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The Reprocessed Hot Biopsy Forceps are intended to be used for endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract.

The device consists of a proximal handle containing an electrosurgical plug which is connected, via a coil, spring or rod mechanism, to the biopsy cup or alligator forceps at the distal tip. The biopsy forceps range from 160 to 240 cm in length and 2.2-2.5 mm in diameter. The jaws range from 2.2 to 2.5 mm in diameter. The cup forceps may or may not have serrated edges, a fenestration, needle, or distal biting tooth. The forceps are covered with a sheath of electrical insulation. The electrosurgical plug on the handle used for connection to the appropriate electrosurgical unit. This submission does not include the electrosurgical box that the forceps connect to or its associated connecting cable.

The provided document describes a 510(k) summary for "Reprocessed Hot Biopsy Forceps" by SterilMed, Inc. It outlines the device's description, intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain information typically found in acceptance criteria tables or detailed study results for AI/ML device performance.

Specifically, the document focuses on regulatory approval for a reprocessed medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies is absent from this regulatory submission.

The "Functional and Safety Testing" section vaguely states that "Representative samples of reprocessed hot biopsy forceps underwent bench testing to demonstrate appropriate functional characteristics." This is a high-level summary and does not provide specific performance metrics or detailed study designs.

Therefore, I cannot provide the requested information for an AI/ML device based on the given input.

Should the request pertain to the reprocessed hot biopsy forceps themselves (as a non-AI device), the relevant information from the document is summarized below, but it does not fit the typical format for AI/ML device performance evaluation criteria.

Based on the provided document, here's what can be extracted regarding the device and its testing, keeping in mind it's for a reprocessed physical medical device, not an AI/ML system:

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

The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/ML device. Instead, it refers to "appropriate functional characteristics" for a reprocessed physical device.

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

• Sample Size for Test Set: The document states "Representative samples" but does not provide a specific number for the bench testing or process validation.
• Data Provenance: Not specified, but generally, such testing would be conducted in a controlled lab environment by the manufacturer (SterilMed, Inc., Minneapolis, MN, USA). The studies are inherently prospective in the sense that they are performed on the reprocessed devices prior to market release, but the data used to inform the reprocessing protocol might stem from retrospective analysis of failed devices or historical data.

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

This information is not provided. For a physical device, "ground truth" often refers to engineering specifications, industry standards, or performance benchmarks established at the time of original manufacturing. It's not typically established by human "experts" in the same way as an AI/ML diagnostic system.

4. Adjudication method for the test set:

Not applicable and not mentioned.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

For a physical reprocessed device, the "ground truth" is implied to be:

• Engineering specifications of the original device.
• Performance benchmarks (e.g., electrical integrity, mechanical strength, sterility, cleanliness) that allow the device to function as intended and safely.
• Regulatory standards for reprocessing in terms of cleanliness, sterilization, and function.

8. The sample size for the training set:

Not applicable/not specified. There is no "training set" in the context of an AI/ML algorithm for this physical device.

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

Not applicable/not specified. There is no "training set" for an AI/ML algorithm.

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Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps are intended to be used during GI procedures for endoscopic tissue sample acquisition.

Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract.

Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.

Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by Clear Medical to Clear Medical protocol Number 40003. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. Clear Medical is a "third party reprocessor" and reprocesses used, single-use medical devices. Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps. CMI intends to reprocess used disposable hot and cold biopsy forceps manufactured by Micovasive. CMI reprocessed biopsy forceps are disposable unless reprocessed again by Clear Medical, Inc.

This document is a 510(k) summary for Reprocessed Used Disposable Biopsy Forceps by Clear Medical, Inc. It mainly focuses on the substantial equivalence of the reprocessed devices to new predicate devices. It does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria in the way a clinical study would for efficacy/performance claims.

Here's an analysis based on the provided text, focusing on what can be extracted or inferred about acceptance criteria directly related to the reprocessing and substantial equivalence, rather than a clinical performance study.

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

Based on the nature of this 510(k) submission, "performance" here refers to the ability of the reprocessed device to meet the functional and safety characteristics of the original device after reprocessing, demonstrating substantial equivalence. The document doesn't provide a table of precise quantitative acceptance criteria with reported numerical performance values from a study. However, it implicitly states the requirement for the reprocessed device to perform equivalently to the new predicate device.

The acceptance criteria for "reprocessed" devices, as stated by Clear Medical, are defined by the FDA's Compliance Policy Guide #7124.16 related to "reusable - by Clear Medical" devices:

• Ability to withstand necessary cleaning and sterilization processes.
• Physical characteristics or quality of the device will not be adversely affected.
• The device remains safe and effective for its intended use.

