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The Prase MIS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Prase MIS Spinal System can be used in an open approach and a percutaneous approach. The Prase MIS Spinal System is intended 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 for lordosis)
• Tumor
• Pseudarthrosis
• · Failed previous fusion in skeletally mature patients.

Prase MIS Spinal System consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surqical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy. All products are made of titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) approved for medical use. The implants will be provided non-sterile.

This looks like a 510(k) summary for a medical device (Prase MIS Spinal System). This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, nor does it describe a study involving human readers or AI.

The 510(k) summary focuses on demonstrating substantial equivalence to pre-existing devices through design, material, indications for use, and mechanical testing (ASTM F1717). It states:

• Mechanical Test Results: "The mechanical test results demonstrated that the Pathloc-L MIS Spinal System performs as well as the predicate device." This implies the acceptance criteria for mechanical performance were met, but the specific criteria (e.g., specific load values, deflection limits) and detailed results are not provided in this summary.

Therefore, based only on the provided text, I cannot complete the table or answer most of the questions.

Here's a breakdown of what could be inferred about the mechanical testing mentioned, and the information that is entirely missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The document only mentions "a worst-case, screw construct" for mechanical testing, but the number of constructs tested isn't stated.
• Data Provenance: Not specified, but generally, such bench testing is conducted in a controlled lab environment by the manufacturer or a contracted lab. Neither country of origin nor whether it's retrospective/prospective applies to this type of mechanical bench testing.

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

• Not applicable. This summary describes mechanical bench testing of implants, not a clinical study involving human patients or expert review for ground truth establishment.

4. Adjudication method for the test set

• Not applicable. This summary describes mechanical bench testing.

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. This document describes a spinal implant system and its mechanical performance, not an AI-powered diagnostic device.

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

• No. This document describes a spinal implant system, not an algorithm or software device.

7. The type of ground truth used

• For the mechanical testing, the "ground truth" would be the standards defined by ASTM F1717 and potentially the measured performance of the predicate device. There is no human expert "ground truth" in this context.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is about a physical medical device, not an AI/ML model.

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

• Not applicable. No training set is mentioned.

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