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Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.

The proposed device Grasping Forceps is a sterile, single-use device, designed to pass through a 2.8 mm or greater working channel of an endoscope.

The main components of Grasping forceps are jaws, spring sheath and handle. Grasping forceps can be used to grasp tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close.

The Grasping Forceps has six (6) specifications, the differences of these specifications are jaws open width, shape configuration of jaws and working length.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 5 years.

The provided document is a 510(k) summary for the Micro-Tech Grasping Forceps. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it explicitly states:

"8. Clinical Test Conclusion: No clinical study is included in this submission."

Therefore, a detailed description of acceptance criteria for a clinical study and the study proving the device meets those criteria, as requested, cannot be provided because no clinical study was conducted or presented in this document.

The document does include a "Non-Clinical Test Conclusion" which states: "Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device."

Here's the relevant information about the acceptance criteria and non-clinical testing from the document:

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

The document does not provide a table with explicit acceptance criteria for performance in a clinical setting. Instead, it relies on non-clinical tests to demonstrate that the device complies with various standards, thereby showing it meets design specifications and is substantially equivalent to a predicate device.

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 sample sizes for each non-clinical test. The provenance of the data is implicitly from Micro-Tech (Nanjing) Co., Ltd. in Jiangsu Province, PRC, as they are the submitter of the 510(k). The tests are non-clinical (laboratory/bench tests), not human clinical data, so the retrospective/prospective and country of origin for patients are not applicable.

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 information is not applicable. The "ground truth" for non-clinical tests is compliance with published international and national standards, not expert consensus interpreting clinical data. Therefore, no experts for establishing ground truth in the context of clinical performance are mentioned.

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

Not applicable, as this refers to clinical data adjudication, which was not performed.

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. No clinical studies, MRMC studies, or AI components are mentioned in the document.

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

Not applicable. No algorithm or AI component is mentioned.

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

For the non-clinical tests, the "ground truth" is adherence to the specified technical standards (e.g., ASTM, ISO, USP). For the claim of Substantial Equivalence, the "ground truth" is that the device's technical characteristics, intended use, and performance (as shown through non-clinical testing) are sufficiently similar to the predicate device, and it raises no new questions of safety and effectiveness.

8. The sample size for the training set

Not applicable. No training set is mentioned as there is no AI or machine learning component.

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

Not applicable. No training set or ground truth for a training set is mentioned.

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The instruments are for use on the laryngeal anatomy, e.g., the vocal cords, false cords, surpraglottis, glottis, epiglottis, tongue base, oral pharynx, and uvula. The instruments are used to grasp and hold tissue for dissection or vaporization. The forceps may be used to coagulate blood vessels within the tissue when it is connected to a unipolar high frequency generator. Depending on where the bleeding vessel is located, coagulate by applying a low dose of HF current. The intensity depends on the severity of the bleeding and on the vessel. Always start with a low dosage and increase the power if necessary.

The forceps are made of medical grade stainless steel, teflon coated medical grade stainless steel, black chrome plating, and plastic. The grasping forceps have been insulated and now allow the application of high frequency current.

The provided text is a 510(k) summary for the RICHARD WOLF Unipolar HF Grasping Forceps. It details the device, its intended use, and the basis for its substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria, study performance, sample sizes, expert qualifications, or ground truth establishment.

Specifically, the document states:

• "5.0 Performance Data None"
• "6.0 Clinical Tests No clinical tests performed."

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, and performance data, as this information is explicitly stated as not being included in the submission. The device's clearance was based on substantial equivalence to existing predicate devices, rather than through a performance study against specific acceptance criteria.

Ask a specific question about this device