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The Disposable Trocars have applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments in abdominal area.

Disposable Trocars are medical devices that penetrate the abdominal wall during laparoscopic surgery. They provide a passageway for the surgical device insertion and removal and maintain pneumoperitoneum during surgical procedures.

The model numbers of Disposable Trocars include AVTB 5-70, AVTB 5-100, AVTB 10-70, AVTB 10-100, AVTB 12-70, AVTB 12-100, AVTC 5-70, AVTC 5-100, AVTC 10-70, AVTC 10-100, AVTC 12-70, AVTC 12-100, AVTC 15-70, and AVTC 15-100.

The AVTB Disposable Trocars comprise an upper sealing component, a casing component, and a puncture rod component.
The upper sealing component is composed of a seal lid, an upper retaining ring, a wave seal ring, a conical sealing ring, a lower retaining ring, and a retaining cover for locking. The casing component is composed of choke valve, self-commissioning sealing cap, casing seat, seal ring, trocar sleeve, gas injection valve, and gas injection switch. The puncture rod component is composed of an upper fixing cover, a locking buckle, a puncture rod, and a lower fixing cover.

AVTC Disposable Trocars comprise casing component, puncture rod component, upper sealing component, and converter component (only applicable to AVTC 15 specification).
The casing component is composed of choke valve, self-commissioning sealing cap, casing seat, sealing ring, trocar sleeve, gas injection valve, and gas injection switch. The puncture rod component is composed of an upper fixing cover and a puncture rod. The upper sealing component (5/10/12 specification) is composed of seal lid, an upper retaining ring, a wave seal ring, a conical sealing ring, a lower retaining ring, and a retaining cover for locking. The upper sealing component (15 specifications) is composed of a seal lid, an elastic seal ring, and a retaining cover for locking. The converter component (15 specifications) is composed of converter, converter cover, sealing cap of upper converter cover, and upper converter cover.

Disposable Trocars are divided into B and C according to different shapes. According to the inner diameter of the trocar, it is divided into four sizes: 5, 10, 12, and 15. According to the length of the trocar, it is divided into two sizes: 70 and 100.

The provided FDA 510(k) clearance letter and summary for Sinolinks Medical Innovation, Inc.'s Disposable Trocars (K250820) do not contain information about acceptance criteria or a study proving the device meets the acceptance criteria in the context of an AI/ML-enabled device evaluation.

The document pertains to a traditional medical device (Disposable Trocars) and its non-clinical performance testing (bench, ex vivo, biocompatibility, sterility, packaging, shelf-life, transport, etc.) to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot extract the information required to answer your prompt, which is tailored for AI/ML device evaluations. The document explicitly states: "No clinical study is included in this submission." and the "Summary of non-clinical testing" section details a range of physical, mechanical, and biological tests relevant to a non-AI/ML medical device.

To answer your prompt for a device that is not an AI/ML device, the following would be the most relevant information:

Acceptance Criteria and Device Performance for Disposable Trocars (K250820)

The acceptance criteria for the Disposable Trocars are demonstrated through a series of non-clinical tests which show the device meets its design specifications and performs comparably to the predicate device. The "performance" in this context refers to the successful completion and passing of these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI/ML device, the "acceptance criteria" are embodied in the successful completion of the various non-clinical tests to predefined standards. The "reported device performance" is that the device met these standards.

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

The document does not explicitly state the numerical sample size for each bench or ex vivo test. It mentions "porcine tissue" for ex vivo studies. It does not provide explicit data provenance in terms of country of origin for the datasets used in these non-clinical tests, though the manufacturer is based in China. The data would be considered prospective for the purposes of these clearance tests, as they were conducted specifically for this submission.

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

This concept is not applicable to the non-clinical testing of a traditional medical device like a trocar. "Ground truth" established by experts is a concept primarily relevant to diagnostic AI/ML models where human interpretation serves as the reference standard. For a trocar, the "ground truth" is determined by established engineering standards, material science principles, and biological safety evaluations.

4. Adjudication method for the test set:

Not applicable for non-clinical performance testing of a traditional device. Adjudication methods (e.g., 2+1 reader consensus) are used in human-in-the-loop or standalone AI/ML studies to resolve discrepancies in expert labeling or diagnoses.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study is specifically for evaluating the impact of AI/ML assistance on human reader performance, which is irrelevant for a disposable trocar.

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

No. This is an AI/ML specific evaluation. The "device" itself performs its function (e.g., creating an entry path) without an "algorithm" in the diagnostic sense.

7. The type of ground truth used:

For this traditional medical device, the "ground truth" is effectively:

• Established engineering specifications and performance standards for mechanical and physical properties (e.g., dimensions, strength, air-tightness).
• Industry consensus standards for biocompatibility (e.g., ISO 10993 series), sterility (e.g., ISO 11135), and packaging (e.g., ASTM standards).
• Biological responses (e.g., no cytotoxicity demonstrated on cell cultures, no irritation in animal models for biocompatibility).

8. The sample size for the training set:

Not applicable. The concept of a "training set" refers to data used to train an AI/ML algorithm. This device does not use AI/ML.

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

Not applicable, as there is no AI/ML training set.

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The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope.

