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The Mondeal® HAND CONTOUR System is intended to be used for the internal fixation of small bones including the hand and the foot.

The Mondeal® Hand Contour System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation

This document is a 510(k) summary for the Mondeal® Hand Contour System. It does not describe a study involving device performance metrics related to acceptance criteria in the typical sense of a diagnostic or AI-driven device. Instead, it demonstrates substantial equivalence to a predicate device based on material, design, and intended use.

Therefore, the following information is not directly extractable from the provided text in the context of a "study that proves the device meets the acceptance criteria" in terms of clinical performance or accuracy:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

However, I can extract information related to the acceptance criteria and the "study" (in this case, a comparative analysis) that led to the device's market clearance based on substantial equivalence.

Here's the information that can be extracted or inferred from the provided text regarding the "acceptance criteria" for 510(k) clearance:

Acceptance Criteria and Reported Device Performance (for 510(k) Substantial Equivalence)

Study Information (for 510(k) Pre-market Notification):

This submission is a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, not a diagnostic accuracy study or a clinical trial.

1. Sample size used for the test set and the data provenance: Not applicable. The "test" here involves comparing characteristics of the subject device to a predicate device. This is a comparison of manufacturing specifications and intended use, not a performance study on a particular data set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" is established by the specifications and regulatory status of the predicate device. The FDA reviews the submitted comparison.
3. Adjudication method: Not applicable.
4. 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 medical device (surgical implant) for internal fixation, not an AI-driven diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
6. The type of ground truth used:
   • Basis for "Ground Truth": The "ground truth" in this context is the established safety and effectiveness of the predicate device (Howmedica Profyle® Hand and Small Fragment System, K961497) as determined by its prior market clearance.
   • The "study" here involves a comparison table highlighting that the subject device (Mondeal® Hand Contour System) has identical or similar characteristics (materials, design, performance specifications like corrosion resistance and mechanical properties, sterilization method, packaging) and substantially similar indications for use to the predicate device.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the "study" described in this document is a comparative analysis demonstrating that the Mondeal® Hand Contour System is substantially equivalent to a previously cleared predicate device, the Howmedica Profyle® Hand and Small Fragment System, based on:

• Identical or similar fundamental technology (titanium plates and screws).
• Similar materials (CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws).
• Comparable performance specifications (corrosion resistance, mechanical properties like hardness, yield/tensile strength, elongation).
• Identical sterilization methods and similar packaging.
• Substantially similar Indications for Use (internal fixation of small bones of the hand and foot).

The acceptance criteria are met by demonstrating this substantial equivalence across these characteristics.

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