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The Versaport™ Bladeless Low Profile trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

The Versaport™ Bladeless low profile housing design is available in 2mm-3mm to 5mm in various lengths with radiolucent fixation sleeve. The 2mm-3mm to 5mm Versaport™ seal system accommodates 2mm-3mm to 5mm instrumentation respectively. There is a luer lock with cap for insufflation and rapid desufflation (in place of a stopcock).

This looks like a 510(k) summary for a medical device called the "Versaport™ Bladeless Low Profile Trocar." It's important to note that this document is a summary and likely doesn't contain all the detailed performance study information typically found in a full submission to the FDA. Based on the provided text, I can extract the following information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, it makes a general statement about substantial equivalence to a predicate device.

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

The document states "In-vitro and in-vivo tests were performed," but it does not specify the sample sizes used for these tests. The provenance of the data is not mentioned (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. For a physical medical device like a trocar, ground truth would typically be established through direct observation of performance in controlled environments (in-vitro) and/or in animal or human studies (in-vivo), rather than expert review of data like in an AI/diagnostic device.

4. Adjudication Method for the Test Set

This information is not provided. This concept is usually more relevant for diagnostic devices where multiple experts might independently assess results and then adjudicate disagreements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This document describes a surgical instrument, not a diagnostic tool that relies on human interpretation of outputs.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable; the device is intended to be used by a human surgeon.

7. The Type of Ground Truth Used

For a physical device like this, the "ground truth" for performance would be based on:

• Direct observation of physical properties and function (e.g., ability to create and maintain a port of entry, seal integrity, instrument insertion/withdrawal, insufflation/desufflation).
• Comparison against the predicate device's established performance.
• Compliance with relevant standards (e.g., ISO Standard 10993-1 for materials).

The document states that in-vitro and in-vivo tests were performed to "verify that the performance of the Versaport™ Bladeless Low Profile trocar is substantially equivalent to the predicate device(s), and to validate that the Versaport™ Bladeless Low Profile trocar will perform as intended." This implies the ground truth was derived from the physical performance outcomes in these tests, evaluated against known performance characteristics of the predicate.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

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

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The SILS™ Port is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures. The SILS™ Port provides the ability to use three conventional laparoscopic trocars and an insufflation port through a single incision while providing the ability to maintain pneumoperitoneum.

Three laparoscopic trocars and an insufflation tube bound by a flexible port.

This document describes a 510(k) premarket notification for the Covidien SILS™ Port, a surgical trocar. The information provided is primarily for regulatory clearance and does not contain the detailed study results typically associated with establishing specific performance criteria for AI/ML devices. Therefore, I cannot fully complete all sections of your request based solely on the provided text.

Specifically, this submission is for a medical device (surgical port/trocar), not an AI/ML diagnostic or assistive device. The "performance data" section in the summary mentions "In-vitro and in-vivo testing has been performed in support of the intended use of this device," but it does not specify acceptance criteria, effect sizes, reader studies, ground truth, or sample sizes in the way one would for an AI/ML product.

However, I will extract and infer what I can from the provided text to address your points as best as possible.

Acceptance Criteria and Study for Covidien SILS™ Port (Surgical Trocar):

Based on the provided 510(k) summary, detailed acceptance criteria and a study design for AI/ML performance metrics are not applicable or provided, as this is a physical medical device (surgical port/trocar). The "acceptance" is primarily based on substantial equivalence to predicate devices and meeting safety and material biocompatibility standards.

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

Since this is a physical medical device and not an AI/ML algorithm, the concept of a "device performance" table as you might expect for an AI/ML product (e.g., sensitivity, specificity) is not present. Instead, performance relates to its functional use and safety. The document states:

For the remainder of your questions, the information is not present in the provided 510(k) summary as these questions are typically relevant to AI/ML device studies, not traditional medical device clearance.

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

• Not Applicable / Not Provided: This information is not typically part of a 510(k) summary for a physical medical device in the context of an AI/ML algorithm. The document mentions "in-vitro and in-vivo testing" but does not detail the sample sizes or provenance for these tests in this summary.

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 Provided: As this device is not an AI/ML algorithm requiring expert interpretation of outputs, this information is not relevant or included in the 510(k) summary.

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

• Not Applicable / Not Provided: This concept is not relevant to the clearance of this physical medical device.

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 / Not Provided: This type of study is specifically for AI/ML diagnostic or assistive devices and is not relevant to the SILS™ Port.

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

• Not Applicable / Not Provided: The SILS™ Port is a physical surgical tool, not an algorithm.

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

• Not Applicable / Not Provided (in the context of AI/ML): For a physical device, "ground truth" might relate to physical tests (e.g., material strength tests, leakage tests), but this is not specified in the summary nor is it the "ground truth" relevant to AI/ML performance.

8. The sample size for the training set

• Not Applicable / Not Provided: There is no AI/ML algorithm to train for this device.

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

• Not Applicable / Not Provided: There is no AI/ML algorithm to train for this device.

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COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 200 degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

COPA AMD is a hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization.

Here's an analysis of the provided text to extract the requested information regarding the device's acceptance criteria and studies:

Assessment: The provided document is a 510(k) Premarket Notification for the COPA AMD Antimicrobial Wound Dressing, specifically for a change in sterilization method from ETO to Gamma irradiation. It is primarily concerned with demonstrating substantial equivalence to a legally marketed predicate device, not with establishing novel performance characteristics through extensive clinical studies. Therefore, many of the typical performance study details for a new device are not present.

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)

The document primarily discusses "in-vitro testing" to support the change in sterilization method. It does not provide details on:

• Sample size for a test set: No specific sample sizes for in-vitro tests are mentioned.
• Data provenance: No country of origin is specified for the in-vitro data.
• Retrospective or prospective: This is not applicable as it's in-vitro testing and not a human study.

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)

This is not applicable to this 510(k) submission. The submission focuses on demonstrating substantial equivalence through in-vitro testing related to a sterilization change, not on diagnostic performance where expert-established ground truth would be required.

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

This is not applicable as there is no mention of a human-read test set or expert adjudication.

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

This is not applicable. The device is an antimicrobial wound dressing, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant.

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

This is not applicable as the device is not an algorithm or AI.

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

For the "in-vitro testing" mentioned, the ground truth would typically be established by standardized laboratory methods and analytical results, not by expert consensus, pathology, or outcomes data in the context of a clinical study. The document does not specify the exact nature of this "ground truth" but implies it's related to material properties, sterility, or antimicrobial effectiveness after gamma irradiation.

8. The sample size for the training set

This is not applicable. The device is a physical wound dressing and does not involve AI algorithms that require training sets.

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

This is not applicable as there is no training set for this device.

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These devices are intended for the injection of medications into or the withdrawal of body fluids from parts of the body below the surface of the skin.

The devices consist of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

This document does not describe an AI/ML powered medical device. It details a 510(k) premarket notification for 30 Gauge Monoject® Hypodermic Needles.

Therefore, I cannot provide the information requested regarding acceptance criteria, study details, ground truth, sample sizes, or MRMC studies, as these concepts are specifically relevant to the evaluation and validation of AI/ML algorithms, not hypodermic needles.

The document indicates that the device's substantial equivalence is based on its conformity to recognized safety and performance consensus standards for needles (ISO 7864, ISO 9626, ISO 594-1, ISO 594-2, and ISO 6009) and its similarity in design and intended use to predicate devices.

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