(69 days)
The Scholten Novatome™ is a surgical device used to perform endomyocardial biopsies.
The Scholten Surgical Instruments, Inc. Novatome is a manually operated hand held surgical instrument designed to remove biopsy samples from the right or left ventricle of the Human Heart via percutaneous venous or arterial access. Specifically via the internal Jugular or subclavian veins or the femoral artery. The device consists of three main parts. The cutting jaws, a polymer coated flexible shaft, and an actuating handle. At the distal end of the forceps is a pair of jaws used to obtain the heart tissue samples. At the proximal end of the forceps is the actuation handle used to activate the jaws and steer the device. The device cutting jaws are single action in that one of the jaws is fixed and is attached to the end of the flexible shaft and the other jaw is movable and is attached to a link that is welded to the end of the actuation wire. The single moving jaw, the distance the jaws open, as well as the orientation of the jaw work in combination to control the amount of tissue obtained. The Novatome's actuation handle is made of an advanced high-performance polymer. The jaws, actuation wire, and other mechanical parts are made of stainless steel. The flexible shaft sheath material is Fluoropolymer tubing. The Novatome™ will be available in 9,8,7, and 6 French cutting jaw sizes, with flexible shaft lengths of 50, 70, and 100cm lengths.
The provided text describes the 510(k) summary for the Novatome™ Endomyocardial Biopsy Forceps. This device is seeking substantial equivalence to predicate devices, and the document details the non-clinical tests performed rather than an AI-driven study. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis of the provided information, addressing the relevant sections and noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as one would expect for a diagnostic AI device. Instead, it describes "performance tests were conducted in several areas." The "reported device performance" is essentially that the device passed these non-clinical tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional | Tests were conducted and passed. |
| Tensile | Tests were conducted and passed. |
| Simulated Biopsy Yield | Tests were conducted and passed. |
| Cutting Jaw Force Tests | Tests were conducted and passed. |
| Sterilization (if applicable) (Implicit based on comparison to predicate) | Device is pre-packaged and sterilized. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are described as "non clinical test" meaning they likely involved simulated environments or in-vitro testing rather than human patient data.
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 applicable. The tests were non-clinical performance tests of a surgical instrument, not an AI diagnostic device requiring expert ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Expert adjudication is not relevant for non-clinical performance tests of a surgical instrument.
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 instrument, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, validation would be against engineering specifications and industry standards for surgical instruments. For example, dimensional tests would be validated against design drawings to ensure it meets specified dimensions, tensile tests against material specifications, and simulated biopsy yield against a measure of tissue acquisition in a controlled environment. The "ground truth" for a surgical device's performance would be its adherence to established engineering and performance benchmarks.
8. The sample size for the training set
Not applicable. This device is a surgical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a surgical instrument, not an AI model.
Summary of the Study Proving Device Meets Criteria:
The document states, "Performance tests were conducted in several areas including, dimensional, tensile, simulated biopsy yield, cutting jaw force tests." It concludes, "The Novatome™ was designed utilizing design control methods and is safe and effective for the application for which it is intended. Based on the comparison of the intended use, the design of the predicate devices, and the results of all testing performed, the proposed Novatome™ shows substantially equivalence to the predicate devices."
The study that "proves" the device meets acceptance criteria consists of these non-clinical performance tests. The specific details of these tests (e.g., number of units tested, exact methodology, detailed results) are not provided in this 510(k) summary but would have been part of the full 510(k) submission. The FDA's letter of October 23, 2007, confirms that based on the provided information, the device was found substantially equivalent to predicate devices, implying these tests were deemed sufficient to demonstrate its safety and effectiveness for its intended use. Clinical studies were explicitly not conducted on the Novatome forceps.
§ 870.4075 Endomyocardial biopsy device.
(a)
Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.(b)
Classification. Class II (performance standards).