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K Number
K111569
Device Name
PLATEAU SPACER SYSTEM
Manufacturer
LIFE SPINE
Date Cleared
2011-07-06

(30 days)

Product Code
MAX
Regulation Number
888.3080
Type
Special
Panel
OR
Reference & Predicate Devices
K080411,K073291,K081177
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.

Device Description

The 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 tantalum 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 Plateau Spacer System components with components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.

AI/ML Overview

This 510(k) summary describes a spinal implant (PLATEAU Spacer System) which is a physical device, not an AI/software as a medical device (SaMD). Therefore, the concepts of acceptance criteria for algorithm performance, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance as typically applied to SaMDs are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving performance against quantitative acceptance criteria for AI model outputs, the submission aims to show that the new device shares the same intended use, materials, basic design, and fundamental technology as previously cleared devices.

Here's an analysis based on the provided text, reinterpreting some of your questions in the context of a physical medical device submission:

  1. A table of acceptance criteria and the reported device performance

    In the context of a physical device 510(k) submission seeking substantial equivalence, acceptance criteria are generally not quantitative performance metrics for a novel algorithm. Instead, the "acceptance criteria" are demonstrating equivalence to predicate devices across key characteristics. "Reported device performance" would refer to how the device aligns with these characteristics.

    Acceptance Criterion (for Substantial Equivalence)Reported Device Performance
    Intended Use (same as predicate)"The additional sizes fall within the range of sizes offered in the predicate systems. Additionally they have the same intended use..."
    Material (same as predicate)"...material..." (PEEK-OPTIMA LT1 with tantalum/titanium markers, compliant with ASTM F2026)
    Basic Design (same as predicate)"...and basic design as the predicate systems." (Intervertebral body fusion device, hollow for bone graft, with teeth)
    Performance (no new worst-case scenario due to added sizes)"Information has been presented to show that the addition of sizes to the system do not impose a new worst case scenario..."

  2. Sample sizes 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 a study involving data for an AI model. The "test set" here would conceptually be a comparison to the predicate devices themselves, rather than a dataset. The document doesn't detail any specific 'test' data provenance for the physical device, beyond general material and design specifications.

  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. Ground truth for an AI model is not relevant here. The "ground truth" for a physical medical device's substantial equivalence is its conformity to established standards, materials, and designs, as assessed by engineering and clinical experts within the manufacturing company and subsequently by the FDA reviewers.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable for a physical device submission.

  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 device is a physical implant, not an AI system or diagnostic tool that would involve human readers or AI assistance.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This device is a physical implant, not an algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    For a physical device 510(k) submission, the "ground truth" for proving safety and effectiveness (as demonstrated through substantial equivalence) is typically based on:

    • Material specifications and testing: Adherence to standards like ASTM F2026.
    • Biocompatibility data: Established for the PEEK-OPTIMA LT1 material.
    • Mechanical testing: To ensure the implant can withstand anticipated physiological loads and that new sizes don't introduce new worst-case scenarios. (General statement in the document: "Information has been presented to show that the addition of sizes to the system do not impose a new worst case scenario...").
    • Clinical history of predicate devices: The track record of similar devices already on the market forms the basis for demonstrating safety and effectiveness without requiring new clinical trials for minor modifications.

  8. The sample size for the training set

    Not applicable. This is not an AI model.

  9. How the ground truth for the training set was established

    Not applicable. This is not an AI model.

§ 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.