Search Results

Regulation Number

Type

Panel

Microwave Ablation Antennas

Reference & Predicate Devices

K201262

Intended Use

Microwave Ablation Generator is indicated for the coagulation (ablation) of soft tissue. The device is not intended for cardiac use.

Device Description

Microwave Ablation Generator consists of microwave source, pump, foot pedal etc. It is a software-controlled microwave generator that delivers the microwave energy at a working frequency of 2450 MHz and can meet various clinical needs of soft tissue ablation therapy. Microwave Ablation Generator delivers microwave energy to Microwave Ablation Antennas into the target tissue through Microwave Ablation Cable(sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged, leading to irreversible necrosis. The Microwave Ablation Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by microwave energy. Coagulated zones are monitored during treatment using appropriate imaging techniques.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a Microwave Ablation Generator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance. Therefore, detailed information required by the request, such as sample sizes, data provenance, number and qualifications of experts, and ground truth establishment, is not present because this type of submission typically relies on non-clinical performance and equivalence to a previously cleared device.

However, I can extract the acceptance criteria for non-clinical performance tests and the reported performance, as well as general information about the submission.

Here's the information that can be extracted from the provided text:

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

Acceptance Criteria / Test	Reported Device Performance
Electrical Safety as per IEC 60601-1	Meets requirements of IEC 60601-1
Electromagnetic Compatibility as per IEC 60601-1-2	Meets requirements of IEC 60601-1-2
Specific Performance as per IEC 60601-2-6	Meets requirements of IEC 60601-2-6
Software validation as per IEC 62304 and FDA Guidance	Embedded software meets requirements of IEC 62304
Thermal Effects Test and Temperature Monitoring Test	Not explicitly stated as "meets criteria" but "Non-clinical performance data is provided in support of the substantial equivalence determination" implies satisfactory results. The table also states "Temperature monitoring features used to ensure safety" for both subject and predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document, as the submission is a 510(k) based on non-clinical performance and substantial equivalence, not a clinical study with patient samples. The document focuses on technical specifications and international standards compliance.

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)

This information is not provided. The submission relies on engineering and regulatory experts to ensure compliance with standards and equivalence to a predicate device. There is no mention of "ground truth" establishment in the context of expert consensus on medical images or diagnostic outputs.

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

This information is not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or outcome assessment, which is not the focus of this 510(k) submission.

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

There is no mention of an MRMC comparative effectiveness study, nor is the device an AI-assisted diagnostic tool. This device is a Microwave Ablation Generator.

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

This concept is not applicable to the device. The "Microwave Ablation Generator" is a medical device for coagulation of soft tissue, not a standalone algorithm. Performance is assessed through compliance with technical standards and physical testing.

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

The concept of "ground truth" in the context of medical imaging or diagnostic accuracy is not applicable to this device's submission. The "truth" for this device's performance is established by its compliance with recognized electrical safety, electromagnetic compatibility, specific performance standards, and software validation according to established engineering and regulatory guidelines. The "Thermal Effects Test" results would be compared against expected thermal ablation patterns or temperatures.

8. The sample size for the training set

This information is not provided and is not relevant for this type of device submission. The device is not an AI/ML algorithm that requires training data in the traditional sense.

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

This information is not provided and is not relevant for this type of device submission.

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K Number

K241825

Device Name

Manufacturer

Canyon Medical Inc.

Date Cleared

2024-09-20

(88 days)

Product Code

Regulation Number

Type

Panel

IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)

Reference & Predicate Devices

K201265

Intended Use

Microwave Ablation Antennas, in conjunction with the compatible Microwave Ablation Generator, is intended for coagulation (ablation) of soft tissue. This device is not intended for cardiac use.

Device Description

Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis. Microwave Ablation Antennas generally consist of the Microwave Ablation Antennas, Microwave Ablation Cable. This device is single-use and sterilized by EO. During ablation, Microwave Ablation Antennas will be punctured into the target tissue of the patients. In order to achieve the intended use, Microwave Ablation Antennas shall be connected with Microwave Ablation Generator which deliver microwave energy to Microwave Ablation Antennas through Microwave Ablation Cable (sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged leading to irreversible necrosis. Coagulated zones are monitored during treatment using appropriate monitoring techniques.

AI/ML Overview

The provided text is a 510(k) summary for the Canyon Medical Inc. Microwave Ablation Antennas (K241825). This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a clinical study to prove device performance against specific acceptance criteria in a human clinical trial setting.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in this type of regulatory submission. These details are typically found in clinical study reports.

