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Intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in the fixation of osteopenic bone and fixation of non-unions and malunions.

Synthes Locking Compression Plate (LCP) System - T Plate is a buttress plate and screw system. The primary feature of the plate is round holes combined with locking screw holes. The locking screws form a locked, fixed angle construct with the plate, while the standard screws facilitate reduction and create compression between the plate and bone. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0 mm locking screws

Here's an analysis of the provided text regarding the Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate:

Based on the provided document (K010766), this is a 510(k) premarket notification for a Class II medical device (bone plate and screw system). The document describes the device, its intended use, and its classification.

Crucially, the provided text does not contain any information about acceptance criteria or a study demonstrating device performance as it relates to clinical effectiveness or specific quantitative metrics like accuracy, sensitivity, or specificity. This type of information is typically found in performance testing reports, clinical study summaries, or validation reports, none of which are present in these excerpts.

The 510(k) process for devices like this primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device, rather than requiring extensive de novo clinical efficacy trials. Substantial equivalence is often established through materials testing, mechanical testing, and comparison of design features and intended use.

Therefore, for aspects related to acceptance criteria and device performance studies (items 1 through 9 in your request), the information is not available in the provided document.

Here's a breakdown of what can be inferred from the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

• Information Not Available in Excerpt. The document does not specify quantitative acceptance criteria or report performance metrics (e.g., in terms of strength, fatigue life, or other mechanical properties) for the device. The 510(k) summary focuses on description and substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Information Not Available in Excerpt. No details on clinical or performance test sample sizes, test set provenance, or type of study (retrospective/prospective) are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Information Not Available in Excerpt. For mechanical devices like bone plates, "ground truth" as it pertains to expert interpretation (like in imaging AI) is generally not relevant. The document doesn't describe expert-adjudicated test sets for clinical studies.

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

• Not Applicable / Information Not Available in Excerpt. No adjudication method is mentioned as there are no expert-interpreted test sets described.

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 is a hardware medical device (bone plate and screw system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant or described.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Information Not Available in Excerpt. For a bone plate, "ground truth" would typically relate to successful bone healing, implant stability, or other clinical outcomes. These are not discussed in the provided regulatory communication. Performance testing for such devices typically involves biomechanical lab tests (e.g., fatigue, static strength), but the details of such tests are not provided in this 510(k) summary.

8. The sample size for the training set

• Not Applicable / Information Not Available in Excerpt. As this is not an AI/machine learning device, there is no "training set."

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

• Not Applicable / Information Not Available in Excerpt. As this is not an AI/machine learning device, there is no "training set" or ground truth for it in this context.

Summary of what the document does provide:

• Device Name: Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate
• Sponsor: Synthes (USA)
• Device Classification: Class II (21 CFR 888.3030 and 888.3040)
• Predicate Device: Synthes T Plates (This is the key piece of information for a 510(k) – the device is substantially equivalent to this predicate).
• Description: Buttress plate and screw system with round holes and locking screw holes, forming a fixed-angle construct. Accepts various screw sizes.
• Indications for Use: Buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia; fixation of osteopenic bone, non-unions, and malunions.
• Material: 316L Stainless Steel, Titanium
• Regulatory Determination: Substantially equivalent to devices marketed prior to May 28, 1976. This allows the device to be marketed.

To get the information you asked for regarding acceptance criteria and performance data, one would need to consult a more detailed technical file, design validation report, and/or mechanical testing reports, which are usually part of the full 510(k) submission but not typically released in the public 510(k) summary letters.

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