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The Safety Trocar Cannula is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (percutaneous Endoscopic Gastrotomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.

The Safety Trocar Cannula is a sterile, single used for guidewire introduction during a gastrointestinal procedure. The device consists of a safety trocar with passive sharps protection and a cannula.

During a gastrointestinal procedure requiring access via a guidewire, the device is inserted into the stomach under direct visualization via an endoscope. Once inserted, the safety trocar is removed from the cannula that provides smooth surface for the needle to slide out during removal as well as a lumen to facilitate guidewire introduction. The passive safety feature of the proposed Safety Trocar Cannula is activated when the safety trocar is separated from the cannula.

The provided text describes a 510(k) premarket notification for a medical device called "Safety Trocar Cannula." It details the device's intended use, technological characteristics, and evidence for substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving that a device meets those acceptance criteria in the context of an AI/ML algorithm.

The document is for a physical medical device, specifically a "Safety Trocar Cannula," and the performance data presented is for benchtop testing, biocompatibility, and sterilization testing of this physical device. It does not involve any artificial intelligence, machine learning, or software-driven diagnostic capabilities that would require the kind of performance evaluation requested in the prompt.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.

The information provided in the document is about the physical device itself.

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The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

The SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable.

The provided text is a 510(k) summary for the SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000. It describes the device, its indications for use, and some of the testing performed to demonstrate its safety and effectiveness.

However, the document does not contain specific acceptance criteria values or detailed study results (like sample sizes, ground truth establishment, expert qualifications, or MRMC study details) that would allow for a comprehensive answer to your request regarding acceptance criteria and performance studies. The "TESTING" section briefly mentions the device's ability to create and maintain a port of entry, maintain pneumoperitoneum, and aid in smoke evacuation, but it doesn't quantify these abilities with specific metrics or acceptable ranges.

The only specific performance detail mentioned is related to sterilization:

• Sterilization: Achieves a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137:2006 and AAMI TIR 27:2001.

Therefore, based only on the provided text, a complete table of acceptance criteria and device performance as requested, along with details about sample sizes, experts, adjudication, and specific study types (like MRMC or standalone), cannot be fully generated.

Here's what can be extracted and what is missing, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for pneumoperitoneum maintenance, smoke evacuation, and port of entry are descriptive ("adequate," "aid in," "ability to create and maintain") rather than quantifiable metrics with specific thresholds. The document does not provide the numerical results or the specific acceptance thresholds for these aspects beyond stating that they were tested successfully.

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

• Sample size for test set: Not specified in the provided text.
• Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The testing is generally referred to as "simulated laparoscopic surgery."

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

• Not specified in the provided text. The testing mentioned in the document appears to be primarily laboratory/technical testing rather than human-expert-driven ground truth establishment for a diagnostic algorithm.

4. Adjudication method for the test set

• Not applicable/Not specified in the provided text. (No diagnostic algorithm or expert review for ground truth described).

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

• Not applicable/Not specified in the provided text. This is a medical device (trocar and insufflator), not an AI-assisted diagnostic tool.

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

• Not applicable/Not specified in the provided text. This is a medical device, not an algorithm. The device itself performs functions.

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

• For Sterility: Established based on compliance with ISO 11137:2006 and AAMI TIR 27:2001 standards.
• For Functional Performance (Pneumoperitoneum, Smoke Evacuation, Port of Entry): The text implies that the ground truth was based on the device's ability to perform these functions during "simulated laparoscopic surgery" in a manner deemed "adequate" or successful. No further details on how "adequacy" or "success" were quantitatively defined and measured are provided.

8. The sample size for the training set

• Not applicable/Not specified in the provided text. There is no mention of a "training set" as this device is not an AI/machine learning solution.

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

• Not applicable/Not specified in the provided text. No training set is mentioned.

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The SurgiQuest AirSeal ® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

The SurgiQuest AirSeal® Optical Trocar & Cannula Device Description: System with integrated Insufflator DPIS 2000 (the "DPIS System") consists of of the following 2000 major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable.

The DPIS 2000 Unit is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent for a comprehensive understanding:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes various tests and standards met by the device, rather than explicit "acceptance criteria" presented as quantitative thresholds. However, we can infer the performance statements from what was tested and validated.

