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The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The VECTEC Disposable Pneumoperitoneum Needle is a disposable, single-use, sterile surgical tool used in laparoscopy for insufflation of the abdominal cavity prior to use of a trocar during abdominal surgery. The device is sterilized using a traditional, validated ethylene oxide procedure per ISO 11135-1: 2007 to a SAL of 10t and with acceptable residual EO levels per ISO 10993-7: 2008.

The provided text describes a 510(k) submission for the VECTEC Disposable Pneumoperitoneum Needle, focusing on its substantial equivalence to predicate devices. The performance testing section details the types of tests conducted but does not specify numerical acceptance criteria or detailed performance metrics in the format you requested for AI/software devices. This document is for a physical medical device, not a software or AI device, which explains the absence of some of the requested information.

Here's an attempt to structure the available information according to your request, with an understanding that many fields will be "Not Applicable" or "Not Provided" due to the nature of the device and the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated for each test. For mechanical bench testing, it's implied that "the predicate" (Ethicon Endopath Veress Needle) was used for comparison. For in vivo testing, the text mentions "a full-sized porcine model," but the number of models or tests performed is not specified.
• Data Provenance:
  • Biocompatibility, Sterilization, EO Residuals: Laboratory testing.
  • Mechanical Bench Testing: Benchtop testing, likely in a lab setting, comparing to a predicate device.
  • In Vivo Testing: "full-sized porcine model," indicating animal testing. No country of origin is mentioned for the in vivo data.
• Retrospective or Prospective: These tests would be considered prospective for the purpose of this 510(k) submission.

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

• Number of Experts: For the in vivo testing, it states "conducted by a general surgeon." This implies at least one expert.
• Qualifications of Experts: "a general surgeon with experience in laparoscopy."

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not provided. The tests described are primarily objective performance tests or animal studies, not requiring human consensus for ground truth on a test set in the way a clinical image analysis study would.

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

• MRMC Study: No, this is not an AI or software device. This section is not applicable.
• Effect Size of AI assistance: Not applicable.

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

• Standalone Performance: No, this is not an AI or software device. This section is not applicable.

7. The type of ground truth used

• Ground Truth:
  • For biocompatibility, sterilization, and EO residuals: Established standards and validated laboratory methods (e.g., ISO standards).
  • For mechanical bench testing: Comparison against the established performance of a legally marketed predicate device (Ethicon Endopath Veress Needle).
  • For in vivo testing (needle puncture, gas flow): Direct observation and assessment by a qualified surgeon in a porcine model. This would be considered 'expert observation' or 'functional demonstration'.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device submission; there isn't a "training set" in the context of an AI/ML algorithm. The "training" here would refer to the design and refinement of the physical device based on engineering principles and prior knowledge of medical devices, which isn't described in terms of a data set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the device's design and engineering would be based on established medical device requirements, engineering standards, and the performance characteristics of predicate devices, which the VECTEC device was designed to emulate or be equivalent to.

Summary of Device Type:
It's crucial to reiterate that the VECTEC Disposable Pneumoperitoneum Needle is a physical medical device, not an AI/software device. Therefore, many of the questions related to AI/ML specific concepts (such as test sets for algorithms, human readers, AI assistance, training sets, etc.) are not applicable to this submission. The "study" referenced refers to standard medical device performance testing (biocompatibility, sterilization, mechanical, and in vivo animal testing) to demonstrate substantial equivalence to legally marketed predicate devices.

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The VECTEC Disposable Monopolar Connection Cable is a sterile single-use device used to connect high frequency monopolar electrosurgical generators to various models of electrosurgical surgical instruments during laparoscopic and endoscopic surgery.

The VECTEC Disposable Monopolar Cable is a 2.5 m cable used during routine laparoscopy and endoscopy procedures as the means of conveying high frequency electrical energy from a standard electrosurgical generator to standard electrosurgical instruments during surgery. Examples of such instruments include the range of VECTEC monopolar Scissors, Forceps, Dissectors, and Hook. VECTEC Disposable Monopolar Cables are single-use, sterile devices that are packaged individually and have a 2 or 5-year shelf life providing that the packaging is not damaged. The VECTEC monopolar cable is convenient for use in the operating room while having the high degree of performance expected from a surgical monopolar cable.

The provided text describes the regulatory clearance for the "VECTEC Disposable Monopolar Connection Cable," which is a cable used in electrosurgery. The information requested in the prompt, such as detailed acceptance criteria with numerical performance targets, a specific study proving those targets are met, sample sizes for test and training sets, data provenance, number and qualifications of experts, and adjudication methods, are typically associated with performance evaluations of AI/ML-based medical devices or diagnostics.

The VECTEC Disposable Monopolar Connection Cable, however, is a physical accessory for electrosurgical equipment, not an AI/ML device or diagnostic tool that analyzes data or images. Its performance is assessed through compliance with established safety and electrical standards relevant to medical electrical equipment.

Therefore, much of the requested information does not directly apply to this type of device. I will extract the relevant information from the provided text as it pertains to the device's assessment and then address the non-applicable items.

Acceptance Criteria and Device Performance for VECTEC Disposable Monopolar Connection Cable

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the summary. For devices compliant with international standards like IEC and ISO, testing is typically performed on a representative sample to validate design and manufacturing processes. The document doesn't specify the exact number of units tested.

Data provenance (country of origin, retrospective/prospective) is not relevant in the context of device hardware testing against engineering standards. The testing would have been done in a laboratory setting.

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

This is not applicable as the "ground truth" concept, in the sense of expert consensus on clinical data (e.g., radiology images), is not relevant for the testing of a monopolar connection cable. Compliance with engineering standards (like IEC 60601-2-2 and ISO 11135-1) is verified through objective measurements and validated processes, not expert clinical interpretation.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective interpretation of data, typically by human readers, which is not the case here.

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 is not applicable. The device is a physical cable, not an AI or imaging diagnostic tool. An MRMC study is completely irrelevant for this product.

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

This is not applicable. The device is a physical cable, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is objective compliance with the specified international standards (IEC 60601-2-2 and ISO 11135-1) and demonstrating substantial equivalence to a predicate device. This is established through:

• Objective measurements and tests against the requirements outlined in IEC 60601-2-2 for electrical safety and performance.
• Validation records for the sterilization process according to ISO 11135-1.
• Engineering analysis and comparison (technical specifications, intended use, materials) to show equivalence to the predicate device.

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train AI/ML models. This device is not an AI/ML product.

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

This is not applicable for the reasons stated in point 8.

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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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