(115 days)
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 non-resectable 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 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 ablation zone relative to the position of the antenna is 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.
Here's a breakdown of the acceptance criteria and study information for the Emprint™ SX Ablation Platform, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative table for this specific device in the same way a clinical trial might for a new drug. Instead, it demonstrates substantial equivalence to a predicate device through various performance testing and comparison of characteristics.
The "performance" is primarily demonstrated by showing that the new device (Emprint™ SX Ablation Platform) performs "Same" or "Better" than the predicate device (Emprint™ Ablation System) in key areas, and meets relevant international safety standards.
| Acceptance Criteria Category (Implied) | Specific Performance Metric (Implied) | Reported Device Performance | Comparison to Predicate Device |
|---|---|---|---|
| Safety and Effectiveness | Sterility (SAL) | 10⁻⁶ SAL (EO sterilized) | Same |
| Residual EO/ECH levels | Verified | Not explicitly stated for predicate in comparison table, but implied "Same" as predicate (which would also meet these requirements). | |
| Biocompatibility | Patient-contacting materials are biocompatible. | Same | |
| Shelf Life | 2 years | Not explicitly stated for predicate, but implied "Same" as predicate. | |
| Electrical Stressors | Passed functional testing | Not explicitly stated for predicate, but implied "Same" as predicate. | |
| Electrical Safety (IEC 60601-1, IEC 60601-2-6) | Compliant | Same (Both comply) | |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant | Same (Both comply) | |
| Microwave Generator Output | Measured output levels did not differ across generator's time and power settings compared to manual control. | Same | |
| Ablation Zone Size and Shape | Equivalent to predicate system. | Same | |
| Performance and Safety in vivo (porcine model) | Passed all requirements; no new risks identified. Clinically acceptable performance and safety profile. | Same or Better | |
| Antenna Placement Attempts (Navigation Feature Impact) | Number of attempts needed was half of that required for the predicate antenna. | Better | |
| System Functionality | Navigation Feature Accuracy | Evaluated and specified in product's labeling. | Not applicable (New feature) |
| Environmental Operating Conditions | Verified functionality across wide range (altitude, temp, humidity). | Not explicitly compared but implied "Meets Requirements". | |
| User Needs/Expectations (Human Factors) | Met user needs and expectations. | Not explicitly compared but implied "Meets Requirements". |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test Set Description: The document does not explicitly define a "test set" in terms of human subjects or a specific dataset. The performance testing involves a combination of engineering tests, ex-vivo tissue testing, and animal studies.
- Sample Sizes:
- Ex Vivo Tissue Testing: Not explicitly stated, but "Ablation zone size and shape were measured at selected generator time and power settings."
- Animal Studies: Two animal studies were conducted using a porcine model. The specific number of animals is not provided.
- Data Provenance: The studies were conducted by Covidien LLC/Medtronic. The data provenance is internal to the manufacturer. The studies are prospective as they were specifically designed and executed for this 510(k) submission. No country of origin is explicitly mentioned for the data, but the manufacturer is based in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts or their qualifications for establishing ground truth in the animal studies or ex-vivo testing.
- For the animal study related to antenna placement attempts, it mentions "participating physicians," but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
- The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in the performance tests. The nature of the tests (measurements, observational assessment of tissue trauma, comparison of ablation zones) suggests direct measurement and observation rather than expert consensus on subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document states: "Clinical studies were not required to demonstrate the substantial equivalence of the new ablation platform and its predicate."
- The closest to a "human readers improve with AI vs without AI" assessment is the animal study that noted: "The number of attempts needed by participating physicians to place the antenna was fewer when using the navigation-guided ablation platform compared to the previous-generator Emprint™ Ablation System, suggesting that the navigation feature enhances the platform's overall usability." This points to improved physician efficiency with the navigation feature but isn't a formal MRMC study measuring diagnostic performance improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
- Yes, a form of standalone performance was assessed. The "Performance Testing" section states:
- "Ex vivo tissue testing was conducted to further characterize the platform's performance. Ablation zone size and shape were measured at selected generator time and power settings and were equivalent to the predicate system." This is an assessment of the device's physical output.
- "The accuracy of the platform's navigation feature was evaluated and is specified in the product's labeling." This refers to the algorithm's accuracy in predicting trajectory and ablation zone.
- "The system's ability to function as designed across a wide range of operating conditions (altitude, temperature and humidity) was verified in an environmentally controlled chamber." This is a standalone system test.
7. The Type of Ground Truth Used:
- Direct Measurement/Observation and Comparative Equivalence:
- For ablation zone size and shape: Direct measurement in ex-vivo tissue.
- For electrical safety and EMC: Compliance with international standards, likely verified through direct testing and measurement against specified limits.
- For sterility, residual levels, biocompatibility, shelf life: Laboratory testing against established specifications.
- For animal studies: Direct observation of tissue trauma, measurement of insertion/extraction forces, macroscopic comparison of ablation zones by researchers, and recording of physician attempts for antenna placement.
- For navigation feature accuracy: The ground truth would be the actual position and trajectory, against which the system's prediction is measured.
8. The Sample Size for the Training Set:
- The document does not provide information on a training set sample size. This is common for predicate-based 510(k) submissions, especially for hardware devices with a software component where "training" in the machine learning sense might not be explicitly detailed. The software functionality would likely be developed and verified through standard software development and verification processes rather than a distinct "training set" for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided. If the navigation feature used any form of machine learning, the ground truth for that would typically involve highly accurate spatial tracking systems or human-annotated data for calibration, but this is not discussed in the document.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.