Search Results

The Anspach Powered Kerrison System" (PKS) is indicated for use as an accessory attachment for I he rulisplay of the systems for cutting, shaping and removal of bone, including bones of the skull and spine.

The Anspach PKS is designed to be operated by either pneumatic or electric power but without the forceful, rapid forward stroke of a stationary blade in other powered rongeur systems. The Anspach PKS removes bone using a high speed rotational (85k max. rpm) cutting blade advanced by an operator controlled trigger mechanism. PKS consists of four basic component parts: Pistol Grip Trigger Assembly housing, Straight Nose-Tube Attachment, Shielded Attachments, Cutters.

The provided text describes a medical device, the Anspach Powered Kerrison System (PKS), along with its design, materials, operation, indications, contraindications, cleaning/sterilization, warnings, cautions, and a comparison to predicate devices for demonstrating substantial equivalence. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone performance studies.

The document's primary purpose is to establish substantial equivalence for regulatory clearance (510(k) submission K022907), which relies on comparing the new device to existing legally marketed predicate devices rather than presenting novel performance acceptance criteria or a dedicated study for the new device's performance.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the PKS itself. The acceptance criteria for the 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices, focusing on design, materials, intended use, and safety similarities.
• Reported Device Performance: No quantitative performance data for the PKS (e.g., cutting speed, precision, force exerted) is provided. The description mentions "quick and effectively cut away" bone, but this is qualitative.

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

• Not provided. No test set or associated data is mentioned for proving device performance.

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 provided. No ground truth establishment is described for a test set. This document relies on regulatory review and comparison to existing devices, not a clinical study with expert-adjudicated ground truth.

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

• Not applicable. No test set or adjudication process is 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. This device is a surgical tool, not an AI-assisted diagnostic tool or system that would typically undergo MRMC studies or involve human readers.

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

• Not applicable. This device is a mechanical surgical tool, not an algorithm. Therefore, standalone performance in the context of AI is not relevant. The device operates with a human surgeon "in the loop."

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

• Not applicable. The document does not describe a study involving a "ground truth" in the context of disease detection or diagnostic accuracy. The "ground truth" for this regulatory submission is essentially that the device is substantially equivalent to predicate devices based on its design, intended use, and operational characteristics, which have established safety and effectiveness.

8. The sample size for the training set

• Not applicable. This device is a mechanical surgical tool. There is no concept of a "training set" as would be used for machine learning or AI models.

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

• Not applicable. As above, no training set or ground truth in that context.

Ask a specific question about this device