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The Bladeless Trocar, Bladed Trocar, and Hasson Trocar have application in a variety of laparoscopic procedures to provide a port of entry for laparoscopic instruments.

The Disposable Surgical Trocar is composed of two parts, one obturator and one guide tube (cannula). The obturator of the Bladeless Trocar is plastic allowing the surgeon to dilate between tissues. The obturator of Bladed Trocar is made of PC and a small blade made of stainless steel, which is released when the surgeon presses the trocar to help with cutting. The Disposable Surgical Trocar Kit, bladed or bladeless, has one obturator and two cannulas or two obturators and four cannulas. The device is for single use only. This device is sterilized with ethylene oxide and has a shelf life of 3 years.

This is an FDA 510(k) summary for a medical device called "Bladeless Trocar; Bladed Trocar; Hasson Trocar." The document describes the device, its intended use, and compares it to a legally marketed predicate device (K141594).

However, your request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically in the context of an AI/ML medical device submission. The provided document is for a mechanical surgical instrument (trocar) and does not involve AI/ML. Therefore, the requested information categories concerning AI/ML performance (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

The document states:

"The subject device trocar models (Bladeless Trocar, Hasson Trocar) are manufactured by the same company that manufactures those of the predicate device (Unimicro) and are identical to those cleared under K141594. As such, performance testing is not required."

This statement indicates that the regulatory acceptance is based on the substantial equivalence to a predicate device, specifically because the new device is identical and manufactured by the same company as the predicate. Therefore, no new performance studies were conducted or required to demonstrate that the device meets acceptance criteria.

To specifically address the prompts given the available information:

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

   • Acceptance Criteria: Substantial Equivalence to predicate device K141594. The key criteria are identical design, materials, manufacturing process, and intended use to a previously cleared device.
   • Reported Device Performance: Not applicable, as performance testing was explicitly stated as "not required" due to the identical nature to the predicate device. The performance is assumed to be equivalent to the predicate device.

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 as no performance study was conducted.

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 as no performance study was conducted.

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

   • Not applicable as no performance study was conducted.

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 is a non-AI device.

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

   • Not applicable. This is a non-AI device.

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

   • Not applicable as no performance study was conducted. Regulatory acceptance is based on substantial equivalence to the predicate device.

8. The sample size for the training set

   • Not applicable. This is a non-AI device.

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

   • Not applicable. This is a non-AI device.

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ENPOLE is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.

The Bladeless Trocar is a sterile single patient use instrument consisting of a sleeve in sizes from 5 mm to 12 mm diameters. The trocar sleeve for the devices contains two seal, an outer integrated self-adjusting seal that accommodates instruments ranging from 5 mm to 12.5 mm in diameter where indicated and an internal seal. Together, these seal minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5 mm trocar sleeve accommodates only 5 mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. Bladeless trocar is access into the abdomen of laparoscopy that is particular to the insertion of surgical instruments through small incisions. The sleeve penetrated into the intra- abdominal by the obturator is inserted and fixed in the abdominal wall, which is a principle that allows laparoscopy to be performed at a constant abdominal pressure state by keeping it sealed to the outside of the human body.

The provided document describes the FDA 510(k) clearance for the ENPOLE® Bladeless Trocar, a single-use medical device used to create a port for inserting endoscopic instruments during endoscopic procedures. It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device. The "Performance Data" section lists several physical and functional tests, but the criteria are generically stated as "Internal standard" and the results as "Pass".

Therefore, I cannot fulfill your request for information regarding AI/ML related acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as this document pertains to a traditional medical device (bladeless trocar) and not an AI/ML-powered one.

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The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) is used to puncture the abdominal wall of human body during laparoscopy and operation to establish the working channel for abdominal surgery.

The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are available in total of eight (8) sizes. The Disposable Abdominal Trocars (Bladed Trocars), knows as Auto-Locking Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladed Trocars) is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The Disposable Abdominal Trocars (Bladeless Trocars) has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladeless Trocars) is available in one (1) size: 5mm. The Disposable Abdominal Trocars (Optical Trocars), knows as Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip, which is designed for open Laparoscopy. The Disposable Abdominal Trocars (Optical Trocars) is available in four (4) sizes: 5mm, 10mm, 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock. Based on the filter valve, the Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are divided into two (2) product series: CNTCI series without smoke evacuation function and CNTCII series with smoke evacuation. The cannula consists of sleeve, stopcock valve, valve lever, gas check valve and lip seal. The obturator consists of fixed base, obturator tube and obturator tip. There are various specifications available depending on the inner diameter and length of sleeve.

