(85 days)
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.
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- 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.
| Test Type | Acceptance Criteria (Not Explicitly Defined) | Reported Device Performance |
|---|---|---|
| Dimensional Verification Tests | Not explicitly defined | All samples passed the test |
| Tensile Tests | Not explicitly defined | All samples passed the test |
| Simulation Test (Insertion & Tissue Samples) | Not explicitly defined | All samples passed the test |
| Shelf Life Testing & Transport Simulation | Not explicitly defined | All samples passed the test |
| Biocompatibility (ISO 10993-1) | Not explicitly defined | Meets ISO 10993-1 requirements |
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.
§ 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).