Search Results

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.

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).

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.

Ask a specific question about this device

The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation on nonresectable liver tumors.

The Emprint™ Ablation System is not intended for use in cardiac procedures

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

• 1. Emprint™ Ablation Generator (2450 MHz)
• 2. Emprint™ Percutaneous Antenna (sterile, single use)
• 3. Emprint™ Ablation Reusable Cable
• 4. Emprint™ Ablation Pump

The system also includes the following optional equipment/accessories:

• 5. Emprint™ Ablation Cart (with Isolation Transformer)
• 6. Ablation Footswitch
• 7. Remote Temperature Probe (sterile, single use)

The current Emprint™ Ablation System utilizes a 2450 MHz 100W generator (CAGEN1) to deliver power to a dedicated single microwave ablation antenna. The optional cart, Emprint™ Ablation Cart is intended to be used with the Emprint™ Ablation Generator.

The new system component, Emprint™ HP Ablation Generator (CAGENHP) [subject device] is similar to the device, Emprint™ Ablation Generator (CAGEN1) [predicate device] as described in K193232 with two exceptions. The new system component, Emprint™ HP Ablation Generator (CAGENHP), will extend the power setting range from 5 to 100W (Emprint™ Ablation Generator - CAGEN1) to 5 to 150W. The increased power will allow clinicians to create larger ablation zones when ablating soft tissue lesions, compared to use of the system with the existing 100-watt microwave generator (CAGEN1). Further the Emprint™ HP Ablation Generator (CAGENHP) is composed of analog and digital circuits with software whereas the predicate Emprint™ Ablation Generator (CAGEN1), is composed of analog and digital circuits with no software or firmware. The Emprint™ HP Generator will be compatible with all current Emprint™ ablation system components and accessories except the cart. The new optional Emprint™ HP Cart (CARTHP) has been added to the system and is compatible with the Emprint™ HP Ablation Generator (CAGENHP).

The optional cart holds the Emprint™ HP Generator (CAGENHP) and the Emprint™ Ablation Pump (CAPUMP1) securely in one location. The optional footswitch can be placed on the cart's lower shelf. There are hooks on both sides of the cart which are meant to hold either the normal saline bag during a procedure, or to loop (and store) the reusable cable over while not in use.

Emprint™ HP Ablation Cart (CARTHP) is similar to the previously cleared (K193232) Emprint™ Ablation Cart (CART1), which holds the Emprint™ Generator (CAGEN1) and the Emprint™ Ablation Pump (CAPUMP1) securely in one location.

The provided document is a 510(k) summary for the Covidien Emprint™ Ablation System with Thermosphere™ Technology. It describes a submission for new components, specifically the Emprint™ HP Ablation Generator (CAGENHP) and its optional accessory, the Emprint™ HP Ablation Cart (CARTHP).

This document does not describe an AI medical device or a study proving its performance against acceptance criteria for an AI or imaging-based diagnostic device. Instead, it focuses on demonstrating substantial equivalence of a microwave ablation system (a physical medical device used for soft tissue coagulation) to a predicate device.

Therefore, many of the questions asked in the prompt, such as those related to AI-specific performance criteria (e.g., sample size for training/test sets, expert consensus, MRMC studies, effect size of AI assistance), are not applicable to the content of this document.

However, I can extract information relevant to the device's acceptance criteria and the studies performed to prove its substantial equivalence as described in the document.

Analysis of Device Acceptance Criteria and Performance (Based on the provided non-AI device document):

Since the document describes a microwave ablation system and not an AI/imaging diagnostic device, the acceptance criteria and supporting studies are focused on the safety and effectiveness of the physical device and its new components, primarily demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal "acceptance criteria" table in the way one might for an AI device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the various tests and verification activities conducted to demonstrate the new components are safe and effective and do not alter the system's fundamental performance compared to the predicate.

The following points are not applicable as the document describes a physical medical device, not an AI/imaging diagnostic device. I'll explicitly state "Not Applicable" or "Not Provided/Relevant" for these.

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

• Sample Size for Test Set: Not explicitly specified for discrete tests. For the animal study, it mentions "an in vivo porcine model" but doesn't give a specific number of animals. For bench testing, typical engineering verification involves numerous tests without a "sample size" in the clinical trial sense.
• Data Provenance (Country of origin, retrospective/prospective): Not specified. The animal study is stated as "GLP-compliant pivotal study," suggesting a prospective, controlled experimental design, but location is not mentioned.

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

• Not Applicable. This is not an AI/diagnostic device where human expert "ground truth" for image interpretation would be established. The ground truth for this device is based on physical measurements (e.g., ablation zone dimensions), engineering specifications, and safety standards.

4. Adjudication Method for the Test Set:

• Not Applicable. No human interpretation for "ground truth" to be adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not a diagnostic device involving human readers.
• Effect size of human readers improve with AI vs. without AI assistance: Not Applicable.

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

• Not Applicable. This is a hardware device, not an algorithm.

