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The devices are indicated for: use in general laparoscopic surgery requiring the use of monopolar electrosurgical cutting and/or coagulation.

The Laparoscopic Electrodes are electrosurgical devices, used for a variety of laparoscopic procedures through a port, for coaqulation and transection of soft tissue and vessels by use of high frequency electric current. The Monopolar cable provides the electrical connection between the Electrode and a suitable electrosurgical generator. Both the Laparoscopic Electrodes and Monopolar cables are single patient use and supplied sterile to healthcare professionals only.

The Laparoscopic Electrodes each consist of a fully insulated, stainless steel shaft. 33cm in length. incorporating three different available types of thermally conductive, insulated metal tip electrodes for conveyance of HF electric current and operated via an ergonomic plastic handle for tactile feedback during surgery procedures. The device should be used through a surgical cannula that has an internal diameter of greater than 5mm.

The Monopolar cable is an insulated copper cord for conveyance of high frequency electrosurgical energy that connects between the HF diathermy connector situated at the end of the handle of the Laparoscopic Electrode and the specified output terminal of a suitable electrosurgical generator (not supplied), with a neutral electrode (not supplied) required to complete the electrosurgery circuit. They are intended for use at a maximum rated voltage of 5.5KVpeak. Coagulation and cutting is achieved using electrosurqical energy supplied via various types of electrosurgical generator.

The associated accessories required to complete the electrosurgical circuit include: Electrosurgical generator. Neutral Electrode.

The provided submission describes a 510(k) premarket notification for "Laparoscopic Electrodes & Monopolar cables" by Purple Surgical International Limited. The submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to meet specific, pre-defined acceptance criteria for a new AI/medical device. Therefore, a direct table of "acceptance criteria" and "reported device performance" in the typical sense of AI model evaluation (e.g., sensitivity, specificity, AUC) is not applicable here.

However, based on the document, we can infer the "acceptance criteria" in the context of a 510(k) submission as demonstrating safety and effectiveness relative to a legally marketed predicate device. The "study that proves the device meets the acceptance criteria" refers to the performance data provided to support substantial equivalence.

Here's an interpretation of your request based on the provided document:

1. Table of Acceptance Criteria (in the context of 510(k) substantial equivalence) and Reported Device Performance:

Details Regarding the "Study" (Performance Data):

As this is a 510(k) submission for a conventional medical device (electrosurgical accessories), not an AI/software device, the questions related to AI-specific evaluation methodologies are largely not applicable. The "studies" here are standard engineering and biological performance tests.

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

• Biocompatibility: The document does not specify the number of samples used for cytotoxicity, sensitization, or irritation testing. These tests typically involve in vitro cell cultures and in vivo animal models (e.g., guinea pigs for sensitization), but specific sample sizes are not provided.
• Electrical Safety & EMC: No specific sample size is mentioned. These tests are usually performed on a representative number of devices according to the standards.
• Functionality Testing: A "simulated surgical procedure, using chicken breast as the test model" was used. The number of devices tested or the amount of chicken breast material is not specified.
• Sterility Testing: No specific sample size is mentioned. Sterility assurance level (SAL) validation typically involves a statistically significant number of samples.
• Shelf Life & Packaging Stability: No specific sample size is mentioned. This usually involves multiple samples tested at various time points (e.g., initial, accelerated aged, and real-time aged).

Data Provenance: The document does not explicitly state the country of origin for the data collection for these performance tests. It's safe to assume they were conducted in certified laboratories, potentially local to the manufacturer or independent testing houses. All tests are inherently prospective as they are conducted specifically to evaluate the new device.

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

• Not Applicable: For these types of physical performance and biocompatibility tests, "ground truth" is established by adherence to recognized international standards and objective measurement, not by expert consensus in the diagnostic sense. The results are typically quantitative measurements or qualitative assessments against defined criteria (e.g., passing/failing a cytotoxicity assay, achieving coagulation effects). No human "experts" are establishing diagnostic ground truth in this context.

4. Adjudication Method for the Test Set:

• Not Applicable: As there are no human-interpreted diagnostic findings to adjudicate, this concept does not apply. Performance is measured against physical and biological standards.

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 device or an imaging device requiring human reader interpretation. Therefore, an MRMC study was not performed.

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

• Not Applicable: This is a physical electrosurgical device, not an algorithm.

7. The Type of Ground Truth Used:

• Objective Measurements and Standard-Defined Criteria: For example:
  • Biocompatibility: Cell viability, skin irritation scores, etc., evaluated against criteria defined in ISO 10993.
  • Electrical Safety: Resistance, leakage current, dielectric strength, etc., measured against limits in IEC 60601 series.
  • Functionality: Observable coagulation and transection effects on tissue, assessed against expectations for electrosurgical devices.
  • Sterility: Absence of microbial growth, assessed against methods in ISO 11137.
  • Shelf Life: Retention of physical properties, sterility, and functionality over time.

8. The Sample Size for the Training Set:

• Not Applicable: There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable: See point 8.

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