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

The Swift™ System is not indicated for use in genital warts or cardiac procedures.

Specific Indication: Treatment of Common and Plantar Warts.

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 genital warts or cardiac procedures.

Specific Indication: Treatment of Common and Plantar Warts.

The Swift™ System is a microwave-based system intended to delivery energy through a surface contact applicator into targeted soft tissue for the purpose of coagulating (ablation) a pre-defined volume of tissue. The Swift™ System serves as a predicate device to the swiftPro™ System, which was originally cleared under 510(k) K222388. The swiftPro™ System is a handheld microwave generator designed to provide the same functionality as the Swift™ System in a more compact package.

The Swift™ System (SWF-SYS) consists of the following components:

• Swift™ Microwave Generator (SWF-GE01)
• Swift™ Applicator Handpiece (SWF-HP01)
• Swift™ Interconnect Cable (SWF-CA01)
• Swift™ Applicator Tip (SWF-AT01)

The Swift™ System was previously cleared under 510(k) K181941.

The swiftPro™ System (SWF-SPS) consists of the following components:

• swiftPro™ Handheld Microwave Generator (SWF-HAN01)
• swiftPro™ DC Power Cable (SWF-DCA01)
• swiftPro™ Cradle (SWF-CRA01)
• swiftPro™ Applicator Tips (SWF-AT02, SWF-AT03)

The swiftPro™ System was initially cleared under 510(k) K222388 and subsequently received updated clearance under K240518 to include the swiftPro™ Charging Dock (SWF-CHA01) and Battery Pack (SWF-BAT01) for cordless operation.

There have been no modifications to the design, principles of operation, or materials used in the Swift™ and swiftPro™ Systems. The clinical functionality of delivering treatment remains unchanged.

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a non-inferiority clinical study comparing the Swift™ System to cryotherapy for the treatment of common and plantar warts. The primary effectiveness endpoint was "Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at three months post final treatment (up to 5 warts in total per subject)."

The acceptance criteria for non-inferiority are not explicitly stated as a numerical threshold (e.g., "non-inferiority margin of X%"). Instead, the study's goal was to demonstrate that the Swift System was not worse than cryotherapy by a significant amount. However, the study failed to meet its primary endpoint for non-inferiority due to insufficient data. Despite this, the effectiveness results were very close, and safety data was favorable for the Swift System.

Given the information, we can construct the following table for effectiveness:

Safety Acceptance Criteria and Performance (Implicit - reasonable assurance of safety)

The document primarily highlights the safety profile of the Swift System compared to cryotherapy. The implicit acceptance criterion would be a reasonable assurance of safety, with no serious adverse events and a comparable or better safety profile than the predicate.

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

• Test Set Sample Size:
  • Randomized subjects: 119
  • Evaluable Per Protocol Population (for primary endpoint): 93 subjects (49 in Swift System group, 44 in cryotherapy group)
• Data Provenance:
  • Country of Origin: US
  • Retrospective or Prospective: Prospective (Randomized, multi-site, open, parallel-group, controlled, blind-assessed clinical study).

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

The document states "blinded site investigator assessing the treated warts." The number of investigators and their specific qualifications (e.g., dermatologists, years of experience) are not specified in this summary.

4. Adjudication Method for the Test Set

The primary endpoint involved assessment by a "blinded site investigator." There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus) if there were disagreements among investigators, or if multiple investigators were used per patient. The phrasing "blinded site investigator" suggests a single investigator making the assessment at each site, blind to the treatment arm.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This was a comparative clinical trial involving a device and a standard-of-care treatment, not an imaging-based "reader" study for diagnostic performance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable here.

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

No, a standalone algorithm performance study was not done. The device itself is a microwave ablation system, not an AI/software algorithm for diagnosis or interpretation. The clinical study evaluated the device's therapeutic effect with human operators.

7. The Type of Ground Truth Used

The ground truth for the primary effectiveness endpoint was based on a clinical assessment by a blinded site investigator, using specific criteria:

• lesion no longer visible, and
• return of dermatoglyphics to the affected area, and
• no pain on lateral compression.

This is a form of expert clinical assessment/consensus based on predefined objective and subjective criteria.

8. The Sample Size for the Training Set

The document describes a single pivotal clinical study to support the expanded indication. This study is the dataset used to evaluate the device against the expanded indication. There is no mention of a separate training set for an algorithm, as this is a physical device, not an AI algorithm requiring a training phase in the context of this 510(k) summary.

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

As there is no explicit training set for an algorithm mentioned in this summary, the question of how its ground truth was established is not applicable in this context. The clinical study described served as the primary evidence for the device's safety and effectiveness for its intended use.

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

The swiftProTM System is not indicated for use in cardiac procedures.

The swiftPro® system is a hand-held microwave generator intended to provide the functionality of the Swift® microwave treatment system in a compact and portable package. The system comprises a hand-held microwave generator and an applicator tip assembly. The generator produces microwave energy at a frequency of 8 GHz with a maximum output power of 6 Watts, the output power is restricted depending on the applicator tip attached, which delivers the microwave energy to the tissue to effect thermal heating, The swiftPro® System interface is intuitive with a quick setup for setting treatment; output power level & treatment duration (seconds). The applicator tip and the handheld generator have been designed to be only connected in a certain way with a single, simple connection mechanism. This prevents the possibility of system malfunction due to incorrect setup or confusion. The SwiftPro® applicator tips have been designed to prevent re-use to mitigate the risk of cross-contamination.

The SwiftPro® system compromises of the following components:

• SwiftPro® Handheld Generator
• SwiftPro® Cradle
• SwiftPro® URT Applicator tip (non-sterile, single use)
• SwiftPro® LRT Applicator tip (non-sterile, single use)

The provided text describes a medical device called the swiftPro™ System and its comparison to a predicate device, the Swift® System, to demonstrate substantial equivalence for FDA clearance. However, the document does not contain information about acceptance criteria, reported device performance in the context of clinical or diagnostic accuracy, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as typically apply to AI/ML powered devices.

The document focuses on the engineering and safety aspects of an electrosurgical cutting and coagulation device. The "performance data" section refers to:

• Biocompatibility testing
• Electrical safety and electromagnetic compatibility (EMC)
• Software verification and validation testing
• Cybersecurity
• Human Factors and Usability Engineering
• Bench Testing (thermal effects analysis in ex-vivo porcine skin, bovine liver, porcine kidney, and porcine muscle)

These are technical performance characteristics of the device itself and not related to diagnostic accuracy or clinical effectiveness in a way that would require the typical AI/ML study details requested in the prompt.

Therefore, I cannot populate the requested table and information based on the provided text, as the nature of the device and its evaluation for FDA clearance (as described here) do not involve those types of criteria or studies. The device is for "coagulation of soft tissue," which is a direct physical action, not a diagnostic or AI-assisted interpretation task.

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