The provided text describes a 510(k) premarket notification for "Disposable Abdominal Trocars." It details the device's classification, intended use, description, and comparison to predicate devices. It also mentions non-clinical testing performed to assess safety and effectiveness.

However, this document does not contain any information about an AI/ML powered device, its acceptance criteria, or a study proving its performance. The device in question is a physical medical device (trocars) used in laparoscopic surgery.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or how ground truth was established, as these concepts are not relevant to the content of the provided document.

The document explicitly states in section H: "No clinical study is included in this submission." This further confirms that no performance study of the type requested was performed or is detailed in this filing.

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The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.

Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.

The provided text describes a 510(k) premarket notification for a medical device called the "Bladeless Trocar - Artemis Lap Cannula" (K231400) and references a previous clearance (K230058) as a primary predicate. This document is a regulatory submission, not a study report, and thus focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical or analytical performance study with acceptance criteria and detailed outcomes in the same way one might describe an AI/ML device study.

Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly aspects like sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable or available in this type of regulatory document for this specific device.

This device (Bladeless Trocar - Artemis Lap Cannula) is a physical surgical instrument, not an AI/ML diagnostic or prognostic system. The performance claims for such devices typically revolve around mechanical properties, biocompatibility, and sterility, which are verified through non-clinical testing and comparison to legally marketed predicate devices.

However, I can extract information regarding the non-clinical testing performed and the conclusion drawn from it, which serves as a form of "proof" of meeting the regulatory requirements for substantial equivalence.

Non-Clinical Testing and Performance for Bladeless Trocar - Artemis Lap Cannula (K231400)

1. Table of Acceptance Criteria and Reported Device Performance (Derived from Regulatory Review)

Explanation of "Acceptance Criteria" for this type of device:
For a physical surgical instrument like a trocar, "acceptance criteria" are typically defined by recognized consensus standards (e.g., ISO standards for medical devices, biomechanical testing standards) and comparison to predicate devices. The primary goal is to demonstrate that the new device is as safe and effective as a legally marketed device.

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

• Sample Size: Not specified in the provided text. Non-clinical testing typically involves a statistically relevant number of units for mechanical or material tests, but the exact count is not detailed here.
• Data Provenance: The testing was "Nonclinical Testing" conducted to support the 510(k) submission. This is laboratory-based testing, not human or patient data. The country of origin of the data is implicitly the country where the manufacturer (T.A.G. Medical Products Corporation, Ltd, Israel) conducted or commissioned the tests.

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

• Not applicable. This information pertains to studies involving expert review for setting ground truth (e.g., for AI/ML algorithms). This device and its associated testing do not involve establishing ground truth from expert clinical review. The "ground truth" for non-clinical testing is typically defined by the test protocol, measurement standards, and device specifications.

4. Adjudication Method for the Test Set:

• Not applicable. This concept relates to reconciling disagreements among experts in setting ground truth for data. Non-clinical physical testing results are usually objective measurements, not subject to expert adjudication in the same manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for comparing the performance of human readers, often with and without AI assistance, on diagnostic cases. This device is a surgical instrument, not a diagnostic tool requiring such a study.

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

• Not applicable. This refers to the performance of an AI algorithm in isolation. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used:

• For the non-clinical tests (leak testing, ISO 80369-7 compliance), the "ground truth" is defined by:
  • Established Test Standards: Adherence to the specified mechanical and performance characteristics outlined in the relevant ISO standard (ISO 80369-7).
  • Predicate Device Performance: Comparison to the performance characteristics of the legally marketed predicate device (K230058) for specific attributes like leak resistance.
  • Device Specifications: Meeting the manufacturer's own design specifications for the device.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of a physical medical device like a trocar. This concept applies to AI/ML algorithms that learn from data.

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

• Not applicable. As there is no training set, this question is not relevant.

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The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.

Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.

This document describes a 510(k) premarket notification for the "Bladeless Trocar - Artemis Lap Cannula." The submission seeks to prove substantial equivalence to a legally marketed predicate device (K032676, the ENDOPATH III Trocar System).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for performance metrics in a table format, nor does it provide detailed quantitative performance data for the Artemis Lap Cannula. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and nonclinical testing.

Here's a summary of the stated performance and comparisons:

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

The document does not explicitly state sample sizes for specific tests (e.g., biocompatibility testing might involve various samples for different analyses, and leak testing would have its own sample size).

• Test Set Sample Size: Not explicitly stated for each test.
• Data Provenance: Not explicitly stated whether retrospective or prospective. Given the nature of pre-market testing for medical devices (biocompatibility, reprocessing, performance testing), it is typically prospective testing conducted specifically for the submission. The country of origin of the data is not specified beyond the applicant's location (Israel).

