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The uses for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, as part of the legally marketed Osteonics® Spinal System, are as follows:

Non-Pedicular Use; fixation of the T4-S2 spine:

• Long and short curve scoliosis
• Vetebral fracture or dislocation
• Spondylolisthesis
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Previously failed fusion
• Spinal tumor

Pedicular Use:

• When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System bone screws are top loading screws that are threaded distally, have a forked proximal design, and are available in both standard and extended ("extra-long" or "long arm") proximal length configurations. The 5.5mm bone screws will be available in standard and extra-long versions in lengths of 30mm, 35mm, 40mm, and 45mm. The 10.0mm bone screws will be available in one standard version only in lengths from 35mm to 60mm in increments of 5mm.

The provided text is a 510(k) Premarket Notification for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, dated September 25, 1998. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. A 510(k) submission for substantial equivalence primarily relies on comparison to a predicate device, as opposed to demonstrating specific performance against predefined acceptance criteria for novel devices. The "reported device performance" section would typically describe results from clinical trials or specific performance tests with quantitative outcomes, which are absent here.

2. Sample size used for the test set and the data provenance:

This information is not applicable/not provided in the context of this 510(k) submission. There is no mention of a clinical "test set" in the traditional sense, nor any data provenance (country of origin, retrospective/prospective). The submission uses mechanical testing as supporting evidence for substantial equivalence, but details of the mechanical testing are summarized rather than presented as a full study with sample sizes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable/not provided. There is no clinical "test set" requiring ground truth establishment by experts in this submission.

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

This information is not applicable/not provided. There is no clinical "test set" requiring adjudication in this 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:

This information is not applicable. This document describes a medical device (spinal screws), not an AI-assisted diagnostic or treatment system, so MRMC studies are not relevant.

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

This information is not applicable. This document describes a medical device (spinal screws), not an algorithm.

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

This information is not applicable/not provided. Since there is no clinical "test set" or diagnostic algorithm being evaluated, the concept of ground truth in that context is not relevant. The basis for determining "substantial equivalence" is a comparison of design, materials, and intended use with previously cleared predicate devices, supported by mechanical testing.

8. The sample size for the training set:

This information is not applicable/not provided. There is no "training set" mentioned in this submission, as it relates to a physical device rather than a machine learning model.

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

This information is not applicable/not provided. As there is no training set, this question is not relevant.

Summary of the Study (as described in the 510(k) notification):

The "study" presented here is a demonstration of substantial equivalence to previously cleared predicate devices, rather than a clinical trial proving performance against specific acceptance criteria.

The key points of the "study" are:

• Objective: To demonstrate that the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws are substantially equivalent to:
  • Existing bone screws within the Osteonics® Spinal System (cleared via K951725).
  • The Danek TSRH Spinal System (for 5.5mm screws).
  • AcroMed Titanium Bone Screws (for 5.5mm screws).
• Methodology for Substantial Equivalence: Comparison of:
  • Intended Uses: Stated to be substantially equivalent.
  • Material: Osteonics® system and AcroMed screws are made from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Danek TSRH system is made from ASTM F-138-92 Stainless Steel alloy.
  • Design: Stated that the design and function remain unchanged and are substantially equivalent.
  • Supporting Testing Summary: The document mentions "supporting testing summary" but does not elaborate on the specific tests, methodologies, or quantitative results within the provided text. This typically refers to mechanical bench testing, but details are not included.
• Conclusion: Based on the similarities in intended uses, materials (with noted differences that are deemed acceptable), design, and supporting testing summary, the devices are considered substantially equivalent.

Important Note from the FDA Letter:

The FDA's response specifies a limitation on the pedicular use of the device. While the sponsor's intended use listed a broader set of conditions for non-pedicular fixation and then for pedicular fixation, the FDA explicitly restricts pedicular use to severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, with other specific conditions (autogenous bone graft, fixed to lumbar and sacral spine, removed after solid fusion). Any other pedicular use is considered Class III and requires a Premarket Approval (PMA) or an Investigational Device Exemption (IDE). This highlights that while the device was found substantially equivalent, its market clearance came with specific, narrowed indications for pedicular use.

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