(134 days)
The PEAK PlasmaBlade® 3.0S 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® 3.0S 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 also incorporates a suction lumen for the evacuation of smoke and fluids. The PlasmaBlade 3.0S is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, and PlasmaBlade EXT.
The provided text is a 510(k) summary for a medical device (PEAK PlasmaBlade® 3.0S) and largely focuses on regulatory approval based on substantial equivalence to a predicate device. It explicitly states that "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."
However, the document does not contain the detailed information required to fill out your request, which pertains to a specific study demonstrating the device meets acceptance criteria. This type of information is usually found in a detailed study report, not a 510(k) summary.
Here's a breakdown of what can be inferred or directly stated from the text, and what is missing:
- Acceptance Criteria/Reported Performance: The document states "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications." However, no specific acceptance criteria or quantitative performance metrics are provided. The core argument for approval is substantial equivalence to the predicate device (PEAK PlasmaBlade® 4.0), implying that if the predicate met its criteria, this device would also.
- Study Details: The document mentions "Laboratory and performance tests," but does not describe a specific study with the required details like sample size, data provenance, ground truth establishment, or expert involvement.
Therefore, most of the requested table and information cannot be directly extracted from the provided text.
In summary, based only on the provided text, here's what can be answered and what cannot:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "functioned as intended and met design specifications" (details not provided) |
| "substantially equivalent to the predicate device" | "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria." |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- Information Not Provided. The document only generally refers to "Laboratory and performance tests."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Information Not Provided. The document does not describe the establishment of ground truth for any tests, nor the involvement of experts beyond the company's internal testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Not Provided.
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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 study was not done, and this device is not an AI/imaging device. The device is an electrosurgical cutting and coagulation device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical instrument, not an algorithm. Performance tests would be standalone in the sense they evaluate the instrument itself, but not in the context of an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information Not Provided directly. Given the nature of the device (electrosurgical instrument), "ground truth" would likely be defined by engineering specifications, material properties, and functional performance benchmarks (e.g., cutting depth, coagulation effectiveness on tissue proxies, safety parameters like temperature increase). However, the specific methodology is not described.
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The sample size for the training set:
- Not applicable/Information Not Provided. As this is not an AI/machine learning device, there isn't a "training set" in the conventional sense. Any internal developmental testing data would precede the performance tests mentioned.
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How the ground truth for the training set was established:
- Not applicable/Information Not Provided. (See point 7)
§ 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.