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The PASS OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the PASS OCT Spinal System may be connected to the PASS LP Spinal System rods with the dual diameter rods. Refer to the PASS LP Spinal System package insert for a list of the PASS LP Spinal System indications of use.

The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.

The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.

The provided document is a 510(k) premarket notification for a medical device called the "PASS OCT Spinal System." This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies as one might find for novel drug or high-risk device approvals.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment is largely not present in this type of FDA submission. The provided text primarily addresses material specifications, intended use, and comparison to predicate devices, along with some mechanical testing information.

Here's an attempt to answer your questions based only on the provided text, highlighting what is available and what is not:

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

The document does not explicitly present a table of acceptance criteria for the device itself or reported performance outcomes in terms of clinical efficacy or diagnostic accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if it is equivalent, it meets the same implicit performance standards.

The only "performance" mentioned is in the "Non-clinical Test Summary":

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

For the non-clinical mechanical testing, the sample size is not specified. The provenance is also not specified, beyond the fact that Medicrea International S.A. is based in France. This was a non-clinical, in-vitro test, not human 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)

This is not applicable as the described "study" is a non-clinical mechanical test, not a study involving human subjects or requiring expert interpretation of results for ground truth.

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

This is not applicable as the described "study" is a non-clinical mechanical test that does not involve expert 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

The document explicitly states: "No reference devices were used in this submission." and later, under "8. Clinical Test Summary": "Published literature was used to demonstrate substantial equivalence." This indicates that neither a clinical trial nor an MRMC study was conducted by the applicant for this submission. The device is a spinal implant, not an AI-based diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

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

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

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

For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and performance requirements outlined in the ASTM F2706-08 standard. It's a pass/fail against established mechanical properties, not a biological or clinical ground truth.

8. The sample size for the training set

This is not applicable. No training set is mentioned as this is a medical device approval and not a machine learning model.

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

This is not applicable. No training set is mentioned.

Summary of what is available from the document regarding acceptance criteria and studies:

• Acceptance Criteria for Device (Implicit): Substantial equivalence to predicate spinal systems (Vertex Reconstruction System, Virage OCT Spinal Fixation System, and a previous version of the PASS OCT Spinal System). This implies meeting the safety and performance characteristics of those already cleared devices.
• Specific Performance Criterion (Mechanical): Conformity to ASTM F2706-08 for dynamic compression tests.
• Study: A non-clinical, in-vitro mechanical evaluation.
• Sample Size (Mechanical Test): Not specified.
• Clinical Data: No new clinical studies were conducted by the applicant. Substantial equivalence was demonstrated through comparison to legally marketed predicate devices and reliance on published literature (though the specific literature isn't detailed).

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