(88 days)
The PEAK PlasmaBlade® PLUS Tissue Dissection Device 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 surgical procedures.
The PEAK PlasmaBlade® PLUS consists of a single insulated bendable blade, telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip incorporates a suction lumen for the evacuation of smoke and fluids. A ball electrode attaches to the finger grip to allow a broader application of energy. The PlasmaBlade PLUS is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, PlasmaBlade EXT and PlasmaBlade 3.0S.
The provided text is a 510(k) Summary for the PEAK PlasmaBlade® PLUS, an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed performance from a study in the format typically used for AI/ML device submissions.
Based on the content provided, here's an attempt to answer your questions, highlighting where information is absent or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and device performance in numerical terms for the PEAK PlasmaBlade® PLUS. Instead, it states that the device "functioned as intended and met design specifications" and "complies with" various electrical safety, sterilization, and biocompatibility standards. It also mentions "Histological studies comparing thermal effects of the device to the predicate devices demonstrated that the PlasmaBlade PLUS is substantially equivalent to the predicate devices and meets safety and effectiveness criteria."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Function as intended and meet design specifications | Device "functioned as intended and met design specifications." |
| Compliance with IEC 60601-1 (Medical Electrical Equipment: General Requirements for Safety) | Device "complies with" IEC 60601-1. |
| Compliance with IEC 60601-1-2 (Medical Electrical Equipment: Electromagnetic Compatibility) | Device "complies with" IEC 60601-1-2. |
| Compliance with IEC 60601-2-2 (Medical Electrical Equipment: Particular Requirements for the Safety of High Frequency Surgical Equipment) | Device "complies with" IEC 60601-2-2. |
| Compliance with ISO 11135-1 (Sterilization of Healthcare Products - Ethylene Oxide) | Device "complies with" ISO 11135-1. |
| Compliance with ISO 10993-1 (Biological evaluation of medical devices: Guidance on selection of tests) | Device "complies with" ISO 10993-1. |
| Compliance with ISO 10993-7 (Biological Evaluation of Medical Devices: Ethylene Oxide Sterilization Residuals) | Device "complies with" ISO 10993-7. |
| Substantial equivalence in thermal effects to predicate devices | "Histological studies comparing thermal effects of the device to the predicate devices demonstrated that the PlasmaBlade PLUS is substantially equivalent to the predicate devices and meets safety and effectiveness criteria." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Laboratory and performance tests were executed" and "Histological studies," but does not specify sample sizes for these tests or studies. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.
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)
The document mentions "Histological studies," which implies microscopic examination, likely performed by pathologists. However, it does not specify the number of experts used, their specific qualifications, or how ground truth was established regarding the "thermal effects" in these histological studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the tests or studies conducted.
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 MRMC comparative effectiveness study was conducted or reported. This device is an electrosurgical tool, not an AI/ML diagnostic aid. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The PEAK PlasmaBlade® PLUS is a physical surgical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "histological studies," the ground truth was presumably based on pathology (microscopic examination of tissue samples to assess thermal effects). The exact nature of the assessment (e.g., specific measurements of thermal damage zones) is not detailed.
8. The sample size for the training set
This question is not applicable. As this is not an AI/ML device, there is no concept of a "training set" in the context of machine learning model development.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
§ 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.