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. The tests described (biocompatibility, reprocessing, ISO standard testing, leak testing) are primarily objective engineering/scientific tests, not typically reliant on expert interpretation for "ground truth" in the same way clinical imaging or diagnostic studies might be.

4. Adjudication Method for the Test Set

Not applicable for the types of nonclinical tests described. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which the "Bladeless Trocar - Artemis Lap Cannula" is not. It is a surgical instrument.

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

A standalone performance study (algorithm only) was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests (biocompatibility, reprocessing, ISO standards, leak testing) typically refers to established scientific methodologies, validated test methods, and pre-defined acceptance criteria based on industry standards and regulatory requirements. For example:

• Biocompatibility: Established ISO standards (e.g., ISO 10993 series) define the ground truth for evaluating biological response.
• Reprocessing: Ground truth is established by validated protocols demonstrating the device can be consistently cleaned and sterilized to meet sterility assurance levels.
• ISO 80369-7: Ground truth is the successful meeting of the dimensional and performance requirements defined in the standard.
• Leak Testing: Ground truth is the quantitative measurement of leakage and its statistical equivalence to the predicate, demonstrating it meets performance expectations for sealing.

8. The Sample Size for the Training Set

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

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

Not applicable. This is not an AI/machine learning device.

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The Inno-Port Disposable Bladeless Trocars are in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry.

The Inno-Port Disposable Optical Trocars are intended for use in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

The Inno-Port Disposable Bladeless Trocar and Inno-Port Disposable Optical Trocar are surgical trocars available in 5 mm, 5-11 mm, and 5-12 mm series. They consist of an obturator and a cannula with a self-adjusting seal and stopcock valve. The optical trocar obturator also contains a scope retention mechanism. The seal system accommodates instruments ranging from 5mm to 12mm in diameter depending on the trocar size.

The provided document is a 510(k) summary for the "Inno-Port Disposable Bladeless Trocar" and "Inno-Port Disposable Optical Trocar." It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the format requested for AI/ML performance.

Therefore, many of the requested details about acceptance criteria for AI/ML performance, sample sizes, expert qualifications, ground truth, and MRMC studies are not applicable or extractable from this document as it pertains to a medical device's physical performance, not an AI/ML algorithm.

However, I can extract the acceptance criteria and reported device performance for the physical device characteristics as presented.

Here's the information that can be extracted or inferred from the provided text:

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

The document provides a comparison of performance criteria between the proposed device and its predicate devices. The "reported device performance" is essentially that the proposed devices met these criteria, as stated in the conclusion: "The test results showed that both proposed devices have the similar device performance compared to the predicate device."

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The devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.

The proposed devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, are basic equipment used during laparoscopic surgical, which consist of Puncture Needle, Puncture Sleeve, Injection Valve, Cap and Safety lock. They are available in multiple configurations, including bladed type, bladeless type and optical type. In order to obtain access to the surgical site during laparoscopic surgery, the Puncture Needle is introduced into Puncture Sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the Injection Valve at its proximal end and once the abdominal/thoracic wall is punctured, the puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. Generically, puncture needle and sleeve are available in a range of lengths and diameters to accommodate different sizes surgical instrument

Here's an analysis of the provided text regarding the acceptance criteria and study that proves the device meets them, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes performance tests and states that the proposed devices performed comparably to predicate devices, concluding "no adverse indications or results." The "performance" column below summarizes the tests performed and the general findings.

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

• Sample Size for Test Set: Not explicitly stated for any of the performance or biocompatibility tests. The document only mentions "an in vivo study was conducted on porcine model" without specifying the number of animals or trials.
• Data Provenance: The tests were conducted by the manufacturer, Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. The in vivo study was done on a porcine model, indicating animal testing. The specific country where these tests took place is not stated, but the manufacturer is based in China. The data is prospective for the tests conducted to support this submission.

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. The statement "results demonstrated that the performances of the proposed device are substantial equivalent to those of the predicate device" implies internal evaluation of test results, but no details on experts or their qualifications for establishing a "ground truth" are given for these types of tests (e.g., force measurements, leak resistance, biocompatibility).

4. Adjudication Method for the Test Set

• This information is not provided as these are objective performance and biocompatibility tests, not subjective interpretations requiring adjudication.

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

• No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was done."

