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These devices are intended for use in providing tracheal access for airway management.
These devices are also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.

The subject devices are sterile, single use dual cannula tracheostomy tube that has 90° curve and biocompatible radiopaque outer cannula with a distal or proximal extension (XLT) designed for patients with challenging anatomy.

All tracheostomy tubes feature flexible disposable inner cannula with full circumference at proximal end and a flexible laser-etched flange with integrated standard 15mm connector. The cuffed devices are provided with low-pressure TaperGuard™ cuff, featuring a thin compliant wall that, when inflated, adapts and conforms to the irregular borders of the tracheal wall. The cuffed devices have an inflation system consisting of an inflation line, pilot balloon and self-sealing inflation valve, allowing for inflation and deflation of the cuff.

The subject devices are manufactured from medical grade polyvinyl chloride (PVC) with non-Di(2-ethylhexyl) phthalate (DEHP) plasticizer and are sterilized by ethylene oxide (EO) sterilization method.

The cuffed and cuffless configurations of subject devices with distal and proximal extensions are available in four (4) sizes from 5.0mm to 8.0mm.

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The Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is indicated for use in the routine monitoring of temperature, as well as heart and respiratory sounds, in an anesthetized patient. The device is intended for insertion into the esophagus.

The subject device of this premarket 510(k) notification is referred to as the Mon‑a‑Therm™ Esophageal Stethoscope with Temperature Sensor 400TM.

The legacy Esophageal Stethoscope (K811862) was originally cleared on July 10, 1981, under the name "Hi-Lo Temp® Esophageal Stethoscope with a Thermistor Sensor." It has since been renamed to "Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM."

The Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is currently the marketed device that is undergoing a material modification to eliminate DEHP and Phthalates.

The Mon‑a‑Therm™ Esophageal Stethoscope with Temperature Sensor 400TM monitors temperature and heart and breath sounds.

Features and benefits:

• Soft, thin cuff
• Male Luer fitting conveniently attaches to standard acoustical earpieces
• Long lead wire keeps connector away from the surgical field
• Compatible with most multifunction patient monitors

The Mon‑a‑Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 12 Fr 50/case CFN 90041, 18 Fr 50/case CFN 90042, 24 Fr 50/case CFN 90043, and 9 Fr 50/case CFN 90049. The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package.

A 400 series thermistor is placed in a PVC clear tube and sealed by a blue plastisol cuff. This end of the tube is inserted into the esophagus and directly contacts mucosa. In the opposite end of the tube, there is a luer connector and a thermistor connector. The luer connector should be attached to a standard earpiece and the thermistor connector should be inserted to an appropriate interface cable.

Each probe is electrically connected to a compatible interface cable which is specified in Table 1. The interface cable connects the probe to a patient monitor, which is compatible with the 400 series thermistor, so that the temperature measurement value is displayed on the screen of the monitor. All patient monitors that meet the specifications for the 400 series thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 3: Illustration of Patient Monitor Compatibility.

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The Hugo™ Robotically Assisted Surgery (RAS) System is intended to assist in the accurate control of instruments and accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/graspers, needle holders, electrosurgical tools and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, and suturing during minimally invasive urologic surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative surgical procedures set forth in the Hugo™ RAS System Indications Document.

The Hugo™ RAS System is a modular assembly of devices intended to assist a surgeon with the accurate control of instruments and accessories for performing tele-operative surgical procedures. It is a system of software-operated, electro-mechanical, cable-connected capital equipment with compatible instruments and accessories.

The major components of the Hugo™ RAS System are capital equipment: (1) System Tower, (2) Surgeon Console, and (3) Arm Cart Assemblies (ACAs). Each Arm Cart Assembly (ACA) consists of a movable cart with casters supporting setup arm connected to a modular and extendable robotic arm containing an instrument drive unit (IDU). Instruments and accessories attach to the IDUs of the robotic arms to perform robotically assisted surgery. The Surgeon Console is the surgeon's interface for controlling the Hugo RAS System. The Surgeon Console is operated by the user to control the robotic arms and attached instruments. The System Tower is a mobile cart that houses system computers, high-definition operating room team interactive (ORTI) display, power-management system and cable hooks for cable storage.

