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FEHLING biopsy forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.

The Biopsy Forceps are designed to allow percutaneous access to the right or left ventricles of the heart to obtain diagnostic tissue samples. The forceps consist of three main components:

• an actuating handle ergonomically designed for comfortable use, 1.
• 2. a flexible shaft,
• and surgical stainless steel cutting jaws. 3.
  At the distal end of the forceps is a pair of stainless steel jaws used to obtain the tissue samples. At the proximately end of the forceps is the actuation handle used to activate the jaws and steer the device.
  The product is provided single for use and sterile.

The provided document is a 510(k) premarket notification for a medical device called "Biopsy Forceps." It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. The document includes non-clinical performance data to support its claims but does not include details about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/ML devices (e.g., performance metrics like accuracy, sensitivity, specificity).

Instead, the document focuses on demonstrating physical and biological compatibility and functionality for a mechanical medical device. Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's an attempt to answer the questions based only on the provided text, recognizing the limitations:

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

The document states that "All samples passed the test and met the acceptance criteria" for several non-clinical tests, but it does not explicitly define those acceptance criteria. The reported "performance" is simply that the device met these (unspecified) criteria.

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

The document mentions "All samples" for the dimensional, tensile, and shelf life tests, but it does not specify the exact number of samples.

For the Simulation Test - Insertion and Taking of Tissue Samples:

• Sample Size: "The process was repeated 10 times per device." The number of devices used is not specified.
• Data Provenance: No country of origin or retrospective/prospective nature is specified for the non-clinical tests. The tissue samples were "fresh porcine heart specimens."

For Biocompatibility: "The full strength EMEM10 test article showed no cytotoxic potential to L-929 mouse fibroblast cells." No specific sample size (number of cells or test articles) is given, beyond indicating "the test article."

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. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML study requiring expert consensus for ground truth.

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

Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device.

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 is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML study.

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

Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML algorithm. The performance tests ("Dimensional Verification," "Tensile Tests," "Simulation Test - Insertion and Taking of Tissue Samples," "Shelf Life Testing") are effectively "standalone" tests of the device itself.

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

For the non-clinical performance tests:

• Dimensional Verification: Comparison to engineering specifications/manufacturing tolerances (implied).
• Tensile Tests: Comparison to mechanical strength specifications (implied).
• Simulation Test: Successful introduction and harvesting of tissue samples from "fresh porcine heart specimens" (functional verification).
• Shelf Life Testing: Maintenance of specified performance after accelerated aging/transport simulation.
• Biocompatibility: Results from standardized cytotoxicity, chemical characterization, and previous toxicological data compared against ISO 10993-1 requirements.

8. The sample size for the training set

Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML algorithm.

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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.

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.

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