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The Cautery Protective Actuation System (CPAS) is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation. The CPAS device includes a safety cover intended to prevent inadvertent actuation of the monopolar electrocautery device, and to prevent secondary burns from a hot tip.

The Cautery Protective Actuation System device is a sterile, single-use, monopolar electrocautery pen intended to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation. The C-PAS device has a retractable cover, which functions to reduce the risk of inadvertent actuation that can result in burns, fires, patient impalement, or secondary contact from exposure to a hot tip. In the resting position, the cover guards both the tip and the rocker switch, and thereby prevents inadvertent actuation of the device. The "dead-man" trigger forces the user to squeeze the trigger in order to retract the safety cover and thereby access the rocker switch to actuate the monopolar electrocautery pen. The C-PAS device functions identically to a standard, monopolar electrocautery pen with the additional benefits of a retractable, protective shield.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

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

The document does not explicitly state acceptance criteria in a quantitative table format for the Cautery Protective Actuation System (CPAS). However, it implies acceptance criteria through the types of testing performed and the conclusions drawn. The primary "performance" being evaluated is safety and usability in relation to the added safety cover, and compliance with electrical safety standards.

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: The document mentions a "summative human factors validation study" but does not specify the sample size (i.e., the number of participants or uses) for this test set.
• Data Provenance: The document does not explicitly state the country of origin of the data. The study was conducted "in compliance with the FDA guidance 'Applying Human Factors and Usability Engineering to Medical Devices'". The nature of human factors validation studies implies a prospective design, where users interact with the device in a simulated or real environment.

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)

The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., expert consensus on image findings) doesn't directly apply here. Instead, the "truth" in a human factors study is based on observing user interactions, task completion, and identifying use errors or difficulties.

• The document does not specify the number or qualifications of experts involved in establishing "ground truth" in the way a diagnostic study would. Instead, "truth" is derived from the observations and data collected during the human factors study by the study facilitators/observers, who are assumed to be trained in human factors methodologies.

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

Adjudication methods like 2+1 or 3+1 are typical for reconciling discrepancies in expert diagnoses for ground truth. This is not directly applicable to a human factors study on device usability.

• The document does not mention any adjudication method in the context of the human factors validation study. Data collection in human factors typically involves recording user performance, errors, and subjective feedback, which are then analyzed.

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, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic imaging or AI systems where human "readers" interpret "cases." The CPAS is an electrosurgical device, not a diagnostic tool with "cases" for human readers.
• The study performed was a human factors validation study focused on the usability and safety of the device's added features, not a diagnostic performance study.

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

• The device is a physical electrosurgical pen with a safety mechanism. It is not an algorithm or an AI system. Therefore, the concept of "standalone (algorithm only)" performance, as opposed to human-in-the-loop performance, is not relevant or applicable here. The device inherently involves human interaction for its function.

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

As explained in point 3, the concept of "ground truth" for a human factors study differs from diagnostic studies.

• The "ground truth" for the human factors validation study was established through observations of user performance, identification of use errors, and assessment of task completion in simulated use environments, as evaluated against predefined safety and usability objectives. It's essentially empirical data derived from user interactions.

8. The sample size for the training set

• The CPAS is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The design and engineering of the device are based on traditional engineering principles and human factors design considerations, not on machine learning training data.

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

• As explained in point 8, there is no training set and thus no ground truth for a training set for this device.

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The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.

The disposable cautery tip cleaner is a 50mm by 50mm small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.

The document discusses the Key Surgical® Cautery Tip Cleaner and its substantial equivalence to a predicate device. It addresses performance data primarily for sterility, functional aspects, and packaging, rather than diagnostic accuracy or AI assistance.

Here's a breakdown of the requested information based on the provided text:

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)

The document does not specify the sample sizes used for each test or the data provenance (country of origin, retrospective/prospective). The tests listed are for device manufacturing and packaging quality, not for clinical performance on patients directly.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests performed are engineering and manufacturing quality control tests (e.g., sterility, adhesive function, packaging integrity), not clinical studies requiring expert interpretation of results to establish ground truth for a diagnostic or AI-assisted device.