Hugo™ RAS system instruments include wristed instruments enabling surgeons to precisely grab, dissect, manipulate and suture tissue. There are nine different wristed instruments currently part of the Hugo™ RAS System grouped into basic instruments and electrosurgical instruments, including Large Needle Driver, Extra Large Needle Driver, Double Fenestrated Grasper, Toothed Grasper, Cadiere Forceps, Secure Cadiere Forceps, Monopolar Curved Shears, Bipolar Maryland Forceps and Bipolar Fenestrated Grasper. Hugo™ RAS system accessories include 3D glasses, surgical drapes, Endoscope Adapters, Sterile Interface Modules, Instrument Key, and Monopolar Tip Covers. These accessories enable the Hugo™ RAS system and instruments to achieve their intended use.

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The devices are indicated for airway management in patients, during surgical procedures involving the head, neck, or mouth, to provide a clear surgical field by directing the circuit and connectors away from the operative area and reduce the risk of kink.

The subject device of this premarket 510(k) notification is referred to as Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye. The Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye has a translucent polyvinyl chloride (PVC) tube shaft with a radiopaque filament along its length. The subject device is offered as cuffless or cuffed in various sizes, for either oral or nasal use. All tubes are single use, sterilized by ethylene oxide, and supplied with a standard 15mm connector. The subject device and its packaging are not made with rubber latex or DEHP.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, and number of murphy eyes.

a) Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye
b) Shiley™ Nasal RAE Tracheal Tube Cuffless Murphy Eye
c) Shiley™ Oral RAE Tracheal Tube Cuffed Murphy Eye
d) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye
e) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye

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These devices are intended for oral or nasal intubation and are indicated for use in airway management, including those procedures requiring flexing of the neck or movement of the patient (e.g., to a lateral or prone position).

The subject devices are sterile, single-use tracheal tubes that incorporate a pre-formed Magill curve and have a continuous stainless-steel spiral wire incorporated into the wall to reduce the risk of collapse or kinking during patient positioning. All tracheal tubes feature standard depth marks, glottic depth marks and 15mm connector. The cuffed devices are provided with two different low-pressure cuff types, featuring a thin compliant wall that, when inflated, adapts and conforms to the irregular borders of the tracheal wall. The cuffed devices have an inflation system consisting of an inflation line, pilot balloon and self-sealing inflation valve, allowing for inflation and deflation of the cuff.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, presence of murphy eye and stylet.

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Sofsilk™ Coated Braided Silk Sutures are indicated for use in soft tissue approximation and/or ligation.

Sofsilk™ 6/0 and 7/0 black braided silk sutures are nonabsorbable, sterile, non-mutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin. This protein is derived from the domesticated silkworm species Bombyx mori of the family bombycidae. The silk fibers are treated to remove the naturally-occurring sericin gum and braided to produce Sofsilk™ surgical silk sutures. The braided sutures are coated uniformly with silicone to reduce capillarity and to increase surface lubricity, which enhances handling characteristics, ease of passage through tissue, and knot run-down properties. Sofsilk™ sutures are colored black with Logwood extract (21CFR73.1410). Sofsilk™ sutures meet all requirements established by the United States Pharmacopeia (USP) and the European Pharmacopeia (EP) for nonabsorbable surgical sutures, Sofsilk™ Coated Braided Silk Suture. Sofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.

The provided text is a 510(k) summary for the Sofsilk™ Coated Braided Silk Suture. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain information about an AI/ML-based device or its performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not discussed in the provided document. The document describes a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence, primarily through bench testing for physical and mechanical performance, and biocompatibility.

The "study" mentioned refers to mechanical and physical bench tests of the suture, not a clinical or AI performance study.

Here's what the document does provide regarding the device's performance evaluation:

• Acceptance Criteria (implied standards compliance):

  • Meets or exceeds requirements of U.S.P. (United States Pharmacopeia) for nonabsorbable surgical sutures.
  • Meets or exceeds requirements of E.P. (European Pharmacopeia) for nonabsorbable surgical sutures.
  • Compliant with ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: Evaluation and testing" for biocompatibility.
  • Sterility Assurance Level (SAL) of 10^-6 for ETO sterilization.

