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The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and reoperation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The ABC Cervical Plating System consists of two spinal implant components: bone plates and bone screws. Both implants are manufactured from titanium alloy, Ti6Al4V according to ISO 5832/3 and are provided non-sterile. The 200 generation screw will be self-locking with an internal locking pin and spring. The outer body of the 2nd generation screw is still manufactured from Ti6Al4V while the internal locking mechanism is made from Phynox (cobalt alloy) per ISO 5832/7. The specialized ABC instruments are made primarily of surgical grade stainless steel according to ISO 7153/1 and are hand-held, re-usable devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ABC Cervical Plating System (ABC 2nd Generation Screw):

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a test set. This report describes a pre-market notification (510(k)) where equivalence to a predicate device is established, primarily through mechanical testing, not human-subject clinical trials with test sets in the typical sense of AI/diagnostic device validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a spinal implant, and the "ground truth" for its performance is assessed via mechanical testing and comparison to an existing predicate device, not through expert consensus on diagnostic images or clinical outcomes in the same way an AI diagnostic tool would be.

4. Adjudication Method for the Test Set

Not applicable. As described above, there is no "test set" in the context of clinical images or diagnostic outcomes requiring expert adjudication. The primary "adjudication" is the FDA's review of the mechanical testing data and the sponsor's argument for substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices involving human readers (e.g., radiologists, pathologists) to assess the impact of an AI tool on their performance. The ABC Cervical Plating System is a surgical implant.

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

Not applicable. The ABC Cervical Plating System is a physical medical device (spinal implant), not an algorithm or AI system. Its performance is assessed through mechanical testing.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by the performance of the predicate device (K000486). The new device's performance, as measured by ASTM F2193-02 mechanical testing, is compared against the predicate's known performance to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this device.

Summary of Findings:

The provided document, a 510(k) summary for the ABC Cervical Plating System, describes a medical device (spinal implant) and its regulatory clearance process. The "acceptance criteria" revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is primarily achieved through mechanical testing (specifically referencing ASTM F2193-02), rather than clinical studies involving human subjects or AI algorithm validation. Therefore, many of the requested categories related to AI/diagnostic efficacy studies are not applicable to this type of device and its submission.

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