(150 days)
The LAPARETTE is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of highfrequency electrical current, irrigate tissue and cavities, as well as suction fluids from the wound. This device is not intended for use in tubal sterilization procedures.
The LAPARETTE is a hybrid device consisting of three reusable (Handle, Electrode-Cannula, and Insulated Sleeve) and two single use components (Cartridge and Sheath). All LAPARETTE components are supplied non-sterile, requiring sterilization by the health care facility before use. The LAPARETTE is sold both as a set and as individual products.
The provided text is a 510(k) summary for the LAPARETTE device and does not contain detailed information about acceptance criteria or a specific study proving the device meets them. The summary focuses on establishing substantial equivalence to predicate devices based on intended use, design, and general operating characteristics, rather than presenting a performance study against predefined acceptance criteria.
The document mentions "Bench and animal testing provided in the 510(k) was used to characterize the performance of the LAPARETTE," but it does not elaborate on the specific tests, their results, or the acceptance criteria for those tests.
Therefore, I cannot populate the requested tables or answer all questions as the necessary information is not present in the provided text.
Here is what can be inferred or stated based on the available text:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary (K971146) for the LAPARETTE device does not explicitly state specific acceptance criteria in a quantitative manner, nor does it detail a comprehensive study that proves the device meets such criteria in the way a clinical trial report would.
The basis for substantial equivalence is primarily founded on comparison to predicate devices regarding:
- Intended use
- Design considerations
- General operating characteristics
The document states, "Bench and animal testing provided in the 510(k) was used to characterize the performance of the LAPARETTE." However, it does not provide details on the methodology, results, or specific acceptance thresholds for these tests.
Given the information, a table of acceptance criteria and reported device performance cannot be generated as requested. Similarly, detailed answers to questions concerning sample size, expert involvement, adjudication methods, or specific study types (MRMC, standalone) are not available.
Below is a partial response based on the limited inferences possible from the text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Device Comparison) | Reported Device Performance (Inferred from Predicate Device Comparison) |
|---|---|
| Intended Use: |
- Electrocautery (cutting and bleeding control)
- Irrigation
- Suction | LAPARETTE performs electrocautery, irrigation, and suction. |
| Operating Characteristics: - Monopolar use | LAPARETTE is designated for monopolar use only. |
| Dimensions: - Usable shaft length: ~30-35mm
- Shaft O.D.: ~5.0-5.4mm | LAPARETTE usable shaft length: 30.5 mm
LAPARETTE shaft O.D. within range. |
| Material Compatibility: - Use of polymers common to medical devices | LAPARETTE uses polymers common to various medical devices. |
| Tip Rotation Feature (for comparison with D&G Multi-Function) | LAPARETTE features tip rotation. |
| Tip Shielding during insertion (for comparison with Ethicon Probe Plus) | LAPARETTE features the ability to shield the tip during insertion. |
| Sterilization: (implicit requirement for reusable components) | Reusable components require steam sterilization; protective sheath requires ethylene oxide. |
2. Sample size and Data Provenance
The document mentions "Bench and animal testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts and Qualifications
Not specified in the provided text. Ground truth for the performance tests is not explicitly defined with expert involvement.
4. Adjudication method
Not specified for any testing done.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study
No MRMC study is mentioned. The primary method for establishing equivalence is comparison to predicate devices, not improvement over human readers.
6. Standalone performance (algorithm only without human-in-the-loop performance)
While "Bench and animal testing" were performed, the details are not provided. It is likely these were standalone performance tests of the device's physical and functional capabilities, but this is not definitively stated or elaborated upon for an "algorithm only" context, as this is a surgical instrument and not an AI/software device.
7. Type of ground truth used
For the "Bench and animal testing," the specific type of ground truth is not elaborated. Given the nature of a surgical electrosurgical instrument, "ground truth" would likely relate to objective measurements of cutting efficacy, coagulative properties, irrigation flow rates, suction effectiveness, mechanical integrity, and biocompatibility, as determined by standard engineering and biological testing rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set
Not applicable. This device is a physical surgical instrument, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable (as above).
§ 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).