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The Kentrospine PSS Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with following indications: degenerative disc disease (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 stenoss; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.

The Kentrospine PSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of PSS Pedicle Screws (Monoaxial, polyaxial), PSS Rods, PSS Locking Cap, and a PSS Crosslink Connectors.

The Kentrospine PSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Kentrospine PSS Pedicle Screw System components are supplied non-sterile, single use and are made from medical grade. biocompatible Titanium alloy (Ti6Al4V ELI) conforming to ASTM F136-13(2021)- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. Various sizes of these implants are available.

The PSS Pedicle Screws are available in diameters from Ø4.50mm to Ø7.00mm and in lengths of 25mm to 55mm. PSS Rods are straight, made from titanium and available in 05.50mm diameter with length from 45mm, 55mm, 65mm, 75mm, 85mm, 100mm, 125mm, 200mm, 250mm, 300mm, 350mm, 450mm and 500mm.

Specialized instruments are available for the application and removal of the Kentrospine PSS Pedicle Screw System. The instruments are made from SAE 316L stainless steel which is complied with ASTM F899 - 20 Standard Specification for Wrought Stainless Steels for Surgical Instruments.

The provided document, an FDA 510(k) summary for the Kentrospine PSS Pedicle Screw System, describes the device's technical specifications, indications for use, and a comparison to a predicate device. However, it explicitly states, "No clinical studies were performed." This means there is no data presented in this document regarding the device's performance in a clinical setting with human subjects, nor any studies that address the performance of an AI algorithm or human-AI teaming.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria, as this document relates to a physical medical implant (pedicle screw system) and not an AI/software as a medical device (SaMD).

Specifically, the document states:

• "No clinical studies were performed." (Page 6, section "2. Clinical Performance Data/Information")
• The "Performance data" section (Page 6) focuses solely on non-clinical performance, referring to mechanical testing like static compression bending, static torsional testing, static tension bending, and fatigue compression testing against ASTM standards. These tests are relevant for the structural integrity and durability of a physical implant, not the performance of a diagnostic or assistive AI.

To directly answer your prompt based on the provided text, the answer to most of your questions is "Not applicable" or "No information provided" because the document is about a physical medical device (spinal implant) and explicitly states that no clinical studies were performed.

Here's a breakdown of why each specific point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The "performance data" provided is for mechanical properties of the screw system (e.g., strength, durability), not diagnostic accuracy or AI performance. There are no acceptance criteria for an AI algorithm presented.
2. Sample size used for the test set and the data provenance: Not applicable. No test set for an AI algorithm is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI algorithm is established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. For the physical device, the "ground truth" for its performance is its compliance with mechanical test standards.
8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document does not contain information relevant to AI device acceptance criteria or performance studies. It is a 510(k) summary for a physical orthopedic implant.

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