7. The Type of Ground Truth Used:

• For the ablation performance, the "ground truth" appears to be physical measurements of ablation zone dimensions (compared directly between the subject and predicate devices under identical power settings) and compliance with engineering design requirements, international safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6), and preclinical (animal) study results demonstrating equivalent therapeutic effect and safety.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI device trained on a dataset.

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

• Not Applicable.

Ask a specific question about this device

The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The Emprint™ Ablation System is not intended for use in cardiac procedures.

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The Emprint™ SX Ablation Platform is not intended for use in cardiac procedures.

The system's optional, 3-D navigation feature assists in the placement of the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted traiectory on a computer monitor. The size and shape of the predicted ablation zone relative to the position of the antenna is displayed on the enhanced ultrasound image.

The Emprint™ Ablation System with Thermosphere™ Technology, Covidien's microwave ablation platform, was released for commercial distribution in the United States in April 2014. The 510(k) Cleared Emprint™ Ablation System consists of the following components: 1. Emprint™ Ablation Generator (2450 MHz), 2. Emprint™ Percutaneous Antenna (sterile, single use), 3. Emprint™ Ablation Reusable Cable, 4. Emprint™ Ablation Pump. The system also includes the following optional equipment/accessories: 5. Emprint™ Ablation Cart, 6. Ablation Footswitch, 7. Isolation Transformer, 8. Remote Temperature Probe (sterile, single use). The ablation platform must be used with a standard IV bag of sterile, normal saline (not provided with the device).

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is a microwave ablation system with an optional navigation feature. It relies on the same principles of operation, fundamental technology, and performance characteristics as its predicate, the Emprint™ Ablation System with Thermosphere™ Technology (K133821, K163105). The main differences between the Emprint™ SX Ablation Platform with Thermosphere™ Technology and the predicate device include software (vs. manual) control of the generator and pump, as well as the addition of an optional navigation feature. Both systems include a 2.45 GHz microwave generator, a cooling pump, and accessories. A bag/bottle of sterile fluid that connects to the antenna's tubing and to the peristaltic pump is required for proper system operation. The 510(k) Cleared Emprint™ Percutaneous Antenna (K163105) can be used with either system to create predictable, spherical ablation zones in soft tissue in percutaneous, laparoscopic, and intraoperative procedures.

The Emprint™ antenna, the applied part of the Emprint™ ablation system with Thermosphere™ Technology and Emprint™ SX ablation platform with Thermosphere™ Technology that delivers microwave energy to the patient, has a sharp, engineered ceramic tip (called "trocar") at the distal end of the device that allows a user to puncture tissue. The shaft of the disposable antenna is inserted directly into the tissue intended to be ablated. The radiating tip of the antenna shaft delivers microwave energy to the target tissue.

Modifications have been made to the Emprint™ Ablation System and Emprint™ SX Ablation Platform's IFU's and Antenna's. Updates were made to the IFU to reduce the possible trocar detachment post ablation resulting from atypical use. Changes made to the bond curing schedule is to enhance the bond strength between the trocar and the fiberglass shaft. Additionally, the clear non-stick heat shrink was extended further on the antennae to reduce tissue adherence post ablation.

The information provided does not describe a study involving a device that uses AI or reports its performance using metrics such as sensitivity, specificity, or AUC. Instead, it describes a medical device (an ablation system) and modifications made to its antenna and instructions for use. The acceptance criteria and performance data discussed are related to the physical and functional characteristics of the ablation antenna, not AI performance. Therefore, I cannot fulfill the request as it pertains to AI-based device performance and study design.

However, I can extract the acceptance criteria and performance data related to the physical modifications of the Emprint Ablation System with Thermosphere Technology and Emprint SX Ablation Platform with Thermosphere Technology antennae based on the provided text, and present it in a modified format relevant to the device's physical changes.

Accepted Criteria and Device Performance (for physical modifications)

Study Details (for physical modifications)

1. Sample size used for the test set and the data provenance: Not explicitly stated for specific tests (e.g., how many antennas were tested for bond strength or insertion force). The verification testing included "thermal ablations in soft tissue during the extended use test" and "ex-vivo liver tissue." The data provenance is implied to be from bench testing conducted by Covidien LLC/Medtronic Inc. (the manufacturer). The study is retrospective in the sense that it evaluates modifications to an existing, cleared device.

2. 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): Not applicable. The ground truth here is related to physical measurements (bond strength, forces, reliability during ablation) demonstrated through bench and ex-vivo testing, not expert consensus on medical images or diagnoses.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was bench and ex-vivo testing, not a clinical study requiring adjudication of expert opinions.

4. 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 document does not describe an AI medical device or a MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe an AI medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the performance claims in this submission is derived from bench verification testing (measuring physical parameters like bond strength, frictional forces, insertion/extraction forces) and ex-vivo testing (thermal ablations in soft tissue, ex-vivo liver tissue).

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device