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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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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 cardiac procedures.

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 predefined volume of tissue. The Swift® System consists of a compact, lightweight power generator with a software free controlled interface, cable and applicator with a single use disposable tip. The generator is intended to generate microwave energy at a frequency of 8GHz, maximum output power of 20Watts, and the distal end of the applicator radiates the microwave energy to effect thermal heating in the tissue. A typical surface area would be around 5mm diameter but would depend on the power & time selected.

The Swift® System interface is extremely intuitive with only two dials requiring to be set which are; output power (watts) & treatment duration (seconds). The applicator/cable connection and the generator/cable connection have been designed to only be connected in a certain way with a single, simple connection mechanism. This prevents the possibility of system malfunction due to incorrect setup or confusion. While the Swift® applicator tip has been designed to prevent re-use and hence mitigate the possibility of cross-contamination should the device not been changed from patient to patient.

The Swift® System comprises of the following components:

• Swift® Generator
• Swift® Applicator handpiece
• Swift® Applicator tip
• Swift® Interconnect Cable
• Swift® Footswitch (optional).

The provided document describes the Swift System, a microwave-based device for coagulating soft tissue. The document focuses on establishing substantial equivalence to predicate devices for FDA 510(k) clearance rather than detailing specific acceptance criteria and a study proving device performance against those criteria in a typical AI/ML medical device context.

Based on the provided text, there is no information about:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or its provenance for proving performance against specific criteria.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of AI assistance on human readers.
• Standalone (algorithm-only) performance.
• The type of ground truth used (expert consensus, pathology, outcomes data in an AI/ML context).
• Sample size for a training set in an AI/ML context.
• How ground truth for a training set was established in an AI/ML context.

The document focuses on the following types of performance data to support substantial equivalence:

1. Biocompatibility Evaluation:

• Acceptance Criteria (Implied): Compliance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
• Study: Tests performed included Cytotoxicity, Sensitization, Irritation, Systemic toxicity, and Hemolysis.
• Results: The Swift System complies with these standards, implying it meets biological safety requirements.

2. Electrical Safety and EMC Testing:

• Acceptance Criteria (Implied): Compliance with applicable Medical electrical equipment standards for safety and essential performance.
• Study: Electrical safety and EMC testing were conducted.
• Results: The Swift System complies with all applicable standards.

3. Ex Vivo and In Vivo Testing:

• Acceptance Criteria (Implied): Demonstrate safe creation of thermal ablation similar to predicate devices. Comparable or lower average area and volumetric energy density compared to predicate devices for effective tissue coagulation.
• Study (Animal Study):
  • Sample Size: 4 pigs underwent 11 treatments.
  • Ground Truth/Evaluation: Macroscopic and histological evaluation of treated tissue.
  • Results: No procedure-related complications or premature deaths. Demonstrated that the Swift System can safely create a thermal ablation similar to that constructed using other microwave devices.
• Study (In-vivo comparison studies):
  • Comparison: Compared Swift System performance with "comparative predicate datasets" from MTCS, DTS-LT, Accu20s, and Emprint.
  • Metrics: Mean and range of energy densities (J/mm² and J/mm³) were compared across porcine muscle, liver, and kidney tissues.
  • Results: The Swift System demonstrated a comparable trend in performance to the predicate examples. It delivered a marginally lower average area energy density (J/mm²) than MTCS and DTS-LT and achieved a maximum area energy density less than both systems. It also recorded lower average volumetric energy density than the cooled DTS-LT. This suggested comparable performance.

Conclusion stated in the document: "No new characteristics have been determined that could impact performance, safety or effectiveness compared to the predicate examples and it can be concluded that the Swift® System is equivalent in terms to the nominated predicate devices."

In summary, the provided text does not contain the specific details requested for acceptance criteria and study design as they would typically apply to an AI/ML device in the modern regulatory context (e.g., ground truth establishment, expert review, MRMC studies). The document describes typical premarket testing for an electrosurgical device to demonstrate substantial equivalence to predicates.

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