(175 days)
Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.
The instrument, model 5DCS, is validated with the US Surgical Force FX-C generator and is only to be used with this generator.
Endoscopic instruments consist of a rigid plastic handpiece with loop handles connected to the distal end scissors or jaws by an elongated, narrow-diameter insulated barrel or shaft. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The handbiece loop handles operate the jaws. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The blades or jaws of endoscopic instruments can deliver a cauterizing current that enters the instrument through the unipolar cautery connector on the handpiece, runs down the insulated shaft and through the tissue in the blades or jaws. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.
The provided documents do not contain the detailed information necessary to fully answer all aspects of your request, as they pertain to the 510(k) summary for a reprocessed medical device rather than a new device with AI components. The study described focuses on demonstrating the substantial equivalence of reprocessed endoscopic instruments to predicate devices through bench and laboratory testing.
Here's a breakdown of the available information and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used:
The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Endoscopic Instruments. This included the following tests:
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation."
The conclusion is: "Performance testing demonstrates that Reprocessed Endoscopic Instruments perform as originally intended."
However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum residual protein levels, specific electrical resistance ranges for cautery function) and the exact reported performance values for each of these tests are not provided in this summary. Therefore, a detailed table cannot be created. The ground truth for this type of testing is typically established by pre-defined engineering specifications, regulatory standards, and comparison to the performance of the original predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for each of the bench and laboratory tests. It generally refers to "testing" without providing numerical details for the test sets.
The data provenance is from bench and laboratory testing of reprocessed medical devices, rather than clinical data from specific countries. It is inherently prospective in the sense that Ascent Healthcare Solutions performed these tests for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is not applicable in the context of this 510(k) summary. The "ground truth" for the performance of a reprocessed medical device is established through objective physical, chemical, and biological testing against predefined engineering and regulatory standards, not through expert consensus on interpretations like with diagnostic imaging.
4. Adjudication Method for the Test Set:
This is not applicable to the type of bench and laboratory testing described. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints.
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:
This is not applicable. This submission is for reprocessed endoscopic instruments, which are physical surgical tools, not AI algorithms. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This submission is for a physical medical device, not an algorithm.
8. The Sample Size for the Training Set:
This is not applicable as there is no AI or algorithm involved that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no AI or algorithm involved that would require a training set.
In summary, the provided document is a 510(k) summary for a reprocessed physical medical device. It describes bench and lab tests to demonstrate substantial equivalence to a predicate device, focusing on safety and effectiveness. It does not involve AI, clinical data from human subjects for ground truth establishment, or multi-reader studies.
§ 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.