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

Not applicable. Adjudication methods are typically relevant for clinical studies where multiple experts evaluate cases and discrepancies need to be resolved. This document describes tests for product quality where results are determined by standardized methods.

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. The device is a "Cautery Tip Cleaner," a physical accessory for surgical tools, not a diagnostic imaging device or an AI-assisted tool requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

Not applicable. This device is not an algorithm or software; it is a physical medical accessory.

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

The "ground truth" for the tests described are the established specifications and methods outlined in recognized standards (e.g., ISO 11137-2, ISO 11607, ASTM F series). For example:

• Sterility: Ground truth is defined by the SAL 10-6 specification, confirmed using ISO 11137-2 methods.
• Functional (adhesive removal): Ground truth is the observable characteristic of being "easily removed," likely assessed against internal engineering standards.
• Packaging: Ground truth is the successful adherence to specific physical properties and integrity tests as defined by the cited ISO and ASTM standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable. Since there is no training set, there is no ground truth to establish for it.

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Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.

Bovie Cauteries are single use, battery operated devices. The device is activated by pressing the green button on the cautery body and is deactivated by releasing the button (in the default position, the cautery does not operate). Once the button is pressed, an internal circuit is completed that directs power from an internal battery to the cautery tip which in turn heats. The heated tip is introduced to the surgical site and the heat vaporizes the water component in blood/tissue, causing a clot that halts the bleeding.

The provided text is a 510(k) summary for the Bovie® Cautery Device. It mostly focuses on describing the device, its intended use, and comparing it to predicate devices, particularly highlighting safety enhancements. It does not contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from the provided text. The device is a cautery device, not an AI/algorithm-based diagnostic tool, so many of the questions related to AI performance metrics, ground truth, and expert studies are not applicable in this context.

Here's a breakdown of what can be inferred or directly stated from the text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document describes the device, its function, technology, and intended use, and compares its characteristics (materials, energy source, design for safety, disposal instructions, sterility) to predicate devices. It does not provide specific performance metrics (e.g., specific coagulation time, temperature output, or other quantitative performance benchmarks) or acceptance criteria for those metrics.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a medical device submission for a physical, battery-operated cautery device, not a software algorithm tested on a dataset. There is no "test set" in the context of diagnostic data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. See point 2.

4. Adjudication Method for the Test Set

Not applicable. See point 2.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This is not an AI-assisted diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

Not applicable. See point 2.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary of what is available in the document regarding the device validation:

The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for 510(k) clearance. This means the manufacturer is asserting that the new device is as safe and effective as existing devices on the market.

The primary method of "proving" the device meets criteria (implicitly, the criteria of safety and effectiveness similar to predicates) is through:

• Comparison of Device Characteristics: The document provides a detailed comparison table (Page 3 of 3 in the 510(k) summary) showing that the Bovie® Cautery Device shares indications for use, sterilization method, materials (patient-contacting tips and handle), and energy source with predicate devices.
• Safety Enhancements: The submission highlights design changes made for enhanced safety, specifically:
  • Easily removable battery pack (allowing for easy battery recycling and prevention of device activation after disposal).
  • Recessed activation button (to prevent inadvertent activation).
• Unchanged Core Technology: The document explicitly states that the "Cautery device technology remains mostly unchanged" and that "Apart from the added safety features, these cautery devices remain mostly unchanged from those previously cleared" (Page 2 of 3). The patient-contacting tip component, cautery handle materials, and cautery tip configurations are also stated to be unchanged.

In essence, the "study" proving the device meets criteria is the detailed technical and functional comparison to already cleared predicate devices, asserting that the new device performs its intended function (stopping small bleeders in hemostasis) at least as safely and effectively, with added safety features. There are no clinical trial results or performance statistics presented in this 510(k) summary for a "test set" in the context of data analysis.

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The disposable Cautery Tip Cleaner is a single use sterile product. Its intended use is as an electrosurgical accessory to clean uncoated cautery blades that are part of an electrosurgical pencil. The cautery blade is "scratched" on the cautery tip cleaner to remove eschar build-up during surgical procedures to allow the cautery blade to function effectively throughout the procedure. The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.

