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The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each construct being tailored to the individual case. The CD Horizon™ Astute™ Spinal System implant components are fabricated from medical grade titanium alloy, tantalum, or polyetheretherketone (PEEK).

This document describes the premarket notification (K191066) for the CD Horizon™ Astute™ Spinal System. However, it does not contain information related to an AI/ML powered device, nor does it present acceptance criteria or a study that proves a device meets those criteria in the context of AI/ML performance metrics.

The document is a 510(k) summary for a spinal implant system. The "Performance Data" section (VII) discusses mechanical testing of the device and reference to clinical literature and a retrospective study of the predicate device to support its clinical use.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves an AI device meets acceptance criteria, as this document is not about an AI device.

To directly answer the prompt's request given the content of this specific document:

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

• Acceptance Criteria: "The subject devices met the pre-determined acceptance criteria for all tests." (Page 5)
• Reported Device Performance:
  • Mechanical Testing (ASTM F1717 & F1798): The subject devices met the pre-determined acceptance criteria for static and dynamic compression bending, static torsion, static axial grip, static torsional grip, and static and dynamic flexion/extension.

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

• Sample Size (Test Set): Not specified for mechanical testing. For clinical performance, it refers to data from the predicate device's unspecified "retrospective study," so the sample size is unknown.
• Data Provenance: Unspecified for mechanical testing. For clinical performance, implies data from a retrospective study, country of origin is not mentioned.

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 is a mechanical device, not an AI diagnostic/prognostic device requiring expert-established ground truth.

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

• No, an MRMC study was not done as this is not an AI device.

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

• Not applicable. This is a mechanical device.

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

• Mechanical Testing: Ground truth is based on the specifications and performance limits defined by ASTM F1717 and F1798 standards.
• Clinical Performance: Ground truth for clinical claims is supported by the outcomes of the predicate device's retrospective study and clinical literature, implying patient outcomes data.

8. The sample size for the training set

• Not applicable. This is not an AI device with a training set.

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

• Not applicable. This is not an AI device.

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