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The Disposable Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars opic procedures.

The Disposable Veress Needles are composed of needle, inner core, handle and made of medical grade stainless steel, PC, PE, ABS, and Model II has a silicone sleeve on the handle. The device is packed in Tyvek dialysis bag with 4058B Tyvek dialysis paper and ESE film. The contact duration is less than 24 hours. The device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures. The device is sterilized by EO and is intended for single-use only. The proposed device is available in a variety of needle lengths. There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle.

The provided text describes a 510(k) premarket notification for a medical device called "Disposable Veress Needles." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, the requested information about acceptance criteria and a study proving device performance (especially points relevant to AI/ML such as test set size, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment) cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

The document primarily discusses non-clinical testing for physical properties, biocompatibility, sterilization, and shelf-life of a physical medical instrument (a Veress needle), not an AI/ML diagnostic or predictive tool.

Here's a breakdown of what can be extracted, and where the requested information is absent:

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

• Acceptance Criteria: The document states, "The tests listed below have demonstrated that the subject device performs as well as the predicate device based on the acceptance criteria." However, the specific numerical or qualitative acceptance criteria (e.g., "puncture force must be within X to Y Newtons") are not explicitly detailed in the provided text. Instead, categories of tests are listed.
• Reported Device Performance: The document only states that the device "performs as well as the predicate device" after these tests. No specific performance results (e.g., actual measured tip pull force, switch operation timing, etc.) are provided.

Regarding points 2-9, which are highly relevant for AI/ML device evaluations, the information is not present in this document because it describes a physical medical device, not an AI/ML algorithm.

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

• Not applicable / Not provided. This document does not describe a study involving data sets for an AI/ML algorithm. The "test set" here refers to physical units of the device subjected to non-clinical tests. The number of samples for each physical test (e.g., how many needles were tested for tip pull) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth definition by experts is not relevant for the non-clinical physical and biological tests described for a Veress needle.

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

• Not applicable / Not provided. Adjudication methods are relevant for expert consensus on AI/ML ground truth, not for physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable / Not provided. This is explicitly for AI-assisted diagnostic devices and does not apply to a standalone physical surgical instrument like a Veress needle.

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

• Not applicable / Not provided. This is for AI algorithms, not a physical medical device.

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

• Not applicable / Not provided. The "ground truth" for the physical device tests would be objective measurements against an engineering standard or predicate device performance, not expert consensus on medical findings.

8. The sample size for the training set

• Not applicable / Not provided. There is no AI/ML algorithm, and thus no training set.

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

• Not applicable / Not provided. There is no AI/ML algorithm, and thus no training set or ground truth establishment method for it.

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The GTK Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The structure of the GTK Veress Needles contain inner needle, outer needle, warning block, spring, handle and valve. It contains a spring-loaded blunt stylet mechanism, which is also the major principle mechanism of GTK Veress Needles to achieve the intended use. It is used to establish pneumoperitoneum prior to trocar and cannula insertion in laparoscopic procedures. The veress needle is connected to the insufflators with a luer connector. There are two models of veress needles: VN-120 and VN-150, with different lengths of needle bodies (120mm and 150mm). The GTK Veress Needles are for single use and are supplied sterile. The contact time is no more than 24 hours. The product is sterilized by Ethylene oxide. The manufacture date and expiry date are shown on the labeling. The GTK Veress Needles are only intended for use in a hospital setting/environment.

The provided text describes the 510(k) premarket notification for the GTK Veress Needles, a medical device used in laparoscopic procedures. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing an AI/ML-based device approval. As such, information regarding AI/ML-specific acceptance criteria, ground truth establishment, training/test set sample sizes, and human reader studies (MRMC) is not present.

However, I can extract the relevant acceptance criteria and the study that proves the device meets the acceptance criteria for the GTK Veress Needles as a hardware medical device, based on the provided document.

Acceptance Criteria and Device Performance for GTK Veress Needles

The study demonstrating the device meets acceptance criteria is a series of non-clinical performance tests. The acceptance criteria themselves are implied by the successful completion and meeting of standards for these tests. All listed tests "meet the acceptance criteria," indicating satisfactory performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the sample size (number of devices) used for each non-clinical test. It only states that the tests were "conducted" or "evaluated."
• Data Provenance: The tests are non-clinical, meaning they were likely performed in a laboratory setting by the manufacturer, Guangzhou T.K Medical Instrument Co., Ltd., in China. The data would be internally generated prospective test data.

