to modify the two piece implant inserter used with PERIMETER® Interbody Fusion Device. The modified design of the subject device does not affect the device's intended use or alter the device's fundamental scientific technology. No changes are being made to PERIMETER® Interbody Fusion Device implants as part of this submission.
This 510(k) submission (K131669) for the PERIMETER® Interbody Fusion Device is for a modification to an existing medical device, specifically the implant inserter, not for a new device requiring extensive clinical trials to prove its effectiveness. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device through non-clinical testing rather than clinical performance acceptance criteria and studies in the traditional sense.
Here's an analysis based on the provided text, addressing your points where applicable:
1. Acceptance Criteria and Reported Device Performance
Note: Since this is a modification to an existing device inserter, the "acceptance criteria" here relate to demonstrating that the modified inserter performs equivalently to, and no worse than, the predicate inserter, and that the overall device (implant + inserter) remains safe and effective.
| Acceptance Criteria (related to device modification) | Reported Device Performance (from non-clinical tests) |
|---|---|
| Mechanical Performance of Modified Inserter: | |
| The modified inserter must securely hold the interbody implant during insertion and impaction, demonstrating equivalent or superior performance to the predicate inserter. | Engineering Assessment and Mechanical Testing: |
| Conducted and "demonstrated that the subject PERIMETER® Interbody Fusion Device, including the modified inserter, is substantially equivalent to the predicate PERIMETER® Interbody Fusion Device." | |
| No Adverse Effect on Implant Performance: | |
| The modification to the inserter should not negatively impact the design, function, or material properties of the PERIMETER® Interbody Fusion Device implants themselves. | No Changes to Implants: |
| "No changes are being made to PERIMETER® Interbody Fusion Device implants as part of this submission." | |
| Material Compatibility and Safety: | |
| Components of the modified inserter should be made from materials with a history of safe and effective use in similar devices. | Stainless Steel Construction: |
| Both subject and predicate implant inserters are constructed of "stainless steels which have a long clinical history of safe and effective use in similar devices." | |
| No Change in Intended Use or Fundamental Scientific Technology: | |
| The modification should not alter the device's fundamental scientific technology or intended use. | No Change in Intended Use/Technology: |
| "The modified design of the subject device does not affect the device's intended use or alter the device's fundamental scientific technology." | |
| "The fundamental scientific technology of the subject PERIMETER® Interbody Fusion Device, including the modified inserter, is identical to the predicate PERIMETER® Interbody Fusion Device." | |
| Failure Modes and Effects Analysis (FMEA): | |
| Potential failure modes associated with the design changes should be analyzed and appropriately addressed. | FMEA Completed: |
| "A failure modes and effects analysis of the design changes was completed in accordance with Medtronic design control procedures." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the mechanical testing. "Mechanical testing" was conducted, implying that a sufficient number of tests were performed to support substantial equivalence, but the exact count is not given.
- Data Provenance: The testing was conducted by Medtronic Sofamor Danek. This is non-clinical bench testing. The data's "country of origin" is implied to be within Medtronic's testing facilities (likely in the USA, where the company is headquartered). The data is not clinical data, so terms like "retrospective or prospective" do not apply in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission is for a device modification validated through engineering assessments and mechanical bench testing, not clinical data requiring expert human interpretation or ground truth establishment. The "ground truth" here is based on engineering principles, material science, and mechanical performance metrics.
4. Adjudication method for the test set
Not applicable for a device modification based on non-clinical engineering and mechanical testing. There are no human "readers" or adjudicators in the context of this type of study.
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
Not applicable. This is a physical interbody fusion device and an inserter tool, with no AI component. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no algorithm.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Engineering principles and design specifications: Ensuring the modified inserter met its functional requirements.
- Material science properties: Verifying the suitability of the materials used.
- Mechanical performance metrics: Quantifiable results from bench testing (e.g., strength, durability, securement force) that demonstrate equivalence to the predicate device.
- Established safety and performance of the predicate device: The fundamental basis for substantial equivalence argues that if the modified device behaves identically (or acceptably similarly) to a previously cleared safe and effective device, then it too is safe and effective.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device or a clinical study that requires a training phase.
9. How the ground truth for the training set was established
Not applicable (as there is no training set).
§ 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.