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The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions. (Note: This Indication has been expanded to include smoke evacuation)

The subject is a surgical trocar and cannula composed of medical grade materials. The device is used to create and maintain a port of entry during endoscopic surgery and evacuate surgical smoke. It incorporates a gas seal utilizing CO2, to maintain pneumoperitoneum during the course of surgery. It is supplied with a re-circulation and filtration pump designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only.

This 510(k) submission does not describe a study involving an AI/ML device, but rather a medical device (trocar and cannula system). Therefore, some of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) is not applicable in this context.

Here's an analysis of the provided text in relation to your request, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions various tests but largely defines them by their purpose rather than explicit quantitative acceptance criteria with corresponding performance metrics. It indicates adherence to standards as the form of "acceptance."

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

Not applicable as this is a physical medical device, not an AI/ML system tested on a dataset. The "tests" described are functional and safety verification tests. The document does not specify the number of units tested for functional performance.

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

Not applicable. Ground truth as typically defined for AI/ML does not apply here. Performance for a physical device is assessed through engineering tests and adherence to standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable.

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 not an AI/ML device or an imaging device requiring human interpretation, so an MRMC study is irrelevant.

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

Not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the functional aspects, "ground truth" would be established by direct measurement of physical parameters (e.g., CO2 pressure for pneumoperitoneum, smoke particle reduction for evacuation) against predefined engineering specifications. For safety and sterility, it's compliance with established international standards (IEC, ISO, AAMI).

8. The Sample Size for the Training Set

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

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

Not applicable.

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The PassPort® Optical Trocar is an access device that may be used with or without visualization that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

The PassPort® Vortex Seal functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

The PassPort® Blunt Tip Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

The PassPort® Shielded Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

The PassPort® Cannula Anchor functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.

The Candidate Devices are a single patient device to be utilized as an access port.

The provided text is a 510(k) summary for several surgical trocar devices. It does not contain information about acceptance criteria or a study proving the device meets said criteria. The document focuses on establishing substantial equivalence to previously cleared predicate devices through device description and indications for use.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance
2. Sample size and data provenance for a test set
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study information
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

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The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic 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 subject is a surgical trocar and cannula composed of medical grade materials. The device is used to create and maintain a port of entry during endoscopic surgery. It incorporates a gas seal utilizing CO2, to maintain pneumoperitoneum during the course of surgery. It is supplied with a re-circulation and filtration pump designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only.

Acceptance Criteria and Device Performance Study for SurgiQuest™ AirSeal™ Optical Trocar & Cannula System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it describes functional requirements and the types of testing performed to demonstrate compliance. The "Reported Device Performance" column reflects what the document states the testing showed.

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

The provided document does not specify the sample size used for the functional performance testing (e.g., number of simulated procedures or test subjects). It states "simulated laparoscopic surgery" for the functional tests.

For sterility validation, ISO 11137:2006 and AAMI TIR 27:2001 are referenced, which are standards for radiation sterilization dose substantiation. These standards inherently involve a statistically significant number of samples, but the exact number for this specific device is not detailed in the summary.

Data Provenance: The data provenance is internal to the manufacturer, SurgiQuest, Inc., as evidenced by the statement "The device has been tested to show..." and "The unit will be tested...". The testing appears to be primarily prospective as it's for pre-market notification to determine substantial equivalence. The country of origin for the data is implicitly the USA, where the company is based.

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

This document does not describe the use of experts to establish a "ground truth" for the functional performance testing. The description indicates engineering and performance testing against industry standards and simulated conditions, rather than expert clinical evaluation for a specific medical outcome. For the safety and sterility testing, the "ground truth" is established by adherence to recognized international standards (IEC, ISO, AAMI).

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as the testing described does not involve subjective interpretations or multiple readers requiring consensus.

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. The SurgiQuest™ AirSeal™ Optical Trocar & Cannula System is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding "human readers improving with AI vs without AI assistance" is not relevant to this device.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

For functional and safety testing, the ground truth is established by:

• Performance against defined simulated conditions: For creating/maintaining port of entry and pneumoperitoneum.
• Adherence to recognized international standards: IEC60601-1, IEC60601-1-2 for electrical safety and emissions; ISO 11137:2006 and AAMI TIR 27:2001 for sterility.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The "training" for the device would be its manufacturing and design optimization processes.

