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The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. These forceps are advanced to the site for sampling via the operating channel of an endoscope.

The device consists of a proximal handle which is connected, via a coil, spring or rod mechanism, to the biopsy jaws at the distal tip. The biopsy forceps range from 100 to 240cm in length and 1.8-3.3mm in diameter. The jaws range from 1.8 to 3.3mm in diameter. The jaws of the forceps may or may not have serrated edges, a fenestration, needle, or distal biting tooth.

The provided document is a 510(k) summary for SterilMed's Reprocessed Cold Biopsy Forceps. This submission is for a reprocessed medical device, not a novel AI/software-as-a-medical-device (SaMD) or diagnostic device that relies on algorithms for analysis or detection. Therefore, many of the typical questions regarding acceptance criteria and study design for AI-based devices are not applicable.

This document describes the functional and safety testing to demonstrate that the reprocessed devices perform equivalently to their original manufactured counterparts and predicate devices.

Here's an analysis based on the information provided, specifically addressing the questions where applicable, and noting where information is not present given the nature of the device:

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

The document states that "Reprocessed Cold Biopsy Forceps underwent bench testing to demonstrate appropriate functional characteristics." It also mentions "Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced."

However, specific numerical acceptance criteria (e.g., tensile strength, bite completeness, cleanliness levels) and quantitative performance results are not detailed in this summary. The conclusion broadly states that the reprocessed forceps are "substantially equivalent" based on "similarities in functional design, materials, indications for use and methods of construction."

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 states "Representative samples" were used for bench testing. It does not specify the exact sample size for the functional and safety testing. Given it's a medical device reprocessing submission, the "data provenance" would refer to the testing results of the reprocessed devices themselves, rather than clinical data from human subjects. The testing described is prospective in nature as it's performed on reprocessed devices to validate the process. There is no mention of country of origin of the data beyond the submitter's location (Minneapolis, MN, USA).

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 question is not applicable to this submission. The "ground truth" for the performance of a reprocessed biopsy forceps would be its ability to safely and effectively retrieve tissue samples, as demonstrated through functional and safety testing. There are no "experts" establishing ground truth in the sense of image interpretation or medical diagnosis as would be relevant for an AI/diagnostic device. The "ground truth" is typically defined by engineering specifications and performance benchmarks compared to new devices.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review processes for diagnostic devices to resolve discrepancies in interpretations. For functional bench testing of a reprocessed mechanical device, direct physical measurements and observations are used, not expert adjudication of interpretations.

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

This question is not applicable as this is a submission for a reprocessed medical device, not an AI/SaMD. There are no human readers or AI assistance involved.

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

This question is not applicable. This device is a physical biopsy forceps; it does not involve algorithms or AI.

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

For this device, the "ground truth" for the functional and safety testing would be adherence to established engineering specifications and performance characteristics of new, equivalent devices, as well as the sterility and cleanliness standards required for a reprocessed device. This relies on benchmarking against predicate devices and validated manufacturing/reprocessing specifications, rather than expert consensus on medical images or pathology.

8. The sample size for the training set

This question is not applicable as this is not an AI/machine learning device. There is no "training set."

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

This question is not applicable as this is not an AI/machine learning device. There is no "training set" or ground truth establishment as it would apply to AI.

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The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.

MediSISS Reprocessed Non-electric GI Biopsy Forceps are designed for endoscopic use to retrieve tissue samples for microscopic inspection. Forceps outer diameters range from 2,2mm to 2.5mm and working lengths vary from 160cm. A syringe-like proximal handle opens and closes the distal instrument jaws, that are available in multiple design configurations such as Oval, Alligator, Smooth, or Fenestrated with and without a needle. The working length of the biopsy forceps is coated with a plastic sheath to decrease friction.

The provided document is a 510(k) summary for the MediSISS Reprocessed Non-electric GI Biopsy Forceps. This type of document is for a medical device that processes existing devices, rather than a diagnostic AI device. As such, the specific criteria for AI model performance (like sensitivity, specificity, MRMC studies, ground truth establishment for training/test sets) are not applicable.

