(20 days)
The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.
The Small PLATEAU Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with radiographic markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Small PLATEAU Spacer System components with components from any other system or manufacturer. The Small PLATEAU Spacer System components should never be reused under any circumstances.
The provided 510(k) summary for the "Small PLATEAU® Spacer System" does not describe an acceptance criteria or a study proving that the device meets specific performance criteria in the way typically associated with AI/ML medical devices. This document is for a medical implant (an intervertebral body fusion device), not a diagnostic or prognostic algorithm.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to the information contained in this submission.
The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than to prove specific performance metrics against pre-defined acceptance criteria through a clinical study.
Here's an analysis based on the information provided, highlighting the non-applicability of certain requests:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: |
- Same intended use
- Same material
- Basic design consistency
- No new worst-case scenarios presented | The Small PLATEAU Spacer System was shown to be substantially equivalent to previously cleared devices in:
- Indications for use
- Design
- Function
- Materials used
(Specifically, the submission aims to add additional sizes within the range of sizes offered by predicate systems and does not present a new worst case.) |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission focuses on demonstrating substantial equivalence of a physical implant by comparing its characteristics and design to legally marketed predicate devices, not on evaluating an algorithm's performance on a test dataset. The "Test Data" section refers to data intended to show that a new worst case is not being presented, which typically involves engineering or biomechanical testing, not a clinical test set for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set with ground truth established by experts is described in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication is described.
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 intervertebral fusion device, not an AI/ML diagnostic tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of an algorithm's "ground truth." The "truth" in this context is the safety and effectiveness profile of the predicate devices against which substantial equivalence is claimed. The "predicate devices" serve as the established "ground truth" for material, design, and intended use.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this type of medical device submission.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or ground truth establishment in the context of an algorithm for this device.
Summary of the Study/Evidence Presented:
The "study" in this context is a comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial or algorithm validation study.
The crucial information provided in the "Test Data" and "Characteristic Comparison" sections indicates:
- Objective: To add additional sizes to an existing cleared system (PLATEAU Spacer System, K093043) and demonstrate substantial equivalence.
- Methodology: Comparison of the new sizes and the Small PLATEAU Spacer System to predicate devices (Plateau Spacer System K093043 and DePuy Bengal System K081917) based on:
- Indications for Use
- Design
- Function
- Materials used (PEEK-OPTIMA LT1, 6-4 Alloy Titanium or unalloyed Tantalum markers)
- Focus: The submission argues that the new sizes fall within the range of the predicate systems, share the same intended use, material, and basic design, and that "a new worst case is not being presented." This implies that prior testing (e.g., mechanical, biocompatibility) on the predicate devices sufficiently covers the new sizes, or appropriate engineering analyses were performed to confirm that the new sizes do not introduce new risks.
In essence, the "study" is a regulatory comparison analysis designed to satisfy the 510(k) requirement for substantial equivalence, not a clinical trial to establish novel performance metrics.
§ 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.