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The Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required.

The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.

The Southern Anterior Screw Fixated Cage (SASCA) is intended to treat pain and functional disorders of the lumbar spine by supporting, stabilizing, and immobilizing the affected segment and facilitating fusion. The SASCA devices are stand-alone devices offered in a variety of sizes to accommodate individual patient anatomy. The SASCA cages are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The fixation screws are manufactured from Ti-6A1-4V per ASTM F136. Note: The subject SASCA device is also labeled in markets outside the United States as the Sasca 2 Anterior Lumbar Standalone Fusion Cage.

The provided text describes a 510(k) summary for the Southern Anterior Screw Fixated Cage (SASCA), an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting clinical study data for device performance against specific acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria, study design, ground truth, and human reader performance are not applicable in this context, as they would typically be found in a clinical study report for novel devices or those requiring higher levels of evidence.

However, I can extract the information that is present in the document.

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

The document does not specify quantitative acceptance criteria in the way one would for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, it states that the device's performance was evaluated through non-clinical mechanical testing, and the "results of this non-clinical testing show that the strength of the SASCA is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the 'acceptance criterion' was essentially meeting or exceeding the performance of the predicate device in these mechanical tests.

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

This information is not applicable as the provided document describes non-clinical mechanical testing, not a clinical study involving a "test set" of patients or data provenance in that sense. The tests were performed on prototypes of the SASCA devices.

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)

This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for clinical studies, especially those involving image interpretation or diagnostic accuracy. The submitted document focuses on mechanical engineering performance.

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

This information is not applicable as there was no clinical test set requiring 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

This information is not applicable. This submission is for an intervertebral fusion device, not an AI-assisted diagnostic tool.

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

This information is not applicable. This is for a spinal implant, not an algorithm.

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

This information is not applicable. The "ground truth" for mechanical testing is established by the specifications of the ASTM standards and validated testing methodologies, not clinical ground truth methods.

8. The sample size for the training set

This information is not applicable. There is no "training set" in a mechanical testing scenario.

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

This information is not applicable. There is no "training set" or establishment of ground truth in the context of mechanical testing.

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