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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 posterical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System 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, 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 cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System 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 Spinal System, with the addition of new components: Polyaxial Cannulated Pedicle Screws.

The provided text is a 510(k) Summary for a medical device (PASS LP Spinal System) and does not contain information about the acceptance criteria and a study proving the device meets those criteria in the way a performance study for an AI/ML diagnostic device usually would.

This document describes a premarket notification for a spinal implant system, which is a physical device, not an AI/ML algorithm. Therefore, the typical "acceptance criteria" and "performance study" as they pertain to AI/ML diagnostic tools (e.g., sensitivity, specificity, AUC, human reader improvement) are not applicable here.

Instead, the performance data provided focuses on:

• Biocompatibility Testing: Ensuring the materials are safe for use in the human body.
• Mechanical Testing: Demonstrating the structural integrity and strength of the physical components.

Here's an analysis of the provided information based on the typical categories for AI/ML device performance, highlighting why much of it is not present in this physical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "No clinical studies were performed. No animal studies were performed." for this 510(k) submission, as it relies on substantial equivalence to predicate devices for its intended use.

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

• Not Applicable: This pertains to an AI/ML algorithm trained and tested on data. The PASS LP Spinal System is a physical implant. The biocompatibility and mechanical tests are performed on materials and components, not a "test set" of patient data.

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

• Not Applicable: Ground truth establishment by experts is relevant for AI/ML diagnostic devices. For a physical spinal system, the safety and performance are assessed through laboratory and material testing against established engineering standards (ASTM, ISO).

4. Adjudication method for the test set

• Not Applicable: Adjudication is for resolving discrepancies in expert interpretations for AI/ML ground truth.

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: An MRMC study is for evaluating human performance with and without an AI diagnostic aid. This device is a physical implant.

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

• Not Applicable: Standalone performance refers to an AI algorithm's diagnostic accuracy without human interaction. This is a physical device.

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

• For the physical device, the "ground truth" for its safety and efficacy is established through a combination of:
  • Adherence to Material Standards: Conformance to ASTM F136 and ISO 5832-3 for titanium alloy and ISO 5832-12 and ASTM F1537 for cobalt-chromium molybdenum alloy.
  • Biocompatibility Testing Standards: Following FDA Memorandum #G95-1 and ISO 10993-1.
  • Mechanical Testing Standards: Specific ASTM standards (F543 for pull-out, F2193 for static torsion and bending).
  • Substantial Equivalence: The primary basis for this 510(k) clearance is that the device is substantially equivalent to previously cleared predicate devices (K141398 and K112493) in terms of indications for use, design, material, and function. The "ground truth" for its clinical safety and effectiveness is inferred from the established track record of these predicate devices.

8. The sample size for the training set

• Not Applicable: This device is not an AI/ML algorithm that requires a training set.

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

• Not Applicable: There is no training set for this physical device.

Summary for the provided document:

The document describes the PASS LP Spinal System, an orthopedic implant. The "performance data" section in this 510(k) summary focuses entirely on the biocompatibility of the materials and the mechanical strength of the components, tested against established industry standards. The submission relies on substantial equivalence to predicate devices. The concepts of acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and training sets are specific to AI/ML diagnostic software and are not applicable to this type of device submission.

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