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The Acrosspine Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fision for the following indications: degenerative disc disease (defined as back. pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthess: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudarthrosis: and failed previous fusion.

The Arthro-DIF Acrosspine Pedicle Screw System is an implant device made from an unalloyed titanium and 6Al4V Titanium Alloy. It is to be implanted from the posterior approach. The screws are available in 5.5, 6.5 and 7.5mm diameters and in lengths from 35-60 mm. The screws are available as polyaxial screws. All rods are available in 5.5mm diameter with curved rod in lengths from 40-100 mm, and straight rods from 150-300mm.

This document is a 510(k) summary for the Acrosspine Pedicle Screw System. It provides information about the device's indications for use, description, predicate devices, and performance testing. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined for an AI/device performance study (e.g., accuracy, sensitivity, specificity, or human reader improvement).

The document is for a pedicle screw system, which is a physical implant used in spinal surgery, not a software or AI device that generates diagnostic outputs or assists in image interpretation. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of medical device submission.

Instead, the "acceptance criteria" for a physical implant like this typically involve mechanical and material testing to ensure its structural integrity and safety. The "study that proves the device meets the acceptance criteria" refers to the pre-clinical mechanical testing performed against established ASTM standards.

Here's an interpretation based on the provided document, addressing what is relevant and indicating what is not applicable:

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

   The document lists pre-clinical mechanical tests and the ASTM standards they conform to. The acceptance criteria for these tests are implicitly defined by the ASTM standards themselves, meaning the device must meet the performance requirements (e.g., strength, durability, resistance to specific forces) outlined in those standards. The document doesn't explicitly state quantitative acceptance criteria or raw performance data (e.g., "device withstood X N-m of torque, exceeding the required Y N-m"). Rather, it states that these tests were "performed" and implies successful completion as part of the substantial equivalence claim.

   Test	ASTM Standard	Implied Acceptance Criteria (from ASTM)	Reported Device Performance
   Static Compression Bend	F1717-13	Must meet minimum static bending strength requirements for pedicle screw systems.	Tests were performed. Implied successful conformance to standard.
   Dynamic Compression Bend	F1717-13	Must meet minimum dynamic bending fatigue life requirements.	Tests were performed. Implied successful conformance to standard.
   Static Torsion	F1717-13	Must meet minimum static torsional strength requirements.	Tests were performed. Implied successful conformance to standard.
   Axial Pullout	F543-13	Must meet minimum axial pullout strength and securement requirements.	Tests were performed. Implied successful conformance to standard.
   Torque to Failure	F543-13	Must characterize the torque required to cause failure (e.g., stripping).	Tests were performed. Implied successful conformance to standard.
   Axial Slip	F1798-97 (08)	Must demonstrate adequate resistance to axial slippage.	Tests were performed. Implied successful conformance to standard.
   Flexural Grip	F1798-97 (08)	Must maintain adequate gripping strength under flexural forces.	Tests were performed. Implied successful conformance to standard.
   Torsional Grip	F1798-97 (08)	Must maintain adequate gripping strength under torsional forces.	Tests were performed. Implied successful conformance to standard.

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

   • Sample Size: Not specified in the document. For mechanical testing, this refers to the number of individual implants or constructs tested for each specific test.
   • Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective). This is laboratory mechanical test data.

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

   Not applicable. The "ground truth" for mechanical testing is defined by the physical properties measured and compared against established ASTM standard specifications, not by expert interpretation of clinical data.

4. Adjudication method for the test set

   Not applicable. Mechanical testing does not involve 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. This device is a physical pedicle screw system, not an AI software.

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

   Not applicable. This device is a physical pedicle screw system, not an algorithm.

7. The type of ground truth used

   The "ground truth" (or basis for evaluation) for this device is the mechanical performance measured against established ASTM standards for spinal implant components.

8. The sample size for the training set

   Not applicable. This is a physical device, not an AI model.

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

   Not applicable. This is a physical device, not an AI model.

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