(90 days)
The InsulScan™ Insulation Testing System is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.
The InsulScan™ system is comprised of a disposable hand-held instrument probe, a control unit, a cable adapter, and a ten-foot long connection cable. The InsulScan™ system is powered by a rechargeable battery housed in the control unit. A battery recharger unit and battery charger cable are provided for recharging. The InsulScan™ probe is provided sterile, single use and may not be resterilized.
The provided document describes the InsulScan™ Insulation Testing System, which is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.
The document does not include specific acceptance criteria or a detailed study proving the device meets those criteria. It focuses on the regulatory submission (510(k) summary) rather than performance validation. Therefore, the requested information cannot be fully provided from the given text.
However, based on the available information, here's what can be extracted and how the missing pieces would typically be presented:
1. A table of acceptance criteria and the reported device performance
The document provides "Device Specifications" which can be interpreted as design specifications or performance targets. However, it does not explicitly state acceptance criteria or show actual measured performance against those criteria.
| Item | Acceptance Criteria (Inferred from Specifications) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|
| Output Voltage | 6,500 Volts, DC ± 1,000 Volts, DC | Not reported |
| Operating Duration | Continuous: 30 minutes (automatic power off) | Not reported |
| Frequency | DC | Not reported |
| Intended Use | Non-destructive, non-patient contact, high voltage insulation tester for electrosurgical instruments | The 510(k) clearance implies the device meets its stated intended use. |
2. Sample size used for the test set and the data provenance
The document does not provide details on a specific test set, its sample size, or data provenance. This type of information would typically be found in a detailed validation study report, which is not included here. This 510(k) summary refers to the device as being substantially equivalent to a predicate device (LIT Insulation Testing System K952889), which implies that the substantial equivalence was demonstrated through comparison to the predicate's established performance, but specific test data for the InsulScan™ is not presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical study or a study involving expert assessment to establish ground truth for a test set. This device is an insulation tester, not a diagnostic or imaging device that would typically rely on expert ground truth.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set that would require an adjudication method.
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. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware testing instrument, not an algorithm. Its performance is inherent in its design and function. The "standalone" performance would typically refer to its ability to accurately detect insulation breaches as designed, but specific testing details are not provided.
7. The type of ground truth used
For an insulation testing device, the "ground truth" would typically be established by:
- Known defective insulation: Electrosurgical instruments with pre-engineered or confirmed insulation failures.
- Known intact insulation: Electrosurgical instruments with confirmed, undamaged insulation.
- Reference standard measurement: Using highly accurate and calibrated laboratory equipment to determine the actual insulation integrity (e.g., breakdown voltage, leakage current) against which the device's measurements are compared.
The document does not detail how the ground truth was established for any internal testing or validation studies.
8. The sample size for the training set
Not applicable. This device is a physical instrument, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical instrument, not a machine learning model that requires a training set.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).