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

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

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

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

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

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

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

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

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

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InnoClip™ Disposable Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

The InnoClip™ Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

InnoClip™ Disposable Clip Applier consists of a molded handle and trigger, a 360° rotational knob, a cartridge housing shaft and a pair of jaws which is easy for surgeon to hold the operation field in the natural position. This device includes models DC5T1-BX and DC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves.

InnoClip™ Disposable Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Disposable Clip Applier enables the surgeon to apply a maximum number of 10 clips for DC5T1-BX or 16 clips for DC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The pre-loaded clips in the shaft are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.

InnoClip™ Clip Applier has two parts, Reusable Handle and a Disposable Clip Cartridge. The Reusable Handle consists of a molded handle, trigger, openable cover and a 360° rotational knob. The Disposable Clip Cartridge consists of a cartridge housing shaft and a pair of jaws which provide secured of the clip to the targeted vessel. The Disposable Clip Cartridge and the Reusable Handle can be easily assembled together by inserting the Disposable Clip Cartridge through a slot located in the Reusable Handle. This device includes models RC5T1-BX and RC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves.

InnoClip™ Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Clip Applier enables the surgeon to apply a maximum number of 10 clips for RC5T1-BX or 16 clips for RC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The reusable handle design also reduces the surgical cost and waste. The pre-loaded clips in the Disposable Clip Cartridge are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.

The provided text is a 510(k) Summary for the InnoClip™ Disposable Clip Applier and InnoClip™ Clip Applier devices. It describes the device, its intended use, and provides a summary of performance testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it describes performance testing and generally states that the devices "met all acceptance criteria" or "have similar device performance compared to the predicate."

Here's a summary derived from the text:

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

• Sample Size: The document does not specify the exact sample sizes (number of devices, number of clips tested, number of animals) used for any of the performance tests. It mentions performing "in-vitro tests" and "in-vivo ligation tests" but lacks quantitative details on sample size.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It is a submission by "Taiwan Surgical Corporation" but this does not confirm the location of the studies.

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 provided in the document. The tests described (e.g., pull-out force, air leakage, in-vivo ligation) are largely objective performance tests of the device itself rather than assessments requiring human expert interpretation for ground truth.

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

This information is not applicable and not provided in the context of this device. The tests are focused on mechanical and functional performance, not diagnostic interpretations requiring adjudication.

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

This information is not applicable and not provided in the document. This device is a surgical clip applier, not an AI-powered diagnostic tool, so MRMC studies are not relevant.

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

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not involve an algorithm.

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

The concept of "ground truth" as typically defined for AI or diagnostic devices (e.g., expert consensus, pathology, outcomes) is not directly applicable to the performance testing described for this mechanical surgical device. The "ground truth" for these tests would be the objective measurement results (e.g., actual pull-out force, actual air leakage rate, observable successful ligation in a animal model) as measured by laboratory equipment and veterinary observation, compared against pre-defined performance acceptance thresholds or predicate device performance.

8. The sample size for the training set

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not use a training set as would an AI/machine learning model.

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

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not use a training set.

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The use of the product is indicated in endoscopic procedures, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels and tubular structures.

The Clip Applier consists of a handle piece and implantable titanium clips. The Clip Applier handle piece consists of a molded handle and trigger, a 360 degrees rotational knob, a cartridge housing shaft and a pair of jaws which provide secured placement of the clip to the desired vessel. The design enables the surgeon to apply several clips during a laparoscopic procedure without the need for withdrawing and reinserting the Clip Applier each time a clip is put in place and closed. The Clip Applier is designed to be used with a black loaded, sterile cartridge supplied in a sterile pouch. The single use disposable clip cartridge sits inside the shaft of the Clip Applier handle piece. While fully squeezing the hand piece trigger, the cartridge is inserted into the shaft through a slot located in the instrument rear.

This device is a surgical CLIP PLUS Disposable Clip Applier, ML and L models, used in endoscopic procedures for ligating vessels and tubular structures. The document is a 510(k) premarket notification letter from the FDA, approving the device for marketing.

