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Cutting, Grasping and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparosopic) Surigcal Procedures.

The Monopolar Sinqle Use Laparoscopic Instruments of Getsch + Hiller is available in two different designs. It is available as system consisting of two parts and as a system consisting of four parts.

The 2-part system is available with reusable handle assembled with a completely insulated shaft on which only a single use tip has to be fixed by the user. This has a working length of 330 mm.

The 4-part system consists of a reusable handle and a reusable shaft insulated, a connection rod with easy snap lock and a single use tip. The system has to be assembled by the user. The 4-part system is available with a working length of 330 mm and 450 mm.

Different types of single use tips are offered for both systems, Maryland grasping forceps, Endoclinch grasping forceps, Aggressive grasping forceps and Johan grasping forceps. Furthermore Metzenbaum scissors in different sizes, straight or curved, are available.

The systems are intended to be used in laparoscopy is an optical examination and diagnostic procedure in which the abdominal cavity and the organs contained therein (liver, gall bladder, spleen, uterus, etc.) are mirrored with an endoscope. During a laparoscopy, in addition to the diagnosis, surgical procedures and biopsies are also made possible whereby surgical micro-instruments are utilized. The Monopolar Single Use Laparoscopic Instruments have to be used in combination with a monopolar HF connector.

The Monopolar Single Use Laparoscopic Instruments can be connected to U.S. FDA cleared Electrosurgical HF-Generator (e.g. K02464, K053290, K94519 and other FDA cleared HFgenerators) which complies with the IEC 60601-1-2 EMC (Electromagnetic Compatibility) testing requirements.

This document describes the premarket notification (510(k)) for the Monopolar Single Use Laparoscopic Instruments. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of its own performance against pre-defined acceptance criteria for a novel AI device.

Therefore, many of the requested categories regarding acceptance criteria, extensive study details for a new device, sample sizes, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of submission. This document highlights a comparison of a new device to existing legally marketed devices, demonstrating similar technological characteristics and performance through testing against established standards for medical devices, rather than a novel AI algorithm's performance.

Here's an analysis based on the provided text, indicating where information is not applicable:

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

Since this is a 510(k) for a medical instrument (not an AI device), the "acceptance criteria" are primarily related to safety, effectiveness, and functional specifications, as demonstrated by adherence to recognized standards and comparison to predicate devices, rather than a quantifiable performance metric for an AI algorithm.

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: Not explicitly stated in terms of numerical units for each test (e.g., number of instruments tested for biocompatibility, electrical safety, or sterilization). The testing is described qualitatively.
• Data Provenance: Not specified. Testing likely occurred at the manufacturer's facilities or a certified testing lab. Given the manufacturer is in Germany, some testing may have occurred there.
• Retrospective or Prospective: Not applicable in the context of device performance testing. These are direct product tests.

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 question is not applicable. This submission is for a physical surgical instrument, not an AI diagnostic device where expert ground truth is required. The "ground truth" for this device's performance is established by objective engineering and biological safety standards (e.g., ISO, EN standards) and functional testing, not expert consensus on medical images or diagnoses.

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for medical data, which is not relevant for the functional and safety testing of a physical 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

• This question is not applicable. An MRMC study is designed for AI-assisted diagnostic tools involving human readers interpreting medical cases. This device is a surgical instrument and does not involve AI assistance or human readers in this context.

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

• This question is not applicable. This device is a manual surgical instrument, not an AI algorithm.

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

• The "ground truth" for this device's performance is based on objective engineering standards, biological safety standards (e.g., ISO 10993-1, EN 60601-1, EN 60601-2-2), and validated test methods. It is not derived from expert consensus, pathology, or outcomes data in the sense typically associated with diagnostic algorithms.

8. The sample size for the training set

• This question is not applicable. This device is a physical surgical instrument, not an AI algorithm that requires a training set.

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

• This question is not applicable. Since there is no AI algorithm or training set, the concept of establishing ground truth for a training set does not apply.

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Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.

The Disposable Re-New Forceps Laparoscopic Surgical Tips are an extension of the Re-New Forceps Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures. The Disposable Re-New Forceps Laparoscopic Surgical Tips consist of a series disposable tip configurations. Tip configurations include: Grasper, Fenestreded Forceps, "Dolphin Nose" Dissector, "Babcock", and "Maryland" Dissector.

The provided text is a 510(k) Summary and related FDA correspondence for the "Disposable Re-New Forceps Laparoscopic Surgical Tips." This document primarily focuses on establishing substantial equivalence to a predicate device and gaining market clearance. It does not contain information about acceptance criteria or specific studies proving the device meets particular performance metrics.

The device in question is a manual surgical instrument, not an AI/ML-driven medical device. Therefore, many of the requested fields related to AI/ML device evaluation (like MRMC studies, training set details, or ground truth for AI) are not applicable.

Here's a breakdown based on the provided text, highlighting the absence of the requested information:

Acceptance Criteria and Device Performance Study

As this device is a manual surgical instrument and the documentation is for 510(k) premarket notification, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against specific acceptance criteria. The document states:

• "The technical characteristics of the Disposable Re-New Forceps Laparoscopic Surgical Tips are identical to those of the Microline Re-New Forceps (K974066)."
• "Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Disposable Re-New Forceps relative to its predicate."

This indicates that the acceptance criteria are implicitly met by demonstrating sameness or non-inferiority in safety and effectiveness compared to the predicate device. Specific quantitative performance metrics and acceptance thresholds are not detailed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The 510(k) summary does not describe a "test set" in the context of an AI/ML or diagnostic device validation. The evaluation is based on a comparison of device characteristics to a predicate, not on clinical performance data from a specific test set.

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

Not applicable. No "ground truth" or expert consensus is described for device validation in this 510(k) summary.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is 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. This is a manual surgical instrument, 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 device is a manual instrument, not an algorithm.

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

Not applicable. No ground truth is described. The evaluation relies on demonstrating substantial equivalence to a predicate device based on technical characteristics, materials, and intended use.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set mentioned.

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

Not applicable. As there's no training set, there's no ground truth establishment for it.

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