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The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion,

Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks.

Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the Talos®-C Cervical Intervertebral Body Fusion Devices does not contain the information necessary to describe the acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a traditional 510(k) clearance letter for a physical medical device (an intervertebral body fusion device). It focuses on substantial equivalence to a predicate device, manufacturing regulations, and labeling requirements. It does not discuss:

• Acceptance Criteria for AI/ML performance: The concept of sensitivity, specificity, AUC, etc., for an AI/ML algorithm.
• Device Performance Metrics: There are no reported performance metrics for an AI/ML model here.
• Sample Size, Ground Truth, Expert Annotations: These are specific to the validation of AI/ML algorithms and are not relevant to the clearance of an orthopedic implant like the Talos®-C.
• MRMC Studies or Standalone AI Performance: These study designs are used to evaluate diagnostic AI and are not applicable to the clearance of a surgical implant.

Therefore, I cannot fulfill your request based on the provided text. To answer your question, I would need a document related to the clearance or validation of an AI/ML medical device.

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The Talos™ IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos™ IBF devices are intended to be used with autologous bone graft to facilitate fusion. The Talos™ IBF device is to be used in patients who have had six months of non-operative treatment.

Talos™ IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The Talos™-P device is implanted in pairs, while the Talos™-A, Talos™-L and Talos™-T devices may be implanted singly or in pairs in the lumbosacral spine. The Talos™-A, Talos™-L, Talos™-P, and Talos™-T are intended to be used with supplemental fixation.

The Talos™ IBF Device is made of PEEK-OPTIMA®. Talos™ IBF Device is available in four The configurations: Talos™-P, Talos™-T, Talos™-L, and Talos™-A. The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos™-P and Talos™-L are rectangular devices and the Talos™-T and Talos™-A have curved lateral walls and rounded edges. The implants are available in a range of sizes, as well as flat and lordotic angled implants, to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allow the Talos™ IBF radiological confirmation for proper positioning.

The provided text describes a 510(k) premarket notification for the "Talos™ Intervertebral Body Fusion (IBF) Device." It outlines the device's description, intended use, and indicates its conformance to specific guidance documents and mechanical testing standards. However, the document does not contain information regarding a study that assesses the device's performance against specific acceptance criteria in terms of clinical outcomes, diagnostic accuracy, or comparative effectiveness (e.g., with human readers, for an AI device).

The "Performance Data" section explicitly states: "Talos™ IBF devices conforms to Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices, June 12, 2007. Mechanical testing was conducted per ASTM F 2077-03 and ASTM F 2267-04." This indicates that the performance data for this device relates to mechanical testing standards, not a clinical or AI-related performance study as typically described by the provided questions.

Therefore, many of the requested fields cannot be filled as they pertain to a type of study not present in the given text.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The document describes mechanical testing, not a clinical or AI performance study with a test set of data.

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

Not applicable. Ground truth for clinical or diagnostic performance is not mentioned. Mechanical testing standards dictate the "ground truth" through specified methodologies and measurements.

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

Not applicable. This pertains to clinical or diagnostic assessment, not mechanical testing.

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 an intervertebral body fusion device, not an AI or diagnostic imaging device. No MRMC study is mentioned.

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

Not applicable. This pertains to AI devices. The Talos™ IBF Device is a physical implant.

7. The type of ground truth used

For mechanical testing, the "ground truth" is defined by the objective measurements and parameters specified in the ASTM standards (F 2077-03 and F 2267-04). These standards dictate the conditions, methods, and acceptance criteria for evaluating the mechanical properties of the device.

8. The sample size for the training set

Not applicable. This pertains to AI/machine learning. The document describes a physical medical device.

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

Not applicable. This pertains to AI/machine learning.

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