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

Not applicable, as there is no "training set" for this type of device.

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The SurgiQuest™ Elastomeric Optical Trocar and Cannula has applications in abdominal and thoracic 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 subject is a surgical trocar and cannula composed of biosafe materials. The device incorporates an expandable elastomer sheath, which serves to hold the cannula vertically in place during endoscopic surgery. The device is used to create and maintain a port of entry during endoscopic surgery. It is fully disposable and is intended for single use only.

The provided text describes a 510(k) submission for the SurgiQuest™ Elastomeric Optical Trocar & Cannula. However, it does not include detailed acceptance criteria or a comprehensive study report with specific performance metrics that would allow for the construction of the requested table. The "TESTING" section is very brief and general.

Therefore, I cannot fully complete the table and the requested information points. Based on the limited information, here's what can be extracted and what is missing:

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

Missing Information for Table: The document does not provide specific acceptance thresholds (e.g., "maintain position with less than X mm of displacement," "insertion force within Y% of predicate"). It also doesn't provide the actual measured performance values that were achieved in the tests, only a qualitative statement of equivalence.

Regarding the study details:

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

• Sample Size (Test Set): Not specified. The document mentions "bench top and animal testing" but gives no numbers for either.
• Data Provenance: Not specified (e.g., country of origin). The testing included "bench top and animal testing," indicating it was likely prospective testing, but no further details are given.

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. This device is a surgical instrument, not an AI or diagnostic imaging device that would require expert-established ground truth in the traditional sense. Performance is assessed through physical and mechanical testing.

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

• Not applicable. This concept is for diagnostic studies with human interpretation, not for evaluating the mechanical performance of a surgical instrument.

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 not an AI-assisted diagnostic device.

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

• Not applicable. This is not an algorithm or AI device. The testing described ("bench top and animal testing") is a standalone performance evaluation of the physical device.

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

• For the physical properties, the "ground truth" would be established by objective measurements against engineering specifications and comparison to the predicate devices' known performance. The document doesn't detail the specific methods or standards used to define this "ground truth" (e.g., "position maintained" might be measured against a predefined displacement limit, and "forces" against a range from predicate devices).

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device.

Summary of Limitations:

The provided 510(k) summary (K063859) is a regulatory document confirming substantial equivalence to predicate devices for a physical medical instrument. It focuses on declaring that testing was performed and that the results show equivalence. It does not provide the detailed quantitative study results, specific acceptance criteria thresholds, or methodology that would be expected in a scientific publication or a more detailed technical report for an AI/diagnostic device. The information required for many of your points is simply not present in this type of regulatory summary for this kind of device.

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The DeRoyal Industries Disposable Surgical Trocar/Cannula is a single patient use disposable device intended for use during operative and/or diagnostic surgery to puncture/penetrate the abdominal wall and to serve as a port of entry for laparoscopic instruments (i.e. laparoscope, forceps, scissors, aspiration/irrigation cannula, etc.).

The DeRoyal Disposable Surgical Trocar/Cannula is a disposable single patient use device fabricated from surgical grade stainless steels, surgical grade aluminum, and biocompatible medical grade polymers. The device comes in 5, 8, 10/11, and 12 mm diameter cannulas. Cannula length ranges from 75 mm - 100 mm. The cannula diameter can be used with equivalent diameter instruments or scopes, but is also equipped with a detachable integrated reducer diaphragm on all large sizes to bring the compatible diameter down to 5 mm. The trocar/cannula is supplied with either a pyramidal tip cutting trocar with safety shield or with a blunt tip trocar/cannula without safety shield for use with open laparoscopic procedures. The cutting trocar/cannula has a tri-segmented safety shield which is comprised of three shield segments that retract and advance independently. The cannula body has a luer fitting to accommodate insufflation apparatus and an external lever for manual opening of the internal flapper valve for rapid desufflation. The cannula shaft is radiotranslucent.

