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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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