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K Number
K073105
Device Name
PEEK SPINAL SPHERES
Manufacturer
INTERBODY INNOVATIONS, LLP
Date Cleared
2008-01-03

(62 days)

Product Code
NVR
Regulation Number
N/A
Type
Special
Panel
OR
Reference & Predicate Devices
K062992,K060415
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.

Device Description

These spheres may be inserted between the vertebral bodies into the disc space from L3 to S1. The Spinal Sphere implants are single use implants and should never be reused under any circumstances. These spheres are available in Ø10-Ø16mm.

Materials: PEEK Optima per ASTM F2026

Function: The Spinal Sphere is a spherical implant designed to hold bone parts in alignment while they heal in order to promote interbody fusion.

AI/ML Overview

The provided text describes a 510(k) summary for PEEK Spinal Spheres but does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a regulatory submission for a medical device seeking clearance to market based on substantial equivalence to existing devices. It focuses on:

  • Device Identification: Trade name, common name, classification, and product code.
  • Predicate Devices: Identification of devices to which the PEEK Spinal Spheres are deemed substantially equivalent.
  • Device Description: Materials (PEEK Optima per ASTM F2026), dimensions (Ø10-Ø16mm), function (to hold bone parts in alignment to promote interbody fusion), and single-use nature.
  • Intended Use/Indications for Use: To be inserted between vertebral bodies (L3-S1) to provide stabilization and promote intervertebral body fusion, used with bone graft.
  • Comparison to Predicate Devices: Stating equivalence in material, design, and indications.
  • FDA Response (Clearance Letter): Affirming substantial equivalence but imposing a labeling limitation regarding motion-sparing, non-fusion procedures.

To answer your request, an actual performance study with defined acceptance criteria would be necessary, which is absent from this 510(k) summary. For devices cleared through the 510(k) pathway, especially those deemed substantially equivalent to a predicate, extensive clinical performance studies demonstrating new acceptance criteria are often not required if the new device is sufficiently similar to an already cleared device. The focus is more on demonstrating that the new device performs as intended and is as safe and effective as the predicate.

Therefore, for each of your points, the answer based solely on the provided text is as follows:

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

    • Not provided. The document does not specify any performance acceptance criteria or report on device performance against such metrics. It states the device's function and intended use.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Not applicable / Not provided. No test set or performance data from a study is mentioned.

  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 / Not provided. No ground truth establishment is described.

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

    • Not applicable / Not provided. No test set or related 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 / Not provided. This device is a physical spinal implant, not an AI-assisted diagnostic tool.

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

    • Not applicable / Not provided. This is not an algorithm-based device.

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

    • Not applicable / Not provided. No ground truth is discussed in relation to device performance. The "ground truth" for a 510(k) device is primarily its substantial equivalence to a legally marketed predicate and its ability to perform its intended function safely.

  8. The sample size for the training set:

    • Not applicable / Not provided. The document does not describe any training sets for an algorithm.

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

    • Not applicable / Not provided. This information is not relevant to the described device.

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