(175 days)
The JustRight Surgical™ Vessel Sealing System is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter wherever vessel ligation is required.
The JustRight Surgical™ Vessel Sealing System consists of the JustRight™ Generator and a JustRight™ Sealer. The JustRight™ Generator is designed to provide low power bipolar RF energy for vessel-sealing applications. The JustRight™ Generator is for use only with JustRight Sealer instruments. The Sealer is a hand held ring handle design with either a 10 cm or a 20 cm Shaft length that is compatible with a 3mm (ID) cannula. The JustRight™ Sealer attaches to the generator via a 10' cord.
The JustRight Surgical™ Vessel Sealing System demonstrated its performance through a series of bench and animal studies to support its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or specific numerical performance targets for the device. Instead, it relies on demonstrating equivalence to predicate devices through various tests.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Device Function & Durability | Not explicitly defined as quantitative criteria, but implicitly means meeting expected operational standards. | Bench testing of the JustRight Surgical™ Vessel Sealing System was performed to evaluate device function and durability. The document states that the testing was performed "to evaluate device function and durability," implying successful operation within expected parameters. Specific results or metrics are not provided. |
| Electrical Safety | Compliance with IEC 60601-1-1 | Testing was conducted and found to be in accordance with IEC 60601-1-1. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Testing was conducted and found to be in accordance with IEC 60601-1-2. |
| Biocompatibility | Compliance with ISO 10993 | Testing was conducted and found to be in accordance with ISO 10993. |
| Vessel Sealing Performance | Equivalence to predicate device (Valleylab Ligasure™ Vessel Sealing System) in ability to seal blood vessels and vascular bundles up to 5 mm. | Animal testing of the JustRight Surgical™ Vessel Sealing System was conducted, which "confirmed device performance to be equivalent to the predicate device." No specific quantitative metrics (e.g., burst pressure, thermal spread) are provided, but the equivalence implies meeting the performance standards of the predicate. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size for the animal testing. It only mentions "Animal testing."
- Data Provenance: The document does not specify the country of origin of the data. The studies were conducted by JustRight Surgical LLC. The information provided is retrospective, as it's part of a premarket notification submitted to the FDA after the tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies described are technical performance tests (bench and animal), not diagnostic or interpretative studies requiring expert ground truth in the typical sense (e.g., radiologists interpreting images). The "ground truth" for the animal study would be the physiological outcomes observed by the researchers/veterinarians involved.
4. Adjudication method for the test set:
This information is not provided. Given the nature of the bench and animal testing, a formal adjudication method as understood in clinical trials or diagnostic studies (e.g., 2+1, 3+1) is not typically applicable. The results would be objectively measured or observed by the testing personnel.
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, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (vessel sealing system), not an AI-powered diagnostic tool, and therefore human reader performance/improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a medical instrument that delivers energy for vessel sealing; it is not an algorithm or AI system. Therefore, a "standalone algorithm performance" assessment is not applicable. The performance evaluated was the direct function of the device itself.
7. The type of ground truth used:
- Bench Testing: The ground truth for bench testing (electrical safety, EMC, biocompatibility, function, durability) would be objective measurements against established engineering standards (IEC, ISO) and internal design specifications.
- Animal Testing: The "ground truth" for the animal testing would be the observed physiological outcomes and performance metrics (e.g., effectiveness of vessel sealing) measured directly in the animal models, compared against the performance of the predicate device. This is essentially outcomes data within a controlled animal study.
8. The sample size for the training set:
The device is a hardware system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
As there is no training set for an AI/ML algorithm, this question is 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.