The Disposable Trocars includes Normal trocars (model A), Balloon trocars (model B), Thread trocars (model C) and Single-port trocars (model E). They are generally composed of cannula and obturator, with or without filter/cleaning ring/protector. The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope. If needed, the CO2 can be infused through the valve. The product is sterilized by Ethylene oxide and is a single-use product.

The provided text is a 510(k) summary for a medical device (Disposable Trocars) seeking FDA clearance. It outlines the substantial equivalence to predicate devices based on various characteristics and non-clinical testing. However, it does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance, or the establishment of ground truth by expert consensus.

The document primarily focuses on bench testing and material biocompatibility for traditional medical device components, not software or AI performance. The details requested in the prompt, such as sample sizes for test sets, data provenance for AI studies, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not present in this type of FDA submission for a device like a trocar.

Therefore, I cannot provide the detailed information requested in the prompt based on the given text. The text describes the testing of the physical device's performance properties (e.g., obturator compatibility, air leakage, balloon rigidity) and biocompatibility, not the performance of an AI or algorithmic component.

If the request refers to the performance criteria for the physical device itself (the trocars), then I can extract some relevant information, though it won't align perfectly with the AI/algorithm-focused questions in the prompt.

Based on the provided text, and assuming "device performance" refers to the physical attributes and functionalities of the Disposable Trocars, here's what can be extracted, acknowledging that many of your specific questions are not addressed by this type of document:

The Disposable Trocars are physical medical instruments used in endoscopic procedures. The "acceptance criteria" and "device performance" discussed in this document relate to their physical and biological properties, not AI or algorithmic performance.

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

The document states that "All the test results were 'PASS'." This implies that the device met pre-defined acceptance criteria for each test. However, the specific quantitative acceptance criteria values are not explicitly listed, only the type of tests performed.

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

• Sample Size: Not specified in the provided text. The document mentions "performance studies and bench testing" but does not give the number of units tested.
• Data Provenance: Not applicable in the context of clinical data for AI. The tests are bench tests performed by the manufacturer, Hangzhou Kangji Medical Instrument Co., Ltd., which is based in China. The data would be prospective in the sense that the company specifically conducted these tests for the submission.

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

• Not applicable. This document describes testing of a physical medical device. Ground truth as understood in AI/image analysis (e.g., expert radiologist consensus) is not relevant here. The ground truth for these tests would be established by validated test methods and measurement standards for physical properties. The tests were evaluated by their "Design Engineer."

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

• Not applicable. This is for AI/image analysis. The "adjudication" for these physical tests would be the measurement against a pre-defined specification or standard.

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 a physical medical device, not an AI or software device that assists human readers.

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

• No. This is a physical medical device.

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

• For biocompatibility: ISO and USP standards (e.g., cell cultures for cytotoxicity, animal models for systemic toxicity).
• For performance: Engineering specifications and test methods for physical properties (e.g., force measurements for insertion, pressure measurements for air leakage).

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable.

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The Disposable Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.

The disposable Trocar has application in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Disposable trocar is mainly composed of Obturator with bladeless tip, Outer Seal Release Lever, Trocar Stability Sleeve, Obturator Locking Button, etc.

The document provided describes a 510(k) premarket notification for a Class II medical device, the "Disposable Trocar," manufactured by Wuxi Shukang Medical Appliance Co., Ltd. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on comparative testing against a predicate, rather than a full, de novo study with acceptance criteria in the traditional sense of a clinical trial.

Here's an breakdown of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Disposable Trocar, and the "acceptance criteria" here are demonstrating equivalency to the predicate device in various non-clinical performance tests and biocompatibility.

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

The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many disposable trocars were tested for insertion force). It only states that "Performance tests were conducted."

• Data Provenance: The tests were conducted internally by the manufacturer or by contract labs on behalf of the manufacturer, to demonstrate conformance with various international standards and equivalency to the predicate device. The country of origin of the data is not explicitly stated beyond the manufacturer being based in China. The data is from non-clinical (bench and lab) studies.

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

Not applicable in the context of this 510(k) submission. This is a non-clinical evaluation, not a clinical study involving human reads or expert consensus for "ground truth." The "ground truth" here is objective physical measurements and biochemical test results compared against established standards and predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of expert opinions. The assessment of test results would be based on comparison to pre-defined acceptance criteria (e.g., within a certain range of the predicate, or passing a specific threshold in a standard).

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 MRMC study was done, as this is a medical device (trocar) and not an AI/imaging diagnostic device.

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

Not applicable, as this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is based on:

• Objective physical measurements: For bench performance tests like insertion force, leakage, penetration force, and retention force, the ground truth is the measured values themselves, compared against the predicate device or a defined specification.
• Established
  biocompatibility standards (ISO 10993): For biocompatibility, the ground truth is defined by the results of specific standardized assays (e.g., cell viability in cytotoxicity tests), which determine if the material is biocompatible according to the standard.
• Sterilization validation standards (ISO 11737-2): For sterilization, the ground truth is the validated sterility assurance level (SAL).
• Accelerated aging protocols: For shelf life, the ground truth is determined by testing product performance after simulated aging, demonstrating it maintains its functionality for the claimed shelf life.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable.

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