The document states that Clear Medical believes these conditions are met, and the FDA's 510(k) clearance implies that the provided data (though not detailed here) was sufficient to demonstrate this belief as valid for substantial equivalence.

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

The document does not specify the sample size, data provenance, or study design (retrospective/prospective) for any specific testing related to establishing substantial equivalence. The submission is for "Reprocessed Used Disposable Biopsy Forceps," indicating that the "test set" would be reprocessed devices. The original disposable biopsy forceps were manufactured by Microvasive.

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)

This 510(k) summary does not mention the use of experts to establish a "ground truth" in the context of a clinical performance study. The primary focus is on the substantial equivalence of the reprocessed device to the predicate device, which would typically involve engineering and sterilization validation rather than expert clinical assessment of patient outcomes for a test set.

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

Not applicable, as a clinical test set requiring adjudication by experts is not described in this document.

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 document pertains to the reprocessing of medical devices (biopsy forceps), not an AI-assisted diagnostic tool or a study involving human readers.

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

Not applicable. This document pertains to the reprocessing of medical devices (biopsy forceps), not an algorithm.

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

For this type of device, the "ground truth" for substantial equivalence would likely revolve around:

• Functional equivalence: Demonstrating that the reprocessed device performs the biopsy function (e.g., tissue sample acquisition) comparably to new devices. This might involve mechanical testing, tissue grip tests, cutting performance.
• Sterility: Proving that the device is sterile after reprocessing.
• Material integrity: Ensuring the device materials do not degrade and no toxic residues remain after reprocessing. This would involve chemical analysis, material compatibility testing, and biocompatibility.
• Biocompatibility: Demonstrating that the reprocessed materials are still biocompatible.

The document does not provide details on which specific "ground truth" methods were employed, but these are typical for reprocessing validations.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an algorithm based on machine learning.

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

Not applicable, as there is no training set for an algorithm.

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The MediSISS Reprocessed Hot Biopsy Forceps and accessories are intended to be used endoscopically to obtain tissue specimens, remove polyps, and cauterize tissue.

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I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for reprocessed hot biopsy forceps, along with a list of substantially equivalent devices and indications for use. It does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies as you have requested.

The letter primarily confirms that the reprocessed devices are substantially equivalent to legally marketed predicate devices and have met the regulatory requirements for medical devices.

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When used with a compatible electrosurgical unit, endoscope and patient grounding pad, electric biopsy forceps are intended for electrocautery and removal of polyps and/or tissue within the gastrointestinal tract. The forceps are prescription devices intended for a single patient use only.

Biopsy forceps are devices used to collect tissue samples and/or remove polyps within the gastrointestinal tract via the operating channel of endoscopic instruments.

Electric biopsy forceps include an electrocautery function when used with a compatible electrosurgical unit.

The devices consist of flexible, electrically isolated sheaths with distal grasping cups that are controlled by a proximal handle. The forceps are guided by endoscopy through a biopsy channel with a minimum dimension of 2.8 mm. Monopolar electrocautery requires electrical connection of the forceps to a compatible electrosurgical unit and use of an appropriate patient grounding pad.

Vanguard receives previously used electric biopsy forceps from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the forceps; and returns them to the healthcare facility.

The provided text describes a submission for reprocessed electric biopsy forceps and does not contain information about acceptance criteria, device performance, or a study design in the context of medical device AI or diagnostic performance measurements. The document is a 510(k) summary for a medical device (reprocessed electric biopsy forceps) and focuses on substantial equivalence to predicate devices, rather than a study evaluating the diagnostic performance of a device against specific acceptance criteria.

Therefore, I cannot provide the requested information. The text discusses:

• Device Name: Vanguard Reprocessed Electric Biopsy Forceps
• Indications for Use: Electrocautery and removal of polyps and/or tissue within the gastrointestinal tract when used with a compatible electrosurgical unit, endoscope, and patient grounding pad.
• Technological Characteristics: Stated to be the same as the predicate devices, with unchanged materials and dimensions, and essentially identical physical characteristics and performance specifications.
• Test Data: Mentions "Decontamination and cleaning, packaging and sterilization validations and functional/performance, shelf life and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." This is related to the reprocessing procedure's validation, not a study to establish diagnostic performance or AI effectiveness.

There is no information on:

1. A table of acceptance criteria and reported device performance in the context of diagnostic accuracy.
2. Sample sizes for test sets, data provenance, or retrospective/prospective study design for diagnostic performance.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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