(157 days)
The AtriCure Isolator Synergy EnCompass Clamp and Guide system is intended to ablate cardiac tissue during surgery.
The CLAMP is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms. The GUIDE is a single-use surgical accessory designed to facilitate the guidance of surgical instruments through tissue during cardiothoracic surgical procedures. The GUIDE has a flexible, malleable shaft, and magnetic attachment ends that connect to the metal tip of the CLAMP jaws inside the jaw magnet cups.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as per your request:
Based on the provided FDA 510(k) summary for the AtriCure Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System (K210477), the device described is an electrosurgical cutting and coagulation device, not an AI/ML-based diagnostic device. Therefore, many of the typical acceptance criteria and study aspects you've asked about (like sensitivity, specificity, human-in-the-loop performance, expert ground truth for image data, MRMC studies, effect size of AI assistance, training set details) are not applicable or not provided in this type of submission for this medical device.
This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here refer to the pre-established benchmarks for these engineering and performance tests, rather than clinical efficacy metrics for a diagnostic algorithm.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document states: "The Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared Isolator Synergy Dual Electrode Clamp (EMR2/EML2)." However, the specific numerical acceptance criteria for each test and the precise reported device performance against those criteria are not detailed in this summary. The summary only lists the types of tests performed.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical Integrity & Functionality | Met predetermined criteria |
| Ablation Performance (Ex vivo) | Met predetermined criteria |
| Reliability | Met predetermined criteria |
| External Surface Temperature | Met predetermined criteria |
| Biocompatibility | Met predetermined criteria |
| Shelf Life | Met predetermined criteria |
| Electrical Safety | Met predetermined criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any of the individual tests. This type of detail is typically found in the full test reports, not the 510(k) summary.
- Data Provenance: The tests are "bench testing" and "Ex vivo Ablation Comparison Testing," and a "GLP Animal Study." This indicates laboratory and animal testing, not human patient data. Therefore, country of origin is not applicable in the same way as with clinical data. The studies are prospective in nature, as they involve testing the new device.
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)
Not applicable. This device is an electrosurgical clamp, not a diagnostic imaging device requiring expert interpretation for ground truth. Ground truth for these engineering tests would be established through physical measurements, chemical analyses, and biological observations (in the animal study/biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the type of testing performed for this device.
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
Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device is established through:
- Engineering specifications and measurements (e.g., clamp force, electrical resistance, temperature).
- Ex vivo and in vivo (animal study) observations of ablation lesion quality and tissue response.
- Standardized biocompatibility tests to assess material interactions with biological systems.
- Accelerated aging for shelf life.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.