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510(k) Data Aggregation
(151 days)
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:
| Acceptance Criteria (Effectiveness - Implied from Non-Inferiority Study) | Reported Device Performance (Swift System) | Reported Performance (Cryotherapy - Comparator) |
|---|---|---|
| Non-inferiority to cryotherapy in clearance of all treated warts at 3 months post final treatment. | 38.8% clearance rate | 38.6% clearance rate |
| Conclusion on Effectiveness: | The analysis showed that the primary endpoint for non-inferiority was inconclusive (p=0.158). From a statistical perspective, there was insufficient data to conclude non-inferiority. From a clinical perspective, the response rates were nearly identical. |
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.
| Acceptance Criteria (Safety - Implicit) | Reported Device Performance (Swift System) | Reported Performance (Cryotherapy - Comparator) |
|---|---|---|
| No serious adverse events related to the device. | No serious adverse events reported. | N/A (no serious adverse events related to Cryotherapy device mentioned) |
| Safety profile comparable to or better than the predicate/gold standard. | Fewer reported adverse events overall (~40% vs ~60%). Significantly larger proportion of subjects reported zero adverse events (18% vs 3%). Lower incidence of specific adverse events (pain, blistering, pruritus, paraesthesia, discoloration, hypersensitivity). Less post-treatment pain. | Higher reported adverse events overall (~60%). Lower proportion of subjects reported zero adverse events (3%). Higher incidence of specific adverse events. More post-treatment pain. |
| No new risks identified that have not been previously considered or assessed. | No new risks identified. |
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.
Ask a specific question about this device
(269 days)
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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