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

This is not applicable to this type of device submission. Ground truth in this context refers to established engineering and medical device standards (e.g., ISO, ASTM, USP) for performance, sterility, and biocompatibility. There are no human "experts" establishing a "ground truth" in the way one would for an AI/ML-based diagnostic device (e.g., radiologists annotating images).

4. Adjudication Method for the Test Set

Not applicable. The tests are laboratory-based and measured against predefined quantitative or qualitative standards. There is no human subjective assessment requiring adjudication in the context of this submission.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices, especially those incorporating AI, to assess the impact of the technology on human reader performance. The GTK Veress Needles are a surgical instrument, not a diagnostic device.

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

Not applicable. This is not an AI/ML algorithm. The device performance is assessed through its physical, material, and functional characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests for this medical device is based on established international and national standards (e.g., ISO, ASTM, USP) and predefined engineering specifications for acceptable performance (e.g., appearance, size, force, leak resistance). The successful completion of these tests against these benchmarks constitutes the "proof" that the device meets its acceptance criteria for substantial equivalence to a predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires training data.

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

Not applicable. This is not an AI/ML device.

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The GRI-Alleset Veress Needle is a disposable, single-use, sterile device intended to be used in minimally-invasive abdominal procedures for the establishment of pneumoperitoneum.

The GRI-Alleset Veress Needle is a disposable, single-use, sterile surgical instrument used during minimally invasive surgery for the establishment of peritoneum of the abdominal cavity prior to abdominal surgery. The device is comprised of a 14 gauge stainless steel needle (120mm and 150mm in length) which is attached to a plastic handle that contains a stopcock with a luer lock connector. The spring-loaded, blunt stylet extends beyond the needle tip and retracts as the needle is pushed through the abdominal tissue; it automatically advances forward once the peritoneum is penetrated. A red safety indicator, attached to the proximal end of the stylet, is exposed above the handle as an indication of an exposed needle tip. The device is provided sterile via ethylene oxide.

This document describes the premarket notification (510(k)) for the GRI-Alleset Veress Needle, a disposable, single-use, sterile device intended for establishing pneumoperitoneum in minimally invasive abdominal procedures. The submission aims to demonstrate substantial equivalence to a predicate device, the Ethicon Endopath Ultra Veress Needle (K983925).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table as "acceptance criteria." Instead, the document outlines performance tests that were conducted and states that the "results show acceptable results and demonstrate that the GRI-Alleset Veress Needle meets its specifications." The direct comparisons are made against the predicate device.

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

The document does not explicitly state the sample sizes for the test sets used in the biocompatibility, sterilization, mechanical bench testing, or shelf-life studies. It only mentions that these tests were "conducted in comparison with the predicate." The data provenance is not specified, but typically such testing would be performed in a controlled laboratory environment. The studies are prospective in the sense that the new device was evaluated against established standards and a predicate.

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

This information is not provided in the document. For medical devices like a Veress needle, "ground truth" is typically established through adherence to engineering standards, validated test methods, and comparison data from a legally marketed predicate, rather than expert consensus on a test set in the way AI algorithms are evaluated (e.g., image interpretation). The "experts" would be the engineers, quality specialists, and toxicologists conducting and interpreting the tests according to relevant ISO standards.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and the tests performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic accuracy assessments where there might be disagreement among human readers or interpreters. For device performance testing against engineering standards, results are typically objective and measurable.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or AI algorithms where human interpretation is involved. The GRI-Alleset Veress Needle is a surgical instrument, and its effectiveness is assessed through physical and mechanical performance tests, not through reader interpretation.

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

This question is not applicable. The GRI-Alleset Veress Needle is a physical surgical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Established ISO Standards: For biocompatibility (ISO 10993 series) and sterilization (ISO 11135-1).
• Performance Specifications: The device must meet its own design specifications and perform comparably to the legally marketed predicate device (Ethicon Endopath Ultra Veress Needle).
• Predicate Device Performance: The predicate device itself serves as a benchmark for acceptable performance.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are used for machine learning models. The GRI-Alleset Veress Needle is a hardware medical device, and its development does not involve machine learning training sets.

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

This question is not applicable, as there is no training set for a hardware medical device.

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The Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

This document is a 510(k) summary for the WickiMed Veress Needle and provides information on its substantial equivalence to a predicate device. It does not describe an AI/ML powered device, therefore no information about acceptance criteria and studies proving the device meets these criteria as would be relevant for an AI/ML system is available.