Instead, the acceptance criteria and study information provided relate to the reprocessing of surgical instruments to ensure they are safe and effective for reuse, demonstrating substantial equivalence to new, unused predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each validation test (cleaning, sterilization, functional performance, packaging). However, it refers to "validation data" and "routine tests" which implies a sampling methodology was used in accordance with the listed standards.

Data provenance refers to the origin and history of data. In this context, it relates to the devices that were reprocessed and tested. The predicate devices are from manufacturers like Bard, Esco Precision, Inc., and Olympus. The MediSISS device itself is a reprocessed version of various OEM models (e.g., Bard 385, Microvasive 1537, Olympus FB-240U, Wilson-Cook SDE 2.5-230). The testing would have been conducted on these reprocessed devices, likely in a controlled laboratory or testing facility ("retrospective" in the sense that the original devices are already manufactured, but "prospective" in the sense that the reprocessing and validation are performed afterward).

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

This type of information (number and qualification of specific experts for ground truth) is typically not applicable to the validation of reprocessed surgical instruments. The "ground truth" here is adherence to established engineering, microbiological, and material science standards. These standards (e.g., ISO, AAMI, ASTM, USP) are developed and maintained by expert committees and are considered the "ground truth" for safe and effective reprocessing. Compliance with these standards is assessed through validated test methods, not by subjective expert consensus on 'cases'.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert disagreement in diagnostic image reading. For device reprocessing validation, objective measurements and adherence to performance specifications of the listed standards dictate acceptance or rejection.

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 reprocessed surgical instrument, not an AI diagnostic tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This refers to AI algorithm performance without human intervention, which is not relevant to a reprocessed surgical instrument.

7. The Type of Ground Truth Used

The "ground truth" for the reprocessed non-electric GI biopsy forceps is defined by:

• Adherence to recognized industry standards: ANSI/AAMI/ISO 11737-1, AAMI TIR No. 12, ASTM D4164, ISO 11607, ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 10993, ASTM F88, ASTM F1980, United States Pharmacopeia 24, ASTM F2096-02. These standards specify acceptable limits for microbial load, sterility, residual levels, functional performance, and packaging integrity.
• Substantial equivalence to legally marketed predicate devices: The "ground truth" for safety and effectiveness is benchmarked against new, unused predicate devices (Bard K912549, Esco Precision K900015, Olympus K955065). Validation data confirmed that the reprocessed devices perform equivalently to these new devices.

8. The Sample Size for the Training Set

Not applicable. This concept is relevant for AI models, not for traditional medical device reprocessing validation.

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

Not applicable, as there is no "training set" in the context of this device's validation.

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GI forceps are designed for insertion through an appropriate sized endoscopy channel for removal and histological sampling of tissue. Biopsy forceps are intended for removal of polyps and/or tissue within the gastrointestinal tract.

Vanguard Reprocessed Non-Electric Biopsy Forceps consist of a flexible sheath with distal grasping cups controlled by a proximal control handle. When used with a compatible endoscope, GI biopsy forceps are intended for removal of polyps and/or tissue within the gastrointestinal tract. Biopsy forceps are designed for insertion through a predetermined diameter biopsy channel. Vanguard receives previously used non-electric GI biopsy forceps from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.

The provided text describes the 510(k) summary for the Vanguard Reprocessed Non-Electric Biopsy Forceps and does not contain the specific information requested about acceptance criteria, device performance tables, study designs (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone), or training set details.

The document focuses on:

• Device Description: Reprocessed non-electric GI biopsy forceps.
• Intended Use: Removal and histological sampling of tissue/polyps within the GI tract.
• Technological Characteristics: "Essentially identical" to OEM devices with no changes to materials or specifications.
• Predicate Devices: Various OEM non-electric biopsy forceps (Class I, 510(k) exempt).
• Test Data: States that "Cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective."

Therefore, I cannot fulfill your request for the detailed acceptance criteria and study information as it is not present in the provided text.

The document only broadly states that "performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective," but does not give any specifics on:

• Quantitative acceptance criteria (e.g., minimum tensile strength, maximum residual protein).
• Reported device performance against those criteria.
• Sample sizes for test sets.
• Data provenance.
• Number/qualifications of experts.
• Adjudication methods.
• MRMC or standalone studies.
• Types of ground truth.
• Training set details.

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