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a) General orthopedic uses.
b) Trochanteric reattachment.
c) Fixation of long bone fractures-elbow, shoulder, ankle, patella.
d) Trauma fixation of shoulder, ankle and patella .
e) General spinal uses.
f) Spinal wiring.

This implant consists of a 0.058" diameter cable, 23" in length, 20" length cable and 3" length lead and a cylindrical crimp with a transverse "through hole". The crimp, cable and lead cable are supplied as a single assembled unit. All three are preassembled in the manufacturing process. The cable is manufactured according to the material specifications for ASTM F136-96 in a 7 x 7 x 0.00064 wire construct. The crimp is also manufactured from ASTM F136-96.

A cable passer may be used to pass the free end of the cable around the bone. The free end is then passed through the transverse hole of the crimp in such manner as to have the free end emerge from the center of the crimp. A cable tensioner may be used to achieve a desired cable tension a which time the surgeon uses a crimper/cutter to crimp near the middle of the "through hole" and cuts the free end from the crimp.

The provided text is a 510(k) summary for a medical device called the "Whiteside Biomechanics Low-Profile Titanium Cable System." This document is part of the FDA regulatory process to demonstrate that a new medical device is substantially equivalent to a previously cleared device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've described for a diagnostic or AI-powered device.

The 510(k) process for a physical implantable device like a surgical cable ("Bone Fixation Cerclage") typically focuses on demonstrating material equivalence, manufacturing processes, and functional equivalence (e.g., tensile strength, fatigue resistance) to a predicate device, rather than diagnostic performance metrics like sensitivity, specificity, or reader improvement with AI assistance.

Therefore, I cannot provide the requested information from the given text because:

• Acceptance Criteria and Device Performance Table: The document does not define specific performance acceptance criteria for the device (e.g., tensile strength thresholds, fatigue cycles) nor does it report the results of a study against such criteria. The focus is on demonstrating "substantial equivalence" to a predicate device based on similar design, material, and intended use.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for diagnostic studies): These categories are relevant for studies evaluating the diagnostic performance of software or imaging devices. They are not applicable to the type of regulatory submission presented for a physical surgical cable. The "study" referenced in K993903 is an assessment of the device's characteristics against its predicate, not a clinical trial or performance study as you might expect for a diagnostic AI.
• Training Set Sample Size and Ground Truth: This is also not relevant as there is no AI or diagnostic algorithm being described.

Summary based on the provided document:

The regulatory document (K993903) for the Whiteside Biomechanics Low-Profile Titanium Cable System asserts substantial equivalence to an existing predicate device (Whiteside Biomechanics Low-Profile Cable System K951844).

• Acceptance Criteria: Not explicitly stated in terms of performance metrics. The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness.
• Study That Proves the Device Meets Acceptance Criteria: The "study" is the comparison made as part of the 510(k) submission. The document states:
  • "There are no different technological characteristics between the Whiteside Biomechanics Low-Profile Cable System and the Whiteside Biomechanics, Inc. Titanium Low-Profile Cable System."
  • The cable is manufactured according to ASTM F136-96 material specifications.
  • The crimp is also manufactured from ASTM F136-96.

This indicates that the device meets the "acceptance criteria" by being materially and technologically identical (or very similar, without introducing new risks) to a device already cleared by the FDA. There is no mention of a human-in-the-loop study, a standalone algorithm, or diagnostic performance metrics because this is a physical medical implant, not a diagnostic AI system.

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