(245 days)
The Small PLATEAU (PLATEAU-C) 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 (PLATEAU-C) 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 either Titanium (Ti-6AI-4V ELI) or 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 (PLATEAU-C) Spacer System components with components from any other system or manufacturer. The Small PLATEAU (PLATEAU-C) Spacer System components should never be reused under any circumstances.
This document is a 510(k) premarket notification for a medical device called "The Small PLATEAU® (PLATEAU-C) Spacer System," an intervertebral body fusion device. The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy or clinical effectiveness in the way one would describe for an AI/ML powered device.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device that was on the market before May 28, 1976 (or has been reclassified). For devices cleared via 510(k), clinical studies demonstrating effectiveness in the same way as an AI/ML device are often not required if substantial equivalence can be shown through other means.
Therefore, most of your requested information (related to acceptance criteria for AI/ML performance, study details, expert ground truth, adjudication, MRMC studies, standalone performance, and training data) is not applicable to this type of regulatory submission.
Here is what can be extracted from the document based on your request, with an explanation of why other parts are not available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document pertains to a physical intervertebral body fusion device, not an AI/ML system with quantifiable performance metrics like accuracy, sensitivity, or specificity. The "performance data" mentioned refers to the mechanical and design characteristics demonstrating substantial equivalence, not clinical efficacy or diagnostic performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not an AI/ML device that was evaluated on a "test set" of data. The submission relies on engineering rationale and finite element analysis (FEA) to compare its mechanical properties to a predicate device, as well as similarity in design, materials, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There was no "test set" requiring ground truth establishment by experts for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication was described for this device.
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 not an AI-assisted device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth, in the context of diagnostic/AI performance, was used. The ground for substantial equivalence is based on regulatory standards for design, materials, and mechanical testing.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
Summary of Device and Evidence Presented (as per the document):
- Device Name: The Small PLATEAU® (PLATEAU-C) Spacer System
- Device Type: Intervertebral Body Fusion Device
- Regulatory Classification: Class II, Product Code ODP, 21 CFR 888.3080
- Intended Use: Spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1), to be used with autogenous bone graft and a supplemental internal spinal fixation system.
- Materials: Titanium (Ti-6AI-4V ELI) or Polyetheretherketone (PEEK-OPTIMA LT1) with radiographic markers.
- Predicate Device: Small PLATEAU (PLATEAU-C) Spacer System (K111835) and Titan Spine Endoskeleton TC IBF (K100889)
- Evidence for Substantial Equivalence:
- Comparison of design, materials, indications for use, and sizing to predicate devices.
- Performance Data: Finite element analysis and engineering rationale were presented to demonstrate substantial equivalency in terms of mechanical performance.
The FDA's review letter indicates that the device was found substantially equivalent based on these submissions, allowing it to be marketed. This clearance process does not involve clinical trials demonstrating improved patient outcomes or diagnostic performance in the way an AI/ML device would.
§ 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.