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This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.

Pectus Pre-bent Support Bar: A stainless steel or titanium bar, variable length from 7 to 17 inches, and 0.50 inches wide, with two holes and notches on both ends for sutures to secure the bar to the lateral chest wall. The bar is pre-shaped based on a CT Scan provided by the Surgeon specifically for a certain patient. The titanium bar is only used when the patient has a nickel allergy.

Pectus Titanium Support Bar Stabilizer: A titanium elongated plate with a dovetail slot in the center of the plate for the Pectus Bar to slide into. Two lips come up over the bar to secure the Pectus Bar within the slot of the stabilizer. The stabilizers have two holes on either side of the slot to suture the stabilizer to the lateral chest wall together with the support bar preventing lateral movement and flipping of the bar.

The provided text is a 510(k) Summary for a medical device (Lorenz Pectus Support Bar System) and associated FDA correspondence. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not necessarily to prove that the device meets specific acceptance criteria through a clinical study with performance metrics in the way a clinical trial for a new drug or diagnostic algorithm would.

Therefore, the requested information about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document. This 510(k) relies on comparison to previously cleared devices.

Here's why the information you're asking for isn't in this document:

• Acceptance Criteria & Reported Performance: The 510(k) process for this type of device (metallic bone fixation appliances) typically focuses on material safety, mechanical properties, and design similarity to a predicate device. Performance is largely inferred from the predicate device's established safety and effectiveness. There isn't a table of specific clinical "acceptance criteria" (e.g., sensitivity, specificity for a diagnostic device) and reported device performance in this context.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone: These are all elements typically found in clinical studies, especially for diagnostic or AI-driven devices. This 510(k) submission is for a surgical implant, where clinical outcomes are often assessed through post-market surveillance or through specific clinical trials if the device is novel enough to warrant a PMA (Premarket Approval) rather than a 510(k). The focus here is on engineering and material equivalence to existing devices.
• Ground Truth: For a surgical implant, "ground truth" wouldn't be established in the same way as for a diagnostic device (e.g., pathology slide for cancer detection). Clinical success (e.g., correction of deformity, absence of complications) would be the outcome measure, but this document specifies the device's intended use and substantial equivalence, not a trial demonstrating these outcomes.
• Training Set: This device is a physical implant, not an AI algorithm. Therefore, there is no "training set" in the computational sense.

Summary based on the provided document:

• No acceptance criteria for device performance (e.g., sensitivity/specificity) is defined or studied in this document. The acceptance is based on demonstrating substantial equivalence to predicate devices (K981789 and K972420).
• No clinical study demonstrating device performance against specific acceptance criteria is described.
• The document does not contain information about:
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type or method of establishing ground truth in a clinical study context.

The "study" that proves the device meets "acceptance criteria" in the context of this 510(k) submission is the comparison of its technological features and materials to predicate devices, and the conclusion that it is substantially similar in application and function. The acceptance criteria here are regulatory: demonstrating that the new device is as safe and effective as a legally marketed predicate device.

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