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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 EndoWrist® Suction Irrigator is intended for use in all endoscopic surgical applications where the compatible da Vinci Surgical System is indicated.

The EndoWrist Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue.

The EndoWrist® Suction Irrigator is a single-use, disposable instrument developed for use with the da Vinci Surgical System. The instrument provides the surgeon with the ability to activate suction and irrigation directly from the surgeon console or by depressing buttons on the instrument. Activation from the surgeon console will be controlled through the foot pedals on the surgeon console. The suction and irrigation sources are supplied by conventional devices (suction - canister, hospital line, etc.; and irrigation - closet, compressed air, gravity flow, etc.) that are available in an operating room setting.

The provided text describes a 510(k) premarket notification for the Intuitive Surgical EndoWrist® Suction Irrigator. This is a medical device submission that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through extensive studies designed for that purpose. Therefore, many of the requested details about acceptance criteria and study particulars, especially those relevant to AI/algorithm performance, are not present in this document.

However, based on the type of information provided, I can infer and extract some relevant details:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative table with corresponding "reported device performance" as one might find for an AI algorithm's metrics. Instead, it compares the characteristics of the subject device to its predicate. The acceptance is implicitly based on demonstrating that the new device is "substantially equivalent" to the predicate.

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

The document describes "bench testing" and "clinical models (animals/cadavers)" for design verification and validation. However, it does not specify sample sizes for these tests. It also does not explicitly state the country of origin or whether the data was retrospective or prospective, though animal/cadaver studies are generally prospective in nature for device testing.

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 "ground truth" in this context would likely be defined by expert observation and assessment of the device's function during the animal/cadaver studies, but the number or qualifications of these experts are not detailed.

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

This information is not provided.

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 such study is mentioned. This is not an AI/algorithm-based device, so MRMC studies in the context of AI assistance are not relevant here.

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

Not applicable, as this is not an AI/algorithm.

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

For "Design Verification (bench testing)", the ground truth would be against engineering specifications and measurable performance metrics. For "Design Validation (animal/cadaver)", the ground truth would be based on observations of safety and efficacy in a simulated clinical setting, likely assessed by experts (e.g., surgeons performing the procedures). This isn't explicitly defined as "expert consensus," "pathology," or "outcomes data" but falls more into the category of expert observation of device function and tissue interaction.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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The Single Use Surgical Suction is indicated to provide suction and irrigation functions in general surgery and laparoscopic surgery to help remove dropsy, hematocele and tissue debris by vacuum aspiration and deliver irrigation fluids to surgical site.

Single Use Surgical Suction Irrigator, models: JM-CX1A, JM-CX4, JM-CX4B

This document is a 510(k) clearance letter for a "Single Use Surgical Suction Irrigator." It does not contain information about acceptance criteria or a study that proves the device meets those criteria. The letter confirms substantial equivalence to a predicate device but does not detail performance testing results. Therefore, I cannot provide the requested information based on the provided text.

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The EndoWrist® One Suction/Irrigator, when attached to an external suction/irrigation source(s), is intended for use with the da Vinci Si Surgical System as a general purpose suction and/or irrigation device used during surgical procedures.

The EndoWrist® One Suction/Irrigator is a single-use, disposable instrument developed for use with the da Vinci Surgical System. The instrument provides the surgeon with the ability to activate suction and irrigation directly from the surgeon console. Activation will be controlled through the foot pedal at the surgeon side console. An additional feature allows manual activation by the patient side assistant. The suction and irrigation sources are supplied by conventional devices (suction - canister, hospital line, etc; and irrigation - closet, compressed air, gravity flow, etc) that are normally available in an operating room setting.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

It appears that the provided document is a 510(k) summary for the Intuitive Surgical EndoWrist® One Suction/Irrigator, a device for use with the da Vinci Surgical System. This document does not describe acceptance criteria in the typical sense of numerical thresholds for performance metrics (like sensitivity, specificity, accuracy) that are met by a particular study.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Surgiflex® WAVE™ Suction-Irrigation System, K992126). This regulatory pathway means the manufacturer needs to show that their new device is as safe and effective as a legally marketed device, not necessarily that it meets specific, predefined performance benchmarks in the same way a novel algorithm might.

Therefore, many of the requested items (like a table of acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in this type of regulatory submission.

Let's break down what is available and what is not:

Acceptance Criteria and Device Performance

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

Explanation: In a 510(k) for a device like this, the "acceptance criteria" are implied by the substantial equivalence pathway. The device must perform comparably to its predicate without raising new safety or effectiveness concerns across its intended use and technological characteristics. Specific numerical performance metrics (e.g., suction flow rates, irrigation volume, articulation range, durability) would be part of the internal design input requirements and verification testing, but these are summarized rather than detailed in the public 510(k) summary.

Study Details (where applicable for a 510(k) substantial equivalence)

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

• Sample Sizes: Not specified. The document mentions "bench and animal lab tests" but does not give specific numbers for devices tested, animals used, or the nature of "test sets."
• Data Provenance: Not specified. Testing would likely have been conducted by Intuitive Surgical, Inc., a U.S. company, but the specific location of the labs or animal facilities is not mentioned.
• Retrospective or Prospective: Not applicable in the context of device function testing for a mechanical surgical instrument. These would be controlled laboratory and animal studies.

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 / Not specified. Establishing "ground truth" with experts isn't relevant in the same way for a mechanical surgical instrument's performance testing. "Ground truth" for this device would relate to its physical functionality (e.g., does it suction, does it irrigate, does it articulate correctly) verified by engineering specifications and direct observation. If animal studies involved surgical outcomes, the assessment would be by veterinary surgeons or pathologists, but details are not provided.

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

• Not applicable / Not specified. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations where human interpretation or consensus is required. For bench and animal lab tests of a surgical instrument, results are usually based on objective measurements or observations by trained personnel following established protocols.

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. This is entirely not applicable. The device is a surgical instrument (suction/irrigator), not an AI diagnostic or assistance system. MRMC studies are used for evaluating diagnostic performance, often for AI in imaging.

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

• Not applicable. The device is a human-controlled surgical instrument. There is no "algorithm only" performance to evaluate. Its function requires human operation.

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

• Inferred based on "bench and animal lab tests": For bench tests, ground truth would be based on engineering specifications, direct measurements, and functional verification (e.g., confirmed flow rates, pressures, sealing integrity, articulation range). For animal lab tests, it would involve direct observation of surgical performance and potentially assessment of physiological effects or outcomes by veterinary professionals. The document doesn't provide specifics.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, no training set for an AI/ML algorithm.

Summary of what the document does convey:

• Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
• Predicate Device: Surgiflex® WAVE™ Suction-Irrigation System (K992126).
• Performance Validation: Bench tests and animal lab tests were conducted.
• Conclusion: The tests demonstrated substantial equivalence, meeting design input requirements, and raised no new safety or effectiveness issues compared to the predicate device. The device is considered equivalent in terms of safety, effectiveness, and performance.

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The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery.

The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. The SIGF is validated per AAMI HF18 for electrocautery application. The tips may be sterile packaged and disposable (single-use only) or non-sterile packaged for reusable purposes. The SIGF is constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. Gamma irradiation validation is per AAMI standard ST 32, method 1, section 5.2.3.1. The minimum dose for an SAL of 10to is 1.66 Mrads.

This document is a 510(k) summary for a medical device and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a clinical study report or a more comprehensive efficacy submission.

Therefore, I cannot extract the requested information. The provided text is a regulatory summary focused on substantial equivalence to predicate devices, material safety, and sterilization validation, rather than a performance study with detailed acceptance criteria and results.

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