(100 days)
The LiNA PowerBlade Plus is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated.
The LiNA PowerBlade Plus is a 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The LiNA PowerBlade Plus is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a sharp blade. LiNA PowerBlade Plus includes a rotation wheel on the handle that rotates the grasper jaws at the tip to improve positioning and ergonomics during the surgical procedure. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet.
The provided text describes a 510(k) premarket notification for the LiNA PowerBlade Plus, a bipolar forceps device. This submission focuses on demonstrating substantial equivalence to a predicate device, the LiNA PowerBlade (K063025), rather than proving that the device meets specific performance acceptance criteria through a standalone study with defined metrics.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Predicate Equivalence | Compliance to IEC60601-1:2006 (General Medical Electrical Equipment) | Device complies | Non-Clinical Performance Testing |
| Compliance to IEC60601-2-18 (Endoscopic equipment) | Device complies | Non-Clinical Performance Testing | |
| Compliance to IEC60601-2-2 (High-frequency surgical equipment) | Device complies | Non-Clinical Performance Testing | |
| Biocompatibility (ISO10993-1) | Device complies | Non-Clinical Performance Testing | |
| Sterilization (ISO1135-1) | Device complies | Non-Clinical Performance Testing | |
| Biocompatibility (ISO10993-7) | Device complies | Non-Clinical Performance Testing | |
| Functionality | Grasping performance comparable to predicate | Demonstrated comparable performance | Comparative Functionality Testing |
| Cutting performance comparable to predicate | Demonstrated comparable performance | Comparative Functionality Testing | |
| Coagulation performance comparable to predicate | Demonstrated comparable performance | Comparative Functionality Testing |
Note: The document does not provide specific numerical acceptance limits (e.g., "cutting force must be > X Newtons") nor detailed quantitative results for the LiNA PowerBlade Plus. Instead, it states that the device "complies" with standards and that comparative functionality testing "demonstrated that the grasping, cutting and coagulation performance of the proposed device was comparable to the predicate device." The acceptance criteria are largely implied to be "being equivalent to the predicate device" and "compliance with relevant standards."
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify sample sizes for the comparative functionality testing. It only mentions "testing" was performed.
- The data provenance is non-clinical testing, performed by the manufacturer (implied to be in Denmark, where the sponsor is located) as part of a premarket submission. It is by definition retrospective in the context of the device's development cycle.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This question is not applicable as the described performance testing is non-clinical and does not involve human expert assessment for "ground truth" in the way a clinical study or diagnostic AI validation would. The "ground truth" for the non-clinical tests would be the established methods and measurements defined by the standards and functional comparisons, not expert human opinion.
4. Adjudication Method for the Test Set
- This question is not applicable for the same reasons as #3. There is no mention of expert adjudication in the context of the non-clinical performance and functionality testing described.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument (bipolar forceps), not an AI diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm-only performance study was not done. This device is a physical surgical instrument, not an algorithm or AI.
7. The Type of Ground Truth Used
- For standards compliance, the ground truth is the requirements laid out in the specified international standards (IEC60601 series, ISO10993 series, ISO1135-1).
- For comparative functionality testing (grasping, cutting, coagulation), the ground truth is the performance of the predicate device, the LiNA PowerBlade (K063025). The proposed device's performance was compared to that of the predicate.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical surgical instrument, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See #8).
§ 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.