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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 re-operation 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 self-locking bone screws. The implants are manufactured from titanium alloy, Ti6Al4V (according to ISO 5832/3) and are provided non-sterile. The specialized ABC instruments are made primarily of surgical grade stainless steel (according to ISO 7153/1) and are hand-held, re-usable devices.

This document is a 510(k) summary for the ABC Cervical Plating System, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, it does not contain the information requested in the prompt.

Specifically, the document focuses on demonstrating substantial equivalence to predicate devices for a spinal implant system, rather than presenting performance data from a clinical or analytical study to assess against acceptance criteria for an AI/ML system.

Here's why the requested information cannot be extracted:

• No AI/ML device: The product described is a physical medical device (cervical plating system), not an AI/ML diagnostic or prognostic tool.
• No acceptance criteria for AI/ML: Since it's not an AI/ML device, there are no specific acceptance criteria for metrics like accuracy, sensitivity, specificity, etc., which are common for AI/ML devices.
• No study data for AI/ML performance: The "PERFORMANCE DATA" section states "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. The ABC implants subject to this 510(k) submission, however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy." This refers to mechanical and material testing, not the type of studies (e.g., clinical trials, reader studies) that would generate the requested AI/ML performance metrics.
• No information on sample size (training/test sets), expert ground truth, adjudication, or MRMC studies: These are all concepts relevant to the evaluation of AI/ML algorithms and are not present in this document, as it deals with a traditional medical device submission.

In summary, the provided text does not contain any of the information requested about acceptance criteria and study data for an AI/ML device.

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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 discongenic pain with generation of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions through anterior cervical intervertebral body screw fixation. Levels of screw fixation for this indication are from C2 to T1.

Not Found

This document is a 510(k) summary for a medical device (ABC Cervical Plating System), which is a premarket submission to the FDA. It does not contain the kind of detailed study information (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, etc.) that would typically be found in a clinical trial report or a performance validation study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on:

• Device Identification: Name, common names, classification, and product codes.
• Intended Use Statement: Clarifying the medical conditions and anatomical levels for which the device is designed.
• Regulatory Actions: FDA's determination of substantial equivalence, general controls, and specific warnings regarding off-label use (pedicular screw fixation).

There is no mention of a study involving device performance metrics against predefined acceptance criteria in the provided text. The substantial equivalence determination by the FDA is based on comparison to legally marketed predicate devices, not on a detailed performance study like what would be described for an AI/algorithm-based device.

Ask a specific question about this device