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The DSSTM Stabilization System - Rigid Coupler is intended for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid Coupler is intended to be used with autografl and/or allograft.

The DSS™ Stabilization System – Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back opin of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal sterensis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

The DSS™ Stabilization System is comprised of a variety of pedicle screws and Rigid Couplers that act as longitudinal spacers. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion.

The DSS™ Stabilization System consists of:

• DSS™ pedicle screw sets .
• DSS™ Rigid Couplers .

The DSS™ Stabilization System is fabricated from wrought Ti-6AI-4V (ISO 5832-3 and ASTM F136).

The provided text is a 510(k) Summary for the DSS™ Stabilization System - Rigid Coupler, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or performance metrics through a standalone clinical study.

Therefore, the input does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, or adjudication methods for ground truth, as these are typically part of a de novo classification or a Premarket Approval (PMA) application requiring clinical trial data.

Based on the provided text, here's what can be extracted and what cannot:

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

• Not available: The document asserts substantial equivalence to predicate devices based on "the same indications for use, design, function, and materials used." It does not define specific performance acceptance criteria or report quantitative device performance data against such criteria. The "Performance Standards" section only states that "Testing performed indicates the DSS™ Stabilization System is substantially equivalent to predicate devices."

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

• Not available: No test set or clinical study data is mentioned in this 510(k) summary. The equivalence is based on design, materials, and established predicate devices, not on a new clinical performance study.

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 available: As no test set from a clinical study is described, there's no mention of experts or ground truth establishment.

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

• Not applicable/Not available: No test set or clinical study 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 available: This device is a pedicle screw spinal system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant.

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

• Not applicable/Not available: This device is a physical implant, not an algorithm.

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

• Not applicable/Not available: No clinical study or ground truth establishment is described. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable/Not available: No training set for an algorithm is relevant to this device submission.

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

• Not applicable/Not available: No training set is relevant.

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

The "study" presented in this 510(k) is a substantial equivalence comparison to legally marketed predicate devices. The manufacturer, Paradigm Spine, LLC, sought to demonstrate that their DSS™ Stabilization System - Rigid Coupler is as safe and effective as existing devices.

• Methodology: The comparison focused on general characteristics like indications for use, design, function, and materials used.
• Predicate Devices: Four predicate devices were identified:
  • DePuy MOSS Miami (K962628)
  • Biomet Synergy VLS Open (K973836)
  • Synthes Pangea (K052123)
  • Zimmer Silhouctte (K993067)
• Materials: The DSS™ Stabilization System is fabricated from wrought Ti-6AI-4V, which is a standard material (ISO 5832-3 and ASTM F136).
• Performance Standards (Testing): The document states that "Testing performed indicates the DSS™ Stabilization System is substantially equivalent to predicate devices." While this implies some form of engineering or mechanical testing was conducted, the specifics (e.g., specific test methods, number of samples, pass/fail criteria, or detailed results) are not provided in this summary. The "tests" would likely relate to mechanical properties, fatigue, and other biomechanical assessments required for spinal implants to ensure they meet established standards and are comparable to predicate devices.

In essence, the "acceptance criteria" here is the FDA's determination of substantial equivalence, which is based on a comparison to predicate devices rather than independent, quantitative performance metrics from a new clinical study.

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