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The PASS LP Spinal System includes 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: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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, rods 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, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. 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

Here's an analysis based on the provided text:

This document is a 510(k) summary for a medical device called the PASS LP Spinal System. A 510(k) submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed acceptance criteria and clinical performance studies of the type described in the prompt. The provided text primarily focuses on comparing the new device to existing legally marketed predicate devices and outlining the mechanical testing performed.

Therefore, the requested information about acceptance criteria and studies demonstrating that the device (i.e., AI/software) meets these criteria cannot be fully extracted from this document, as it pertains to a mechanical spinal implant system, not a software device.

However, I can extract what is available regarding the mechanical aspects of the device and structure it to the best of my ability according to your request, while highlighting the absence of information relevant to software performance studies.

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

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

• Sample Size: Not specified for the mechanical tests.
• Data Provenance: Not specified, but generally, mechanical testing is performed in a lab setting, not on patient data.

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. This information is for medical device software performance evaluations involving expert interpretation. The provided document describes mechanical testing of a spinal implant.

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

• Not applicable. This information is for medical device software performance evaluations involving expert interpretation. The provided document describes mechanical testing of a spinal implant.

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 MRMC study was done. This device is a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic tool.

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

• Not applicable. This device is a mechanical spinal implant, not an algorithm.

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

• For the mechanical performance, the "ground truth" would be the standards set by ASTM (e.g., F1717, F1798) for mechanical properties and the ASTM F136 standard for titanium alloy material properties. The device's performance is compared against these engineering standards and to the performance of predicate devices.

8. The sample size for the training set

• Not applicable. This document describes a mechanical implant, not a machine learning model that requires a training set.

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

• Not applicable. As above, this is for a mechanical implant, not a machine learning model.

Summary of Device and Study:

The device is the PASS LP Spinal System, an orthopedic implant designed for spinal fixation. This 510(k) submission is for an "Additional components" to the already cleared system, specifically noting the "PASS MIS" product as having the same material and geometry as existing PASS LP devices, but with restrained indications for use.

The "study" or performance data presented focuses on mechanical testing:

• Tests Performed: Static torsion, static and dynamic compression bending (per ASTM F1717), static axial sliding, static torsion, and dynamic flexion/extension (per ASTM F1798).
• Purpose of Testing: To demonstrate that the additional components are "as mechanically sound as other devices commercially available."
• Material Conformance: The device is manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The document does not contain information related to AI/software performance studies, human reader performance, or clinical efficacy trials beyond the statement that mechanical tests were performed to demonstrate mechanical soundness compared to predicates. The 510(k) clearance (K112493) confirms substantial equivalence to the predicate devices based on the information provided, including the mechanical testing.

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