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The PASS LP Spinal System includes a pedicle system intended to provide 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 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 is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having, implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also includes hooks and sacral/iliac 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 stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, 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 allograft 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, 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 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: "Monoaxial Pedicle Screws' and 'Rod Connectors'.

The provided text is a 510(k) summary for the PASS LP Spinal System, which is a premarket notification to the FDA for a medical device. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The document states that no clinical studies, animal studies, or performance data in the context of acceptance criteria demonstrating device performance were conducted or provided in support of substantial equivalence beyond biocompatibility and mechanical testing. The submission relies on the substantial equivalence principle, meaning the device is similar enough to an already approved device that it does not raise new questions of safety and effectiveness.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document because a traditional comparative effectiveness study or controlled clinical trial, as implied by your request, was not performed for this 510(k) submission.

However, I can extract the information that is present:

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

This information is not provided in the document as no specific acceptance criteria for a clinical or performance study are detailed, nor is there reported device performance against such criteria. The document states "no clinical studies were performed."

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

Not applicable. No test set (in the context of clinical or performance data against specific criteria) was used for this 510(k) submission.

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):

Not applicable. No ground truth was established for a test set as no clinical or performance study was conducted.

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

Not applicable. No test set required 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:

Not applicable. No MRMC study was conducted. The device is a spinal implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is a spinal implant, not an algorithm or AI device.

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

Not applicable. No ground truth for a clinical study was required or established.

8. The sample size for the training set:

Not applicable. This is a spinal implant, not a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of available "Performance Data" and "Acceptance Criteria" type information from the document:

The "Performance Data" section (Page 7) describes the types of testing that were performed to support the substantial equivalence:

• Biocompatibility Testing:

  • Tests Performed: Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Pyrogen Testing.
  • Standards Followed: FDA blue book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995," and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
  • Device Classification for Biocompatibility: Defined as an implantable device in contact with tissue and bone, with permanent contact.
  • Material Conformance: Ti-6Al-4V ELI, following standards ASTM F136 and ISO 5832-3 for chemical composition.
  • Acceptance Criteria (Implied): Conformance to the cited standards and demonstration of biocompatibility (i.e., no adverse findings in the specified tests).

• Mechanical Testing:

  • Tests Performed: Dynamic axial compression according to ASTM F1717 (when applicable to the new components).
  • Acceptance Criteria (Implied/Stated Performance): The products are "as mechanically sound as other devices commercially available." This is a comparative statement rather than a specific numeric acceptance criterion.

This 510(k) submission primarily establishes substantial equivalence based on the device's similarity in design, materials, intended use, and mechanical/biocompatibility performance to a previously cleared predicate device, rather than through new clinical performance studies with specific acceptance criteria that would typically be seen in a de novo or PMA submission for a novel device.

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