The acceptance criteria and the study proving the device meets them are not explicitly detailed in the provided text in the way one would typically find for performance metrics of a diagnostic or treatment device. This submission is for a medical device (Disposable Surgical Trocar/Cannula) under a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the context of AI/software.

The provided information emphasizes technological characteristics and intended use for comparison. The core of the submission is to show that the new device is as safe and effective as existing legally marketed predicate devices.

However, based on the provided text, here's an attempt to extract relevant information and highlight what is missing given the structure of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: "Acceptance Criteria" here are inferred from the shared characteristics with predicate devices that formed the basis of the substantial equivalence determination. There are no specific quantitative performance metrics (e.g., success rates, complication rates, force required for penetration) provided in this summary that would typically be associated with explicit acceptance criteria for a clinical study. The "reported device performance" is essentially that it matches the predicate device in key design and material characteristics.

Missing Information (Not provided in the text; these questions are more applicable to software/AI devices or clinical trials for novel devices):

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 is a physical medical device, and the submission focuses on design and material equivalence, not clinical study data, in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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 not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. The "ground truth" for this device's substantial equivalence is its comparability to existing devices in terms of design, materials, and intended use as assessed by the FDA.
8. The sample size for the training set: Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/software device.

Summary of the "Study" and How it Meets Criteria:

The "study" in this context is not a traditional clinical trial or performance study with quantified metrics as you might expect for an AI algorithm or a novel therapeutic. Instead, it is a substantial equivalence comparison to legally marketed predicate devices.

The text states:

• "The DeRoyal Disposable Surgical Trocar/Cannula has similar/same technological characteristics as the predicate devices in that they are comprised of similar design, materials, and are intended to be used as a port of entry for laparoscopic instruments."
• "The proposed device has the same intended use and the same basic technology as the legally marketed predicate devices identified in the premarket notification submission."
• "The proposed device contains, in some combination, similar/same features, materials, and design as the predicate devices and does not pose any new questions concerning safety and effectiveness."

Conclusion: The device meets the implied "acceptance criteria" by demonstrating that its technological characteristics, intended use, materials, and design are substantially equivalent to those of existing, legally marketed predicate devices (Auto Suture® Surgiport® Disposable Trocar & Sleeve and Ethicon Endopath Disposable Surgical Trocar and Sleeve). This process, sanctioned by the FDA's 510(k) pathway, indicates that the device is considered as safe and effective as its predicates without requiring new clinical performance data to directly prove its efficacy or safety.

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Both the Auto Suture* Cannula** and the Auto Suture* Modified Versaport* Trocar (K954108) are intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry

The Auto Suture* Cannula** is a two piece device which consists of a reusable sleeve and a disposable plastic housing with seal adapter. While the Auto Suture* Modified Versaport* Trocar (K954108) is a totally disposable trocar with cannula.

The provided text is a 510(k) summary for a surgical instrument (Trocar Cannula) from 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than conducting extensive clinical studies with acceptance criteria for performance metrics like accuracy, sensitivity, or specificity that are common for diagnostic AI devices.

Therefore, the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not applicable to this 510(k) summary for a manual surgical instrument.

Here's why each point isn't applicable:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) process for this type of device relies on comparing design, materials, and intended use to a legally marketed predicate, not on quantitative performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for this device.
4. Adjudication method for the test set: Not applicable.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

The 510(k) summary provided details about:

• Submitter and Contact Person: United States Surgical Corporation, Janet G. Johnson.
• Date Prepared: August 9, 1996.
• Classification Name: Manual Surgical Instrument for general use.
• Common Name: Trocar Cannula.
• Proprietary Name: Trademark name not yet determined.
• Predicate Device: Auto Suture* Modified Versaport* Trocar (K954108).
• Device Description: A two-piece device consisting of a reusable sleeve and a disposable plastic housing with seal adapter. Compared to the predicate which is totally disposable.
• Intended Use: For use in various endoscopic procedures (gynecologic, general, thoracic, urologic) to create and maintain a port of entry.
• Materials: Component materials are in accordance with ISO Standard #10993-1, indicating biocompatibility assessment.

In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic AI or imaging device, and therefore the requested information regarding performance studies and acceptance criteria is not found within this context.

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