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The Bovie IDS-400 Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.

The Bovie IDS-400 Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena. The Generator operates by delivering high frequency radiofrequency (RF) energy which, when used in conjunction with other electrosurgical accessories, is used to cut and coagulate tissue. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms arc comparable between the generator and predicate devices. The Generator functions in any of six user selectable modes: Monopolar Cut I/II, Blend, Coagulation (Pinpoint), Fulguration (Spray Coagulation), and Bipolar.

The provided text describes a 510(k) submission for the Bovie IDS-400 Electrosurgical Generator. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel therapeutic or diagnostic device might.

Therefore, the requested information elements (1 through 9) related to a study proving acceptance criteria are largely not applicable in this context. The document focuses on demonstrating that the new device operates similarly to an already cleared device and presents no new safety risks.

Here's a breakdown of why and what information can be gleaned:

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

• Not Applicable. The document does not define specific performance acceptance criteria for the Bovie IDS-400 in terms of clinical outcomes or diagnostic accuracy. Instead, it states that the device's electrical waveforms (frequency and duration) "produce the clinical effect (i.e. cut, coagulation)" and are "comparable between the generator and predicate devices." This implies that the 'acceptance criteria' are functional equivalence to the predicate, verified through engineering design and testing, rather than clinical performance metrics.

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 document does not describe a clinical study with a test set of patients or data samples. The "testing" mentioned would typically involve engineering verification and validation (V&V) on the device itself (e.g., measuring output parameters, safety testing, electromagnetic compatibility) to ensure it meets its own design specifications and is comparable to the predicate. No patient data is involved.

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. As no clinical "test set" or diagnostic evaluation is described, there's no ground truth established by experts in this context. The validation involves engineering expertise to compare device parameters and performance to the predicate.

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

• Not Applicable. There's no clinical test set requiring adjudication.

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 is an electrosurgical generator, not an AI-assisted diagnostic or interpretive device.

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

• Not Applicable. This device is a surgical tool, operated by humans to perform electrosurgery. It is not an algorithm running in standalone mode.

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

• Not Applicable. For this type of device, the "ground truth" for substantial equivalence is the established and safe performance of the predicate device. The Bovie IDS-400 is compared against the Aaron IDS-300's known operational characteristics and safety profile.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an electrosurgical generator's regulatory submission. There is no machine learning model involved.

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

• Not Applicable. No training set is involved.

Summary of Device Performance (from the document):

The Bovie IDS-400 Electrosurgical Generator's performance is established through equivalence to its predicate device, the Aaron IDS-300. The key performance claims are:

• Operation: Delivers high-frequency radiofrequency (RF) energy.
• Clinical Effect: Electrical waveform properties (frequency and duration) produce cutting and coagulation effects.
• Comparability: "The shape and duration of waveforms are comparable between the generator and predicate devices."
• Modes of Operation: Functions in six user-selectable modes: Monopolar Cut I/II, Blend, Coagulation (Pinpoint), Fulguration (Spray Coagulation), and Bipolar.
• Safety: Designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility. "There are no new hazards presented with the use of the Bovie IDS-400 Electrosurgical Generator as compared with the predicate device."

Conclusion:

This document is a 510(k) summary, which aims to demonstrate substantial equivalence to a legally marketed predicate device (Aaron IDS-300) rather than presenting a clinical study with detailed performance acceptance criteria and associated study data as might be seen for a novel diagnostic or therapeutic device. The "acceptance criteria" here are effectively met by demonstrating that the new device functions similarly to the predicate and introduces no new safety or effectiveness concerns.

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