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The DSS™ Stabilization System - Rigid 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 DSSTM Stabilization System - Rigid is intended to be used with autograft and/or allograft.

Note: The Rigid Couplers are for single-level use only. The traditional straight rods are for single- and multi-level use.

The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis).

In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients:

• Who are receiving fusions with autogenous graft only;
• Who are having the device fixed or attached to the lumbar or sacral spine;
• Who are having the device removed after the development of a solid fusion mass.

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSSTM Stabilization System is comprised of a variety of pedicle screw sizes, couplers, and straight rods that act as longitudinal components that are uniquely fitted for each individual case. The pedicle screws, couplers, and straight rods are manufactured from medical grade titanium alloy (Ti6Al4V).

The purpose of this 510(k) is to add multi-level use for the traditional straight rod components of the DSSTM Stabilization System - Rigid.

The provided text is a 510(k) Summary for the DSS™ Stabilization System - Rigid. This document describes a medical device and its substantial equivalence to previously cleared devices. It does not contain information about a study involving human readers or AI assistance. The "study" described is a performance test to demonstrate mechanical equivalence, not clinical performance.

Here's an analysis based on the information provided and what is typically found in a 510(k) for devices like this:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
For this type of device (spinal fixation system), the primary "acceptance criteria" and "device performance" in a 510(k) submission are typically based on mechanical testing per recognized standards (like ASTM F1717) to prove that the new device is functionally equivalent to existing cleared predicate devices. The document explicitly states that "Previous performance testing per ASTM F1717... and comparison to the predicates the DSS™ Stabilization System - Rigid is substantially equivalent to predicate devices." This means the performance of the new device met or exceeded the performance of the predicate devices in these mechanical tests, thus demonstrating substantial equivalence. The predicate devices themselves would have already established their safety and effectiveness through similar mechanical testing and potentially clinical use.

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

• Sample Size: The document does not specify the exact sample size for the mechanical tests. ASTM F1717 generally specifies the number of samples required for each test. For medical device mechanical testing, these are typically small numbers of physical device units (e.g., n=5, n=6, n=10 per test condition) rather than human subjects or data sets.
• Data Provenance: Not applicable in the context of this 510(k). The "data" comes from physical mechanical testing of the device components, not from patient data, and is prospective in the sense that the tests were performed specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This question is not applicable as the "test set" here refers to mechanical performance testing of a physical device, not an AI algorithm evaluated by human experts. The "ground truth" is based on the physical properties and mechanical behavior of the device components under various loads, as measured by standard laboratory equipment and procedures, not expert consensus.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as (3). Mechanical test results are typically objective measurements, not subject to individual expert adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This document pertains to a physical medical device (spinal stabilization system), not an AI algorithm. Therefore, there is no discussion of human readers, AI assistance, or effect size related to AI improvement.

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

• No, a standalone algorithm performance study was not done. This document is for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the device's performance is established by objective measurements from standardized mechanical tests (per ASTM F1717). This involves measuring properties like displacement, load at failure, and fatigue cycles. The "truth" is the physical behavior of the material and design under controlled conditions, not a clinical outcome or expert interpretation.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

• Not applicable. There is no "training set" or corresponding ground truth establishment for a physical device.

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