However, based on the non-clinical test summary, we can infer some "acceptance criteria" related to the device's engineering performance and safety.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for clinical performance and corresponding device performance data from a clinical study. Instead, it lists non-clinical tests and states that the "results from testing performed confirm the design requirements." This implies that the device met the acceptance criteria for each listed non-clinical test.

Aspect	Acceptance Criteria (Implied from tests)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1 standards for medical electrical equipment.	"Results from testing performed confirm the design requirements." (i.e., Met criteria)
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 standards for EMC of medical electrical equipment.	"Results from testing performed confirm the design requirements." (i.e., Met criteria)
Specific Performance	Compliance with IEC 60601-2-6 standards specific to Microwave Ablation Equipment.	"Results from testing performed confirm the design requirements." (i.e., Met criteria)
Thermal Effects & Temp. Monitoring	Performance as per FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. (Implies achieving expected thermal ablation zones and accurate temperature monitoring).	"Results from testing performed confirm the design requirements." (i.e., Met criteria)
Biocompatibility	Compliance with ISO 10993 series standards for biological evaluation of medical devices (for an externally communicating device with tissue for limited duration

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K Number

K240480

Device Name

Manufacturer

Varian Medical Systems, Inc.

Date Cleared

2024-07-19

(150 days)

Product Code

Regulation Number

Type

Panel

Temperature Sensor Probe (ABL-18TP20)

Reference & Predicate Devices

K200796,K100744

Intended Use

IntelliBlate Microwave Ablation System:

The IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures.

IntelliBlate Ximitry Probe Assembly:

The IntelliBlate Ximitry Probe Assembly, used with the IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue.

The IntelliBlate Ximitry Probe Assembly is not intended for use in cardiac procedures.

Device Description

The IntelliBlate Microwave Ablation System is a software-controlled microwave therapy delivery system with graphical user interface and hardware to control and monitor the therapy delivered to the target tissues.

The system consists of a 2.45 GHz microwave generator (console) with an integrated peristaltic pump assembly for coolant fluid delivery, a coolant Fluid Mount and an optional mobile cart for the console. Accessories for the system include IntelliBlate Ximitry Probe Assembly - a sterile, single-use disposable microwave ablation assembly with ablation probes and a cassette for coolant fluid tubing (closed cooling circuit).

AI/ML Overview

The provided text does not contain detailed acceptance criteria for the IntelliBlate Microwave Ablation System that would typically be found in a clinical study report or a more extensive submission. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing summaries.

However, based on the information provided, we can infer some general acceptance criteria related to safety and performance, and describe the studies conducted as reported in the "Performance Data" section.

Here's an attempt to structure the information based on the provided text, acknowledging the limitations in detail for many of the requested points:

Implicit Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Performance Data)	Reported Device Performance (as stated in the document)
Functional Design and Performance: Device meets established design criteria.	The subject devices successfully completed functional testing.
Ablation Performance in Ex-vivo Tissues: Ablation performance is substantially equivalent to predicate devices in various tissues.	Ex-vivo testing of the devices at single, double, and track ablation settings in porcine liver, kidney, and muscle demonstrated that the differences in design and system characteristics do not affect the ablation performance of the subject device in comparison to the predicate device.
Usability and Performance (Acute Animal Model): Devices are usable and perform as expected in living tissue models.	Acute GLP studies validated usability and performance of the devices on porcine soft tissue models.
Reliability: Device maintains consistent operation over time.	The subject devices successfully completed reliability testing.
Electrical Safety: Device complies with relevant electrical safety standards.	The IntelliBlate Microwave Ablation System and its accessories comply with applicable IEC 60601 series of standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-6, and IEC 60601-1-2.
Electromagnetic Compatibility: Device complies with relevant electromagnetic compatibility standards.	The IntelliBlate Microwave Ablation System and its accessories comply with applicable IEC 60601 series of standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-6, and IEC 60601-1-2.
Sterility: Ximitry Probe Assembly achieves a minimum sterility assurance level of 10^-6.	Ximitry Probe Assembly is sterilized utilizing 100% ethylene oxide gas to ensure a minimum sterility assurance level of 10^-6 in accordance with ISO 11135, ISO 10993-7, ISO 11138-1, ISO 11737-1, and ISO 11737-2.
Software Verification: Software functions are verified according to medical device software standards and FDA guidance.	Software verification was conducted in accordance with IEC 62304 and FDA guidance "Content of Premarket Submissions for Device Software Functions."
Cybersecurity: Cybersecurity requirements are assessed and addressed per FDA guidance.	Cybersecurity requirements were assessed per FDA guidance's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Postmarket Management of Cybersecurity in Medical Devices."
Thermal Effects and Temperature Monitoring: Thermal performance is substantially equivalent to predicate devices and monitoring is effective.	Comparison of thermal effects between IntelliBlate Microwave Ablation System and its predicate demonstrated that the performance of the subject device is substantially equivalent to the predicate device. Thermal effects and temperature monitoring testing were completed in accordance with FDA Guidance.
Biocompatibility: Patient-contacting components are biocompatible.	Biocompatibility testing of the Ximitry Probe Assembly in accordance with ISO 10993-1 demonstrated that the patient-contacting components are biocompatible.
Packaging Integrity and Shelf Life: Packaging maintains integrity and device remains viable for its intended shelf life.	Packaging integrity and shelf-life testing was performed in accordance with ISO 11607-1 and ISO 11607-2.

