Search Results

Disposable Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

Disposable Bipolar Forceps consists of forceps pieces, forceps holder, wire. The tail end of the forceps pieces are connected with the forceps holder. The forceps holder is provided with a high frequency input wire, and the wire can be connected with the high frequency surgical equipment through a plug. The outer surface of the forceps pieces are provided with an insulation layer. Disposable Bipolar Forceps materials: forceps tips material: silver plated brass; forceps pieces material: brass; forceps pieces coating: epoxy resin; packaging: PETG tray, Tyvek lid. The structure of Disposable Bipolar Forceps is double forceps pieces. Two fingers pinch the left and right forceps pieces, so that the forceps tips gently clamp the tissues, through the high frequency current to achieve electrocoagulation hemostasis. The rebound action is realized by the rebound force of the forceps pieces.

This is a 510(k) summary for a medical device, specifically Disposable Bipolar Forceps. It describes the device, its intended use, and its comparison to a predicate device to demonstrate substantial equivalence to the FDA.

The document does not describe an acceptance criteria table or specific study results to prove a device meets acceptance criteria in the way typically expected for a diagnostic AI/ML device.

Instead, this 510(k) pertains to a physical medical device (electrosurgical forceps) and its acceptance criteria are primarily met through non-clinical testing to demonstrate performance, safety, and substantial equivalence to a legally marketed predicate device. The "acceptance criteria" here are essentially compliance with recognized standards and demonstration of comparable performance to the predicate device.

Here's an attempt to answer your questions based on the provided text, acknowledging that the format of the "acceptance criteria" and "study that proves the device meets the acceptance criteria" will not align with a diagnostic AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this physical medical device are derived from compliance with recognized industry standards and demonstration of comparable performance to the predicate device. The document does not present a formal "acceptance criteria table" with numerical targets as might be seen for a diagnostic device's sensitivity/specificity. Instead, it lists the types of tests performed and implies that the results met the requirements of these standards and showed equivalence to the predicate.

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in the context of diagnostic performance. For the described non-clinical tests (electrical safety, biocompatibility, mechanical strength), the "sample size" would refer to the number of device units tested according to the specific testing protocols for those standards. This information is not detailed in the summary.
• Data Provenance: The studies are described as "Ex-vivo experimental study on Thermal Effects" and other non-clinical tests. This indicates laboratory testing, not human subject data from a specific country or retrospective/prospective clinical data.

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 is not applicable as the device is a physical electrosurgical tool, not an AI/ML diagnostic system requiring expert interpretation for ground truth. The "ground truth" for performance is established by objective measurements against engineering specifications and validated test methods (e.g., measuring current leakage, tissue temperature changes, mechanical force).

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

Not applicable for this type of physical medical device and its non-clinical testing. Adjudication methods are typically relevant for human interpretation in diagnostic studies.

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, and no MRMC study was performed.

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

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

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

For the non-clinical tests described:

• Electrical Safety & EMC: Ground truth is defined by the passing criteria of the referenced IEC standards.
• Biocompatibility: Ground truth is defined by the absence of toxicity, sensitization, or reactivity as measured by specific cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity assays.
• Thermal Effects: Ground truth relates to measurable tissue changes (e.g., temperature, coagulation effect) produced by the device in ex-vivo experimental settings, evaluated against established scientific principles and potentially in comparison to the predicate device's known effects.
• Mechanical Strength: Ground truth is defined by resistance to breakage or deformation under specified forces/stresses.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."

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

Not applicable, as there is no training set.

Ask a specific question about this device