The document discusses the following types of non-clinical testing for the Veress Needle:

• Biocompatibility tests: Conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012. These included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, and Material-Mediated Pyrogenicity.
• Sterilization validation: Performed per ISO 11135:2014.
• Performance tests:
  • Tip Pull Test
  • Switch Operation
  • Spring Obturator Operation
  • Needle Puncture Force Test

The document states that "All the test results demonstrate the performance of Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide the specific numerical acceptance criteria for these tests, nor the reported device performance values. It also does not discuss any of the other specific items from your request (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) as these are not relevant to a traditional medical device submission like a Veress Needle.

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The LaparoLight™ Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The LaparoLight™ Veress Needle is a Veress needle that includes an LED indicator. This product is used to establish pneumoperitoneum prior to start of laparoscopic procedure. LaparoLight™ Veress Needle is available in two lengths: 120mm and 150mm to use in different size patients and applications. LaparoLight" Veress Needle is provided sterile and intended for single-use only in a healthcare facility/hospital.

LaparoLight™ Veress Needle includes a spring loaded blunt stylet mechanism. When pressure is applied on blunt tip, it retracts and allows the sharp edge of cannula to cut through the tissue. Product also includes a slip sheet which when pulled activated the LED indicator. LED will turn ON and stay ON as long as the blunt tip of the product is extended forward past sharp edge of cannula. Thus during the puncture of peritoneum wall the LED will turn OFF while there is a pressure against blunt tip and turn back ON when cannula has entered a cavity allowing the blunt tip to spring forward.

In addition LaparoLight™ Veress Needle includes a luer lock for syringe connection to perform saline flow test and insufflation tubing for gas delivery. Stop cock is present downstream of luer lock to control the flow of liquid or gas through the needle with possible positions ON and OFF.

The provided document is a 510(k) premarket notification for a medical device called the LaparoLight™ Veress Needle. It does not present acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/ML-driven diagnostics. Instead, it describes tests performed to demonstrate substantial equivalence to a predicate device for regulatory approval.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and device.

However, I can extract the relevant information regarding performance data presented for the substantial equivalence determination.

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like the Veress Needle, "acceptance criteria" are usually framed as meeting design specifications, industry standards, and demonstrating equivalence to a predicate device through various tests.

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The U-Blade Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The U-Blade Veress Needle is a slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a surgical/radiological procedural method. It is used for percutaneous insertion into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The device consists of an external stainless steel needle tube with a sharp point to puncture tissue. It is also equipped with an internal spring-loaded round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage to internal organs from the sharp point. The subject device also has a handle with a red indicator mark to verify when the spring-loaded obturator is retracted and a valve connector which connects to an insufflation pump.

As described in the following table, the U-Blade Veress Needle is available in 120mm and 150mm needle lengths and two types of handles with different shapes (U shape and Bugle).

This is a sterile and single-use device.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "U-Blade Veress Needle." It outlines the device's intended use, description, non-clinical testing, and a comparison to a predicate device to establish substantial equivalence.

Based on the information provided in the document, here's a breakdown regarding acceptance criteria and the study that proves the device meets them:

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

The document states that "The performance test results demonstrate that the U-Blade Veress Needle meet its acceptance criteria." However, the specific numerical acceptance criteria and the reported device performance values for each test are not quantitatively detailed in this summary. Instead, it lists the types of performance tests conducted:

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

The document does not specify the sample sizes used for the non-clinical performance tests (Tip Pull, Switch Operation, Spring Obturator Operation, Needle Puncture Force Tests). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) submission from "Tianjin UWell Medical Device Manufacturing Co. Ltd." located in China, it's highly probable the testing was conducted in China, but this is not explicitly stated as the data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable to the type of testing described in the document. The studies were non-clinical performance (mechanical/material) tests of a physical device, not studies involving human subjects, image interpretation, or diagnostic accuracy where expert consensus or ground truth would be established by medical professionals.

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

This is not applicable to the non-clinical performance tests conducted. Adjudication methods are typically used in clinical studies or studies involving subjective assessments (e.g., image interpretation) to resolve disagreements among reviewers.

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 conducted as part of this submission. This type of study is relevant for AI-powered diagnostic devices, which the U-Blade Veress Needle is not. It is a physical surgical instrument.

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

A standalone algorithm performance study was not conducted. This device is not an algorithm or software. It is a manually operated surgical instrument.

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

For the non-clinical performance tests, the "ground truth" (or reference standard) would be the specific engineering and material specifications of the device and relevant industry standards (e.g., ISO, ASTM). For example, the "Needle Puncture Force Test" would have an expected range of force for successful puncture, defined by engineering requirements, rather than expert consensus or pathology. The document lists compliance with several ISO standards (ISO 10993-1, -5, -10, -12; ISO 11137-1, -2) which serve as the "ground truth" for biocompatibility and sterilization.

