(65 days)
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.
Surgical procedures would include the following:
General Surgery
Bowel
Breast Biopsies
Hernia Repair
Lysis of Adhesions
Upper GI
GI (other)
Cholecystectomy
Thyroid
Splenectomy
OB/GYN Surgery
Hysterectomy
Salpingo-oophrectomy
Mvomectomy
Endometriosis
Ovariohysterectomy
Oncological Surgery
Mastectomy
Axillary Node Dissection
Plastic Surgery
Mammoplasty
Blepharoplasty
Rhytidectomy
Panniculectomy
Forearm Pedicle Flap
Facial
Urological Surgery
Nephrectomy
Prostatectomy
Cystotomy
Ear, Nose & Throat Surgery
Neck Mass
Mastoidectomy
Typanoplasty
Tonsillectomy
Cardiovascular/Thoracic Surgery
Femoral Popliteal Bypass
Internal Mammary Artery (IMA) Harvesting
Pericardial Window
Biopsy of the Thymus
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 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 provided text is related to a 510(k) submission for the PowerStar Bipolar Scissors, a surgical device. The document details the device description, intended use, and a statement of substantial equivalence to an existing device.
However, the text does not contain any information regarding acceptance criteria, specific performance metrics, sample sizes for test or training sets, ground truth establishment methods, or details about any studies (standalone, MRMC, or otherwise) that would "prove the device meets the acceptance criteria." The document states that "Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended" and "Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended," but it does not provide any specifics about these evaluations or the data.
Therefore, I cannot populate the table or answer the specific questions requested because the necessary information is not present in the provided document.
Summary of missing information:
- Acceptance Criteria & Reported Performance: Not specified.
- Sample size (test set) & Data provenance: Not specified.
- Number of experts & qualifications: Not specified.
- Adjudication method: Not specified.
- MRMC comparative effectiveness study: No details provided; only a general statement about clinical evaluations.
- Standalone performance study: No details provided.
- Type of ground truth used: Not specified.
- Sample size (training set): Not applicable, as this is a physical medical device, not an AI/algorithm-based device in the context of "training set."
- How ground truth for training set was established: Not applicable.
§ 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.