Search Results
Found 2 results
510(k) Data Aggregation
(22 days)
DEXIDE BIPOLAR FORCEPS II** DEVICE
The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic and open bipolar procedures, to grasp, coagulate and transect tissues.
The Dexide Bipolar Forceps II** device is a grasping, coagulating, and transecting bipolar forceps, which is intended for use in laparoscopic and open procedures. The device is intended for use with bipolar outputs of compatible electrosurgical generators.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Dexide Bipolar Forceps II** device) and primarily discusses its intended use, classification, and substantial equivalence to previously marketed devices based on compliance with manufacturing and safety standards. It does not include specific performance data or a study report with quantitative acceptance criteria.
Therefore, the requested tables and information cannot be extracted from the provided text.
Ask a specific question about this device
(22 days)
DEXIDE BIPOLAR FORCEPS II ** DEVICE
The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic bipolar procedures, to grasp, coagulate and transect tissues.
The Dexide Bipolar Forceps II** device is a laparocopic grasping, coagulating, and transecting bipolar forceps, which is intended to be passed down a laparoscopic cannula. The device is intended to be used with the bipolar outputs of compatible electrosurgical generators.
Acceptance Criteria and Study for Dexide Bipolar Forceps II** Device
This document describes the acceptance criteria and the study performed for the Dexide Bipolar Forceps II** device, based on the provided 510(k) Summary.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993. | The Dexide Bipolar Forceps II** device is in compliance with ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993. |
| Component materials are in accordance with ISO Standard # 10993-1 (Biocompatibility). | All component materials of the Dexide Bipolar Forceps II** device are comprised of materials which are in accordance with ISO Standard # 10993-1. |
| Substantial equivalence to the predicate device: Minisite* Bipolar Forceps** device (K972415), for indications of use in laparoscopic bipolar procedures to grasp, coagulate, and transect tissues. | The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. |
Note: The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant standards rather than establishing specific quantitative performance metrics beyond these compliance statements.
2. Sample Size and Data Provenance
The provided document does not specify a sample size used for a test set in the context of clinical performance evaluation (e.g., patient data, in vitro or ex vivo samples for comparative testing). The evaluation primarily relies on compliance with standards and substantial equivalence to a predicate device.
The data provenance for the reported performance is from device testing against specified standards and material biocompatibility assessments, rather than clinical trial data.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set. The evaluation is based on engineering and material compliance standards.
4. Adjudication Method
Not applicable. The evaluation does not involve an adjudication method for a test set, as no clinical performance study with human-interpreted outcomes is described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The 510(k) summary does not describe any human-in-the-loop performance studies or comparisons of human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical instrument (bipolar forceps), not an algorithm or AI-based system. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The ground truth used for this submission is primarily based on:
- Compliance with recognized industry standards: ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993.
- Compliance with material biocompatibility standards: ISO Standard # 10993-1.
- Demonstration of substantial equivalence to a predicate device (Minisite* Bipolar Forceps** device K972415) based on design, materials, intended use, and performance claims.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument and does not involve a training set as would be used for an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI or machine learning model, the establishment of ground truth for such a set is not relevant.
Ask a specific question about this device
Page 1 of 1