Search Results

The TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding and wiping the laparoscope lens from debris, grease, blood, and bodily fluids. The access device is compatible with the da Vinci Si Surgical System.

The TroKit Laparoscope Lens Wiper is a sterile, single-use and disposable laparoscopic accessory device that fits onto the distal end of a trocar and with its lens wiper serves to clean the camera lens from blood, tissue, fog, grease, and other surgical debris. The lens wiper itself is a mechanical device within the TroKit that employs a thermoplastic elastomer squeegee. The TroKit is translucent. When the laparoscopic camera is inserted through the trocar into the TroKit its insertion opens the mechanical jaws that house the lens wiper. The wiping is done automatically upon the passage of the laparoscopic camera through the TroKit jaws. The TroKit can be activated and used multiple times during surgery. One device is adequate for one surgery.

The provided FDA 510(k) summary for the TroCare TroKit Laparoscope Lens Wiper (K241796) focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, and non-clinical performance data. It does not contain information related to the acceptance criteria and study design elements specified in the request, such as a table of acceptance criteria with reported device performance, sample sizes for test sets, expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or details about the training set.

Based on the document, here's what can be extracted and what information is missing:

Information available from the document:

• Type of Ground Truth Used: Non-clinical testing demonstrates that the subject device "performs as well as the legally marketed predicate device." The performance data section specifies "mechanical characteristics" testing to show it is safe and performs as intended. Implied ground truth is the performance of the predicate device and established safety and performance benchmarks for such devices.
• Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/ML algorithm.
• How Ground Truth for Training Set was Established: Not applicable as this is a physical medical device, not an AI/ML algorithm.

Information NOT available from the document:

1. A table of acceptance criteria and the reported device performance: While the document states "The TroKit Laparoscope Lens Wiper was evaluated for mechanical characteristics to demonstrate that it is safe and performs as intended," it does not provide a table with specific acceptance criteria (e.g., in terms of cleaning effectiveness, durability, or ease of use) nor the reported quantitative device performance against those criteria.
2. Sample sized used for the test set and the data provenance: The document indicates that "non-clinical testing" was performed, but it does not specify the sample size of devices tested or any details about data provenance (e.g., country of origin, retrospective or prospective).
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): Since this is not an AI/ML device, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or diagnosis is not applicable here. The evaluation of mechanical characteristics would typically involve engineers or laboratory personnel following test protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the non-clinical mechanical testing described.
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: The device is a physical laparoscopic lens wiper, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI/ML algorithm.

In summary, the provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence based on design, indications for use, and non-clinical mechanical and biocompatibility testing. The detailed information requested, particularly concerning performance metrics, test set specifics, and expert involvement for ground truth, is typically provided for AI/ML-driven devices or more complex diagnostic tools, which this device is not.

Ask a specific question about this device