The disposable Cautery Tip Cleaner is a small 2" x 2" square polyurethane foam pad which features a textile abrasive layer with an adhesive backing. A radiopaque strip within the adhesive makes the device x-ray detectable. The adhesive backing allows for universal placement as well as allowing the device to remain in place while the tip of the electrosurgical cauterization device is "scratched" on the abrasive surface to remove eschar buildup.

The provided text is a 510(k) summary for a Cautery Tip Cleaner and does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document focuses on the device description, intended use, technological characteristics comparison to a predicate device, and the FDA's determination of substantial equivalence.

Therefore, I cannot provide the requested information from the given text.

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The disposable Cautery Tip Cleaner is a single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electro surgical instruments during the course of a surgical procedure.

Not Found

This is a premarket notification for an Electro-Cautery Tip Cleaner, a device designed to remove eschar build-up from electrosurgical instruments. The FDA has determined it is substantially equivalent to legally marketed predicate devices. Unfortunately, the provided document does not contain any information regarding specific acceptance criteria, performance data, or a study report for this device.

Therefore, I cannot provide the detailed information requested regarding the acceptance criteria and the study proving the device meets them. The document focuses on the regulatory approval process and not on the performance testing of the device itself.

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Simultaneous cutting and cauterization of soft tissue during surgery.

The Starion Instruments thermal cautery grasper/dissector is a single use, hand-held surgical instrument intended for simultaneously cutting and cauterizing soft tissue during surgery. The Starion Instruments thermal cautery grasper/dissector contains handle controls that allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a finger switch, which activates a heating element in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.

This 510(k) submission (K994019) focuses on demonstrating substantial equivalence of the Starion Instruments Thermal Cautery Grasper/Dissector to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth is not applicable.

The submission is a summary of safety and effectiveness data, as required by 21 CFR 807.92, for a Class II device. The core argument for clearance is based on its substantial equivalence to the Starion Instruments thermal cautery forceps (K990728).

Here's a breakdown of the applicable and non-applicable information based on the provided text:

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

Not applicable. The document does not describe specific numerical acceptance criteria for performance metrics (e.g., cutting speed, tissue damage, sealing strength) nor the results of specific tests against such criteria. The "performance" reported is its substantial equivalence to the predicate device in terms of intended use, target population, energy source, and principles of operation.

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

Not applicable. This is not a study comparing the device against a defined acceptance criterion with a test set. This is a regulatory submission for substantial equivalence.

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. There is no mention of a test set requiring ground truth established by experts.

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

Not applicable. No test set requiring expert 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 a surgical instrument, not an AI-assisted diagnostic or imaging tool. MRMC studies are irrelevant here.

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

Not applicable. This device is a manual surgical instrument, not an algorithm.

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

Not applicable. The concept of "ground truth" as it pertains to medical device performance studies (especially for diagnostic or AI devices) is not relevant in this substantial equivalence submission for a surgical tool. The "truth" in this context is that the device functions similarly to a legally marketed predicate.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or AI-driven device.

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

Not applicable. As there is no training set, there is no ground truth establishment for one.

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Simultaneous cutting and cauterization of soft tissue during surgery.

The Cautery Clamp, a hand-held surgical instrument, is powered by a disposable Battery Pack Power Supply. The Cautery Clamp consists of two components that are sold separately: a reusable Surgical Clamp, and a disposable Clamp Insert with power cord. The Cautery Pack Power Supply is intended for the simultaneous cutting and cauterization of soft tissue during surgery, to be used in essentially all major surgical disciplines.

This looks like a 510(k) premarket notification for a medical device. Unfortunately, the provided text does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a summary describing the device (a thermal cautery clamp), its intended use, and its substantial equivalence to a predicate device. It also includes the FDA's letter of clearance.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and performance studies based on the provided text. To answer your questions, I would need a different document, such as a test report, clinical study summary, or a more detailed section of the 510(k) submission that discusses performance data.

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