Here's a breakdown of the other requested information based on the provided text. Please note that many of these details are not explicitly stated in the summary document.

2. Sample size used for the test set and the data provenance:

Test set sample size: Not explicitly stated for specific non-clinical tests. For the ex-vivo ablation performance study, it mentions testing in "porcine liver, kidney and muscle," but no specific numbers of samples or experimental runs are provided.
Data provenance:
- Ex-vivo ablation performance: Porcine tissues. Origin of the pigs not specified.
- Acute animal testing: Porcine soft tissue models. Conducted in accordance with GLP Regulations (21 CFR Part 58) in the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The studies mentioned (ex-vivo, animal GLP) would likely involve trained personnel or researchers, but their specific qualifications or role in establishing "ground truth" (e.g., assessing ablation zones) are not described. The document primarily focuses on engineering and animal model performance rather than human expert interpretation of results.

4. Adjudication method for the test set:

This information is not provided in the document. Given the nature of the non-clinical and animal studies described, a formal adjudication method (like 2+1 or 3+1 often used for diagnostic AI) is very unlikely to have been applied. The evaluation would be based on direct measurements and observations by the researchers.

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:

No, an MRMC comparative effectiveness study was not done. The IntelliBlate Microwave Ablation System is a hardware-based therapeutic device, not an AI diagnostic or assistance tool for human readers. Therefore, this type of study is irrelevant to this device.

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

This device is a physical system for microwave ablation. The "software" mentioned in the document is for controlling the device's functions and user interface, not for standalone diagnostic or interpretive performance. Therefore, the concept of "standalone (algorithm only)" as it applies to AI diagnostics is not applicable here. The device's performance is inherently "standalone" in its therapeutic action, but this is not an algorithm acting independently of human control.

7. The type of ground truth used:

For Ex-vivo Ablation Performance: The "ground truth" would be the actual measured ablation zone characteristics (e.g., volume, size, shape) in the porcine tissues, determined by direct observation or histological analysis post-ablation.
For Acute Animal Testing: The "ground truth" would be the observed acute effects of ablation in porcine soft tissues, assessed through direct observation, physiological measurements, and potentially necropsy/histopathology.
For Sterilization, Biocompatibility, Electrical Safety, etc.: The "ground truth" is adherence to specified standards and objective measurements (e.g., sterility assurance level, physical/chemical properties, electrical performance).

8. The sample size for the training set:

This information is not applicable in the context of the studies described. The device is a microwave ablation system, and the testing described (functional, ex-vivo, animal, electrical, etc.) are verification and validation studies against pre-defined engineering and safety criteria, not training of a machine learning model.

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

This information is not applicable for the reasons stated in point 8. There is no mention of a "training set" for a machine learning model. The "training" that occurs is in the development and refinement of the device's design and operational parameters based on engineering principles and iterative testing.

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K Number

K240784

Device Name

Manufacturer

Varian Medical Systems, Inc.

Date Cleared

2024-05-29

(69 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K200796

Intended Use

The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site.

