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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.

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The BoVac Electrosurgery Suction Device removes smoke, odors, gases, particles, and fluids directly from the surgical site during electrosurgery procedures. The device is single-use and disposable.

Not Found

This document is a 510(k) clearance letter for the "BoVac Electrosurgery Suction Device." It indicates that the device has been found substantially equivalent to a predicate device, but it does not contain acceptance criteria or a study proving device performance against such criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a dedicated study. This type of document typically does not include the detailed study information requested in the prompt.

Therefore, I cannot provide the requested information based on the provided text.

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The intended use of the cutting and coagulation accessory is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders.

The cutting and coagulation system consists of a system controller that is connected to a power source. Two cables extend from the system controller, one to a foot-pedal to allow the operator to control the device; the other cable leads to the wand portion, which functions in the surgical site. The wand is the accessory for which MIT has developed the reprocessing technology.

This submission (K012640) describes the reprocessing of electrosurgical wands. The document provided does not contain the detailed acceptance criteria or a study demonstrating that the reprocessed device meets such criteria in a format applicable to AI/ML device studies. This 510(k) is for a reprocessed electrosurgical wand, not an AI/ML device. Therefore, the questions regarding AI/ML device performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this submission.

However, based on the provided text, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to general controls. The primary "study" or justification for acceptance is the assertion that the reprocessed device maintains the same technological characteristics and intended use as the original, legally marketed predicate devices.

Here's an attempt to structure the information based on the prompt, acknowledging that much of it is not relevant to a traditional AI/ML device evaluation:

1. Table of acceptance criteria and the reported device performance

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 (N/A). This K012640 submission is for a reprocessed medical device (an electrosurgical wand), not an AI/ML diagnostic or prognostic device requiring a test set of data for performance evaluation in the usual sense. The testing mentioned (e.g., dielectric test for sheathing) would have been performed on the reprocessed physical devices.

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)

• N/A. Ground truth in the context of expert consensus for AI/ML performance is not applicable to a submission for a reprocessed physical device. Device functionality and material equivalence are evaluated through engineering tests and comparison to specifications.

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

• N/A. Not applicable, as there isn't a "test set" requiring expert adjudication for this type of device 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

• N/A. This is not an AI/ML device, so MRMC studies are not relevant.

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

• N/A. This is not an AI/ML device.

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

• N/A in the context of AI/ML ground truth. For this device, the "ground truth" for demonstrating equivalence would be based on:
  • Predicate Device Specifications: The known design, material, and performance specifications of the original Mitek (K974022) or Arthrocare Wands (K962321).
  • Engineering Tests: Such as the dielectric test mentioned for the sheathing, demonstrating specific physical properties.
  • Functional Testing: Ensuring the reprocessed device performs its intended functions (ablation, cauterization) as expected.

8. The sample size for the training set

• N/A. Not an AI/ML device.

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

• N/A. Not an AI/ML device.

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The DeRoyal Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.

The DeRoyal Surgical Electrosurgical Grounding Pad Adapter functions in the same manner as predicate devices in that it sed to connect one type of electrosurgical grounding pad to a particular type of jack on the electrosurgical cautery ... achine being used.

Device Design/Materials Used/Physical Properties: The DeRoyal Grounding Pad Adapter is made of materials commonly used for their purpose. The concept of use is that the adapter converts one type of connection to another type of connection without any alteration of the circuit or any impact on the original circuit.

This document is a 510(k) summary for an electrosurgical grounding pad adapter. It describes a simple connector device and asserts its equivalence to predicate devices. The information provided is insufficient to answer most of your detailed questions regarding acceptance criteria and study design for performance. This type of device does not typically involve the kinds of advanced algorithms or human-in-the-loop studies implied by your questions.

Here's why and what can be extracted:

• Device Type: This is a physical adapter for connecting electrosurgical grounding pads. It's a passive component that facilitates a connection without altering the electrical circuit.
• Nature of the Submission: This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with complex studies.
• Missing Information: The document does not contain details about performance metrics, clinical studies, sample sizes, ground truth establishment, or expert reviews, as these are typically not required for this class and type of device. The "performance" for such a device is primarily about fit, electrical conductivity, and safety, often demonstrated through bench testing and adherence to standards rather than clinical trials with human readers.

However, I will attempt to address the parts of your request that can be inferred or directly stated from the provided text, and explicitly state when information is missing.

Acceptance Criteria and Study Information for DeRoyal Industries, Inc. Electrosurgical Grounding Pad Adapters

Given the nature of the device (a passive electrosurgical grounding pad adapter) and the context of a 510(k) premarket notification from 1996, the concept of "acceptance criteria" and "study" as typically applied to AI/software-driven medical devices (which your questions imply) is not applicable here. The "study" for such a device would primarily involve bench testing for electrical safety, mechanical fit, and material compatibility, demonstrating equivalence to predicate devices. The document provided does not detail specific acceptance criteria or performance study results beyond the general assertion of functional equivalence.

Here's what can be gathered, with limitations noted:

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

• Note: The "acceptance criteria" here are inferred to be basic functional and safety requirements for an adapter. The "reported device performance" is essentially a statement of equivalence and proper function, as detailed in the 510(k) summary. Specific quantitative metrics (e.g., resistance values, force to connect/disconnect) are not provided in this summary.

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

• Information Not Provided: The summary does not mention any formal "test set," sample size, or data provenance from a study comparing its performance in a clinical setting. For this type of device, testing would typically involve a small number of physical prototypes undergoing bench tests rather than a large data set.

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)

• Information Not Provided: This question is not applicable to a simple electrosurgical adapter. There is no "ground truth" in the sense of expert interpretation of data. Functional verification would be performed by engineers or technicians against design specifications.

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

• Information Not Provided: Not applicable.

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

• Answer: No. This is not an AI/software device. An MRMC study is completely irrelevant for an electrosurgical grounding pad adapter.

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

• Answer: Not applicable. This is a passive physical adapter, not an algorithm.

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

• Answer: Not applicable. The "ground truth" for this device would be its ability to correctly form an electrical and mechanical connection as per engineering specifications and relevant electrical safety standards. This is validated through bench testing, not clinical "ground truth" data.

8. The sample size for the training set

• Information Not Provided: Not applicable. This device does not involve a "training set" as it's not an AI/machine learning model.

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

• Information Not Provided: Not applicable.

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