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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 TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding and wiping the laparoscope lens from debris, grease, blood, and bodily fluids. The access device is compatible with the da Vinci Si Surgical System.

The TroKit Laparoscope Lens Wiper is a sterile, single-use and disposable laparoscopic accessory device that fits onto the distal end of a trocar and with its lens wiper serves to clean the camera lens from blood, tissue, fog, grease, and other surgical debris. The lens wiper itself is a mechanical device within the TroKit that employs a thermoplastic elastomer squeegee. The TroKit is translucent. When the laparoscopic camera is inserted through the trocar into the TroKit its insertion opens the mechanical jaws that house the lens wiper. The wiping is done automatically upon the passage of the laparoscopic camera through the TroKit jaws. The TroKit can be activated and used multiple times during surgery. One device is adequate for one surgery.

The provided FDA 510(k) summary for the TroCare TroKit Laparoscope Lens Wiper (K241796) focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, and non-clinical performance data. It does not contain information related to the acceptance criteria and study design elements specified in the request, such as a table of acceptance criteria with reported device performance, sample sizes for test sets, expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or details about the training set.

Based on the document, here's what can be extracted and what information is missing:

Information available from the document:

• Type of Ground Truth Used: Non-clinical testing demonstrates that the subject device "performs as well as the legally marketed predicate device." The performance data section specifies "mechanical characteristics" testing to show it is safe and performs as intended. Implied ground truth is the performance of the predicate device and established safety and performance benchmarks for such devices.
• Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/ML algorithm.
• How Ground Truth for Training Set was Established: Not applicable as this is a physical medical device, not an AI/ML algorithm.

Information NOT available from the document:

1. A table of acceptance criteria and the reported device performance: While the document states "The TroKit Laparoscope Lens Wiper was evaluated for mechanical characteristics to demonstrate that it is safe and performs as intended," it does not provide a table with specific acceptance criteria (e.g., in terms of cleaning effectiveness, durability, or ease of use) nor the reported quantitative device performance against those criteria.
2. Sample sized used for the test set and the data provenance: The document indicates that "non-clinical testing" was performed, but it does not specify the sample size of devices tested or any details about data provenance (e.g., country of origin, retrospective or prospective).
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): Since this is not an AI/ML device, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or diagnosis is not applicable here. The evaluation of mechanical characteristics would typically involve engineers or laboratory personnel following test protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the non-clinical mechanical testing 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: The device is a physical laparoscopic lens wiper, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
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 AI/ML algorithm.

In summary, the provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence based on design, indications for use, and non-clinical mechanical and biocompatibility testing. The detailed information requested, particularly concerning performance metrics, test set specifics, and expert involvement for ground truth, is typically provided for AI/ML-driven devices or more complex diagnostic tools, which this device is not.

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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 Monik™ - Disposable Endoscopic Trocar has applications 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 Endoscopic Trocar is sterile single patient use instrument consisting of a radiolucent sleeve and obturator in sizes 5mm, 10mm, 12mm long and 15mm diameter. The obturator contains a clear tapered optical element. The 10mm, 12mm diameter obturators accommodate an appropriately sided 0° endoscope and provide visibility of individual tissue layers during insertion. The trocar sleeves for the 5 mm, 10 mm, 12mm, 12mm long and 15 mm devices contain two seals. An outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 mm to 15 mm in diameter where indicated and an internal seal. Together these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.

This document does not contain any information about an AI/ML device, therefore, an answer to the request cannot be generated. It describes a traditional medical device, the Monik™ - Disposable Endoscopic Trocar, and its substantial equivalence to predicate devices based on design, materials, sterilization, packaging, and performance testing.

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The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.

The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the surgical site. The disposable portion of the system is sterilized via irradiation and has limited (

The provided document describes the troCarWash™ System, a device intended to remove visual obstructions from the distal lens of a laparoscope during surgery.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, it details various validation and testing activities with implied acceptance criteria being successful completion of these tests according to specified standards.

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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 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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This device is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or minimally invasive procedures to establish a path of entry for minimally invasive instruments.

The NexPort™ Trocar System is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed devices are available to accommodate 5mm and 10mm surgical instruments.

The 5mm NexPort™ Trocar System is consisted of:

• Obturator Shaft a)
• Cannula Cap b)
• Seal c)
• Duckbill Valve d)
• e) Cannula Body
• f) Luerlock Cap
• g) Obturator Tip Protector
• Cannula Tip Protector h)

The 10mm NexPort™ Trocar System is consisted of:

• a) Obturator Shaft
• Cannula Cap b)
• Seal c)
• Cannula Intermediate Plate d)
• Duckbill Valve e)
• f) Cannula Housing
• Stopcock g)
• Face Seal h)
• i) Cannula Sleeve
• Reducer j)
• Adaptor Cap k)
• I) Adaptor Top Body
• m) Adaptor Seal
• n) Adaptor Bottom Body

This is a 510(k) premarket notification for a medical device called the "NexPort™ Trocar System". This document does not describe a study that uses AI or machine learning. Therefore, most of the requested information regarding acceptance criteria and study design for AI/ML performance evaluation is not available in this document.

However, I can provide the available information related to the device's validation and comparison to predicate devices, as well as the non-clinical tests performed.

Current Device: NexPort™ Trocar System

Summary of Device Validation and Performance (based on provided text):

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a standalone performance study with specific acceptance criteria that would typically be seen for an AI/ML device. The validation involves non-clinical tests and comparison to legally marketed predicate devices.

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

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML algorithm with metrics like sensitivity, specificity, or AUC. Instead, it details that the device has undergone various non-clinical tests and has been found to conform to applicable medical device safety standards.

The relevant "performance" is implicitly demonstrated through:

• Identical Intended Use/Indications for Use as predicate devices.
• Identical Principles of Operation as predicate devices.
• Identical Application Sites as predicate devices.
• Identical Single Use nature and Operation Mode (Manually) as predicate devices.
• Identical Sterilization Assurance Level (SAL) ($

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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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