Device Description

Temperature Sensor Probe is an optional accessory designed for use with compatible Varian ablation systems. Principal components of the temperature sensor probe include:

Needle
Handle
Lead cable and connector

AI/ML Overview

The provided text describes the regulatory clearance of a Temperature Sensor Probe (ABL-18TP20) for use with Varian ablation systems for monitoring tissue temperature. The submission focuses on demonstrating substantial equivalence to a predicate device, the Emprint™ Ablation System with Thermosphere Technology: K200796, specifically the Ablation Remote Temperature Probe (RTP20).

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Feature/Characteristic	Acceptance Criteria (Predicate Device K200796, RTP20)	Reported Device Performance (Subject Device: Temperature Sensor Probe)
Intended Use/Indications for Use	Monitoring tissue temperature at or near the ablation site.	Monitoring tissue temperature near the ablation site.
Operating Principle	Measures tissue temperature in real time via a thermocouple within the tip of the probe.	Measures tissue temperature in real time via a thermocouple within the tip of the probe.
Product code, FDA regulation, class	NEY, 21 CFR 878.4400, Class II	NEY, 21 CFR 878.4400, Class II
Prescription (Rx only)	Yes	Yes
Optional Accessory	Yes	Yes
Measuring Site	At or near ablation site	Tissue near ablation site
Temperature Range (Accuracy)	37°C - 60°C (±1.5°C)	10°C - 60°C (±2°C)
Thermocouple-based sensor at tip	Yes	Yes
Signal Processing & Display	Real-time, continuous display of tissue temperature.	Real-time, continuous display of tissue temperature.
Tissue Contact per ISO 10993-1	External communicating device, in contact with tissue/bone/dentin and limited contact duration (A) (

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K Number

K240518

Device Name

swiftPro System

Manufacturer

Emblation Limited

Date Cleared

2024-04-23

(60 days)

Product Code

Regulation Number

Type

Panel

Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B)

Reference & Predicate Devices

K222388

Intended Use

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.

Device Description

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.

AI/ML Overview

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:

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.

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.
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.
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.
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.
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.
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.
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.
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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K Number

K233838

Device Name

Manufacturer

Medtronic, Inc

Date Cleared

2024-03-28

(115 days)

Product Code

Regulation Number

Type

Special

Panel

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)

Reference & Predicate Devices

K133821,K163105,K200796

Intended Use

The Emprint™ ablation system is intended for use in percutaneous, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

The Emprint™ ablation system is not intended for use in cardiac procedures.

The Emprint™ ablation system overlapping technique is only intended for use in the liver.

Device Description

The Emprint™ Ablation System with Thermosphere™ Technology, Covidien's microwave ablation system, was released for commercial distribution in the United States in April 2014.

The Emprint™ Ablation System is a microwave-based ablation system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablating) a defined volume of that tissue. The Emprint™ Ablation System utilizes a 2450 MHz 100W, or 150W generator to deliver power to a single microwave ablation antenna. The Emprint™ Ablation 100W Generator is composed of analog and digital circuits with no software or firmware. The Emprint™ Ablation 150W Generator utilizes software and firmware, however both generators' settings are controlled in the same fashion. Emprint™ Ablation Generators provide for user setting of ablation time (0-10 minutes) and ablation power (5 to 150W). With an optional temperature probe, the ablation generators can be set to monitor the temperature of a desired target and to automatically shut the generator off when the target reaches a pre-set temperature.

The Emprint™ Ablation System uses circulating room temperature normal saline to cool the non-radiating portion of the antenna shaft and to provide a more consistent ablation zone. The normal saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system. No saline is in contact with the patient.

The 510(k) Cleared Emprint™ Ablation System consists of the following components:

Emprint™ Ablation Generator (2450 MHz) ●
Emprint™ HP Ablation Generator (2450 MHz) .
EmprintTM Percutaneous Antenna (sterile, single use) ●
Emprint™ Ablation Reusable Cable ●
Emprint™ Ablation Pump ●

The system also includes the following optional equipment/accessories:

. Emprint™ Ablation Cart (with Isolation Transformer)
Emprint™ HP Ablation Cart (with Isolation Transformer)
Ablation Footswitch ●
Remote Temperature Probe (sterile, single use) ●

The system must be used with a standard IV bag of sterile normal saline (not provided with the system).

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves a device (specifically an AI/machine learning device) meets acceptance criteria, as the Emprint Ablation System is a microwave ablation system, not an AI/machine learning device. The 510(k) submission for the Emprint Ablation System describes updates to the instructions for use (IFU) to include "overlapping" and "ramp-up" ablation techniques, which were already observed in published literature and clinician practice.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them for an AI/machine learning device based on the given input, as the device in question is a traditional medical device and the submission focuses on updating its IFU, not on AI/ML performance.

