(133 days)
The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments are indicated to be used in laparoscopic and other minimally invasive procedures for cutting, clamping, suturing and dissecting and to allow high frequency monopolar cutting and coagulation.
Snowden-Pencer MicroLap 3mm Laparoscopic Instruments consists of a handle and insert assembly. The insert assembly contains a shaft and end-effector (jaw pattern). There are several device models that encompass various lengths, diameters and jaw patterns based on the surgeon's needs.
The provided document is a 510(k) summary for the Snowden-Pencer MicroLap 3mm Laparoscopic Instruments. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, and it typically relies on non-clinical performance data rather than extensive clinical studies as seen with AI/ML devices. Therefore, much of the information requested in your prompt (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance) is not applicable or not found in this document.
However, I can extract the relevant information regarding the device's acceptance criteria and the studies that prove it meets those criteria based on the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Characteristic | Performance Results (Acceptance Criteria implicitly met if "PASS") |
|---|---|
| Instrument strength | PASS (Strength Tests) |
| Device must be reusable | PASS (Cleaning and Sterilization Tests) |
| Device must maintain pneumoperitoneum | PASS (Pneumoperitoneum Test) |
| Device to meet required electrosurgical safety standards | PASS (IEC 60601-1, IEC 60601-2, IEC 60601-2-2, IEC 60601-2-18) |
| Device is able to be cleaned and sterilized | PASS (AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665) |
| Device materials are biocompatible | PASS (ISO 10993) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: This document does not specify the sample sizes (i.e., number of instruments tested) for each of the non-clinical performance tests. It states "Results Summary," which typically means the overall outcome for the tested batch/type.
- Data Provenance: Not specified, but these are typically lab-based, internal company tests conducted to industry standards. They are non-clinical and not derived from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for non-clinical performance tests like instrument strength or sterilization efficacy is established by adherence to recognized industry standards (e.g., ISO, AAMI, IEC standards), not by expert consensus in the medical sense for diagnostic tasks. The "experts" would be the engineers and technicians performing and verifying the tests in accordance with these standards.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies involving human interpretation or clinical outcomes. For performance tests of a physical device, the "adjudication" is the objective measurement against a defined standard.
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:
- No. This is a physical surgical instrument, not an AI/ML diagnostic tool. Therefore, an MRMC study is not relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical surgical instrument, not an algorithm. Standalone performance for an algorithm is not applicable.
7. The type of ground truth used:
- The "ground truth" for these tests is defined by the specific parameters and pass/fail criteria outlined in the referenced national and international performance standards (e.g., IEC 60601 series for electrosurgical safety, ISO 10993 for biocompatibility, AAMI/ANSI standards for cleaning and sterilization). For example, a "strength test" would have a defined force it must withstand without breaking or deforming.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of a physical medical device like a laparoscopic instrument. (This term is relevant for AI/ML algorithms).
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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.