(83 days)
The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.
PlasmaBlade X 4.0: The PlasmaBlade™ X 4.0 is a single-use- only device designed for use with qualified Generators as a System (Surgery System). The PlasmaBlade™ X has integrated hand switch control, or alternatively, may be controlled with a qualified Footswitch, supplied as an optional accessory to the Generator. The PlasmaBlade™ X 4.0 consists of a single bendable shaft and rotatable nose piece that can be adjusted by hand. The system components are designed to be used together and operated as a single unit.
PlasmaBlade X 3.0S: The PlasmaBlade™ X 3.0S is a single-use, monopolar RF device. It is designed to be used with the qualified Generators as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The PlasmaBlade™ X 3.0S consists of a single bendable blade and telescoping shaft that can be configured in both standard and extended length. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids.
This document is a 510(k) Premarket Notification from the FDA regarding Medtronic's PlasmaBlade X 4.0 and PlasmaBlade X 3.0S devices. It does not describe an AI/ML-driven medical device, but rather an electrosurgical cutting and coagulation device. Therefore, the requested information about acceptance criteria for an AI/ML device, including details about test sets, expert ground truth, MRMC studies, and training sets, is not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis based on the provided document, addressing what information is not applicable and what little can be inferred:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the AI/ML sense. This document doesn't define quantitative performance metrics (like accuracy, sensitivity, specificity) for an AI/ML algorithm.
- Implied Acceptance Criteria for an Electrosurgical Device: The acceptance criteria for this device appear to be primarily related to safety and functionality, demonstrating that it performs as intended for cutting and coagulation of soft tissue and that its thermal effect is substantially equivalent to predicate devices.
- Reported Device Performance: "The thermal effect of the X series of products was found to be substantially equivalent to that of the predicate devices." This is a qualitative statement of equivalence, not a specific quantitative performance metric.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided. The document mentions "comparative performance testing was conducted in an in-vivo/ex-vivo animal model." It does not specify the sample size of animals or the details of the "test set" in an AI/ML context. Data provenance (country, retrospective/prospective) is also not provided.
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. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant for an electrosurgical device's performance evaluation as described here. The evaluation seems to be based on physical measurements of thermal effect.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No human interpretation or adjudication of output is described.
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 an electrosurgical device, not an AI-assisted diagnostic tool. No MRMC study was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no "algorithm" in the AI/ML sense to test standalone performance. The device itself is the "standalone" item being evaluated for its physical effects.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" for this device's evaluation would be physical measurements of thermal effect in animal tissue, comparing it to predicate devices. It's not a diagnostic or prognostic tool requiring expert consensus or pathology for "ground truth."
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set for model development.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set mentioned or implied.
In summary, this document is a regulatory submission for a physical medical device (electrosurgical) and does not contain the information requested for evaluating an AI/ML-driven device's acceptance criteria and study data.
§ 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.