Search Results

The Black and Black Surgical monopolar electrodes and forceps are reusable devices intended for use in surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate soft tissue.

The Black and Black monopolar forceps and electrodes are handheld, reusable devices designed to deliver monopolar RF electrosurgical energy to a surgical site to cut and/or coagulate tissue. The surgeon activates the desired electrosurgical mode from the sterile field by using buttons on the device. Three electrosurgical modes are available: Cut: cuts tissue with minimal coagulation / hemostasis; Hemostasis with Division: divides tissue with controlled hemostasis; Coag: coagulates bleeding vessels to promote hemostasis.

Based on the provided text, a detailed description of acceptance criteria, device performance, and the study methodologies is not available. The document is a 510(k) summary for a medical device (electrosurgical cutting and coagulation forceps and electrodes), which primarily focuses on establishing "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Here's a breakdown of what can and cannot be extracted from the given text:

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria or a specific study designed to "prove" the device meets these criteria in the typical sense of a clinical trial or performance study with defined metrics.

Instead, the core of this 510(k) submission is to demonstrate substantial equivalence to already marketed predicate devices. This means the new device is deemed safe and effective because it shares similar technological characteristics, intended use, and operational principles with existing devices that have already undergone FDA clearance.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document because it does not exist in this context. The "performance" being demonstrated is conceptual substantial equivalence to predicate devices, not measured against specific numerical targets.

Study Information (Based on what's typically implicit in a 510(k) for substantial equivalence):

Given the nature of a 510(k) for "substantially equivalent" devices, a traditional standalone performance study with a test set, ground truth experts, and statistical analysis as described in the prompt is generally not required or presented in detail in the summary.

Here's what can be inferred or stated based on the provided text, with acknowledgments for what is missing:

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

   • Cannot be generated from the provided text. The document focuses on "substantial equivalence" to predicate devices rather than specific measurable performance against defined acceptance criteria.

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

   • Not applicable/Not provided. This type of information would be relevant for a clinical or performance study. In a 510(k) focused on substantial equivalence for a device like electrosurgical instruments, the "test set" is often conceptual, referring to the engineering design, materials, and functional tests demonstrating that the device operates as intended and similarly to predicates. There's no mention of human subject data 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):

   • Not applicable/Not provided. Ground truth (e.g., expert consensus, pathology) is typically established in studies evaluating diagnostic or predictive devices. For an electrosurgical device, safety and functional performance tests are more relevant, often conducted by engineers and technicians, not clinical experts establishing "ground truth" on patient data.

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

   • Not applicable/Not provided. This is relevant for studies involving human interpretation or data adjudication, which is not the primary focus of this 510(k) submission.

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:

   • No. This device is an electrosurgical tool, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC comparative effectiveness study involving human "readers" and AI assistance is not relevant and was not conducted.

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

   • No. This device is a physical electrosurgical tool, not an algorithm or software. It requires a human surgeon for its operation ("human-in-the-loop" is inherent to its intended use). Therefore, a standalone algorithm-only performance assessment is not applicable.

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

   • Not applicable in the typical sense. For this type of device, "ground truth" often refers to engineering specifications, material properties, electrical output measurements, and functional testing results (e.g., ability to cut and coagulate tissue in a controlled laboratory setting). The document does not detail specific "ground truth" methodologies.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is not an AI/ML model that requires a "training set."

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

   • Not applicable/Not provided. As above, no training set for an AI/ML model is involved.

Summary of Device and its "Proof" of Meeting Criteria:

The Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes are characterized as handheld, reusable devices designed to deliver monopolar RF electrosurgical energy for cutting and/or coagulating tissue. They offer three modes: Cut, Hemostasis with Division, and Coag.

The study that "proves" the device meets criteria (implicit in a 510(k) context) is the comparison to legally marketed predicate devices. The document states:

• "The Black and Black Surgical monopolar forceps and electrodes are substantially in function and intended use to the Colorado MicroDissection Needle (K033232), Valleylab Bayonet Forceps, Conmed Bayonet Straight Tip with Cable, Snowden-Pencer Endo-Plastic Electrosurgical Dissector. Snowden-Pencer Monopolar Insulated Forceps, and Olsen Hand Activated Monopolar Forceps."
• "The Black and Black monopolar forceps and electrodes have the same basic technological characteristics as the predicate devices noted above."

The FDA's letter further confirms this method: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Therefore, the "proof" is the demonstration of substantial equivalence to existing, cleared devices, implying that if the predicates are safe and effective, then a substantially equivalent device with the same technological characteristics and intended use will also be safe and effective. The specifics of how this equivalence was demonstrated (e.g., through bench testing, material comparisons, electrical safety tests) are not detailed in this summary but would have been part of the full 510(k) submission.

Ask a specific question about this device