(149 days)
The Bard V-Max24 Roller Bar is indicated for ablation and coagulation of soft tissue and is intended for use with compatible resectoscopes.
The Bard V-Max24 Roller Bar is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrosurgical generator cleared for medical use.
The provided text describes a medical device, the Bard V-Max24 Roller Bar, and compares it to a predicate device, the Circon ACMI VaporTrode™. However, the document is a 510(k) summary (a premarket submission to FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device).
This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance data in the manner typically seen for novel devices undergoing rigorous efficacy testing.
Therefore, many of the specific details requested in your prompt (e.g., sample sizes for test/training sets, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not present in this document. The provided text focuses on technological equivalence and intended use.
Here's an attempt to answer your questions based only on the information available in the provided text:
1. Table of acceptance criteria and the reported device performance
Based on the provided text, specific performance "acceptance criteria" and "reported device performance" in a quantitative sense (e.g., sensitivity, specificity, accuracy targets) are not detailed. The document focuses on demonstrating technological characteristics and intended use equivalence to the predicate device. The "performance" assessment is implied through this equivalence rather than explicit metrics.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Indications/Intended Use Equivalence: Device's intended use is substantially similar to the predicate device. | The Bard V-Max24 Roller Bar is indicated for ablation and coagulation of soft tissue, intended for use with compatible resectoscopes. This is very similar to the predicate's intended use for vaporization and coagulation of tissue with compatible resectoscopes. |
| Resectoscope Compatibility Equivalence: Device is compatible with a similar range of resectoscopes as the predicate. | Bard V-Max24 Roller Bar is compatible with Circon ACMI (USA and Classic), Wolf, Storz, and Olympus resectoscopes, which includes and expands upon the predicate device's compatibility. |
| Electrode Tip Design Equivalence: Device has a similar electrode tip design. | Bard V-Max24 Roller Bar has a "Surface finished (smooth, grooved, etc.) metal roller." The predicate has a "Grooved metal roller." This indicates design equivalence. |
| Body Construction Equivalence: Device has a similar body construction. | Both devices have "Conductive wire jacketed with polymer insulator tubing and further jacketed with distal stainless steel outer shaft." |
| Proximal Construction Equivalence: Device has similar proximal construction for compatibility. | Both devices have "Conductive contact compatible with specific resectoscopes." |
| Stabilizer Presence Equivalence: If applicable, stabilizer is present similar to predicate. | Bard V-Max24 Roller Bar has a stabilizer "On applicable models" while the predicate has it "On both models." This indicates functional equivalence where relevant. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text is a 510(k) summary, which typically focuses on demonstrating equivalence to a predicate device through technological characteristic comparison and intended use, rather than presenting new clinical study data with test sets.
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 provided in the document. Ground truth establishment for a test set is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are not discussed.
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
A multi-reader multi-case (MRMC) comparative effectiveness study and any discussion of AI assistance or human reader improvement are not mentioned in this document. The device is an electrosurgical electrode, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the device described. The Bard V-Max24 Roller Bar is a physical electrosurgical electrode, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. The concept of "ground truth" concerning performance metrics is not explicitly discussed as the submission focuses on substantial equivalence based on design and intended use.
8. The sample size for the training set
This information is not provided in the document. A training set is not discussed, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not provided in the document. This concept is not applicable as there is no training set for an AI/machine learning component.
§ 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).