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Electro Lube™ NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue sticking and eschar on electrosurgical instruments, including robotic assisted electrosurgical instruments.

Electro Lube NXT is a single-use sterile electrosurgical accessory device intended to be used on electrosurgical electrodes to reduce sticking. It is intended to be used by professional practitioners of electrosurgery in clinical environments where electrosurgery is performed.

Electro Lube NXT is sterilized by irradiation and provided to the end user in an individual sterile barrier package with one bottle containing 4mL of the solution and one foam pad for application of the solution during use included in each pack. The foam pad includes an adhesive backing and barium filament strand of material for radiopacity.

The provided FDA 510(k) clearance letter for Electro Lube NXT does not contain the detailed information necessary to answer all sections of the request regarding acceptance criteria and the study proving the device meets those criteria. Specifically, it lists criteria for various non-clinical tests but does not provide the reported device performance for these tests, nor does it describe a clinical study (like an MRMC study) or details about ground truth establishment, expert qualifications, or sample sizes for clinical data.

The document primarily focuses on non-clinical performance and substantial equivalence to a predicate device, which is typical for a 510(k) submission for this type of device (an electrosurgical accessory).

However, I can extract and infer some information based on the provided text.

Here's an attempt to answer the questions based only on the provided document. For many points, the answer will be "Information not provided in the document."

Acceptance Criteria and Device Performance Study for Electro Lube NXT

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

The document lists various acceptance criteria for non-clinical tests. However, it does not report specific quantitative device performance results against these criteria. Instead, it generally states that the "proposed device is as safe, as effective and performs at least as well as the legally marketed predicate device."

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

• Sample Size for Test Set: Information not provided. The tests described are laboratory/benchtop performance tests, not clinical studies involving patient data.
• Data Provenance (Country of origin, retrospective/prospective): Information not provided. These are non-clinical lab tests, so typical data provenance details like "country of origin" for patient data are not applicable.

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

Information not provided. The "ground truth" for these performance tests would be established by the test protocols themselves and measured by laboratory equipment or validated methods, not primarily by expert consensus in a clinical image interpretation setting. For subjective evaluations (e.g., visual inspection for appearance, odor profile), the experts would be the lab personnel or qualified assessors, but their number and specific qualifications are not detailed.

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

Information not provided. Adjudication methods are typically used in clinical studies with human assessors (e.g., radiologists reviewing images) to resolve discrepancies. This is not applicable to the described non-clinical performance tests.

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

No. An MRMC study was not done. The device is an electrosurgical accessory (a lubricant), not an AI-powered diagnostic imaging device. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device.

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

Not applicable. This is a physical lubricant device, not an algorithm.

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

For the non-clinical tests described, the "ground truth" would be established by:

• Standardized test methods and protocols (e.g., ASTM standards, ISO standards for biocompatibility).
• Quantitative measurements (e.g., weight loss, force measurements, temperature readings).
• Visual inspection against predefined specifications (e.g., clear and homogenous, no particulates).
• In-vitro or benchtop simulations (e.g., tissue models for adherence, eschar removal).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. No training set is used for this device.

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Electro Lube NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue adhesion and eschar on electrosurgical instruments.

Electro Lube NXT is a single-use sterile electrosurgical accessory device intended to be used on electrosurgical electrodes to prevent sticking. It is intended to be used by professional practitioners of electrosurgery in clinical environments where electrosurgery is performed.

Electro Lube NXT is sterilized by irradiation and provided to the end user in an individual sterile barrier package with one bottle containing 4mL of the anti-stick solution and one foam pad for application of the solution during use included in each pack. The foam pad includes an adhesive backing and barium filament strand of material for radiopacity.

The provided text describes the regulatory filing for a medical device (Electro Lube NXT) and details the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. It is not an AI/ML device, so information like sample size for training set, number of experts for ground truth, or MRMC studies are not applicable. However, I can extract the acceptance criteria and the "study" (non-clinical tests) that proves the device meets the criteria.

Acceptance Criteria and Reported Device Performance

The "study" in this context refers to a series of non-clinical tests performed to demonstrate the safety and effectiveness of the Electro Lube NXT, and its substantial equivalence to the predicate device.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify exact sample sizes for each non-clinical test (e.g., number of electrodes tested, number of tissue samples, number of animals for biocompatibility).
   • Data Provenance: Not explicitly stated regarding country of origin. The study appears to be a pre-market non-clinical validation conducted by the manufacturer (STERIS Corporation, based in Mentor, OH, USA), rather than a clinical trial. The tests are likely performed in controlled laboratory settings. The nature of these tests is prospective in the sense that they are specifically designed experiments to evaluate the device.

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

   • Not applicable as this is a non-AI/ML device. The "ground truth" for these tests isn't established by human experts interpreting data. Instead, it's determined by objective measurements and standardized protocols for physical and chemical properties, and biological responses.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where inter-reader variability needs to be resolved for establishing ground truth. For non-clinical device performance testing, results are based on direct measurement against defined criteria.

4. 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/ML device, and no MRMC study or assessment of human reader improvement is mentioned or relevant.

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

   • Not applicable. This is not an AI/ML device involving an algorithm. The "performance" is the device's physical, chemical, and biological interaction, not an algorithmic prediction.

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

   • The "ground truth" for this device's non-clinical performance is defined by established scientific and engineering principles, material science, and biological compatibility standards. For example:
     • Physical/Chemical Properties: Measured values (e.g., flash point, viscosity) compared to specified thresholds.
     • Functional Performance: Observations of the device's behavior (e.g., coating ability, eschar removal, cutting force) under controlled experimental conditions, often compared to an uncoated or predicate substance.
     • Biocompatibility: Standardized in vitro and in vivo tests (e.g., cytotoxicity, sensitization, systemic toxicity) with results compared against acceptable biological response criteria.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that undergoes a "training" phase.

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set mentioned for this device.

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