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The following are specific indications for the Osteonics® Spinal System:

For non-pedicular fixation of the T4-S2 spine:

• Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis) .
• . Vertebral fracture or dislocation
• . Spinal stenosis
• Spondylolisthesis ●
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by patient history and radiographic studies).
• . Previously failed fusion
• . Spinal tumor

For pedicular use:

• Additionally, 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 cylindrical bone screws will be available in standard and extra-long versions in lengths and diameters identical to the predicate top loading tapered screws.

This document is a 510(k) Premarket Notification for the Osteonics® Spinal System Cylindrical Bone Screws. It's a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving performance against acceptance criteria for a novel device. Therefore, a direct answer to your request in the format provided is not fully applicable as the document does not contain a study with acceptance criteria and device performance in the way you've outlined for a new device's validation.

However, I can extract the relevant information from the document to address aspects of your request within the context of a 510(k) submission for substantial equivalence.

Here's an analysis based on the provided text, outlining why some requested information is not present in this type of document and what can be inferred:

Key Takeaway: The provided document is a 510(k) submission, whose primary goal is to demonstrate "substantial equivalence" of a modified device (cylindrical bone screws) to an existing, legally marketed predicate device (tapered bone screws within the same Osteonics® Spinal System), not to establish novel performance against clinical acceptance criteria through a new study.

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable in this format: A 510(k) submission for substantial equivalence typically does not present new acceptance criteria and reported device performance in the way a clinical trial or performance study for a novel device would. The core "acceptance criteria" here are that the modified device demonstrates substantial equivalence to the predicate device in terms of intended use, materials, design, and safety/effectiveness.
• Inferred Performance: The document states: "The function of the modified spinal system bone screws remains unchanged and is identical to that of the predicate Danek TSRH bone screws." This is the core "performance" claim for a 510(k) – that the new device performs equivalently to the predicate. The "study" here would be the comparative analysis outlined in the submission.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable (Clinical Study): This document does not describe a clinical "test set" in the sense of a patient cohort for a performance study.
• Inferred "Test": The "test" in this context refers to the comparison of the cylindrical bone screws with the tapered predicate screws. This comparison is based on design parameters, material specifications, and intended uses. The "sample size" would effectively be "one" (the modified cylindrical bone screw design) compared against "one" (the predicate tapered bone screw design).
• Data Provenance: Not applicable for a clinical study. The data provenance would relate to the design specifications, material testing (if new), and intended use statements.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: There is no mention of experts establishing a "ground truth" for a clinical test set because a clinical performance study (as you might see for a diagnostic AI device) was not conducted or reported here.
• Inferred Experts: The "experts" involved are likely the engineering and regulatory teams at Osteonics® who designed the device and prepared the submission, and later, the FDA reviewers who assessed the submission for substantial equivalence. Their qualifications are inherent in their roles, but not explicitly stated as "experts for ground truth."

4. Adjudication Method for the Test Set

• Not Applicable: No clinical test set or adjudication method is described. The "adjudication" in this regulatory context is the FDA's review and decision on substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Conducted/Applicable: This is not a study type relevant to the submission of a medical implant (bone screws) for substantial equivalence. MRMC studies are typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. There is no AI component here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Conducted/Applicable: This concept is not relevant to bone screws. There is no algorithm or AI component in this device.

7. Type of Ground Truth Used

• Not Applicable (Clinical): There isn't a "ground truth" derived from patient data, pathology, or outcomes in the traditional sense of a clinical performance study.
• Inferred "Ground Truth": The "ground truth" for this submission is the established safety and effectiveness of the predicate device (the tapered bone screws within the Osteonics® Spinal System) and the regulatory framework that dictates how substantial equivalence is demonstrated. The ground truth relies on the assertion that the design changes (cylindrical vs. tapered) do not alter the fundamental function, safety, or effectiveness when compared to the predicate, as evidenced by engineering principles, material science, and the lack of new risks.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/ML device or a device requiring a clinical training phase as part of its development.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As there is no training set, this question is not relevant.

Summary of Information from the Text Regarding Substantial Equivalence:

The "study" in this context is the comparison presented in the 510(k) to demonstrate substantial equivalence.

• Acceptance Criteria for Substantial Equivalence:
  • Intended Uses: Must be identical to the predicate device.
  • Material: Must be identical or equivalent (same medical-grade titanium alloy, ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI)).
  • Design: Changes (cylindrical vs. tapered) must not introduce new questions of safety or effectiveness and the fundamental function must remain unchanged.
• Reported Device "Performance" (Comparison to Predicate):
  • Intended Uses: "The intended uses of the subject bone screws are identical to those of the predicate bone screws."
  • Material: "The Osteonics® Spinal System is manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI)." (Implied identical to predicate).
  • Design: "The design of the modified cylindrical bone screw differs from the predicate bone screw in that the modified bone screw distal diameter is the same as the proximal diameter. The function of the modified spinal system bone screws remains unchanged and is identical to that of the predicate Danek TSRH bone screws."

This 510(k) submission successfully argued substantial equivalence based on these points, leading to FDA clearance (K984302).

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