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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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The PASS LP Spinal Systems include a pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine:

• Fractures
• Dislocation
• Failed previous fusion (Pseudoarthrosis)
• Spinal stenosis
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Spinal deformations such as scoliosis or kyphosis.
• Loss of stability due to tumors.

The PASS LP Spinal Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also include hooks and rods and sacralitiiac screws indicated for degenerative disc disease (ddd) 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 deformities or curvatures (i.e., scollosis, kyphosis, and/or lordosis), turnor, stenosis. pseudoarthrosis and 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. The PASS LP Spinal System is intended to be used with allografi and/or 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, illac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-SAI-4V ELI) that conforms to ASTM F136 or cobalt-chromiummolybdenum 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. Similarly to the PASS LP implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

Function: The PASS LP was developed as an implant:

• To provide immobilzation and stabilization of posterior spinal segments
• to augment the development of a solid spinal fusion
• to provide stability to ease fusion
• to be mechanically resistant to allow the fusion of the operated level

The provided text describes a 510(k) summary for the MEDICREA® INTERNATIONAL PASS LP Spinal System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of features, rather than a study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested elements regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the non-clinical tests performed to demonstrate mechanical equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The "test set" in this context refers to mechanical testing of components, not a clinical data set. The document states "mechanical testing... was conducted following the ASTM F1717" and "additional components... tested following the ASTM F1798". No specific sample size (number of constructs tested) is provided in the summary.
• Data Provenance: Not applicable in the context of clinical data. The mechanical tests were performed on the device components.

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

• Number of Experts: Not applicable. Ground truth, in the clinical sense, is not established for mechanical testing.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable for mechanical 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

• MRMC Study: No. The document explicitly states: "No clinical studies were performed." This is a regulatory submission for a medical device implant, not an AI diagnostic device.

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

• Standalone Performance: No. This device is a spinal implant, not an algorithm.

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

• Type of Ground Truth: For the mechanical performance, the "ground truth" is adherence to established ASTM standards (ASTM F1717 and ASTM F1798) and comparison to the mechanical performance of previously cleared devices. This is a technical/engineering "ground truth," not a clinical one.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no AI component or machine learning model described as part of this device or its evaluation.

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

• Ground Truth for Training Set Establishment: Not applicable. There is no AI component or machine learning model described.

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