The "Performance Data" section (9.9) explicitly states:

"Clinical Studies in human subjects were not required to demonstrate the performance and safety of the Emprint Ablation System with Thermosphere Technology." (9.9.2)
"Studies or testing in animal subjects were not required to demonstrate the performance and safety of the Emprint Ablation System with Thermosphere Technology." (9.9.3)
Bench testing was conducted to generate zone charts for updated techniques (9.9.1). This is a standard ex-vivo engineering characterization, not a clinical study involving AI/ML methods or human readers.

None of the points outlined in the prompt (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are relevant or discussed in the provided document, as it pertains to a physical medical device and not an AI/ML system.

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K Number

K233140

Device Name

Manufacturer

Hygea Medical Technology Co., Ltd.

Date Cleared

2024-01-31

(126 days)

Product Code

Regulation Number

Type

Panel

NEUWAVE Microwave Ablation System and Accessories

Reference & Predicate Devices

K201262,K201265

Intended Use

The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use.

Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.

Device Description

The Microwave Ablation Device with Sterile Microwave Ablation Probe is a device system which is intended for soft tissue coagulation. The Microwave Ablation Device consists of power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, and temperature probe. The Sterile Microwave Ablation Probe is a single-use sterile product, consisting of a handle, RF connector, RF coaxial cable, needle bar, inner tube, pinhead, temperature sensor and coolant tube. The Microwave Ablation Device also contains a single use Sterile Temperature Probe.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which means the FDA has determined it is "substantially equivalent" to an existing legally marketed device (the predicate device). In this context, "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance and testing performed to demonstrate that the new device is as safe and effective as the predicate, despite minor differences.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with specific numerical targets and corresponding reported performance for clinical efficacy. Instead, the "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating compliance with regulatory standards and comparable performance to the predicate device.

Test Category	Implied Acceptance Criteria (Demonstrated Compliance/Equivalence)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1	"Passed the testing in accordance with internal requirements, and international standards." Specifically, ES60601-1 was met.
EMC	Compliance with IEC 60601-1-2	"Passed the testing in accordance with internal requirements, and international standards." Specifically, IEC 60601-1-2 was met.
Performance (Device Specific)	Compliance with IEC 60601-2-6 (Microwave Therapy Equipment)	"Passed the testing in accordance with internal requirements, and international standards." Specifically, IEC 60601-2-6 was met.
Software Validation	Compliance with FDA guidance for software in medical devices	"Software validation is in compliance with FDA guidance for the content of premarket submissions for software contained in Medical devices."
Shelf Life	Validity of 3-year shelf life claim for probe (accelerated aging, package tests)	"Accelerated aging and package tests were conducted to confirm the validity of the 3 year shelf life claim for the Sterile Microwave Ablation Probe." (Implies successful confirmation).
Thermal Effects Test	Comparable thermal effects to predicate, demonstrating no new safety/performance risks for power/length differences.	"The thermal effects test with ex vivo animal tissues device and does not raise new safety and performance risks." (Comment 2 & 4)
Temperature Monitoring Test	Functionality and accuracy of temperature monitoring. Demonstrates no new safety/performance risks for "Mode B".	"Tissue protection temperature need the subject device will monitor tissue temperature using the Sterile Temperature Probe. After tissue temperature reach the setup protection value, Microwave output to control the tissue temperature stable around the ±3% tolerance of the set temperature, the protection value range is 37.0 ℃~100.0 ℃. Mode B does not raise new safety and performance risks."
Package Verification	Compliance with ISO 11607-1:2016	"Passed the testing in accordance with internal requirements, and international standards." Specifically, ISO 11607-1:2016 was met.
Sterilization Validation	Compliance with ISO 11135-1:2014 (Ethylene Oxide Sterilization)	"Passed the testing in accordance with internal requirements, and international standards." Specifically, ISO 11135-1:2014 was met.
Biocompatibility	Compliance with ISO 10993-1 and applicable parts	"The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, 'Biological Evaluation of Medical Devices'." (Implies successful compliance)
Probe Stability Tests	Stability with maximum output power and extended treatment duration.	"Sterile Microwave Ablation Probe Stability Tests with maximum output power and extended treatment duration." (Implies successful completion and meeting requirements, though specific results not detailed).
Temperature Sensor Accuracy Verification	Accuracy of temperature sensor measurement.	"Temperature Sensor Measurement Accuracy Verification Tests." (Implies successful completion and meeting requirements, though specific results not detailed).