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

• This question is not applicable to this device. This is a physical medical device (trocar), not an AI algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to the objective measurements and established standards for physical device performance (e.g., force values, leak rates, biological response to materials, sterility assurance levels) as defined by international standards (ISO, ASTM, USP) and general safety/performance requirements for medical devices. The comparison is also made against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

• This question is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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

• This question is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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The Reprocessed Ethicon Bladeless Trocars are intended for use in thoracic, gynecologic, laparoscopic and other abdominal or minimally invasive surgical procedures to establish a path of entry for endoscopic or minimally invasive instruments. The reprocessed optical trocar may be used with or without visualization for primary and secondary insertions.

The Reprocessed Ethicon Universal Trocar Sleeves are intended for use in thoracic, gynecologic, laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the port, and; the obturator which is a mechanism that allows the cannula to penetrate the abdomen. The trocars contained in this submission are bladeless. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.

The provided document is a 510(k) summary for a reprocessed medical device, specifically Reprocessed Ethicon Bladeless Trocars and Universal Trocar Sleeves. It does not describe an AI/ML-based device or a diagnostic algorithm, but rather a physical medical device that is reprocessed for reuse.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, expert adjudication, MRMC studies, and training/test set data, which are typical for AI/ML-based diagnostic devices, is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (the new Ethicon trocar) through:

1. Comparison of Technological Characteristics: Indications for Use, Materials, Design, Energy Source.
2. Performance Testing: Benchtop functional tests (Seal Drag, Seal Leakage, Insertion, Fixation, Removal Force Test), Product Stability (Shelf Life Testing), Cleaning Validation (Residual Protein and Hemoglobin, Visual Inspection, Cleaning Performance Qualification), Sterilization and Packaging (EtO Sterilization Testing, Simulated Shipment Testing), and Biocompatibility Testing.

The "acceptance criteria" for this device are that its performance, once reprocessed, is equivalent to that of a new, original equipment manufacturer (OEM) device. The study proving this involves side-by-side benchtop testing and cleaning validation.

To directly answer your prompt's questions based on the provided document, where applicable:

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

The document describes the types of tests performed and the overarching goal of demonstrating "substantial equivalence" to the OEM device. It doesn't provide specific numerical acceptance criteria (e.g., "Seal Drag

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The VersaOne™ Fascial Closure System Bladed Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.

The VersaOne™ Fascial Closure System Bladeless Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.

The VersaOne™ Fascial Closure System Optical Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.

The VersaOne™ Fascial Closure System Bladed Trocar (12mm) is available in standard length (100mm) transparent cannula. The Bladed Trocar obturator has a dolphin nose (conical) shaped tip with a sharp linear blade and a spring-loaded locking shield. The blade is used to cut the tissues as the trocar is inserted into the body cavity. The shield advances to cover the blade upon entry into a free space. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows, 180 degrees apart, covered by a pierce-able membrane. A guide is provided which fits inside the trocar cannula to guide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.

The VersaOne™ Fascial Closure System Bladeless Trocar (12mm) is available in standard length (100mm) transparent cannula. Bladeless Trocar obturator has a dolphin nose (conical) shaped bladeless tip. The conical shape is for smooth insertion into the body cavity by spreading the tissue layers during insertion. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows, 180 degrees apart, covered by a pierce-able membrane. A guide is provided which fits inside the trocar cannula to guide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.

The VersaOne™ Fascial Closure System Optical Trocar (12mm) is available in standard length (100mm) transparent cannula. The Optical Trocar with transparent cannula and obturator allows for visualization of tissue layers during insertion. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows. 180 degrees apart, covered by a pierce-able membrane. A guide is provided which fits inside the trocar cannula to guide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.

The provided document is a 510(k) premarket notification for a medical device (VersaOne Fascial Closure System Trocar). It describes the device, its intended use, and comparisons to predicate devices to demonstrate substantial equivalence. Crucially, this document does NOT describe the performance of an AI/ML-driven medical device. It details bench testing, in-vivo testing (on animals), biocompatibility, sterilization, and cleaning studies for a physical surgical instrument.

Therefore, I cannot provide the information requested in your prompt (Acceptance Criteria and Study for an AI/ML device) because the provided text is about a surgical trocar, not an AI/ML system.

The prompt specifically asks for details relevant to AI/ML device validation, such as:

• A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, AUC).
• Sample size and data provenance for the test set (relevant for imaging datasets for AI).
• Number of experts and their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC studies for human reader improvement with AI.
• Standalone AI performance.
• Type of ground truth (e.g., pathology, outcomes data).
• Training set sample size and ground truth establishment for AI.

None of this information is present or applicable to the conventional medical device described in the provided text.

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The U-IGNITE Bladeless Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.

