(219 days)
The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.
The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft, is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 shaft lengths: 30 cm, 37 cm, and 44 cm.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "CoolSeal Trinity," an electrosurgical instrument. It details the device's indications for use, comparison to a predicate device, and performance data submitted to support its substantial equivalence.
However, the request asks for specific information regarding acceptance criteria and a study proving the device meets these criteria, particularly focusing on elements common in studies for AI/software-based medical devices (e.g., sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance).
Crucially, the provided document does NOT describe a study involving AI, machine learning, or software performance that would necessitate such detailed criteria or the specific study types listed in the prompt's requirements (e.g., sample sizes for training/test sets, expert ground truth for image data, MRMC studies, standalone algorithm performance).
The "performance data" mentioned in the document relates to:
- Electrical and Thermal Testing: Verifying the device performs as expected when connected to a new compatible generator (Da Vinci E-200).
- Ex-vivo Vessel Burst Pressure: Testing on excised fresh porcine blood vessels to demonstrate effective bipolar electrosurgical vessel sealing performance equivalent to the predicate device.
Therefore, many parts of your request about AI/software-specific study details cannot be answered from the provided text. The CoolSeal Trinity is a hardware electrosurgical instrument; the "study" described is a benchtop performance comparison to an existing predicate hardware device, not a clinical trial or AI model validation.
Based on the provided text, here is what can be inferred or stated regarding "acceptance criteria" and "study":
The core "acceptance criterion" for this 510(k) submission is substantial equivalence to a predicate device (CoolSeal™ Trinity K211579). This means demonstrating that the new device is as safe and effective as the predicate device and has the same technological characteristics. The only difference identified is the compatibility with a new electrosurgical generator (Da Vinci E-200).
The "study" described is a set of performance tests to support this substantial equivalence, particularly due to the identified difference.
Here's a breakdown based on your prompt, addressing what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics in the way one would for an AI/software device (e.g., "sensitivity > X%", "specificity > Y%"). Instead, the acceptance is qualitative: "performs as expected" and "effective...equivalent to the predicate device."
| Acceptance Criteria (Implied for Substantial Equivalence due to change) | Reported Device Performance |
|---|---|
| Electrical and thermal performance with new compatible generator (Da Vinci E-200) | "Electrical and thermal testing verified that the proposed subject device performed as expected when connected to the E-200 generator." |
| Ex-vivo vessel sealing performance (e.g., burst pressure) equivalent to the predicate device | "Ex-vivo burst pressure testing of excised fresh porcine blood vessels was conducted on the subject device to demonstrate effective bipolar electrosurgical vessel sealing performance that is equivalent to the predicate device." |
| Overall safety and effectiveness compared to predicate device | "Based on a review of performance data, comparison of the device classification, intended use, operating principles, and technological characteristics, the subject device is safe, as effective, and performs as well as the legally marketed predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for either electrical/thermal testing or ex-vivo burst pressure testing. The term "excised fresh porcine blood vessels" implies biological material was used, but the quantity of vessels is not specified.
- Data Provenance:
- Country of Origin: Not specified, but "porcine" suggests animal tissue.
- Retrospective or Prospective: These are laboratory benchtop tests, not clinical studies on human subjects, so the terms "retrospective" or "prospective" in the clinical sense don't strictly apply. The tests were likely conducted prospectively as part of the validation for the 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware device performance test, not an AI/software diagnostic accuracy study involving human expert interpretation for ground truth. The "ground truth" for electrical/thermal testing would be instrument readings against specifications, and for burst pressure, it would be measured burst pressure.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 is not an AI/software device; therefore, no MRMC study or AI assistance evaluation would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device. There is no "algorithm" or "standalone performance" in the sense of a software-based diagnostic tool. The performance measured is that of the physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Electrical/Thermal Testing: The "ground truth" would be established engineering specifications derived from the predicate device and general safety standards for electrosurgical equipment.
- For Ex-vivo Vessel Burst Pressure: The "ground truth" is the empirically measured burst pressure of the sealed vessels, likely compared against a pre-defined threshold or against measurements from the predicate device under similar conditions. This is a direct physical measurement.
8. The sample size for the training set:
- Not Applicable. This is not an AI/software device; there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.