(56 days)
The Aquamantys3 BSC 9.1S is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Pump Generator. The device delivers bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone and monopolar RF energy for cutting of soft tissue. It is intended for, but not limited to, orthopaedic, spine, thoracic, and open abdominal surgery.
The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The proposed Aquamantys3 BSC 9.1S is a sterile, single-use hemostatic sealing and cutting device. The device employs bipolar radiofrequency (RF) energy and saline for hemostatic sealing and coagulation, and monopolar radio-frequency (RF) energy for cutting. The device is equipped with a dual electrode tip with saline orifices on both sides of the inner electrode at its distal end. Saline and RF energy are supplied to the device from lines on the proximal end of the hand piece. The cassette provides the electrical connection and saline fluid delivery from the Aquamantys3 Generator. The hand piece is equipped with an on-off Transcollation® Sealing Saline button that simultaneously activates both bioolar RF and saline flow for hemostatic sealing using both electrodes. The hand piece is equipped with an on-off Cut button that activates the monopolar RF energy for cutting on a single electrode.
The provided text describes a medical device, the Aquamantys3 BSC 9.1S, and its substantial equivalence determination based on nonclinical data. Clinical data was not required for this determination. Therefore, several of the requested sections regarding the study design and ground truth establishment (items 2, 3, 4, 5, 6, 7, 8, 9) are not applicable as no clinical study was performed.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission notes that the device underwent "bench performance testing to verify and validate the performance features and specifications." While specific quantitative acceptance criteria are not explicitly detailed in the provided text, the list below represents the types of tests performed to ensure the device met its intended performance characteristics. The reported device performance is that it successfully met the requirements of these tests, leading to a substantial equivalence determination.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical Integrity & Durability | |
| Static Cable Pulls | Passed testing to ensure cable integrity. |
| Dynamic Cable Pulls | Passed testing for cable resilience under movement. |
| Static Saline Tube Pulls | Passed testing for saline tube integrity. |
| Cassette Separation | Passed testing to ensure appropriate cassette function and attachment. |
| Shaft Deflection/Pull | Passed testing for shaft flexibility and strength. |
| Electrode Pull | Passed testing to ensure electrode secureness. |
| Functional Performance | |
| Visual Inspection | Device met visual quality standards. |
| Air Leak and Flow | Passed testing for air tightness and proper flow characteristics. |
| Hipot Testing (Dielectric Withstand) | Passed electrical safety testing. |
| Saline Flow Testing | Passed testing for accurate and consistent saline delivery. |
| Continuity (Electrical) | Passed testing to ensure proper electrical pathways. |
| Animal Tissue Testing | Device demonstrated expected hemostatic sealing, coagulation, and cutting performance on animal tissue. |
| Electrical Safety | Device met electrical safety standards. |
| Biocompatibility | |
| Biocompatibility Assessment | Device materials were assessed and found to be biocompatible for intended use. |
Summary of the Study Proving Acceptance Criteria:
The study that proved the device met its acceptance criteria was a series of nonclinical bench performance tests. These tests were conducted to "verify and validate the performance features and specifications" of the Aquamantys3 BSC 9.1S. The purpose of these tests was to demonstrate the device's substantial equivalence to a legally marketed predicate device (Aquamantys3 8.2L Bipolar Sealer with Cutting K111285) rather than to establish clinical efficacy or safety from human clinical trials.
The specific tests performed included: visual inspections, static and dynamic cable pulls, static saline tube pulls, air leak and flow tests, hipot testing, saline flow testing, cassette separation, shaft deflection/pull, electrode pull, continuity tests, biocompatibility assessment, animal tissue testing, and electrical safety tests. The conclusion drawn from these tests was that the Aquamantys3 BSC 9.1S is substantially equivalent to the predicate device based on its design, test results, and fundamental scientific technology.
Detailed Information (as requested by enumeration, with N/A where not applicable from the given text):
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text for each individual bench test. Bench tests typically involve a relevant number of device units to ensure consistency and reliability of results, but specific numbers are not given.
- Data Provenance: The tests were "bench performance testing," implying they were conducted in a laboratory or engineering environment by the manufacturer (Medtronic Advanced Energy). There is no mention of country of origin of the data in a geographical sense, or if it was retrospective or prospective, as these terms typically apply to clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. For bench performance testing of this nature, "experts" in the context of clinical ground truth (e.g., radiologists) are not typically involved in establishing the "ground truth" of mechanical, electrical, or functional performance. Engineering and quality control personnel within the manufacturer's R&D are responsible for conducting and evaluating these tests against predefined specifications.
- Qualifications of Experts: Not applicable for establishing clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert readers. For bench testing, test results are typically compared against predefined engineering specifications and criteria (e.g., pass/fail), often with established quality control and review processes rather than expert adjudication in the clinical sense.
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:
- MRMC Study: No. The provided text explicitly states, "Clinical testing was not required to establish substantial equivalence between the proposed and predicate devices." Therefore, no MRMC study, or any clinical study involving human readers or AI assistance, was performed according to this submission.
- Effect Size with AI: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. The device is a physical electrosurgical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm only" performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the nonclinical bench testing, the "ground truth" was established based on engineering specifications, design requirements, and performance standards for the device's mechanical, electrical, and functional characteristics. For animal tissue testing, the "ground truth" would be the observed physical effects (hemostatic sealing, coagulation, cutting) consistent with the device's intended mechanism of action.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for machine learning models, not for traditional medical devices like this electrosurgical accessory.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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.