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The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurqical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The Valleylab™ SM Smoke Management Pencils are monopolar electrosurgical smoke evacuation pencils intended for cutting and coagulation of tissue while simultaneously removing surgical smoke. The pencils are designed to capture surgical smoke and improve visibility to target tissues, while reducing staff and patient exposure to the hazards of surgical plume. The Valleylab™ SM Smoke Management Extended Nozzle accessories are for use with longer electrodes for deeper access procedures. The predicate device is the Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772.

The proposed devices are compatible with Covidien electrosurgical generators at a maximum peak voltage 4500 Vpk having a 3-prong connector and smoke evacuators having a 3/8" port. Electrode compatibility includes use with standard 3/32" diameter hex and non-hex electrodes. The pencils are available in 10' and 15' tubing/cable lengths models.

This document pertains to the 510(k) premarket notification for the Valleylab™ SM Smoke Management Pencil and accessories. It's important to note that this device is a physical electrosurgical tool and does not contain an AI component. Therefore, much of the requested information regarding acceptance criteria and studies for AI-driven devices (like sample sizes for test sets, ground truth establishment for AI, MRMC studies, standalone algorithm performance, and training set details) is not applicable here.

However, I can extract and present the acceptance criteria and performance testing conducted for this device, which are relevant to its substantial equivalence determination.

Acceptance Criteria and Reported Device Performance

The substantial equivalence determination for the Valleylab™ SM Smoke Management Pencil and accessories is based on meeting various performance standards and demonstrating safety and efficacy comparable to its predicate device (Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772).

Here's a summary of the performance testing and their acceptance criteria, as reported in the 510(k) summary:

Study Details Regarding Acceptance Criteria (as applicable to a non-AI medical device)

Given that this is a 510(k) submission for an electrosurgical pencil and accessories, and not an AI-driven device, the detailed questions regarding AI study methodology are largely not applicable. However, I will address what is known from the provided text for each point:

1. A table of acceptance criteria and the reported device performance: See the table above.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • The document does not specify exact sample sizes for each test (e.g., number of units tested for sterilization, biocompatibility, electrical safety, or bench performance).
   • The data provenance is not explicitly stated in terms of country of origin but is from Covidien LLC, a Medtronic company. The tests would be prospective in nature, as they involve testing the actual device prototypes or production samples against established standards.
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): Not applicable for this type of device testing. Ground truth (e.g., sterility, electrical safety, mechanical integrity) is established by adherence to recognized international and national standards, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Device performance against technical standards is typically assessed through objective measurements, not human adjudication.
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, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, "ground truth" refers to the objective, measurable parameters defined by recognized international and national standards (e.g., ISO for sterilization and biocompatibility, IEC for electrical safety and EMC, ASTM for packaging and shelf-life).
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In conclusion, the Valleylab™ SM Smoke Management Pencil and accessories have undergone rigorous non-clinical performance evaluations against established medical device standards to demonstrate substantial equivalence to a predicate device. The nature of this product as a physical electrosurgical tool means that many of the AI-specific questions are not relevant.

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The Edge™ Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

The Edge™ Insulated Blade Electrode (E1455G) is a sterile, single-use, monopolar electrode intended to conduct radiofrequency (RF) current. It is a coated stainless-steel electrode blade with insulation. It is compatible with electrosurgical pencils that have a 0.093" insertion diameter or commonly referred to as a standard 3/32" insertion diameter, this includes the Covidien Valleylab™ Rocker Switch Pencil Family (SEP5000, SEP5015) cleared in K182772.

The provided FDA 510(k) summary for the Edge™ Insulated Blade Electrode (K210338) describes performance testing, but it fundamentally differs from the study of an AI/ML powered device. This document is for a traditional medical device, an electrosurgical electrode, not a software or AI/ML product. Therefore, the specific questions regarding AI/ML powered devices, such as sample sizes for test/training sets, ground truth establishment for AI, number of experts, adjudication methods, and MRMC studies, are not applicable to this submission.

The "acceptance criteria" and "reported device performance" in this context refer to traditional engineering and biological testing to ensure the device is safe and effective and substantially equivalent to a predicate device, not evaluation of algorithmic accuracy.

Here's an interpretation of the available information for a traditional device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally derived from recognized standards and internal specifications to demonstrate safety and effectiveness and substantial equivalence to the predicate. The performance reported here relates to meeting those standards, not to a specific quantitative metric like sensitivity or specificity.

Regarding AI/ML specific questions (2-9):

Since this is not an AI/ML powered device, the following points are not applicable and cannot be answered from the provided document:

2. Sample sizes for the test set and data provenance: N/A (No AI/ML test set)
3. Number of experts used to establish the ground truth for the test set and their qualifications: N/A (No AI/ML ground truth)
4. Adjudication method: N/A (No AI/ML adjudication)
5. Multi-reader multi-case (MRMC) comparative effectiveness study: N/A (Not an AI-assisted diagnostic/interpretive device)
6. Standalone (algorithm only) performance: N/A (No algorithm in this sense)
7. Type of ground truth used: N/A (No AI/ML ground truth)
8. Sample size for the training set: N/A (No AI/ML training set)
9. How the ground truth for the training set was established: N/A (No AI/ML training set)

This submission demonstrates substantial equivalence for a physical electrosurgical electrode primarily through comparisons of technological characteristics and standard safety and performance testing.

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