• Reported Device Performance (bench tests):

  • USP/EP diameter: Tested, found equivalent to predicate.
  • USP needle attachment: Tested, found equivalent to predicate.
  • USP tensile strength: Tested, found equivalent to predicate.
  • Biocompatibility: Evaluated and confirmed compliant with ISO 10993-1 for its intended patient contact profile.
  • Shelf life: Stability studies conducted, proposed 5-year shelf life demonstrated.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This further confirms that there was no clinical study, let alone one involving AI/ML performance.

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The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™ stapler. The Signia™ circular adapters are composed of motor-mating connectors, sensor gauges and device communication interfaces to provide functionality and communication between compatible reloads and the Signia™ circular adapters are available in two shaft lengths, standard (25 cm) and extra-long (30 cm).

The Signia™ Circular Adapter are for use with the Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.

This FDA 510(k) summary for the Signia™ Circular Adapter (K240881) does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.

The device in question, the Signia™ Circular Adapter, is a surgical stapler component. The document describes its physical and functional characteristics, and the non-clinical testing performed to establish its substantial equivalence to a predicate device. This testing primarily focuses on device performance, safety, and manufacturing quality, not on the performance of a diagnostic or therapeutic AI/software.

Therefore, I cannot provide a response to your request, as the provided input does not include the details regarding acceptance criteria for an AI/SaMD or a study to demonstrate its performance.

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The Mon-a-Therm™ General Purpose Temperature Probe 400TM is indicated for use in the routine monitoring of temperature in an anesthetized patient. The device is intended primarily for insertion into the esophagus or rectum, although medical judgment may dictate the selection of other anatomical sites such as the nasopharynx for some patients.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is a finished medical device that monitors temperature and are versatile probes that may be used for esophageal, nasopharyngeal or rectal placement.

Features and benefits:

• Fully enclosed sensor helps ensure patient safety
• Satin Slip™ finish for easy insertion ●
• Compatible with most multifunction patient monitors. Refer to Table 1: Summary of Mon-a-. Therm™ 400 Series Thermistor Interface Cables.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 9 Fr 100/case CFN 90050 and 12 Fr 100/case, CFN 90050.The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM components are illustrated in Figure 2.

• 1. Tube Blue
• 2. Sleeve GP
• 3. Thermistor Assembly
• 4. Slurry Mixture

The structure of Mon-a-Therm™ General Purpose Temperature Probe 400TM is illustrated in Figure 3 below. The tip of the probe is sealed with PVC and silicone at the end of the thermistor which is where the sealed tube directly contacts the mucosa as shown in "Detail A".

A temperature probe is located near the distal tip. Refer to Figure 3: Structure of Subject Device. The catheter of the subject device features a frosted external surface, referred to as Satin Slip surface. This specialized surface coating extends across the entire external area of the subject device.

Each probe is electrically connected to a compatible reusable cable which is specified in Table 1: Summary of Mon-a-Therm™ 400 Series Thermistor Interface Cables and compatible monitors by the connector in the tail of the probe. The reusable connects the probe to a patient monitor, which is compatible with YSI-400 Series thermistor, so that the temperature measurement value is displayed on the screen of monitor. All patient monitors that meet the specifications for YSI-400 thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 4: Illustration of Patient Monitor Compatibility.

The provided text is a 510(k) summary for the Mon-a-Therm™ General Purpose Temperature Probe 400TM. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on benchtop performance testing and adherence to relevant standards. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts for image analysis.

Therefore, many of the requested details regarding acceptance criteria for an AI/ML device, and studies involving human readers, ground truth establishment, or multi-reader multi-case (MRMC) studies, are not applicable or described in this document.

However, based on the provided text, I can infer the acceptance criteria for the temperature probe's performance and what demonstrates that the device meets those criteria for certain aspects, primarily focusing on its temperature measurement accuracy.