Here’s an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents a comparison of the subject device's performance against a predicate device. The performance data is presented as a comparison, implying that the subject device's results needed to be comparable or equivalent to the predicate.

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

• Sample Size for Test Set: The document does not specify the exact sample size for the performance tests (clip formation, clip gap, pull tests, airtight capability). It refers to "the clips" and "tested clips" without providing numbers.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is "TAIWAN SURGICAL CORPORATION" located in Hsinchu County, Taiwan, suggesting the testing likely occurred in Taiwan. The study appears to be retrospective in the sense that it's a bench test comparison against an existing predicate, not a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the document describes a medical device (clip applier) and its mechanical and material performance, not an AI/algorithm-based diagnostic device requiring expert ground truth for interpretation. The "ground truth" for these tests is based on objective physical measurements and established international standards (e.g., ISO 10993, ISO 11137-2).

4. Adjudication Method for the Test Set

Not applicable for this type of device and performance testing. Adjudication methods like 2+1 or 3+1 are typically used for assessing disagreements among human readers or experts in diagnostic studies, which is not the case here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not applicable to a surgical clip applier.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (a clip applier), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The ground truth used for the performance evaluation includes:

• Objective Measurements: For clip gap, perpendicular clip pull, and parallel clip pull, the "ground truth" is the measured physical property of the clips and their strength.
• Pass/Fail Criteria based on expectations/standards: For clip formation and airtight capability, the "ground truth" is a binary outcome (Pass/Fail) based on whether the clips functioned as intended and prevented air leakage.
• International Standards: For biocompatibility (ISO 10993) and sterilization (ISO 11137-2), the "ground truth" is compliance with these recognized international standards.
• Predicate Device Performance: The primary comparison for "ground truth" or acceptable performance is explicitly stated as the performance of the legally marketed predicate device (MICROLINE PENTAX, K013695).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its design and performance are based on engineering principles, material science, and mechanical testing.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set is not relevant.

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Suction Irrigation is indicated for general purpose use as suction/irrigation device to facilitate lavage during laparoscopic surgery and general surgery. The device functions to aid flushing blood and tissue debris from the surgical site.

The suction irrigation set, consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure. The suction irrigation set is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood. tissue debris, and smoke from the surgical site while the hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.

The provided text describes a 510(k) summary for the "Disposable Suction Irrigation" device by Taiwan Surgical Corporation. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves specific acceptance criteria for a novel device. Therefore, a direct mapping to all requested points is not fully possible as the nature of the submission is different from a typical de novo study evaluating a new device's performance against predefined metrics.

However, based on the information provided, I can extract and infer some details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and relevant standards. The "performance" here refers to the device meeting these criteria, often by being "same" as the predicate or passing specific tests.

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

The document does not explicitly state sample sizes for tests. It details "bench report" findings, meaning the testing was likely conducted in a lab setting. The provenance of the data is from Taiwan Surgical Corporation's internal testing as part of their 510(k) submission. The type of data is prospective as it involves tests specifically conducted for this submission, not retrospective analysis of past data.

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

This information is not provided. For a device like this, the "ground truth" often relates to meeting engineering specifications or established biological safety standards, which are typically assessed by qualified technicians or engineers, rather than clinical experts like radiologists for image-based diagnostics.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to resolve discrepancies, which does not appear to be the primary focus of this type of submission.

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 diagnostic devices that involve human interpretation of medical images or data. The "Disposable Suction Irrigation" is a surgical tool, and its effectiveness is determined by its functional performance and safety, not by human reader interpretation.

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

This question is not applicable as the device is a physical surgical tool and not an algorithm or AI.

7. The Type of Ground Truth Used

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

• Engineering Specifications: Meeting predefined physical dimensions, pressure tolerances, and functional requirements.
• Established Standards: Adherence to international standards like ISO 10993 for biocompatibility and ISO 11137-2:2012 for sterilization.
• Predicate Device Comparison: The predicate device (UNIMAX MEDICAL SYSTEM INC., K103509) serves as a benchmark for comparison, implying its established safety and effectiveness forms part of the "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train AI models. This device is a physical product, not an AI/software device.

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

This information is not applicable for the same reason as point 8.

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