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The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument is used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

The SurgiQuest AirSeal® iFS System (cleared as AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000) 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 "AirSeal® iFS"). The cannula, trocar and tube sets are sterile, single-use products. The AirSeal® iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal® iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode. The device contains software. The device is designed for use in hospitals and clinics.

The provided text describes the SurgiQuest AirSeal® iFS System, a laparoscopic insufflator. Here's a breakdown of the requested information, based solely on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a threshold). Instead, it discusses the device's adherence to various engineering and quality standards, and the results of a bench test demonstrating "substantial equivalence."

However, we can infer some "performance" from the bench test mentioned:

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

• Sample Size for Test Set: Not applicable in the context of this document. The study described is an "engineering in-vitro bench test," not a human clinical trial or a dataset of patient cases.
• Data Provenance: Not applicable. The "data" comes from an in-vitro bench test, not from patient data (e.g., country of origin, retrospective/prospective).

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, as the "ground truth" for an engineering bench test is typically defined by the physical parameters being measured and the established performance of a predicate device, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data (e.g., image interpretation), which is not the nature of the described engineering bench test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This document does not mention an MRMC study. The device described is a physical medical device (laparoscopic insufflator), not an AI-powered diagnostic or therapeutic tool that would assist human readers in interpreting medical cases.

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

• Not applicable. The AirSeal® iFS System is a physical device with embedded software for its operation, but it is not an "algorithm only" device in the sense of an AI/ML diagnostic or predictive algorithm. Its performance is evaluated through engineering tests, not standalone clinical performance as an AI algorithm.

7. The Type of Ground Truth Used

• For the described engineering bench test, the "ground truth" or reference for comparison appears to be the performance of a legally marketed predicate device (Olympus High Flow Insufflation Unit UHI-4) in a controlled in-vitro environment, as well as adherence to various industry standards (IEC for electrical safety, ISO for sterilization, biocompatibility, etc.). The goal was to demonstrate "substantial equivalence" to this predicate.

8. The Sample Size for the Training Set

• Not applicable. The device described is a physical medical device. It does not involve a "training set" in the context of machine learning algorithms.

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

• Not applicable. There is no training set for this type of device.

Summary of the Study Discussed:

The document primarily describes an engineering in-vitro bench test (Engineering Test No. 0206151530 01) comparing the SurgiQuest AirSeal® iFS System with its predicate device, the Olympus High Flow Insufflation Unit UHI-4. This test was conducted in a "small cavity" to demonstrate substantial equivalence in performance for the purpose of maintaining pneumorectum. The study concluded that the AirSeal® iFS System is "safe and effective in creating and maintaining pneumorectum" and that its performance is "substantially equivalent" to the predicate. The document also lists adherence to numerous ISO and IEC standards for various aspects of the device (sterilization, biocompatibility, electrical safety, etc.).

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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 subject device of this filing is a modification to the original filing. The modification is to allow the operation of two trocars simultaneously, one AirSeal trocar and one conventional trocar. The predicate filing was a modification to allow the simultaneous operation of two AirSeal* trocars.

Here's a summary of the acceptance criteria and study information for K132169, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes general functionalities that the device's testing aimed to demonstrate.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The text refers to "Engineering Test summaries" but does not provide details on the number of units or test runs.
• Data Provenance: The tests are described as "Engineering Tests." It's highly probable these were conducted internally by SurgiQuest, Inc. in the US (Milford, CT is their location). The data is prospective in nature, as it involves active testing of the device's performance.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable. The tests described are engineering performance tests, not clinical studies requiring expert interpretation of medical data.

4. Adjudication Method for Test Set

Not applicable, as this was an engineering performance study, not a clinical study requiring adjudication of expert interpretations.

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

Not applicable. This submission concerns an insufflator and trocar system, and the studies mentioned are engineering performance tests, not studies analyzing human reader performance with medical images.

