Search Results

Sharpoint Lukens® bone wax is indicated for use for control of bleeding from bone surface during surgical operations.

The Sharpoint Lukens® Bone Wax is a sterile mixture of beeswax, paraffin, and isopropyl palmitate. It has a waxy ordor.

The provided documents for K050292 do not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for AI/ML-driven medical devices. This submission pertains to a traditional medical device (bone wax) and its clearance is based on substantial equivalence to predicate devices, rather than performance against pre-defined metrics in a clinical study with a test set, ground truth, or expert readers.

Therefore, many of the requested categories are not applicable to this 510(k) summary. I will address the applicable points based on the information provided, explicitly stating where information is not available or not relevant to this type of device submission.

Acceptance Criteria and Reported Device Performance

For a traditional medical device like Sharpoint Lukens® Bone Wax, the "acceptance criteria" for FDA clearance primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device. This means showing that the device has the same intended use, is made of the same materials, operates by the same technological characteristics, and raises no new issues of safety or effectiveness when compared to the predicate device. Performance is largely inferred from the predicate device's established safety and effectiveness.

Study Details (Not Applicable for this specific 510(k) submission type)

The following information is typically relevant for AI/ML device submissions or devices requiring clinical performance studies to establish safety and effectiveness. This 510(k) submission for bone wax relies on substantial equivalence to existing devices, not a new performance study.

1. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical performance study described.
2. 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. No test set or ground truth described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set described.
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 not an AI-assisted device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for performance metrics is not established for this type of submission.
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.

In summary: The K050292 submission for Sharpoint Lukens® Bone Wax is a traditional 510(k) submission based on demonstrating substantial equivalence to predicate devices (Ethicon Bone Wax and CP Medical Bone Wax). It does not involve a clinical performance study with defined acceptance criteria, a test set, ground truth determination, or AI/ML components as detailed in your request. The "study" proving the device meets criteria is the comparison and analysis of its materials, intended use, and technological characteristics against already cleared devices, which found them to be "the same" and raising "no new issues of safety and efficacy."

Ask a specific question about this device