(398 days)
The LTC VAD.400 is an electrosurgical generator coupled with designated LTC electrosurgical instruments for bipolar tissue fusion. The LTC VAD.400 electrosurgical generator and designated LTC electrosurgical instruments (i.e., "the VAD System") are intended for use in open general surgical procedures where ligation of vessels and ducts is desired and as an alternative to mechanical clamping (clips or staples) or suturing. The LTC VAD System can be used on vessels up to 7mm in diameter, on ducts up to 2mm in diameter, and tissue bundles as large as will fit in the jaw electrodes of the instrument.
The LTC VAD system has not yet been tested for use in tubal sterilization or tubal coagulation for sterilization procedures; therefore, the company does not recommend the use of the LTC VAD system for such procedures. In addition, LTC recommends against the use of the VAD System for male circumcisions.
The LTC VAD System consists of: a bipolar electrosurgical generator and two distinct and dedicated electrosurgical instruments.
The provided text is a 510(k) summary for the Live Tissue Connect Inc.'s VAD System, which is an electrosurgical bipolar device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics against a set of acceptance criteria in a detailed study. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and specific performance metrics is largely not available in the provided document.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states "In all instances, the LTC VAD System functioned as intended and all results observed were as expected." This is a general statement of compliance, not a report against specific, quantified acceptance criteria. Acceptance criteria and detailed performance metrics are not provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document mentions "Bench, animal and clinical testing was conducted." However, it does not provide details on the sample sizes for these tests, the number of cases, or the provenance of the data (e.g., country of origin, retrospective/prospective nature).
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)
- Not applicable / Not available. The device is an electrosurgical tool, and its performance is typically evaluated by objective measures (e.g., burst pressure of sealed vessels, thermal spread) and clinical outcomes, rather than by expert review of diagnostic images to establish a "ground truth." The document does not describe any human expert review process for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not available. As explained above, this type of adjudication is typically for diagnostic devices where human interpretation errors might be present. For an electrosurgical device, the
adjudication methodis not a relevant concept for evaluating its performance.
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
- Not applicable. The LTC VAD System is an electrosurgical device, not an AI-powered diagnostic tool that assists human readers. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an electrosurgical device and not an algorithm. Its performance inherently involves human operation; there is no "standalone" algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied ground truth through functional assessment. While not explicitly stated as "ground truth," the performance testing (bench, animal, clinical) would have based its assessment on objective functional criteria relevant to vessel sealing, such as:
- Successful ligation of vessels/ducts up to 7mm/2mm respectively.
- Lack of complications (e.g., excessive thermal spread, incomplete seal).
- Achievement of intended surgical outcome.
However, the document does not detail how "intended function" and "expected results" were objectively defined or measured to serve as a ground truth.
8. The sample size for the training set
- Not applicable / Not available. This is not an AI/machine learning device, so the concept of a "training set" in that context does not apply. If "training set" refers to data used for initial development or optimization, it is not mentioned in the document.
9. How the ground truth for the training set was established
- Not applicable / Not available. As explained above, there is no mention of a training set or its associated ground truth in the context of an electrosurgical device.
In summary, the provided 510(k) summary for the LTC VAD System is focused on demonstrating substantial equivalence to existing predicate devices based on intended use, technological characteristics, and general performance (bench, animal, and clinical testing showing it "functioned as intended"). It does not contain the detailed, quantitative efficacy study information typically found for devices requiring a more rigorously defined performance evaluation against specific acceptance criteria.
§ 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.