Search Results

Analysis of the provided document (K052605, External Fixation) reveals that it is a 510(k) premarket notification for an external fixation system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific quantitative acceptance criteria through clinical studies. Therefore, the information requested regarding acceptance criteria, study details, and data provenance for a device performance study is not typically found in these types of documents.

Here's a breakdown of why the requested information is not present and what is available:

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

Not Applicable: 510(k) submissions for devices like external fixation systems (which are typically Class II, as indicated by the regulation number 21 CFR 888.3030) do not usually include a table of quantitative acceptance criteria and reported device performance derived from a study designed to prove these criteria. The approval is based on demonstrating substantial equivalence to a predicate device. This often involves comparing design features, materials, and intended use, and sometimes non-clinical (e.g., mechanical) testing to ensure the device meets safety and performance standards equivalent to the predicate. However, these are typically engineering specifications rather than clinical performance metrics relative to a specific efficacy target.

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: Since no human clinical study demonstrating performance against specific acceptance criteria is described, there's no "test set" in the context of clinical data. If non-clinical bench testing was performed, details about the "sample size" would refer to the number of devices tested, and provenance would relate to the testing facility and methodology, but this document does not provide such details.

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: "Ground truth" established by experts is relevant for studies involving diagnostic or interpretive tasks (e.g., image analysis). An external fixation system is a therapeutic device, and its performance is typically assessed through mechanical properties, biocompatibility, and clinical outcomes (e.g., fracture healing rates). The 510(k) summary provided does not detail any such clinical study or expert consensus for ground truth.

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

Not Applicable: Adjudication methods are relevant when there are subjective assessments or disagreements among experts, such as in clinical trials with multiple reviewers. This information is not relevant to the type of submission or device 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: An MRMC study is specific to diagnostic imaging devices, often involving AI assistance. This device is an external fixation system, not a diagnostic imaging device with AI components.

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

Not Applicable: This question pertains to AI/algorithm performance studies. The device is a physical medical implant/device, not an algorithm.

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

Not Applicable: As established earlier, the concept of "ground truth" as requested is not applicable to a 510(k) submission for an external fixation device. Performance is typically gauged by successful mechanical function and clinical outcomes which, if studied in detail, would involve patient follow-up and clinical assessments, but this level of detail for a performance study is not in a 510(k) summary.

8. The sample size for the training set:

Not Applicable: There is no "training set" in the context of an external fixation device being submitted via a 510(k). This term applies to machine learning algorithms.

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

Not Applicable: Similar to point 8, this is not relevant to an external fixation device.

In summary, the provided document K052605 is a 510(k) premarket notification for an External Fixation system. The approval is based on demonstrating substantial equivalence to a predicate device, as confirmed by the FDA letter. It does not contain information about clinical performance studies with specific quantitative acceptance criteria, test sets, ground truth establishment, or AI-related metrics like those requested.

The core of a 510(k) for such a device is typically focused on:

Indications for Use: Clearly stated as Bone Fracture Fixation, Osteotomy, Arthodesis, Correction of deformity, Revision procedures where other treatments/devices have been unsuccessful, and Bone reconstruction procedures.
Technological Characteristics: Comparison of materials (metallic fasteners), design, and performance with a predicate device.
Substantial Equivalence: A conclusion by the FDA that the new device is as safe and effective as a legally marketed predicate device.

Ask a Question

Ask a specific question about this device

Page 1 of 1