8. The sample size for the training set

There is no mention of a training set because this is not an AI/ML device. The testing described is for a physical medical instrument.

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

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

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a series of non-clinical performance tests and biocompatibility tests.

• Non-Clinical Performance Tests: These included "Tip Pull Test," "Switch Operation Test," "Spring Obturator Operation Test," and "Needle Puncture Force Test." The document states that these tests were performed and their results "demonstrate that the U-Blade Veress Needle meet its acceptance criteria." However, the actual numerical acceptance criteria and the quantitative test results are not provided in this summary document.
• Biocompatibility Tests: These tests were conducted in accordance with ISO 10993 series standards, specifically ISO 10993-1 (general), -5 (cytotoxicity), -10 (irritation and sensitization), and -12 (sample preparation). The device was categorized as an external communicating device with limited contact duration (

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The Unimicro Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The Unimicro Veress Needle is a sterile and single-use product. It incorporates a spring-loaded blunt stylet mechanism. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Unimicro Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

The provided document is a 510(k) summary for the Unimicro Veress Needle. It outlines non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing specific performance metrics against acceptance criteria. Therefore, directly addressing all points of your request for a study proving device acceptance criteria is not fully possible from this document, as it focuses on non-clinical performance and comparison.

However, I can extract the relevant information regarding acceptance criteria and testing where available.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The Unimicro Veress Needle underwent non-clinical testing to demonstrate its safety and effectiveness, and to establish substantial equivalence to its predicate device (Unimax Veress Needle, K111441). The acceptance criteria for these tests were "pre-defined," and the device "met the requirements of the pre-defined acceptance criteria." The specific numerical or qualitative values of these pre-defined acceptance criteria are not explicitly stated in the provided text. The study involved a series of in vitro and in vivo preclinical physical, mechanical, and biocompatibility tests.

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

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

The document does not specify sample sizes for any of the non-clinical tests. It also does not discuss data provenance in terms of country of origin or whether the study was retrospective or prospective, as these are typically considerations for clinical studies and not explicitly for non-clinical lab testing of a medical device's physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The tests described are non-clinical, mechanical, and biocompatibility tests conducted in a laboratory setting. Ground truth in this context would typically refer to established scientific standards (e.g., ISO standards) and objective measurements rather than expert consensus on interpretations of data (as would be the case for medical imaging or diagnostic devices).

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

This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment. The tests performed are objective laboratory tests.

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 diagnostic devices often involving human interpretation and AI assistance, neither of which are discussed for this device. The document explicitly states "non-clinical testing" and compares the device to a predicate based on physical, mechanical, and biocompatibility properties.

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

This information is not applicable and not provided. The device is a physical Veress Needle, not an algorithm or software. Therefore, the concept of standalone algorithm performance is not relevant.

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

The "ground truth" for the non-clinical tests described would be based on objective measurements against established engineering, material, and biological safety standards (e.g., force values, operational efficiency, compliance with ISO 10993 standards for biocompatibility). It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms, which are not involved with this physical medical device.

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

This information is not applicable and not provided as there is no training set for a physical medical device.

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The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The Unimax Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120mm and 150mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

The Unimax Veress Needle is not an AI/ML device, but rather a traditional medical device (a surgical instrument). Therefore, the provided document does not contain the information typically associated with AI/ML device evaluations, such as studies on algorithm performance, human-in-the-loop performance, ground truth establishment for training/test sets, or sample sizes related to AI model development.

The document describes the non-clinical testing performed to demonstrate the safety and effectiveness of the Unimax Veress Needle and its substantial equivalence to a predicate device.

Here's the information extracted from the document based on the provided categories, with "N/A" for criteria not applicable to a non-AI/ML device:

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

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

The document lists "A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests" but does not specify the sample sizes (e.g., number of needles tested for each physical/mechanical test) or the exact provenance of the data (e.g., where the in vivo tests were conducted). It is indicated that the manufacturer is based in Taipei, Taiwan. The tests are non-clinical (preclinical), not clinical data, and appear to be prospective testing of the device itself rather than data collection from a population.

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)

N/A. This is a non-AI/ML device. Ground truth, in the context of AI, refers to expert-labeled data. For a physical medical device, performance is evaluated against engineering specifications and international standards, not against expert interpretation of data.

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

N/A. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI ground truth. For this device, performance is measured against technical specifications and standard compliance.

