(77 days)
The Reusable hot biopsy forceps are intended for use in flexible endoscopy procedures to biopsy, grasp, dissect and transect tissue.
Lesions/polyps of the lower or upper gastrointestinal tract may be biopsied for the purpose of diagnosing malignancies and other disorders.
The Reusable hot biopsy forceps are intended for use in flexible endoscopy procedures to biopsy, grasp, dissect and transect tissue.
The lesion/polyp is grasped between the jaws of the biopsy forceps; the forceps are then lifted from the intestinal wall and the tissue is ablated with electric current.
The provided text does not contain a study that demonstrates the device meets specific acceptance criteria in the manner requested. The document is primarily a 510(k) submission summary for "Monopolar Biopsy Forceps," focused on regulatory approval based on substantial equivalence to existing devices, rather than detailed performance study results against predefined acceptance criteria.
The "Safety and Effectiveness Summary" section mentions that the device "manufactures and tests the product to performance U. S. E. specifications based on predicate and/or substantially equivalent devices," and that "Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications." This indicates that internal testing and quality control occur, but it does not describe a formal study with acceptance criteria and reported device performance in a format that would allow filling out the requested table.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can be inferred or explicitly stated, and what is missing:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not list specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or specific physical performance metrics) for the device's function (biopsy, grasping, dissection, transection). It also does not report the device's performance against such criteria. The approval is based on substantial equivalence to predicate devices, implying that if the predicate devices meet performance standards, this device, by being equivalent, is also deemed safe and effective.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided. No clinical or performance study details are given, so there is no mention of a test set, its sample size, or data provenance.
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):
- Cannot be provided. No clinical study details involving expert evaluation or ground truth establishment are present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. No clinical study details provided.
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 instrument (biopsy forceps), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. No clinical study details provided for ground truth.
8. The sample size for the training set:
- Cannot be provided. No training set for a study is mentioned. The document primarily discusses manufacturing processes and quality assurance rather than a data-driven training of an algorithm or a clinical study with a training phase.
9. How the ground truth for the training set was established:
- Cannot be provided. No training set for a study is mentioned.
Summary of available information related to performance/testing:
The document states:
- "manufactures and tests the product to performance U. S. E. specifications based on predicate and/or substantially equivalent devices."
- "U.S.E. manufacturing processes and procedures are based on good manufacturing practices."
- "Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications."
- "Materials used in the manufacturing process are certified to standards appropriate for their use."
This indicates an internal validation process focused on manufacturing quality and conformance to design specifications that are themselves based on predicate devices. It is not a report of a stand-alone clinical or performance study with defined acceptance criteria and reported device performance metrics in the context of diagnosis or treatment outcomes. The FDA approval is based on "substantial equivalence" as per the 510(k) pathway, not necessarily on a novel performance study against new, explicit clinical acceptance criteria.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).