(224 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Firing Test | Passed (fired on average 50 times before failing) |
| Intracutaneous Reactivity | Passed |
| Acute Systemic Activity | Passed |
| Pyrogen Test | Passed |
| Cytotoxicity | Passed |
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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NOV 21 1996
K961407
.
ll
ll
PI 12
510K SUMMARY
Owner:
Gallni s.r.l. 88/90 Via S. Faustino 41037-Mirandola-Italy
Contact:
Paul L. Hawthorne U.S. Representative C/O Coeurage Enterprises 3106 Bretton Court Glen Allen, VA 23060
April, 1996 Submission Date:
Speed-Cut® - Automatic Biopsy System Device Name:
ACECUT Automatic Biopsy System Predicate Device: Meadox Medical, Inc.
Description of The Speed-Cut® is an automatic spring loaded, Device Function depth programmable, disposable biopsy instrument.
Intended Use: An automatic biopsy system designed to take core samples from a variety of soft tissues, including (but not limited to) liver, prostate, kidney.
TECHNOLOGICAL CHARACTERISTICS
The SPEED-CUT® Automatic Biopsy System is equivalent to the predicate device in terms of technological characteristics.
Due to the variety of sizes available for this device, it may be used in laparascopic procedures. The small size and longer needles facilitate placement through one of the incisions while the surgeon "views" the tlssue to be blopsied using fiber optics or ultra-sound.
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P2012
2
510K SUMMARY
The following tests were performed to verity the safety and efficacy of the instrument.
| TEST | RESULTS |
|---|---|
| Firing Test* | Passed |
| Intracutaneous Reactivity | Passed |
| Acute Systemic Activity | Passed |
| Pyrogen Test | Passed |
| Cytotoxicity | Passed |
-
- Gallini exhaustive test procedures (firing until failure) indicate the Speed-Cut® biopsy instruments may be fired on average fifty (50) times before failling. The manufacturer feels a ten to one (fire to fail/max.pl. use)ratio provides adequate safety margin.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.