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The swiftPro™ System is a surface-based device intended for the coagulation of soft tissue during non-invasive procedures.

The swiftPro™ System is not indicated for use in cardiac procedures.

The core swiftPro™ System, comprising the hand-held microwave generator (SWF-HAN01), DC power cable (SWF-DCA01), cradle (SWF-CRA01), and applicator tips (SWF-AT03), has previously received FDA clearance under K222388. This new 510(k) application has been submitted to incorporate optional accessories: the Battery Pack (SWF-BAT01), Charqing Dock (SWF-CHA01), and Charging Dock DC power adaptor (SWF-DCA02) for cordless operation.

The clinical functionality of delivering treatment via the swiftPro™ System remains unchanged. The only distinction is the introduction of an additional potential energy source. The power is supplied to swiftPro™ system by either a (external) medical-grade AC-DC adaptor with direct connection to the rear panel of the hand-held microwave generator or via a removable, rechargeable (optional) battery pack.

There haven't been any alterations to the design, or the material used in the swiftPro™ hand-held microwave generator. The operation of the subject device follows the same steps as the predicate device. The addition of the accessories does not have any effect on the mode of operation.

The provided text is a 510(k) Summary for a medical device called the "swiftPro™ System." This document is part of a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

After reviewing the document, there is no mention of an acceptance criteria table, device performance metrics (like sensitivity, specificity, accuracy, etc.), or any study involving human readers or experts for establishing ground truth. The submission is primarily focused on demonstrating the substantial equivalence of the swiftPro™ System with added accessories (Battery Pack, Charging Dock) to its previously cleared version (K222388).

The document details:

• Device Description: The swiftPro™ System is an electrosurgical cutting and coagulation device, specifically a microwave ablation system for soft tissue coagulation during non-invasive procedures. The new submission is for optional accessories (battery pack and charging dock) that allow for cordless operation. The core functionality and hand-held microwave generator remain unchanged from the predicate device.
• Comparison to Predicate Device: The submission explicitly states that the swiftPro™ hand-held microwave generator is identical to that in the predicate device. The primary change is the introduction of an additional energy source (battery).
• Performance Data: The performance data primarily consists of bench testing to demonstrate that the new power options do not negatively impact the device's performance. It also includes compliance with various standards related to biocompatibility, electrical safety, electromagnetic compatibility, software verification/validation, cybersecurity, and human factors/usability engineering.

Therefore, since the request is to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" for a diagnostic or AI-assisted device, and the provided text describes an electrosurgical device with a focus on hardware modifications and safety/performance standards, much of the requested information (like sensitivity/specificity, MRMC studies, expert ground truth, etc.) is not applicable or not present in this type of 510(k) submission.

Attempting to answer based on the provided text, while acknowledging the limitations:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly provide a table of acceptance criteria with corresponding performance numbers in the way one would for a diagnostic device (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by compliance with various medical device standards and the demonstration of "substantial equivalence" through bench testing. The key "performance" demonstrated is that the addition of battery power does not alter the clinical functionality or safety/effectiveness of the microwave energy delivery compared to the predicate device.

   Acceptance Criteria (Implied)	Reported Device Performance (Summary from text)
   Biocompatibility Compliance (ISO10993)	Performed and complies with Cytotoxicity, Sensitisation, Irritation, Systemic toxicity, Pyrogenicity. Note: SWF-BAT01 and SWF-CHG01 are not designed for patient contact, but their materials (Cycoloy HC1204 HF Resin) are biocompatible and same as hand-held microwave generator & applicator tip.
   Electrical Safety & EMC Compliance (IEC 60601-1, -2-6, -1-2, IEC 62133-2)	System and accessories comply with all applicable medical electrical equipment standards for safety and essential performance, specifically mentioning these IEC standards. The additional accessories comply with electrical safety and IEC 60601 requirements.
   Software V&V Compliance (IEC 62304, FDA Guidance)	Software and firmware updated to accommodate battery functions, in accordance with IEC 62304 and FDA guidance. This implies successful verification and validation.
   Cybersecurity Assessment	Assessment to mitigate cybersecurity vulnerabilities completed. (Note: Device is not networked, no OTS software for internet connection).
   Human Factors & Usability Engineering Compliance (ANSI/AAMI HE75, IEC 60601-1-6, IEC 62366-1, FDA Guidance)	System and accessories comply with applicable requirements of these standards.
   Performance Equivalence with various power options	Bench testing in ex vivo tissue demonstrated performance equivalence when powered by battery vs. wired options. Assessment of impact of battery charge levels on performance was carried out (CN-901 CAIRN Power Source Bench Equivalence Test Report assesses performance at various charge levels). The bench testing proves the swiftPro™ System and Accessories performs substantially equivalent to the predicate device.
   Mechanical & Material Equivalence (for core device)	The hand-held microwave generator is identical to the predicate in materials and design. Dimensions and weight are unchanged for the core unit; new accessories have documented dimensions/weight. Applicator tip functionality and material composition are unchanged.
   Clinical Functionality Preservation	The clinical functionality of delivering treatment via the swiftPro™ System remains unchanged with the addition of battery power. The same frequency and magnitude of microwave energy are delivered.
   Indications for Use Preservation	Indications for use are identical to the predicate device.

2. Sample sizes used for the test set and the data provenance:
   The document mentions "bench testing in ex vivo tissue" but does not specify the sample size for this testing. It refers to a "CN-901 CAIRN Power Source Bench Equivalence Test Report" where further details might be found, but these are not in the provided text.
   Data Provenance: The testing appears to be primarily laboratory/bench testing rather than clinical data from a specific country. It is not an AI/diagnostic study, so terms like "retrospective or prospective" don't directly apply in the usual sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This question is not applicable. The device is an electrosurgical tool, not a diagnostic AI. "Ground truth" in this context would likely refer to engineering specifications and performance benchmarks, not medical diagnoses established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as this is for diagnostic interpretations, not a medical device's physical/electrical performance.

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 not an AI-assisted diagnostic device, nor does it involve human readers in an interpretative capacity.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This device does not have a standalone AI algorithm for performance evaluation. Its "performance" refers to how it delivers microwave energy and its safety as a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For this type of device, the "ground truth" for performance testing (bench testing) would be established by validated measurement techniques against pre-defined engineering and safety specifications (e.g., power output, temperature, electrical safety limits). For instance, for power output, the ground truth would be what an independent, calibrated power meter measures.

8. The sample size for the training set:
   Not applicable. This device does not use machine learning in a way that would require a "training set" for an AI model. Its software/firmware updates accommodate hardware changes, implying traditional software engineering verification and validation, not AI model training.

9. How the ground truth for the training set was established:
   Not applicable. As there's no training set for an AI model, there's no ground truth to establish for it.

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