(133 days)
The Covidien Emprint™ Ablation System 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 Covidien Emprint™ Ablation System is not intended for use in cardiac procedures.
The Emprint™ Ablation System is a microwave-based 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 generator to deliver power to a single microwave ablation antenna.
The Emprint™ Ablation Generator is composed of analog and digital circuits with no software or firmware. The Emprint™ Ablation Generator provides for user setting of ablation time and ablation power (5 to 100W). With an optional temperature probe, the Emprint™ Ablation Generator 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 Emprint™ Ablation System consists of the following components: Emprint™ Ablation Generator (2450 MHz), Emprint™ Ablation Antenna (sterile, single use), Emprint™ Ablation Reusable Cable, and Emprint™ Ablation Pump. The system also includes the following optional components: Emprint™ Ablation Cart (with Isolation Transformer), Remote Temperature Probe (sterile, single-use), and Footswitch.
The system must be used with a standard IV bag of sterile normal saline (not provided with the system).
The provided text describes a 510(k) premarket notification for the Emprint™ Ablation System, a microwave-based system for soft tissue ablation. However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "The performance of the proposed device was characterized using the same methods used for one of the predicate devices. Coagulations were conducted on several ex vivo and in vivo tissue types at various power and duration settings. The shapes of the coagulation zones created were analyzed and compared to that of the predicate. Bench testing also included verification of dimensional characteristics, surface temperatures, and skin penetration."
However, specific numerical acceptance criteria (e.g., minimum ablation zone size, maximum temperature deviation, etc.) and the precise reported performance values against these criteria are not provided in this summary. The comparison to the predicate device is mentioned as the primary method for demonstrating substantial equivalence, but the detailed results of that comparison are not given.
Therefore, a table cannot be fully constructed.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "several ex vivo and in vivo tissue types" but does not specify the sample sizes for these tests.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies an internal study conducted by the manufacturer (Covidien llc).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth. The performance data focuses on physical characteristics of the ablation zone.
4. Adjudication Method for the Test Set:
Not applicable, as no expert review or human interpretation of cases is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. The document describes performance testing of the device itself (ablation characteristics) and not a study involving human readers or the AI's impact on human performance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
This device is a physical medical instrument (microwave ablation system), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" does not apply in this context. The performance data presented relates to the device's physical capabilities and effects on tissue.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation appears to be the physical measurements and characteristics of the ablation zones created by the device in ex vivo and in vivo tissue, and a comparison of these to a predicate device. This is based on direct observation and measurement of the device's physical output.
8. The Sample Size for the Training Set:
The concept of a "training set" is relevant for machine learning algorithms. This device is a hardware system, not an AI algorithm, so there is no training set in the machine learning sense. The device's "training" or development would involve engineering design, testing, and optimization based on physical principles, not data input for an algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for an AI algorithm. The device's design and optimization would be based on engineering specifications and empirical testing.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through performance testing related to the physical characteristics of the ablation system. It does not provide the level of detail regarding acceptance criteria, sample sizes, expert involvement, or specific ground truth methodologies that would typically be found in an AI/software device submission.
§ 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.