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The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.

The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.

This document is a 510(k) clearance letter for the Speed-Cut Automatic Biopsy System and only confirms the device's substantial equivalence to a predicate device. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information.

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An automatic biopsy system designed to take core samples from a variety of soft tissues, including (but not limited to) liver, prostate, kidney.

The Speed-Cut® is an automatic spring loaded, depth programmable, disposable biopsy instrument.

The provided text describes a medical device, the Speed-Cut® Automatic Biopsy System, and its testing for safety and efficacy. However, it does not include information about acceptance criteria or a study that uses a test set, ground truth, or expert review in the way typically expected for evaluating AI/algorithm performance.

The "tests" mentioned are traditional medical device performance and biocompatibility tests, not studies evaluating diagnostic accuracy or clinical utility that would involve reader performance, ground truth, or specific statistical metrics like sensitivity/specificity.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated as "not available" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not applicable / Not available. The listed tests are engineering and biocompatibility tests performed on the device itself or in animal models, not on a "test set" of patient data for diagnostic evaluation.

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

• Not applicable / Not available. There is no mention of a "test set" or "ground truth" in the diagnostic sense. The tests describe physical device performance and biological reactions.

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

• Not applicable / Not available.

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 study is not an MRMC study. It's for a physical biopsy device, not an AI or imaging diagnostic tool.

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

• No. This device is a physical biopsy system, not an algorithm.

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

• Not applicable / Not available. The "results" are based on laboratory testing protocols (e.g., "firing until failure" for the Firing Test, standard biological assays for the others).

8. The sample size for the training set

• Not applicable / Not available. There is no "training set" as this is not an AI/algorithm.

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

• Not applicable / Not available.

Summary of what the document does provide:

The document describes the Speed-Cut® Automatic Biopsy System, its intended use (to take core samples from soft tissues), its predicate device, and a list of performance and biocompatibility tests it underwent to verify safety and efficacy. The firing test, for instance, established a mean firing count of 50 before failure, with the manufacturer establishing a 10:1 safety margin. The other tests confirmed biocompatibility and lack of systemic toxicity or pyrogenic reactions.

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