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for specific tests. For the thermal effects test, it mentions "ex vivo animal tissues," but the number of samples is not provided. Other tests refer to compliance with standards rather than specific sample sizes of device units tested.
Data Provenance: The tests are "non-clinical." This implies laboratory or bench testing. The origin of the animal tissues for the thermal effects test is not specified (e.g., country of origin). All tests were conducted by the manufacturer, Hygea Medical Technology Co., Ltd.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. This is a 510(k) for a hardware device (Microwave Ablation Device and Probe) and the non-clinical tests described are primarily engineering and performance tests, not clinical evaluations requiring human expert interpretation of diagnostic images or outcomes. Therefore, there is no "ground truth" established by experts in the context of clinical data for this submission.

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

This information is not applicable. Adjudication methods are typically used in clinical studies involving human readers and interpretations (e.g., radiologists reviewing images) to establish a consensus ground truth. The tests described are engineering and biochemical in nature and would not involve such 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

This information is not applicable. This device is a microwave ablation system, not an AI-powered diagnostic or assistive tool, and the submission does not include any clinical studies, MRMC studies, or AI components.

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

This information is not applicable. The device is a physical ablation system, not an algorithm.

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

For the non-clinical tests, the "ground truth" is generally defined by:

Established engineering and performance standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6, ISO 11607-1, ISO 11135-1, ISO 10993-1.
Physical measurements and observations in bench testing (e.g., temperature stability within ±3% tolerance, confirmation of thermal effects in ex vivo tissues, successful completion of stability tests).
Successful software validation against established FDA guidance.

There is no "expert consensus, pathology, or outcomes data" mentioned as ground truth in this non-clinical submission.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The non-clinical tests are validating the device's physical and electrical performance.

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

This information is not applicable as there is no training set.

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K Number

K231738

Device Name

Manufacturer

NeuWave Medical, Inc.

Date Cleared

2023-11-16

(155 days)

Product Code

Regulation Number

Type

Panel

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)

Reference & Predicate Devices

K200081,K130399

Intended Use

The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.

The NEUWAVE Microwave Ablation System is not indicated for use in cardiac procedures.

Device Description

The NEUWAVE Microwave Ablation System is a self-contained stand-alone system of hardware and software designed for the ablation of soft tissue, including the partial or complete ablation of non-resectable liver tumors, via applying microwave energy to produce tissue heating effects generating tissue necrosis.

The system consists of three major components:

(1) The system cart which contains the components necessary to deliver microwave power to the microwave ablation probes, monitor and control system functions, a graphical user interface for the user to interact with the system and a CO2 based cooling system.
(2) Power Distribution Module (PDM), which allows power to be transferred from the system generator to the ablation probes.
(3) Range of microwave ablation probe accessories for energy delivery.

The system cart has a single 2.45 GHz signal microwave source with three 140W microwave power amplifiers, a touch-screen graphical user interface, and a CO2 based cooling system for limiting the temperature of the ablation probe, handle, and cable.

The CO2 cooling system enables the Tissu-Loc™ function, which involves formation of an ice ball to adhere the probe in place prior to starting ablation therapy. This helps eliminate probe migration during imaging (CT scans, ultrasounds, etc.) and additional probe placement. The cooling system is responsible for controlling the pressure of the incoming CO2 gas from two Esized CO2 cylinders located on the back of the cart.

The graphical user interface allows the user to set, adjust and activate the power setting per probe, time setting for each probe, ability to synchronize ablation initiation on probes, ablation activation, cauterization activation, audible volume, probe temperature, and Tissu-Loc™ function.

Up to three (3) NEUWAVE Ablation Probes can connect to the PDM at once and the PDM allows power to be transferred from the system cart to the ablation probes.

The microwave ablation probes are accessories which transfer microwave energy from the system cart to the target tissue to create regions of thermal necrosis. Each probe contains thermocouples that monitor the temperature of the probe. The probes can be used for Surgical Mode or Ablation Mode with various limits of maximum selectable power based on the probe type.

The antenna of the NEUWAVE PR probe family is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. NEUWAVE PR Probes were developed to provide physicians with an additional ablation probe option with a different ablation burn pattern compared with NEUWAVE LK/LN/SR probes. The NEUWAVE PR probes are designed to produce ablations that quickly encompass the tip of the probe while limiting the overall length of the ablation compared with other NEUWAVE ablation probes.