It is a rigid hand-held surgical instrument with a rounded conical point used to manually puncture a bodily entry point to assist in the location and positioning of gently part the surrounding soft tissue. The trocar assembly punctures the muscle and tissue layers in the body. The trocar assembly's obturator is removed leaving the cannula to provide a port through which laparoscopes and other laparoscopic instruments can be introduced. The cannula sealing system shall be able to maintain pneumoperitoneum.

The U-IGNITE Bladeless Trocar is a sterile single patient use instrument consisting of a radiolucent sleeve and obturator in various sizes diameter. The obturator contains a clear, taped optical element. The obturator accommodate an appropriate sized 0 degree endoscope and provide visibility of individual tissue layers during insertion. Basic type do not have the optical element for its obturator.

In addition, the U-IGNITE Bladeless Trocar with Endo-assistant part is a design enhancement that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocarinduced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.

The trocar sleeves for the 12 mm devices contain two seals, an outer integrated removable self-adjusting seal that accommodates instruments ranging from 5mm to 12 mm in diameter where indicated and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdraw through the trocar. The 5 mm trocar sleeve does not contain an integrated removable outer seal and accommodates only 5 mm instruments.

A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

This is an irradiation sterilized single use disposable device to avoid cross infection.

The provided text describes the U-IGNITE Bladeless Trocar and its substantial equivalence to predicate devices, but it does not contain a table of acceptance criteria and reported device performance for a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, nor does it provide sample sizes, ground truth details for such studies.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics for an AI/algorithm-based device.

Here's a breakdown of what is available in the text regarding acceptance criteria and studies for the U-IGNITE Bladeless Trocar, specifically focusing on its non-clinical performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states: "All the test results demonstrate U-IGNITE Bladeless trocar meet the requirements of its predefined acceptance criteria and intended uses." However, it does not provide a specific table detailing these acceptance criteria alongside the quantitative reported device performance for each test. The "Performance Testing Item" section lists the types of tests conducted:

2. Sample Sizes and Data Provenance (for test set of performance tests):

The document mentions "animal simulation test" for "Trocar System Puncture Performance" and "Trocar sleeve retention force". However, it does not specify the sample sizes (number of animals or test replicates) used for these or any other performance tests.
The data provenance is not explicitly stated beyond "animal simulation test", but given it's a premarket submission from Tianjin UWell Medical Device Manufacturing Co. Ltd. (China), the tests were likely conducted internally or by a contracted lab. It is a retrospective summary of non-clinical bench testing.

3. Number of Experts and Qualifications:

Not applicable to the non-clinical performance tests mentioned. These are bench tests, not expert-read image analysis.

4. Adjudication Method:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned for human readers improving with AI vs. without AI assistance. This device is a surgical instrument, not an AI-enabled diagnostic tool.

6. Standalone (Algorithm Only) Performance:

No standalone algorithm performance study was done, as this is a physical medical device (trocar), not a software algorithm.

7. Type of Ground Truth Used (for performance tests):

For the performance tests, the "ground truth" would be established by the physical and engineering properties being measured against predefined specifications or industry standards. For example:

• Obturator & Cannula Compatibility: Physical fit and function.
• Air Leakage: Measurement against specified leakage rates.
• Puncture Performance/Retention Force: Measurement against biomechanical force thresholds.
• Endoscope Visualization: Likely subjective assessment or objective measurement of clarity/obstruction.

The document does not detail the exact methodology for establishing these ground truths, but they would derive from engineering specifications and testing protocols.

8. Sample Size for Training Set:

Not applicable, as this is not an AI/ML device.

9. How Ground Truth for Training Set Was Established:

Not applicable.

Summary of what the document focuses on:

The entire document (510(k) summary) serves as a study to demonstrate substantial equivalence to existing legally marketed predicate devices, particularly the ENDOPATH XCEL Bladeless Trocar with OPTI VIEW Technology (Ethicon Endo-Surgery, LLC) and the Unimicro Trocar Kit (Unimicro Medical Systems). This is achieved through:

• Comparison of Indications for Use, design, materials, dimensions, and classification.
• Demonstration of compliance with biocompatibility standards (ISO 10993 series).
• Conducting a series of non-clinical performance tests on the subject device and the predicate device to show comparable performance. These tests include Obturator & Cannula Compatibility, Insertion & Cannula Stability, Air Leakage, Puncture Performance, Trocar sleeve retention force, Endoscope Visualization Image Quality, and Endo-Assistant Part Liquid Absorbing Performance.

The "acceptance criteria" referred to are the predefined internal specifications and expected performance benchmarks for these non-clinical tests, which the device "met." The "study" proving this involves the execution of these listed performance tests and the declaration that the results "demonstrate U-IGNITE Bladeless trocar meet the requirements of its predefined acceptance criteria and intended uses."

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