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The Specimen Bag is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Specimen Bag is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Specimen Bag is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.

The provided text is a 510(k) Pre-Market Notification for a medical device (Specimen Bag models), indicating it is seeking substantial equivalence to a predicate device. This document primarily details the device's intended use, description, and comparison to the predicate device, along with the non-clinical tests performed.

However, the provided text does not contain information about a study that proves a device meets acceptance criteria related to an AI/Machine Learning algorithm's performance, nor does it provide the detailed breakdown requested regarding acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies (MRMC).

The "tests listed below demonstrate the performance of Specimen Bag meets the requirements of its pre-defined acceptance criteria and intended uses" (page 5) refer to a series of engineering and biocompatibility tests typical for a physical medical device, not an AI/ML algorithm. These tests include:

• Tensile strength
• Bag load-bearing
• Opening force
• Rope tension test
• Puncture Force Test
• Pouch Leakage Test
• Biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-Mediated Pyrogenicity)

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets AI-related acceptance criteria, as this information is not present in the provided document. The device is a "Specimen Bag," a physical medical device, not an AI/ML-driven diagnostic or assistive tool.

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The Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

The Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.

The suction irrigation set consists of a hand piece equipped with two trumpet style valves,a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.

The hand piece of the suction irrigation is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.

The provided document is a 510(k) summary for a medical device called "Suction Irrigation Set". This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a robust clinical setting.

Therefore, the requested information regarding detailed acceptance criteria and a study proving the device meets them, especially in the context of AI/ML or diagnostic performance, is not available in this document. The tests described are primarily non-clinical, focusing on safety and functional equivalence to a predicate device.

However, I can extract the available information regarding the non-clinical testing performed and the general statement about meeting acceptance criteria.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Available: The document states that "All the test results demonstrate the performance of Suction Irrigation set meets the requirements of its pre-defined acceptance criteria and intended uses." However, the specific numerical acceptance criteria and the quantitative reported performance for each test are not provided. Only the types of tests are listed.

2. Sample size used for the test set and the data provenance:

• Not available in explicit detail. The document mentions "A series of tests" but does not specify sample sizes for each test. Data provenance (country of origin, retrospective/prospective) is not relevant for these non-clinical, bench-level tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not available. These are non-clinical, engineering/materials tests. There is no "ground truth" established by human experts in the context of a diagnostic or interpretative device.

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

• Not applicable/Not available. Adjudication methods are relevant for expert-driven diagnostic assessments, not for the physical/chemical tests 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:

• Not applicable. This device is a manual suction irrigation set, not an AI/ML-powered diagnostic or assistive device for human readers.

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

• Not applicable. This is not an algorithm-based device.

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

• Not applicable. For the physical/chemical tests conducted, the "ground truth" would be established by objective measurements against engineering specifications and industry standards (e.g., ISO for sterilization).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" as it is not an AI/ML device.

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

• Not applicable. This device does not involve a "training set."

In summary: The provided document is a regulatory submission for a traditional Class II medical device, demonstrating substantial equivalence through non-clinical testing. It does not contain information typically found in studies for AI/ML or diagnostic devices, which involve clinical performance and human reader assessment.

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