Search Results

The ConMed Linvatec Osprey™ Drill System is intended for cutting, drilling, and manipulation of soft tissue and bone in the following applications: orthopedic, neurosurgical, spinal, cranial, otolaryngological, oral/maxillofacial, reconstructive, and plastic.

Not Found

The provided text describes a 510(k) summary for the ConMed Linvatec Osprey™ Drill System. A 510(k) submission is a premarket notification demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed information about acceptance criteria and specific studies proving those criteria, especially in the context of AI/ML performance metrics as requested in the prompt.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert qualifications, and ground truth are not present in this document. The document focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific quantitative acceptance criteria through detailed studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not list specific quantitative acceptance criteria or detailed performance metrics in the way that would be found in a study proving algorithm performance (e.g., sensitivity, specificity, AUC thresholds). The "performance" described implicitly is the substantial equivalence to predicate devices, meaning it performs as intended and is as safe and effective.

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

• Cannot be provided. The document describes a medical device, not an AI/ML algorithm that would use test sets of data. Therefore, there's no mention of sample sizes or data provenance for a test set.

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)

• Cannot be provided. As above, there's no mention of a "test set" or involvement of experts to establish ground truth in the context of an algorithm's performance.

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

• Cannot be provided. Not applicable to this type of device submission.

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

• Cannot be provided. This is not an AI-assisted device. The document pertains to an electric surgical drill system.

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

• Cannot be provided. This is not an AI algorithm.

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

• Cannot be provided. Not applicable. The "ground truth" for a surgical drill system would be its mechanical and functional performance, safety, and effectiveness in surgical procedures, as demonstrated through engineering tests and comparison to predicate devices, not through expert consensus on data interpretation.

8. The sample size for the training set

• Cannot be provided. There is no "training set" as this is not an AI/ML device.

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

• Cannot be provided. Not applicable.

Summary based on the provided document:

The ConMed Linvatec Osprey™ Drill System is an electric surgical system, not an AI/ML powered device. The 510(k) submission process focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific quantitative acceptance criteria through studies with data sets, ground truth, and expert adjudication, which are typically associated with AI/ML device evaluations. Therefore, the requested information regarding acceptance criteria and study details (sample size, experts, ground truth, MRMC studies) is not found in this 510(k) summary.

Ask a specific question about this device