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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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The DeRoyal Industries. Inc. Multider "Plus Oel in chronic, non-healing wounds, ulcers, and over burns to provide a procecive film and a moist wound environment conducive to healing.

The DeRoy I Industrics, In Multidex "Plus Gel is the same as Multidex" Plus Powder in the same manner as Multider " Plus Powder, it is used in case of thoric, nombaling would, ut car, and over burn as a protection in the same in the same prodicate devices, the plater, in the strong nonealing would , ulces, ac over buns as a pocecive film. Like that for the devices is used o cover wouds and a provide a moist the basis for the device is a bot the proces and in provide a most environment conductive on healing concept of the bacesing be the form the basis for the decise in that the Device DesignMaterials UsedPhysical Propries: The proposed DeRoyal Industries, Inc. Multics I Plus Gr. Includes the same materials as the same of the country stour riop. The proposed Dekoyal Industries, Inc. Multies." Plus Colincludes the same Multidex Plus Powder. The concept of use is that it can be easi

This document is a 510(k) summary for the DeRoyal Industries, Inc. MULTIDEX® PLUS GEL. It describes the device and its intended use, and compares it to legally marketed predicate devices.

However, it does not contain any information about a study that tests specific acceptance criteria and reports device performance against those criteria.

The document states that "The DeRoyal Industries, Inc. Multidex® Plus Gel is the same as Multidex® Plus Powder... Like its predicate devices, the Multidex® Plus Gel is used to cover wounds and to provide a moist environment conducive to healing." It highlights the difference in form (gel vs. powder) for easier application and flexibility but doesn't present data from a clinical or performance study about this.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence based on materials, intended use, and existing knowledge of a key ingredient (glycerin), rather than providing results from a specific performance study.

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

The DeRoyal Surgical Electrosurgical Cautery Pencil Adapter functions in the same manner as predicate devices in that it is used to connect one type of electrosurgical Cautery Pencil to a particular type of jack on the electrosurgical cautery machine being used.

Device Design/Materials Used/Physical Properties: The DeRoyal Cautery Pencil Adapter is made of materials commonly used for its 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 510(k) summary describes a device that is an adapter for electrosurgical cautery pencils. It explicitly states that the device "functions in the same manner as predicate devices" and "converts one type of connection to another type of connection without any alteration of the circuit or any impact on the original circuit." The provided text does not contain a study demonstrating performance against acceptance criteria in the way a diagnostic or therapeutic medical device submission might. Instead, it relies on a comparative analysis to predicate devices to establish substantial equivalence.

Therefore, the following answers are based on the information provided, which indicates a lack of a formal performance study with acceptance criteria as would be typical for more complex devices.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

Given that this is a 510(k) for an electrosurgical cautery pencil adapter and the submission focuses on substantial equivalence, the "acceptance criteria" and "reported device performance" are primarily demonstrated through direct comparison to legally marketed predicate devices, rather than through a separate, quantitative performance study as might be seen for a diagnostic or therapeutic device. The core acceptance criterion is that the adapter performs identically to predicate devices in its function of enabling electrical connection without altering the circuit.

1. A 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)

• Sample Size: Not applicable. No dedicated "test set" in the context of a performance study is described. The evaluation is based on a design and functional comparison to predicate devices.
• Data Provenance: Not applicable. The submission relies on a comparison of device characteristics rather than data from a study.

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. No "ground truth" establishment by experts for a test set is described. The claim is based on the device's design and functional similarity to predicate devices already on the market.

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

• Not applicable. No test set requiring adjudication is described.

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 device is an electrosurgical adapter, not an AI-powered diagnostic tool, so an MRMC study is irrelevant to its evaluation.

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

• Not applicable. This device is a passive adapter, not an algorithm.

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

• Not applicable in the typical sense for a performance study. The "ground truth" for this submission is implicitly the established safety and effectiveness profile of the predicate devices to which the DeRoyal adapter is compared. The claim is that the adapter achieves equivalence by performing the same function using similar materials and design principles.

8. The sample size for the training set

• Not applicable. There is no training set for this type of device.

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

• Not applicable. There is no training set for this type of device.

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