(11 days)
The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.
Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrosurgical system. The instrument is to be used only with the Olympus ESG-400 Generator. As a result of the PK AIM cable modifications which are the subject of this submission, no modifications were required or made to the ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in the original PK AIM K152219 for any patient contacting materials that contain colorants. Except for the cable design modification that is being implemented to address a capacitive coupling concern, the subject Olympus PK AIM and predicate Olympus PK AIM are physically identical no other design or material changes.
The provided text is a 510(k) summary for a medical device (Olympus PK AIM) and focuses on demonstrating substantial equivalence to a predicate device based on bench testing. It does not describe a study that involves human readers, AI assistance, or complex ground truth establishment methods typically found in studies for AI/ML-based diagnostic devices.
Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and the nature of ground truth beyond engineering specifications, are not applicable to the information contained within this document.
The document describes performance testing of the device itself (electrical, physical, mechanical characteristics), not an AI algorithm's diagnostic performance.
Here's a breakdown of the applicable information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document lists various tests performed to ensure the device meets its specifications. The general statement is that "All performance testing passed or met prescribed acceptance criteria." Specific quantitative results are not provided in this summary, but the categories of testing and their objectives serve as the acceptance criteria.
| Description | Specification/Objective (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Cable/Cord Length | Meet length specification | Passed/Met Criteria |
| Electrical Functionality | Generator confirmation | Passed/Met Criteria |
| Package Testing | ISTA-2A, ASTMD4169-09 | Passed/Met Criteria |
| IEC 60601 | Meet relevant requirements | Passed/Met Criteria |
| Label/Package damage | Visual inspection | Passed/Met Criteria |
| Bubble Leak | ASTM-F2906-11 | Passed/Met Criteria |
| Continuity | Meet specification | Passed/Met Criteria |
| Hi-Pot | Meet specification | Passed/Met Criteria |
| HF Leakage | Meet monopolar HF leakage from bipolar electrodes | Passed/Met Criteria |
| Electrical Characterization | Meet internal comparable power outputs | Passed/Met Criteria |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not specified quantitatively. The document states "Summary of bench, Performance Testing (no clinical testing was conducted)." This implies that samples of the device were subjected to the physical and electrical tests listed, but specific numbers of units tested are not provided.
- Data Provenance: Not applicable in the context of clinical data. This is bench testing of a physical medical device.
The study described is retrospective in the sense that the testing was performed on the device prototypes/pre-production units to demonstrate substantial equivalence for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context refers to the defined engineering specifications and international standards which the device must meet, rather than expert interpretation of medical images or conditions. The tests measure objective physical and electrical properties.
4. Adjudication method for the test set
Not applicable. Testing involves engineering and laboratory measurements against predefined specifications, not human adjudication of subjective interpretations.
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 an electrosurgical tool, not a diagnostic imaging device involving human readers or AI assistance in interpretation. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not contain an AI algorithm. Its performance is related to its physical and electrical functions, not computational interpretations.
7. The type of ground truth used
The "ground truth" for this device's performance testing is established by engineering specifications, international performance standards (e.g., ISO, IEC, ASTM), and comparison to the established performance of the predicate device. For instance, HF leakage must meet a certain maximum value as per a standard, or power outputs must be comparable to the predicate.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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.