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The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolistis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP, with the addition of new components: 'Dominoes & Iliac Connectors'.

The provided document is a 510(k) premarket notification for the "OLYMPIC Posterior Spinal Fixation System" (K182239) and later references the "PASS LP Spinal System" (K182240). It appears that these are related or the K182240 is meant to be the direct subject of the 510(k) summary. I will answer based on the information provided for K182240, as that is where the performance data is detailed.

The document does not describe an acceptance criteria table with reported device performance for an AI/ML powered device. Instead, it details the substantial equivalence of a spinal fixation system to predicate devices based on biocompatibility and mechanical testing. The questions asked are typically relevant to the evaluation of AI/ML software.

However, I will extract the information that is present concerning performance testing for the spinal fixation system, even though it doesn't align with the AI/ML focus of the prompt's questions.

Here's the closest interpretation of the prompt's questions based on the provided text:

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

The document does not provide a formal "acceptance criteria" table with specific quantitative thresholds. Instead, it states that the performance data "indicate that the products are substantially equivalent as other devices commercially available."

Here's a table based on the types of tests performed and the general conclusions:

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

• Sample Size: Not explicitly stated for either biocompatibility or mechanical testing. Biocompatibility tests are typically performed on material samples, and mechanical tests on a set number of device samples according to the standard.
• Data Provenance: Not specified.

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

This question is not applicable. For a spinal fixation system, ground truth (e.g., successful fusion, mechanical integrity) is established through standardized testing (biocompatibility, mechanical tests) rather than expert consensus on a test set.

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

Not applicable. Adjudication methods are typically for subjective assessments, which are not described here.

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. This is not an AI-assisted device. The document explicitly states "No clinical studies were performed." and "No animal studies were performed."

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for this device's performance is based on:

• Standardized Material Properties: Conformance to ASTM F136 and ISO 5832-3 for titanium alloy.
• Standardized Biocompatibility Testing: Results of tests (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) against recognized international standards (ISO 10993).
• Standardized Mechanical Testing: Performance against ASTM F1717-15 for static axial compression, static torsion, and dynamic axial compression. The implicit ground truth is that the device should meet or exceed the performance of predicate devices as outlined by these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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