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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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The VECTEC Disposable Trocar and Laparoscopic Accessories are single-use, sterile devices intended to provide access to and visualization of body cavities, organs, and canals and to cut, dissect, manipulate, and/or cauterize various tissues during endoscopic/laparoscopic, general, vascular, gynecological and thoracic surgical procedures. Accessories include scissors, forceps, dissectors and a hook.

The VECTEC Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and thoracic surgical procedures) to cut, dissect, manipulate, and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories. The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated ethylene oxide procedure per EN 550:1994 to a SAL of 106 and with acceptable residual EO levels per ISO 0993-7:1995.

Here's a breakdown of the acceptance criteria and the study details for the VECTEC Disposable Trocars and Laparoscopic Accessories, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VECTEC device were based on demonstrating substantial equivalence to predicate devices, particularly regarding safety and performance. The primary performance criteria centered on the dielectric withstand testing requirements for electrosurgical devices.

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

The document does not specify a "test set" in the context of clinical data or patient samples. The performance testing described is bench electrosurgical device performance testing. Therefore, there is no information on sample sizes related to human or animal subjects, nor on data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based on the device itself.

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

This information is not applicable to this submission. The "ground truth" for the performance testing was adherence to the ANSI/AAMI HF-18:2001 standard for dielectric withstand testing and comparison to the characteristics of predicate devices. This is a technical standard rather than a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable. Since there's no clinical test set requiring human interpretation or consensus, there's no adjudication method mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices and bench testing.

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

This question is not applicable. The device is not an algorithm or AI system. It is a physical medical device (trocars and laparoscopic accessories) designed for direct surgical use.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's acceptable performance was primarily:

• Engineering Standards: Meeting the dielectric withstand testing requirements of ANSI/AAMI HF-18:2001.
• Predicate Device Equivalence: Direct comparison of technological characteristics, intended use, materials, and energy source compatibility with already legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

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

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