6. Standalone Performance Study

Yes, the studies described ("Engineering Test 0627131045 01" and "Engineering Test 0627131059 01") are standalone performance studies. They assess the device's technical capabilities (e.g., smoke evacuation, CO2 consumption) directly.

7. Type of Ground Truth Used

The ground truth for these engineering tests would be derived from:

• Measured physical parameters: Data obtained from sensors and instruments measuring aspects like gas flow, pressure, CO2 consumption, and smoke evacuation rates during simulated procedures.
• Engineering specifications and standards: Adherence to established performance parameters as defined by internal design specifications and relevant industry standards (e.g., ISO for sterility).

8. Sample Size for Training Set

Not applicable. This is an engineering device, not an AI/machine learning algorithm that requires a training set of data.

9. How Ground Truth for Training Set Was Established

Not applicable.

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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 AnchorPort® SIL Kit has applications in abdominal minimally invasive surgical procedures to include single skin incision applications and specifically where the surgeon anticipates using at least three 5mm cannula ports to establish a path of entry for operating endoscopic instruments.

The subject is a surgical trocar and cannula kit is 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 information provided does not contain traditional "acceptance criteria" and "reported device performance" in the context of AI/ML device studies (e.g., sensitivity, specificity, AUC, F1-score). This document is a 510(k) summary for a medical device that is a surgical trocar and cannula kit, not an AI/ML diagnostic or predictive device. Therefore, the questions related to AI/ML specific aspects like sample size for test sets, data provenance, ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through nonclinical (bench top) and in vivo animal studies. The acceptance criteria here are implicitly met by demonstrating that the device performs "at least as safely and effectively as the predicate(s)" across various performance attributes.

Here's a breakdown based on the provided text, adapted to the context of a non-AI/ML device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Bench Data): Not explicitly stated how many devices were tested for each bench test, but it is implied that a sufficient number was used to confirm substantial equivalence. No country of origin is mentioned for the bench data itself, but the submission is from SurgiQuest, Inc. in Orange, CT (USA). This is retrospective for the submission, as the tests were performed to support the 510(k).
• Test Set (Animal Data): The document mentions "in vivo animal studies were performed, including a porcine cholecysectomy." The exact number of animals or procedures is not specified, but it refers to "studies" (plural). No country of origin for the animals is specified, but the submission is from a US company. This is retrospective for the submission.

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

• For the in vivo animal studies, it states: "by surgeons familiar with the predicate device(s)." The exact number and specific qualifications (e.g., years of experience) are not provided. For bench testing, "robust engineering test methods" were used, implying engineers or technical experts established the ground truth (e.g., measurements, performance against specifications), but details are absent.

4. Adjudication method for the test set

• Not applicable/Not specified in the provided text. The evaluation appears to be direct performance assessment (bench tests) and expert observation/assessment (animal studies), rather than an adjudicated review for ground truth establishment.

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, and no MRMC study was performed.

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

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

7. The type of ground truth used

• Bench Data: Objective measurements against engineering specifications and comparison to predicate device performance.
• Animal Data: Direct observation and assessment of device performance by "surgeons familiar with the predicate device(s)" during a surgical procedure (porcine cholecystectomy), with the "clinical outcome" being a success. This can be considered expert observation/assessment and outcome data (no adverse effects).

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. This is not an AI/ML device.

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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.

SurgiQuest AirSeal™ Optical Trocar & Cannula System

This document is a 510(k) premarket notification from the FDA, primarily concerned with establishing substantial equivalence for the SurgiQuest AirSeal™ Optical Trocar & Cannula System to legally marketed predicate devices. It does not contain the detailed information required to answer your specific questions regarding acceptance criteria and study data.

My analysis of the provided text confirms that the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, nor data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect sizes.
6. Results from a standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any study.
8. The sample size for a training set.
9. Information on how ground truth for a training set was established.

This document is a regulatory approval letter based on substantial equivalence, not a detailed technical report of device performance studies. Therefore, it lacks the specific study design and results information you are looking for.

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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 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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