There are 2 changes covered by this 510(k) submission:

1. A new Microwave Ablation Probe, the Surgical PR Probe (PRS35), available for use with the NEUWAVE System.
1. Updates to the NEUWAVE System software to accommodate the new PRS35 probe and to implement various enhancements to the user experience and correct minor software anomalies that do not impact safety or effectiveness.

The new NEUWAVE Surgical PR Ablation Probe (PRS35) has a 11/13-gauge and 35cm length cannula with a 2.9m cable in length. The proposed PRS35 probe uses a similar cannula and antenna design to the predicate probes PRS15 & NWSR25, and the ablation pattern also closely resembles the above stated predicate. The longer cannula length is a primary purpose of the new probe to enable access to targets farther from the skin surface due to insufflation in laparoscopic procedures.

The subject embedded software utilizes the existing firmware and software architecture design, technological characteristics and functions but incorporates enhancements and features as described below:

Procedure Profiles
PRS35 Probe Support ●
Planning: Time and Power Guide available without probe ●
Cybersecurity
Misc. Bug fixes ●
Additional Languages to support country specific registration globally (Finnish, Norwegian, Turkish)

No changes were made to the currently marketed family of NEUWAVE Ablation Probes nor to any hardware aspects of the currently marketed NEUWAVE system cleared under K220472.

The selection of available ablation probes provides physicians with the opportunity to select the length, stiffness, burn pattern and number of probes to use to create a wide variety of ablation zone sizes and shapes.

AI/ML Overview

The provided text describes the 510(k) summary for the NEUWAVE™ Microwave Ablation System and Accessories, specifically focusing on the addition of a new probe (PRS35) and software updates. It states that all acceptance criteria were met, but it does not provide a detailed table of acceptance criteria with reported device performance, information on sample sizes, ground truth establishment methods, or the specifics of a study proving all acceptance criteria were met.

Therefore, many of the requested items cannot be definitively answered from the provided text.

Here is a summary of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states: "All testing passed, and all acceptance criteria were met." however, it does not specify what those acceptance criteria were or provide a table of performance data against them.

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

Not available in the provided text. The document highlights "Nonclinical Testing" including "Probe Ablation Performance Testing in ex-vivo liver, kidney, muscle and lung tissue," but does not explicitly state the sample sizes (e.g., number of probes, number of ex-vivo tissue samples) or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

Not applicable / Not available. This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies). For a microwave ablation system, the "ground truth" for non-clinical performance likely refers to measurable physical outcomes (e.g., ablation zone size, temperature profiles) in ex-vivo tissue, which would not typically involve expert consensus in the same way. The document does not mention any expert involvement for establishing ground truth in the non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable / Not available. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies. For the non-clinical performance testing of a microwave ablation system, this concept does not directly apply.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical data was generated in support of this Premarket 510(k) Notification." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly for the software updates. The submission includes "Software Verification and Validation" testing, which would assess the algorithm's performance in a standalone manner. However, no specific performance metrics of the software algorithm itself (e.g., accuracy of a particular feature) are provided. The software updates are described as accommodating the new PRS35 probe, implementing user experience enhancements, and correcting minor anomalies.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the "Probe Ablation Performance Testing in ex-vivo liver, kidney, muscle and lung tissue," the ground truth would likely be physical measurements (e.g., dimensions of the ablation zone, temperature reached) observed directly from the ex-vivo tissue after ablation. The document does not specify the exact methodology, but for such a device, these are standard methods.

8. Sample Size for the Training Set

Not applicable / Not available. The document describes a "510(k) premarket notification," which is for demonstrating substantial equivalence to a predicate device, not for a new device requiring a de novo clearance or PMA where extensive training data for AI/ML models might be detailed. The software updates mentioned are for "enhancements to the user experience and correct minor software anomalies" and "PRS35 Probe Support," not for developing a new AI/ML algorithm that would typically require a training set.

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

Not applicable. As the device submission does not describe the development of a new AI/ML algorithm requiring a training set, the establishment of ground truth for a training set is not relevant to the provided information.

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K Number

K232241

Device Name

Manufacturer

Betters(Suzhou) Medical Co., Ltd

Date Cleared

2023-11-13

(108 days)

Product Code

Regulation Number

Type

Panel