Here's a breakdown of the available information:

Implied Acceptance Criteria and Reported Device Performance for the Mon-a-Therm™ General Purpose Temperature Probe 400TM

Since this is a thermal probe and not an AI/ML device, the acceptance criteria are not for diagnostic performance metrics like sensitivity, specificity, or AUC, but instead for physical and performance characteristics of a temperature measurement device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that the subject device (Mon-a-Therm™) has been updated to align with the latest regulation EN ISO 80601-2-56:2017, which expanded the required temperature range.

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

• The document mentions "Bench Performance Testing" and specifically a "Verification Test Report for Temperature Accuracy and Storage Temperature" for assessing the impact of PVC material changes on temperature accuracy.
• However, no specific sample sizes (number of probes tested) are provided for these bench tests.
• Data Provenance: This is not explicitly stated in terms of country of origin but is implied to be internal testing conducted by Covidien, Ilc, which is located in Boulder, CO, USA. The testing is described as validation and verification testing, which is typically prospective for new product development.

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

• Not applicable. This is a temperature probe, not an AI/ML device requiring clinical expert interpretation for ground truth. Ground truth for temperature accuracy is established via calibrated reference thermometers and controlled environmental conditions.

4. Adjudication method for the test set:

• Not applicable. No expert adjudication process is described or relevant for this type of device testing.

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 device is a temperature probe, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

• Not applicable. There is no "algorithm only" performance for this device in the context of AI/ML. The device's "standalone" performance refers to its accuracy and other physical characteristics measured against established standards.

7. The type of ground truth used:

• For temperature accuracy, the ground truth is established by calibrated reference standards/thermometers in controlled environments, as per the requirements of standards like EN ISO 80601-2-56.
• For biocompatibility, safety, EMC, usability, and sterilization, the "ground truth" is compliance with the specific requirements and test methods outlined in the cited international standards (e.g., ISO 10993 series, IEC 60601 series).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. No training set for machine learning.

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VLFT10GEN: The Valleylab FT10 energy platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7mm thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.

Valleylab ™FT10 Electrosurgical Generator (VLFT10FXGEN): The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab ™FT10 Vessel Sealing Generator (VLFT10LSGEN): The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

Valleylab™ FT10 Energy Platform (VLFT10GEN): The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. The generator provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion, and vessel-sealing applications (LigaSure/vessel sealing function) and cardiac applications. It is a combination of a full-featured general surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure/Bipolar section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery.

Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN): The Valleylab™ FT10 Electrosurgical Generator is a high frequency electrosurgical only version of the VLFT10GEN Energy Platform. It is intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN): The Valleylab™ FT10 Vessel Sealing Generator is the vessel sealing only version of the VLFT10GEN Energy Platform. It is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

The provided text is a 510(k) summary for a medical device, the Valleylab™ FT10 Energy Platform Software Version 5.0. It describes the device, its intended use, a comparison to a predicate device, and performance data. However, this document does not contain details about a study evaluating a device based on AI/ML. Instead, it describes an electrosurgical generator and highlights performance data related to electrical safety, EMC, software verification/validation, and mechanical testing.

Therefore, I cannot extract information pertaining to:

1. A table of acceptance criteria and the reported device performance regarding AI/ML performance metrics (e.g., sensitivity, specificity, AUC). The document refers to "acceptance criteria" for engineering and safety tests, not for AI performance.
2. Sample sizes used for the test set and the data provenance for AI/ML evaluation.
3. Number of experts used to establish the ground truth for an AI/ML test set and their qualifications.
4. Adjudication method for an AI/ML test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done for AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done for an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/ML.
8. The sample size for the training set for an AI/ML algorithm.
9. How the ground truth for the training set was established for an AI/ML algorithm.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means that no clinical studies (which would typically involve human readers for an MRMC study or large datasets for standalone AI performance) were conducted or included in this 510(k) submission. The "Software verification and validation testing" mentioned is general software quality assurance, not specific to AI/ML model performance.

In summary, the provided text does not contain the information requested about AI/ML device performance and testing.

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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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