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The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation) 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 3D 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 trajectory on a computer monitor. The size and shape of the predicted zone relative to the position of the antenna are displayed on the enhanced ultrasound image.

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablation) a defined tissue volume. The Emprint™ SX Ablation Platform utilizes a 2450 MHz 100W generator to deliver power to a single microwave ablation antenna. The platform is software-controlled and a touchscreen Graphical User Interface is used to select the desired ablation time (up to 10 minutes) and power (5 to 100W) settings. Using an optional temperature probe, the ablation platform can be set to monitor the temperature of a desired target and to automatically turn the generator off, when the target reaches a pre-set temperature. The ablation platform uses circulating, room-temperature, normal saline to cool the non-radiating portion of the antenna shaft and to provide a 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.

Using an optional/selectable navigation feature, the Emprint™ SX Ablation Platform assists physicians in the accurate placement of the trackable Emprint™ SX Navigation Antenna into a target anatomical structure by overlaying the image of the antenna and its trajectory onto an ultrasound image in real time.

Sensors are attached to platform-compatible, open and laparoscopic ultrasound probes and to the platform's trackable antenna. These sensors detect fluctuations in an electromagnetic field emitted from the system's Table Top Field Generator (TTFG). The TTFG is placed underneath the patient and transmits positional information that is processed by the system's navigation hardware and interpreted by its software. The platform's software allows the surgeon to see a representation of the ablation zone on an auxiliary display and the system's operator to control the ablation system via the touchscreen interface.

This document is a 510(k) summary for a software update (Emprint™ SX 1.1.1 Software Update) to an existing device, the Emprint™ SX Ablation Platform with Thermosphere™ Technology. It focuses on demonstrating substantial equivalence to the predicate device, which is the previous version of the same system. Therefore, the document primarily addresses the software change and its impact rather than the original device's full acceptance criteria and clinical efficacy.

Since this submission is a software update to an already cleared device and not an initial clearance for a new device type, there is no detailed acceptance criteria table, clinical study data, or ground truth establishment presented in sections 1-7 of your request. The submission argues that the software update does not affect the device's fundamental performance, indications for use, or underlying principles of operation.

Here's a breakdown based on the provided text, addressing as many of your points as possible:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative clinical performance metrics for the device as a whole in this software update submission. The acceptance criteria for this specific submission relate to the successful implementation and verification of the software change without introducing new safety or effectiveness concerns.
• Reported Device Performance: The document states that "Comprehensive SW Verification testing was performed by Medtronic in support of the proposed change." The conclusion is that "The results of comprehensive verification testing raised no new questions of safety or effectiveness." This implies the software update met internal verification criteria to ensure it did not negatively impact the previously established performance.

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

• Test Set: Not specified for this software update. "Comprehensive SW Verification testing" was performed, but details on the number of test cases or scenarios are not provided in this summary.
• Data Provenance: The testing was performed by Medtronic, the manufacturer. The document doesn't specify if external data was used for this software update's verification. It's internal testing.

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

• Not applicable for this software update submission. The "ground truth" for a software verification typically involves predefined expected software behaviors and outputs, which are assessed by software engineers and quality assurance personnel. It doesn't involve clinical experts in the same way a diagnostic device's clinical performance study would.

4. Adjudication method for the test set:

• Not applicable/Not specified in the provided summary. Software verification typically follows defined test protocols and review processes by the development and quality assurance teams, rather than a clinical adjudication method.

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. This document describes a software update to a microwave ablation platform, not an AI-assisted diagnostic or interpretative device that would typically involve MRMC studies. The device's navigation feature does assist in antenna placement, but the current submission is about a software bug fix related to error handling, not an enhancement to the navigation's clinical efficacy or human reader performance.

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

• Yes, in essence. The "software verification testing" would assess the algorithm's (software's) performance in isolation, ensuring it functions as intended (e.g., clearing errors, processing messages correctly) without human intervention in the execution of the software's core logic. However, since this is a system that always involves human-in-the-loop operation (a surgeon using it for ablation), the "standalone" here refers to the software component's functional correctness.

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

• For this software update, the ground truth would be the expected and correct behavior of the software based on its design specifications. This is established during the software development lifecycle through requirements definition, design documents, and coding standards, and is then verified through testing. It's not clinical "ground truth" like pathology for a diagnostic device.

8. The sample size for the training set:

• Not applicable. This submission is not for a machine learning or AI algorithm that requires a training set. It's for a traditional software update that fixes an error handling behavior.

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

• Not applicable, as there is no training set for this type of software update.

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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.

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