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The CORE E3 Suction/Irrigator is designed to be used in conjunction with the CORE Trumpet Handpiece and probes to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.

The CORE E3TM Suction/Irrigator consists of a suction/irrigation handpiece and dual tubing that connects to a battery-powered mechanical pumping system to generate fluid output and can include a suction/irrigation probe. The device connects to a standard suction apparatus to deliver suction. Control of the flow (suction/irrigation) is generated by depressing the color-coded buttons on the handpiece. The handpiece can also be attached to separate compatible electrodes or probes, including reusable probes. The mechanical pumping system is powered with six (6) standard AAA alkaline batteries.

The provided text describes the 510(k) summary for the CORE E3 Suction/Irrigator, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The information provided in this document is primarily focused on demonstrating "substantial equivalence" based on design, materials, indications for use, principles of operation, and technological characteristics, supported by bench testing, electrical safety, EMC, biocompatibility, packaging, and sterilization data.

However, the provided text does not describe a study that would involve acceptance criteria for an AI/ML device, a test set with ground truth established by experts, or any MRMC (Multi-Reader Multi-Case) studies. The device in question is a surgical suction/irrigator, a physical medical device, not an AI-powered diagnostic or therapeutic software device.

Therefore, many of the specific questions about acceptance criteria and study design for AI/ML devices (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth) are not applicable to this document.

The document does provide information on performance criteria relevant to this specific physical device. I will extract the closest analogous information to your request based on the provided text.

Regarding the CORE E3 Suction/Irrigator:

This document is for a traditional medical device (a suction/irrigator for laparoscopic procedures), not an AI/ML-powered device. Therefore, the concepts of acceptance criteria, test sets, ground truth established by experts, MRMC studies, and training sets as typically understood for AI/ML devices do not apply in the same way.

Instead, the "acceptance criteria" for this device are demonstrated through various bench tests ensuring its physical and electrical functionality and safety. The "study" proving it meets these criteria refers to these performance tests.

Here's an attempt to answer your questions based on the provided FDA 510(k) summary for the CORE E3 Suction/Irrigator, interpreting the questions in the context of a physical medical device submission for substantial equivalence:

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

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

• Sample Size for Test Set: The document mentions "bench testing" and "simulated use testing." It does not specify the exact number of units or test runs performed for each test (e.g., how many devices were tested for flow rate, how many electrical safety tests were conducted). This level of detail is typically in the test reports, not the 510(k) summary. For device performance testing, multiple devices would be tested, often according to statistical sampling plans defined by internal quality systems and standards.
• Data Provenance: The testing was conducted by ConMed Corporation. The country of origin of the data is implied to be within the US, where ConMed is based (Utica, NY). The tests are prospective in the sense that they are specifically performed for this regulatory submission on newly manufactured devices.

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 in the context of AI/ML experts. For this physical device, "ground truth" is established by direct measurement (e.g., flow rate meters, electrical test equipment) and adherence to recognized international standards (e.g., ISO, IEC). The "experts" would be the engineers, technicians, and quality assurance personnel conducting and verifying these tests, as well as the experts involved in drafting and interpreting the relevant ISO and IEC standards. Their qualifications are in engineering, quality assurance, and regulatory affairs, not clinical expertise for image interpretation.

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

• Not Applicable in the context of AI/ML expert consensus. For physical device testing, "adjudication" typically refers to quality review processes. Test results are reviewed and approved by authorized personnel, and any deviations or non-conformances would be investigated and resolved according to quality system procedures. This is not an "adjudication method" in the sense of reconciling divergent human interpretations of clinical data.

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. Not applicable. This device is a physical surgical tool and does not involve human readers interpreting cases or AI assistance.

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

• Not Applicable in the context of AI/ML algorithms. The device's "standalone" performance is its fundamental operation (e.g., delivering irrigation at a specified rate when activated). The "human-in-the-loop" is the surgeon using the device. The performance tests evaluate the device's ability to function as intended by itself.

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

• Physical Measurements and Standard Compliance: The "ground truth" for this device's performance is based on objective physical measurements (e.g., measured flow rates) and compliance with established engineering and safety standards (ISO, IEC). It is not based on expert clinical consensus, pathology, or outcomes data in the way an AI diagnostic device would be.

8. The sample size for the training set

• Not Applicable in the context of AI/ML training data. This device is not AI/ML-driven. There is no concept of a "training set" for an algorithm.

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

• Not Applicable. See point 8.

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The Subcutaneous Illuminator is indicated for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

The Smith & Nephew Subcutaneous Illuminator transfers light to the surgical site via glass fiber optics and includes irrigation via an irrigation channel. The Subcutaneous Illuminator allows it to gain access to the surgical site.

The provided K99/323 510(k) summary for the Smith & Nephew Subcutaneous Illuminator does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use. The FDA letter confirms the substantial equivalence primarily based on these comparisons.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

The primary "proof" of the device's acceptability in this context is its substantial equivalence to already legally marketed devices, rather than a specific performance study with measured acceptance criteria.

Ask a specific question about this device