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The LiNA PowerBlade Plus™ HC is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated

The PowerBlade Plus HC is a sterile 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The proposed device is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a mechanical sharp blade. The LiNA PowerBlade Plus HC 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. Two types of connectors are provided: the two pin connector is for use with most standard electrosurgical generators with a bipolar outlet, and a 3-pin connector that is attached to the cable of the LiNA PowerBlade Plus HC for use with ValleyLab™ generators with a LigaSure™ outlet. When the 3-pin connector is used, the control button on the hand piece can be used to activate the coagulation. When using the 2pin connector the coagulation function of the PowerBlade Plus HC is foot pedal controlled.

This document describes an FDA 510(k) premarket notification for a medical device and does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with AI/ML-based medical devices or diagnostic tools.

Instead, this submission is for a traditional medical device (an electrosurgical cutting and coagulation device) and focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "acceptance criteria" here implicitly refer to the regulatory requirements for showing substantial equivalence, and the "study" is the non-clinical performance data and comparison to the predicate.

Given this, I will reframe the requested information in the context of this specific regulatory submission.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not detail a "test set" in the sense of patient data or a specific clinical study with a defined sample size for statistical analysis of a diagnostic or predictive algorithm. Instead, the "testing" refers to non-clinical performance data and verification testing of the device's engineering and functionality.

• Sample Size for Non-Clinical Testing: Not explicitly stated (e.g., number of devices tested, number of cycles). This typically involves engineering benches and lab testing.
• Data Provenance: Not applicable in the context of patient data. The non-clinical testing would have been conducted by the manufacturer (LINA Medical ApS in Denmark) or contracted labs, adhering to recognized international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a submission for an electrosurgical instrument, not a diagnostic device requiring expert interpretation of medical images or patient data to establish ground truth. The "ground truth" for this device's performance would be objective measurements of coagulation, cutting, and mechanical function in a lab setting, against predefined specifications and recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As there is no human interpretation of data requiring adjudication, this concept does not apply to the non-clinical verification testing mentioned.

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/ML diagnostic tool, and no MRMC study was conducted or required. The device is an electrosurgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm. It is a manually operated surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device would be established through:

• Engineering specifications.
• Objective measurements obtained during mechanical and electrical testing (e.g., power output, temperature, tissue effects on surrogate materials, tip rotation, activation reliability).
• Compliance with recognized international standards (IEC60601-1, IEC60601-2-2).

8. The sample size for the training set

Not applicable. This device is not an AI/ML-based device and does not involve a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

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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

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).

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