Search Results

The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.

The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of a single tapered plate, screws (cancellous and cortical design), and spacer blocks in various sizes. The plate in this system accepts 6 mm cancellous screws proximally and 4.5 mm cortical screw distally. The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is manufactured from Titanium/Titanium Alloy and will be provided sterile.

The provided document describes a 510(k) submission for the Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data detailing acceptance criteria and performance against those criteria as would be required for a novel device or a PMA.

Therefore, many of the requested details, particularly those related to a study proving the device meets specific performance acceptance criteria for an AI/algorithm-based medical device, a multi-reader multi-case (MRMC) study, or a standalone algorithm performance study, are not applicable and not present in this document. This document concerns a physical orthopedic implant system, not a software algorithm.

Here's a breakdown of the information that can be extracted and an explanation of the missing information based on the provided text:

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

Explanation: In a 510(k) submission for a physical device like this, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The performance is typically demonstrated through non-clinical testing (e.g., biomechanical testing) rather than clinical trials with specific clinical performance metrics.

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

• Not Applicable / Not Provided. The document mentions "biomechanical testing" but does not specify sample sizes for test sets, data provenance, or whether it was a retrospective or prospective study. This type of detail is not typically required or included in a 510(k) summary for a mechanical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided. This concept (experts establishing ground truth for a test set) is primarily relevant to AI/diagnostic imaging devices. For a physical orthopedic implant, "ground truth" relates to material properties, mechanical performance, and surgical outcomes, which are assessed through engineering and clinical evaluations, not expert consensus on image interpretation.

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

• Not Applicable / Not Provided. Adjudication methods are typically used in clinical trials or studies to resolve discrepancies in expert interpretations (e.g., of medical images). This is not relevant to the biomechanical testing of a bone plate system.

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

• No. This is a physical medical device (bone plating system), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.

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

• No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

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

• Inferred based on "Biomechanical testing": The "ground truth" for this device would be established by engineering standards for mechanical strength, fatigue, fixation stability, and material biocompatibility. This would involve laboratory testing against established benchmarks or comparative data from the predicate device. It is not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic tools.

8. The sample size for the training set

• Not Applicable / Not Provided. "Training set" refers to data used to train an AI model. This device is not an AI model. Mechanical and materials testing would involve specific sample sizes for tests such as ultimate tensile strength, fatigue life, etc., but these are not referred to as "training sets."

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

• Not Applicable / Not Provided. As this is not an AI device, there is no "training set" or "ground truth for a training set" in that context.

Ask a specific question about this device

Ask a specific question about this device