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The Endomyocardial Biopsy Forceps are designed for endomyocardial biopsies.

The EMB is sterile, single use, radiopaque, disposable device that is delivered non-toxic and non-pyrogenic. The device is transvascularly deployed to the right ventricle of the heart for the acquisition of endomyocardial tissue samples Typically, the approach is made from the jugular vein or femoral arteries. The EMB consists of 4 major components: the moveable handle, end-effectors (jaws), core wire, and sheath. The core wire is attached to the handle. Moving the handle opens and closes the jaws.

This document is a 510(k) premarket notification for a medical device called the Endomyocardial Biopsy Forceps (EMB) manufactured by Medcanica, Inc. It seeks to establish substantial equivalence to a predicate device, the BiPal Biopsy Forceps from Cordis Corporation (510(k) K914567).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance" in the way one might expect for a diagnostic or AI device study. Instead, it focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with recognized consensus standards.

The closest representation of "acceptance criteria" and "performance" can be inferred from the comparison table of technological characteristics and the declaration of compliance with standards.

The general acceptance criterion is "substantial equivalence" to the predicate device. The performance is demonstrated by the device sharing similar technological characteristics and meeting the cited consensus standards, indicating that it performs "as well as or better than the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document primarily describes bench testing for the EMB device to demonstrate substantial equivalence. It does not refer to a "test set" in the context of a dataset of cases or clinical images.

• Sample Size for Test Set: Not applicable in the context of image analysis or AI. The testing described is for the physical device itself. The specific number of devices tested for tensile, flexibility, dimensional, and performance tests is not quantified in the provided text.
• Data Provenance: Not applicable. The "data" refers to the results of bench tests on the physical device, not patient data or clinical images.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this document. The device in question is a physical endomyocardial biopsy forceps, not a diagnostic algorithm or AI system that requires expert-established ground truth from images or patient data. The "ground truth" here would be the physical properties and performance characteristics of the device under specific testing conditions, measured by engineering methods.

4. Adjudication Method for the Test Set

This information is not applicable to this document, as there is no "test set" of cases/images requiring expert adjudication in the context of a 510(k) for a physical medical 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

No, an MRMC comparative effectiveness study was not done. This type of study relates to the performance of diagnostic algorithms or AI systems and their impact on human reading, which is not relevant to a physical biopsy forceps.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the EMB device is established through bench test results against engineering specifications and comparison to the characteristics of the predicate device. This includes:

• Dimensional measurements: Jaw volume, working lengths, sizes.
• Material properties: Compliance with ASTM F899 95 for stainless steel.
• Biocompatibility: Through selection of materials with a "long history of biocompatibility" and compliance with ISO 10993-7 for sterilization residuals.
• Sterilization efficacy: Compliance with ANSI/AAMI/ISO 11135-1994 and 21 CFR, § 821.100 regarding ethylene oxide sterilization.
• Functional performance: "Tensile, flexibility, and performance tests" demonstrating similar function to the predicate device.

Essentially, the ground truth is established by direct physical and chemical testing of the device and its components against established engineering and regulatory standards, and by comparison to the known characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing process are guided by engineering principles, regulatory standards, and the characteristics of the predicate device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI/machine learning model. For the device itself, the design and manufacturing are founded on established engineering principles, materials science, and medical device regulations. Compliance with Good Manufacturing Practices (GMP) and the Quality System Regulation (QS) for Medical Devices (21 CFR Part 820) ensure the device is safe and effective.

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