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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:

1. an actuating handle ergonomically designed for comfortable use,
2. a flexible shaft,
3. and surgical stainless steel cutting jaws.

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.

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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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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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The T-REX™ biopsy forceps are intended to obtain endomyocardial biopsy specimens. The specimens are taken for diagnosis of diseased heart tissue or for identification and monitoring of rejection factors in a transplanted heart.

The T.REX™ forceps are designed to allow percutaneous access to the right or left ventricles of the heart in order to obtain diagnostic tissue samples. The forceps consist of three main components: a handle ergonomically designed for comfortable use, a body and surgical stainless steel cutting jaws.

The provided text is a 510(k) summary for the T-REX™ Biopsy Forceps. It describes the device, its intended use, and compares it to a predicate device (Bycep® biopsy forceps). However, it does not include specific acceptance criteria or a detailed study proving the device meets them in the way a clinical trial report would.

The document focuses on demonstrating substantial equivalence to a previously approved predicate device (Bycep® biopsy forceps) through comparing design modifications and conducting bench testing and biocompatibility evaluations. It explicitly states that clinical studies were not conducted.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the typical sense of metrics like sensitivity, specificity, or accuracy, as these are usually derived from clinical studies with defined endpoints.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

As clinical performance metrics are not provided, this table focuses on the types of performance evaluated and the overall conclusion of the substantial equivalence claim.

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

• Test Set Sample Size: Not specified for any of the in vitro (bench) tests. The document mentions "comparative testing" and "testing included modified joints and the overall tensile strength of complete devices" but does not give numerical sample sizes for these tests.
• Data Provenance: All testing appears to be in vitro (bench testing) performed by Boston Scientific Corporation Northwest Technology Center, Inc. There is no mention of geographical data provenance as the data is from laboratory testing, not human subjects. It is retrospective in the sense that it's comparing a new design to an existing one, but the data itself is from newly performed bench tests.

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

• This information is not applicable as the studies described are in vitro bench tests (mechanical, material, and sterility evaluations), not clinical studies involving expert interpretation of patient data or samples.
• Ground truth for mechanical properties would be engineering specifications and measurements.
• Ground truth for biocompatibility would be established by validated laboratory protocols and expert toxicologists/biocompatibility specialists interpreting the results against established standards (e.g., ISO 10993).
• Ground truth for sterility would be established by microbiological testing and validation against SAL standards.

4. Adjudication Method for the Test Set

• Not applicable, as no human-based assessment or adjudication of a "test set" (e.g., diagnostic images or clinical outcomes) occurred. The assessments were based on engineering measurements and laboratory results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done.
• The document explicitly states: "Clinical studies were not conducted on the T.REX™ forceps."
• Therefore, an effect size of human readers improving with or without AI assistance cannot be provided.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a manual biopsy forceps, not an AI algorithm or a device with an automated algorithm. The performance described relates to the physical characteristics and function of the forceps itself.

7. Type of Ground Truth Used

• For cutting ability and tensile strength: Engineering specifications, direct physical measurements, and comparison to the predicate device's measured performance.
• For biocompatibility: Results from validated laboratory assays (cytotoxicity, pyrogenicity, hemocompatibility) interpreted against established biocompatibility standards.
• For sterility: Microbiological testing and validation against a Sterility Assurance Level (SAL) of 10⁻⁶.
• For packaging: Testing to confirm protection and sterility maintenance (details not provided on specific ground truths, but likely industry standards for package integrity).

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not applicable, as there is no training set for a physical medical device.

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The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

The Heartport Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

The provided 510(k) notification for the Heartport® Endoaortic Clamp™ Catheter does not include specific acceptance criteria or a study that proves the device meets such criteria.

Instead, the submission relies on substantial equivalence to predicate devices. The key statement regarding device performance is:

"Based on the equivalence in design to the predicate device, performance testing was not warranted for this device. The device will meet the same criteria established for the currently marketed Heartport® Endoaortic Clamp™ catheter."

Therefore, most of the requested information cannot be extracted from this document as no new performance study was conducted.

Here's a breakdown of what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The subsequent questions relate to a performance study, which was explicitly stated as "not warranted" for this device due to its substantial equivalence to a predicate device. Therefore, the answers to these questions are generally "Not applicable" or "Not specified in this document."

2. Sample size used for the test set and the data provenance

• Not applicable. No new performance testing was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No new performance testing was conducted for this submission.

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

• Not applicable. No new performance testing was conducted for this submission.

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 medical catheter, not an AI-assisted diagnostic tool, and no performance 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 medical catheter, not an algorithm. No standalone performance study was done for this submission.

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

• Not applicable. No new performance testing requiring ground truth was conducted for this submission. The device's "ground truth" for regulatory purposes is its substantial equivalence to existing, legally marketed devices for which safety and effectiveness have already been established.

8. The sample size for the training set

• Not applicable. This device is a medical catheter, not a machine learning model, so there is no concept of a "training set" in this context.

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

• Not applicable. As above, no training set for a machine learning model is relevant here.

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