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The Plasma Shield is to be used prior to and during endoscopic procedures to prevent fogging of the scope lens

The Plasma Shield is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. The Plasma Shield device is designed for reducing laparoscopic lens fogging by performing cold plasma treatment of a laparoscope lens. The Plasma Shield device is a cold plasma-based device to be used in an operating room, prior to and during laparoscopic procedures. The cold plasma creates a super hydrophilic scope lens surface after treatment (aka activation). The device does not interact directly with the patient's body.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the "Plasma Shield" device:

Acceptance Criteria and Device Performance

A formal table of "acceptance criteria" is not explicitly presented in the provided text with numerical targets for all performance aspects. However, based on the non-clinical testing sections and the conclusions regarding substantial equivalence, we can infer the key performance criteria the Plasma Shield was evaluated against. The primary implicit acceptance criterion is demonstrating substantial equivalence to the predicate devices, particularly regarding anti-fogging effectiveness.

Here's an inferred table of key performance aspects and how the Plasma Shield performed:

Study Details Proving Device Meets Acceptance Criteria

The primary study mentioned to demonstrate the core anti-fogging effectiveness is an animal study.

1. A table of acceptance criteria and the reported device performance:
Refer to the table above.

2. Sample sized used for the test set and the data provenance:
* Test Set Sample Size: The document mentions "live anesthetized pig" and refers to "swine" in the comparison study. It does not explicitly state the number of pigs or the number of specific procedures/measurements performed within those pigs. It refers to "a series of experiments" and "all experimental conditions tested."
* Data Provenance: The study was conducted on "live anesthetized pig/swine." The country of origin of the data is not specified. It is a prospective animal study ("Comparison of Plasma Shield vs. Clearify. Anti-fogging Devices, and Using Laparoscopy in Swine" was conducted and included in the submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This information is not provided in the document. The evaluation involved "video evaluation," but it doesn't state how many experts performed this evaluation or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not specified. The document mentions "video evaluation" but does not detail any adjudication process for how scores or conclusions were reached from this evaluation.

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, an MRMC study was NOT done. This document describes an animal study comparing the device against a predicate device and no treatment. It is an anti-fogging device, not an AI-based diagnostic tool, so the concept of human readers improving with AI assistance is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* This is not an AI algorithm. The device, "Plasma Shield," is a physical device that performs cold plasma treatment. Its "standalone" performance was evaluated in the animal study by directly observing its anti-fogging effect compared to predicate devices and no treatment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* The ground truth for anti-fogging effectiveness appears to be established through direct visual assessment (via video evaluation) of fog formation during laparoscopic procedures in swine, compared to a control (no treatment) and a predicate device. This is a direct measurement of the device's intended function in a relevant physiological model.

8. The sample size for the training set:
* Not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established:
* Not applicable. See point 8.

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The ClearCam System is indicated to provide lens clearing during laparoscopic procedures.

The ClearCam System is a laparoscopic accessory lens clearing device consisting of a sheath and handle that slides over the laparoscope. The handle contains a wire connected to a wiper at the distal end of the sheath that provides lens clearing when activated. The device is intended to clear the intra-operative view of the surgical site during minimally invasive surgery by physically removing debris, blood, and bodily fluids from the laparoscope lens.

The provided text is a 510(k) premarket notification for the ClearCam System and describes its substantial equivalence to a predicate device, ClickClean (K170103). The document primarily focuses on demonstrating that the ClearCam System is as safe and effective as existing legally marketed devices, rather than presenting a performance study with acceptance criteria in the context of an AI/algorithm-driven medical device.

Therefore, the information required to answer many of the specific points about acceptance criteria and a study proving performance (especially in the context of AI and human readers) is not present in the provided document. The ClearCam System is a physical medical device (a laparoscopic accessory lens clearing device) and not an AI-based diagnostic or assistive system.

However, I can extract the information that is present and indicate where information is missing.

Here's the breakdown of what is available and what is not:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the ClearCam System

Based on the provided 510(k) summary, the ClearCam System is a physical medical device designed to clear laparoscopic lenses during surgery. The "acceptance criteria" and "study" described in the document are primarily focused on demonstrating substantial equivalence to a predicate device (ClickClean) through mechanical, functional, pre-clinical, and biocompatibility testing, rather than statistical performance metrics of an algorithm or human-in-the-loop study typical for AI/diagnostic devices.

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device, "acceptance criteria" are typically defined by engineering design specifications and regulatory standards. The document reports "Pass" for all tested criteria, indicating that the device met these predefined specifications.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not specify the sample size for the mechanical and biocompatibility testing. It only states that "devices were tested." For these types of tests, sample sizes are typically determined by relevant ISO standards or internal quality procedures, but the specific number is not disclosed here.
• Data Provenance: Not applicable in the context of patient data for an AI/algorithm. The data provenance refers to materials and samples used for mechanical and biocompatibility testing of the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This question is not applicable as the device is a physical tool for clearing lenses, not an AI or diagnostic device requiring expert interpretation of images/data to establish ground truth. The "ground truth" for this device's function is its ability to physically clean the lens and its biological compatibility.

4. Adjudication Method for the Test Set:

• Not applicable for this type of device and testing. Adjudication is relevant for subjective assessments, primarily in diagnostic accuracy studies involving multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not done. This type of study is specifically for evaluating the impact of an AI system on human reader performance, which doesn't apply to a physical lens-clearing device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not applicable. The ClearCam System is a physical accessory, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by compliance with engineering design specifications, international standards (ISO), and successful completion of predefined functional and biocompatibility tests. For instance, "pass" for sterilization means it meets the defined sterility assurance level, and "pass" for functional testing means it performs its intended lens-clearing action as specified.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. See point 8.

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