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Holder for electrosurqical diathermy system conducting unit and/or other long instruments during surgery. For single use only.

The Quiver Laparoscopic Extendable is a telescoping instrument holder comprised of two separate parts. One component (the outer or top component) has two open ends and the other component has one open end and one closed end. It is provided assembled and sterile, allowing compact storage and shipment then extension by the user to hold long surgical instruments. After use, the device can be collapsed for compact disposal. A loop handle attached to the top can be used for hanging the device in a convenient place.

This document is a 510(k) premarket notification for a medical device called the "Quiver Laparoscopic Extendable." It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets a specific set of acceptance criteria through a full-scale clinical trial in the way a novel AI algorithm might. Therefore, many of the requested items related to "study" and "ground truth" are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with specific quantitative thresholds that the device was required to meet, as would be typical for an AI algorithm. Instead, it lists various evaluations and tests conducted to ensure the device's safety and functionality in comparison to a predicate device. The performance is described qualitatively.

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

The document does not specify a distinct "test set" in the context of clinical data for an AI/algorithm, as this is a physical medical device. The "tests" performed (e.g., Extension/Collapsing Test, Drop Test, Packaging Integrity Test) would involve a sample size of the manufactured device units, but these specific numbers are not provided.

The "data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a data-driven device.

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

Not applicable. This device does not involve expert-established ground truth in the way an AI diagnostic tool would. The ground truth for functional product testing is typically based on engineering specifications and validated test methods.

4. Adjudication method for the test set

Not applicable. There's no adjudication in the sense of expert review for diagnostic agreement in this context.

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 physical instrument holder, not an AI-assisted diagnostic or treatment device.

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

Not applicable. This is a physical instrument holder, not an algorithm.

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

The "ground truth" in this context is based on:

• Engineering Specifications: For dimensional measurements, assembly, and functional parameters.
• International Standards: Such as ISO 11135:2007 for sterilization validation, and EN ISO 14971:2012 for risk management.
• Material Science Principles: For biocompatibility and thermal resistance.
• Internal Quality Control Procedures: For visual inspection and various in-house tests.

8. The sample size for the training set

Not applicable. This is a physical device and does not involve AI model training.

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

Not applicable. This is a physical device and does not involve AI model training.

Summary of the Study (Performance Data):

The document describes the following evaluations and tests performed on the Quiver Laparoscopic Extendable:

• Visual inspection and dimensional measurement of all molded components: To ensure parts meet design specifications.
• Full assembly physical inspection and measurement: To verify proper assembly and final dimensions.
• Extension/Collapsing Test: To confirm the device's ability to extend and collapse as intended.
• Application Test: To verify its function as an instrument holder.
• In-house Drop Test: To assess the device's durability under typical handling conditions.
• Packaging Integrity Test: To ensure the sterility barrier and physical protection of the device during transport and storage.
• Accelerated aging test (real-time aging test ongoing): To predict shelf-life and material stability over time.
• Biocompatibility testing: For hemocompatibility, cytotoxicity, sensitization, irritation, and systemic injection of the material, even though it's not a patient-contact device.
• ETO sterilization method validation: According to ISO 11135:2007 Sterilization of Health Care Products, achieving a Sterility Assurance Level (SAL) of 10^-6.
• Risk evaluation: Conducted in accordance with EN ISO 14971:2012 (Risk Management) and EN 62366:2008 (Usability Engineering), leading to the definition and implementation of mitigation measures for identified risks.

The overall "study" is a collection of engineering and material verification tests aimed at demonstrating that the device is safe and performs as intended, and importantly, is substantially equivalent to the predicate device. These tests, rather than a clinical trial, are the basis for the FDA's 510(k) clearance for this type of device.

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The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.

The Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector. The conductive area is 143 sq cm and the adhesive area is 242 sq cm. Units are packaged individually and typically sold 25 pieces to a box.

This document describes a 510(k) submission for the Nikomed Electrosurgical Grounding Pad. However, the provided text does not contain detailed acceptance criteria or a study design with specific performance metrics (like sensitivity, specificity, AUC, etc.) that are typically associated with AI/ML device evaluations.

The submission is for a medical device that appears to be a passive electrosurgical grounding pad, not an AI/ML-driven diagnostic or therapeutic device. The "SUMMARY of TESTING" section only mentions biocompatibility testing.

Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this particular document.

Here's an attempt to answer the questions based on the provided text, highlighting where information is missing or not applicable:

Description of Acceptance Criteria and Study for Nikomed Electrosurgical Grounding Pad

This 510(k) submission is for a traditional medical device (an electrosurgical grounding pad), not an AI/ML diagnostic or therapeutic device. Consequently, the "acceptance criteria" and "study" described herein are primarily focused on safety, fundamental device function, and substantial equivalence to a predicate device, rather than performance metrics typically associated with AI/ML.

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

Given the nature of the device (an electrosurgical grounding pad), the "acceptance criteria" appear to be related to safety and material compatibility rather than diagnostic performance.

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