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The ANATOMIC PEEK CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC® PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from PEEK™ OPTIMA™ and is to be used with autogenous bone graft. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM consists hemicylindrical of cages of various widths, heights and depths. The hollow geometry of the implants allows them to be inserted between two cervical vertebral bodies packed with autogenous bone graft in cervical fusion procedures. The ANATOMIC PEEK™ device is to be used with cleared cervical supplemental fixation.

The provided text describes a 510(k) premarket notification for the "ANATOMIC PEEK™ CERVICAL FUSION SYSTEM" and does not contain information about a study proving the device meets acceptance criteria in the context of a software or AI-based medical device. Instead, it details non-clinical testing performed on the physical device to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested categories in your prompt are not applicable to the provided document. I will fill in the information that is present and indicate where information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria were based on established ASTM standards: ASTM F2077-03, ASTM F2267-04, and ASTM F-04.25.02.02 (Draft Static Push-out Test Method). The specific numerical thresholds for acceptance are not detailed in this document but are implied to be part of these standards.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable as the document describes non-clinical physical device testing (mechanical characteristics) rather than testing related to AI/software performance or human subject data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The "ground truth" for the physical device performance was established by the technical specifications outlined in the ASTM standards for mechanical testing.

4. Adjudication Method for the Test Set

This information is not applicable. The mechanical tests would have objective pass/fail criteria based on measured physical properties, rather than expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. No MRMC study was conducted or is relevant for this type of physical device submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth was based on pre-defined mechanical performance specifications as outlined by the standards ASTM F2077-03, ASTM F2267-04, and ASTM F-04.25.02.02. This is a form of engineering or objective performance metrics, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, and there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for a physical device, no ground truth was established for it.

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The CORNERSTONE® PSR Cervical device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of nonoperative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.

The CORNERSTONE® PSR Cervical Fusion System consists of spacers which can be inserted between two cervical vertebral bodies to give support and correction until fusion occurs. The hollow geometry of the implant allows it to be packed with autogeneous bone graft. The CORNERSTONE® PSR Cervical Fusion System also includes instrumentation that enables the surgeon to implant the devices via an open, anterior approach. The device sizes are available in various heights and in a 4º lordotic angle option. The implant devices are manufactured from medical grade polyetheretherketone (PEEK -OPTIMA® LT1) per ASTM F2026 and also contain either tantalum markers per ASTM F-560 or titanium alloy markers per ASTM F-136 so that the position of the implant can be determined on X-ray or other imaging.

This document is a 510(k) summary for the CORNERSTONE® PSR Cervical Fusion System, which is an intervertebral body fusion device. It describes the product, its indications for use, and how it demonstrates substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request:

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

Study Proving Acceptance Criteria:

The document states: "The following pre-clinical studies were conducted using worst case CORNERSTONE® PSR devices: static and dynamic compression, static and dynamic torsion, static and dynamic compression shear per ASTM F2077-03; subsidence per ASTM F2267-04; and expulsion. The results of these studies were found to be substantially equivalent to legally marketed devices."

The study described is a series of pre-clinical mechanical and physical performance tests designed to demonstrate that the CORNERSTONE® PSR system performs similarly to existing, legally marketed predicate devices. The basis of acceptance in a 510(k) submission is showing "substantial equivalence" to a predicate device, meaning it is as safe and effective.

The remaining information requested is not available in the provided text, as this is a 510(k) summary for a medical device (an intervertebral fusion device), not an AI/software device. The questions are specifically tailored for AI/ML performance evaluations and thus do not apply to this type of regulatory submission.

Therefore, for questions 2 through 9, the answer is: This information is not applicable or not provided in the context of a 510(k) summary for this type of medical device. The document focuses on demonstrating substantial equivalence through pre-clinical mechanical testing and material compatibility, not on human-AI interaction or algorithm performance on a test set.

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