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

N/A. This is a non-AI/ML device. MRMC studies are used to evaluate diagnostic performance of AI-assisted systems.

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

N/A. This is a non-AI/ML device. "Standalone performance" refers to the performance of an AI algorithm without human involvement.

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

For this medical device, the "ground truth" or standard for acceptance is adherence to recognized international standards (e.g., ISO 10993 series, ISO 11135-1) and demonstrating performance at least equivalent to the predicate device through physical and mechanical testing (e.g., Tip Pull Test, Switch Operation, Spring Obturator Operation, Needle Puncture Force Test). There is no "ground truth" in the AI sense for this type of product.

8. The sample size for the training set

N/A. This is a non-AI/ML device, so there is no training set for an algorithm.

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

N/A. This is a non-AI/ML device, so there is no training set for an algorithm.

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The intended use of the New Device is the establishment of pneumonperitoneum.

The ENDOPATH® Ultra Veress Insufflation Needle has applications in gynecologic laparoscopy and other minimally invasive abdominal procedures for establishment of pneumonperitoneum.

The ENDOPATH® Ultra Veress Insufflation Needle is a spring-loaded, blunt stylet safety mechanism similar in function to a Veress needle. It is used to establish pneumoperitoneum prior to abdominal endoscopy. The 14 gauge stainless steel needle is attached at its proximal end to a plastic handle. The handle is shaped for comfort in the hand and contains a stopcock and a luer lock connector for insufflating the abdominal cavity. Inside the needle sleeve and extending beyond the needle tip is a spring-loaded, blunt stylet. The stylet retracts as the needle is pushed through the abdominal tissue and automatically advances forward once the peritoneum is established.

The provided text describes a 510(k) summary for the ENDOPATH® Ultra Veress Insufflation Needle. This submission is for a medical device that establishes pneumoperitoneum, and as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate device, rather than proving diagnostic performance in the way an AI algorithm or diagnostic test would be evaluated.

Here's the breakdown based on your request, adapted for this type of medical device submission:

Acceptance Criteria and Study for ENDOPATH® Ultra Veress Insufflation Needle

The acceptance criteria for the ENDOPATH® Ultra Veress Insufflation Needle are established by demonstrating that its performance is equivalent to a legally marketed predicate device. This is a common approach for 510(k) submissions, where the new device is shown to be substantially equivalent in terms of safety and effectiveness to an already approved device.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states "From the data generated, it can be concluded that the New Device performed equivalent to the Predicate Device." This "equivalence" is the core of meeting the acceptance criteria for a 510(k) pathway.

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

• Sample Size: The document does not specify the exact sample sizes used for the bench tests. It broadly states "Bench data was used to evaluate the performance."
• Data Provenance: The studies were bench studies conducted by the manufacturer, Ethicon Endo-Surgery, Inc. The exact country of origin is not explicitly stated for the data generation, but the manufacturer is based in Cincinnati, Ohio, USA. The studies are prospective in the sense that they were designed and executed to evaluate the new device's performance against the predicate.

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

This question is not applicable to this type of device submission. The "ground truth" here is the established performance characteristics of the predicate device, not expert consensus on medical images or diagnoses. The FDA evaluates the submission based on engineering and performance data compared to the predicate, and does not involve experts establishing ground truth in the diagnostic sense for these comparisons.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or subjective interpretations. For objective bench performance tests comparing device characteristics, an adjudication method is not relevant.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a diagnostic aid (often AI) on human reader performance, usually in interpreting medical images or data. The ENDOPATH® Ultra Veress Insufflation Needle is a surgical instrument, and its evaluation focuses on physical performance characteristics rather than diagnostic interpretation.

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

• Yes, a form of "standalone" evaluation was done. The performance data presented (flow rate, spring force, audible rate, needle penetration) represent the intrinsic, standalone performance of the device itself, without a "human-in-the-loop" directly influencing these physical metrics during the test. The human element would be in using the device, but the tests evaluate its inherent mechanical and functional characteristics.

7. The Type of Ground Truth Used:

• The "ground truth" for this comparative evaluation is the established and legally marketed performance of the predicate device. The new device's performance metrics were compared to those of the predicate device to establish substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. The device is a mechanical surgical instrument, not an AI algorithm or a statistical model that requires a "training set" in the computational sense. The "training" for such a device would be the engineering design and manufacturing processes, not data-driven learning.

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

This question is not applicable for the same reasons as #8. There is no "training set" or corresponding ground truth establishment in the context of an AI or statistical model.

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