(90 days)
The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.
The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.
The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.
The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.
The provided text describes a 510(k) summary for the PowerStar Bipolar Scissors, a medical device for cutting and coagulating soft tissue. However, it does not contain information about acceptance criteria, specific performance metrics, or a detailed study proving the device meets acceptance criteria as would be
expected for AI/ML-based medical devices.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device. Therefore, I cannot generate the requested table and detailed study information based on the provided text.
Here's why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Information in text: The document states, "Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended. Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended."
- Missing Information: No specific acceptance criteria (e.g., minimum cutting efficiency, maximum coagulation time, specific power delivery, etc.) are provided. No quantitative performance data against any such criteria is reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information in text: The document mentions "preclinical laboratory and clinical evaluations" and "pre-clinical and clinical testing."
- Missing Information: No details on sample sizes for any test sets, data provenance (country, retrospective/prospective), or the nature of these tests are supplied.
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):
- Information in text: This concept is not applicable to the device described. The device is a surgical instrument, not an AI/ML diagnostic tool that relies on expert interpretation for ground truth.
- Missing Information: Not relevant to this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information in text: Not relevant to this type of device.
- Missing Information: Not relevant to this type of device.
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:
- Information in text: Not applicable. This is a surgical instrument, not an AI/ML diagnostic aid.
- Missing Information: Not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information in text: Not applicable. This is a surgical instrument, not an AI/ML algorithm.
- Missing Information: Not relevant to this type of device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Information in text: Not applicable. The "ground truth" for a surgical instrument would be its functional performance (e.g., ability to cut tissue cleanly, achieve hemostasis) demonstrated through direct observation or measurable physical parameters in laboratory or clinical environments.
- Missing Information: Not relevant in the context of typical AI/ML ground truth definition.
8. The sample size for the training set:
- Information in text: No training set is mentioned as this is not an AI/ML device.
- Missing Information: Not relevant to this type of device.
9. How the ground truth for the training set was established:
- Information in text: No training set is mentioned as this is not an AI/ML device.
- Missing Information: Not relevant to this type of device.
Summary from the provided text:
The document states that the PowerStar Bipolar Scissors are "substantially equivalent" to an existing legally marketed device. This determination is based on "preclinical laboratory and clinical evaluations" that "ensure that the device functions as intended" and provide "sufficient data...to assess that the device performs as clinically intended" and "assess the safety and effectiveness characteristics of the modified device."
Key Takeaway: The provided text is a 510(k) summary for a conventional surgical instrument, not an AI/ML-driven device. As such, it details the intended use, indications, and substantial equivalence claim, but it does not include the specific types of performance metrics, study designs (like MRMC), and ground truth methodologies that would be relevant for an AI/ML medical 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.