(89 days)
Laparoscopic Electric Instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, mobilization, and dissection of tissue.
Laparoscopic electric instruments are devices that are designed for use via laparoscopes or open surgical procedures. The devices have a handle, a rotating insulated shaft with a diameter of 5mm, a length of 19-33 cm and a distal tip. The distal tip of the devices consists of a variety of configurations including: dissectors, scissors and cutting forceps. The devices may be monopolar or bipolar and have a cautery connector on the handle or a connector cable. The device is connected via a cautery cable to a RF generator which provides electrical current to the device.
The provided document is a 510(k) summary for reprocessed laparoscopic electric instruments. It details the device description, intended use, and a summary of functional and safety testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria and a detailed study proving the device meets those criteria, as typically found in a clinical study report or detailed validation protocol.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted:
Information available in the document:
- 1. A table of acceptance criteria and the reported device performance: Not explicitly provided in this format. The document generally states "functional testing to demonstrate appropriate functional characteristics" and "process validation testing to validate the cleaning and sterilization procedures as well as device packaging" but does not detail specific acceptance criteria or quantitative performance results against those criteria.
- 2. Sample size used for the test set and the data provenance: Not specified for the functional testing. The document states "Representative samples" were used.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This type of information is usually relevant for diagnostic devices involving expert review, not for reprocessed surgical instruments undergoing functional and safety testing.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/provided.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned as it's not relevant for this device type.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithms, not reprocessed medical devices.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For reprocessed devices, "ground truth" generally refers to meeting safety and functional specifications comparable to new devices, or demonstrating effective cleaning/sterilization. The document implies this was done through "functional testing" and "process validation testing," but doesn't detail the specific benchmarks or "ground truth" beyond "appropriate functional characteristics."
- 8. The sample size for the training set: Not applicable. This refers to AI/machine learning.
- 9. How the ground truth for the training set was established: Not applicable.
What the document does state regarding testing and validation:
- Functional and Safety Testing: "Representative samples of reprocessed laparoscopic electric instruments underwent functional testing to demonstrate appropriate functional characteristics." This implies a comparison to the function of original equipment manufacturer (OEM) devices, but no specifics are given.
- Process Validation: "Process validation testing was done to validate the cleaning and sterilization procedures as well as device packaging."
- Manufacturing Process: "In addition, the manufacturing process includes visual and functional testing of all products produced."
- Conclusion of Substantial Equivalence: The reprocessed devices are deemed substantially equivalent based on "similarities in functional design, materials, indications for use and methods of construction." This suggests that the testing aimed to confirm these similarities met an acceptable standard.
In summary, while the document confirms that functional and safety testing was performed, it does not provide the detailed acceptance criteria or the study results in a quantitative manner that would allow for filling the requested table or answering the specific questions about sample sizes, ground truth establishment, or expert involvement. The letter is an FDA clearance summary, which often provides generalizations about testing rather than the detailed technical reports themselves.
§ 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.