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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. Prevention of Secondary Burns: The safety cover should prevent secondary burns from a hot tip.
3. No New Risks: The addition of the safety cover should not introduce new risks to clinicians or patients. | The summative human factors validation study concluded that "the addition of the safety cover to the subject device does not introduce a new risk for either the clinician or the patients." The "dead-man" trigger mechanism (which forces the user to squeeze the trigger to retract the cover and access the rocker switch) implies the device's design directly addresses protection against inadvertent actuation and secondary burns. The "Device Description" states the cover "guards both the tip and the rocker switch, and thereby prevents inadvertent actuation." |
   | Usability/Effectiveness | 1. Safe and Effective Use: Intended users should be able to safely and effectively use the device with the safety cover.
4. Functionality: The device should function identically to a standard monopolar electrocautery pen, with the added safety benefits. | The summative human factors validation study showed that "intended users of the subject device can safely and effectively use the subject device with support from its labeling." The "Device Description" states: "The C-PAS device functions identically to a standard, monopolar electrocautery pen with the additional benefits of a retractable, protective shield." |
   | Electrical Safety | The device must comply with relevant electrical safety and electromagnetic compatibility standards. | The device "complies with the following electrical safety performance standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2." |
   | Thermal Performance | The addition of the safety cover and minor geometrical/material differences should not negatively impact the thermal performance of the device. | It was determined that "no thermal effects testing was required to demonstrate substantial equivalence" because "the compatible electrosurgical unit (ESU) and blade electrode are previously FDA cleared and the specific shape of the buttons and housing are not relevant to the thermal performance of the device." This implies the acceptance criterion for thermal performance was met by demonstrating the core thermal components are unchanged and the new features do not affect it. |

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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