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The Kronos Electrocautery Device is a single-use, disposable and battery-operated electrocautery device utilized to control bleeding post-biopsy procedure of solid organs (i.e., liver, kidney, lungs, etc.). The Kronos electrosurgical device consists of:

a power supply: Two AA batteries
a Stainless Steel (SS) distal probe with a rounded heated tip that is connected to the handle to cauterize targeted areas of tissue. The tip is heated (75 °C - 100 °C) via electrical current through a coiled wire. The temperature of the distal tip is controlled with a thermistor while the temperature of the tip is distributed with a thermal conductive epoxy.
The ergonomic handle includes an on/off switch and a push button to activate the heated tip.
Kronos Electrocautery Device is available in two models, K10 and K15. K10 model is compatible with 10cm guide needle whereas K15 is compatible with 15cm guide needle.

AI/ML Overview

The provided text describes the Kronos Electrocautery Device, a device for achieving hemostasis through coagulation, and its substantial equivalence to a predicate device (Bovie Cautery Device). It outlines various performance tests and their results.

Here's an analysis of the provided information based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Physical Attributes	Device dimensions meet specifications (distal tip, working length, outer diameter).	All test samples passed testing.
Surface Contamination	Absence of particulates on device surface.	All test samples passed testing.
Time-Temperature Characterization	Device temperature when submerged under water, while turned on, meets specified range (75 °C - 100 °C, as per device description).	All test samples passed testing.
Tensile Test (Distal Tip)	Distal tip tensile force meets specified requirements.	All test samples passed testing.
Animal Testing (Usability)	All Usability Evaluation Ratings for Device Condition (Visual Inspection), Maneuverability to Target Tissue, Device Performance (Blood Control), and Compatibility with Guide Needle Withdrawal Force scored ≥3 (acceptable).	All test samples passed testing.
Histopathological Assessment	No significant differences in thermal damage compared to the predicate device in porcine tissue explants (liver, lung, kidney, skeletal muscle). Similar intensity of thermal damage, structure of cauterized areas, mild cellular damage, and no major thermal damage beyond the active tip.	There were no significant differences between the thermal damage induced by subject device as compared to the predicate device. The subject device is equivalent in safety and efficacy of the predicate device. The intensity of the thermal damage and structure of cauterized areas were similar. Mild cellular damage along with tinctorial changes were found at the site of treatments in all tissues. There was no major thermal damage beyond the active tip of the probe. The subject device induced a stronger thermal injury on the surface of the tissues with visible burn margins separating the treatment sites from the adjacent healthy tissues.
US Clinical Study (Primary Outcomes)	Absence of Hematoma formation; measure and categorize amount of blood loss from biopsy access site; absence of the need for ultrasound examination due to observation of bleeding.	All Test Samples Passed Primary and Secondary Outcomes.
US Clinical Study (Secondary Outcomes)	Absence of secondary reintervention; time to hospital discharge.	All Test Samples Passed Primary and Secondary Outcomes.
OUS Clinical Study (Primary Outcomes)	Absence of Hematoma formation; measure and categorize amount of blood loss from biopsy access site; absence of the need for ultrasound examination due to observation of bleeding.	All Test Samples Passed Primary and Secondary Outcomes.
OUS Clinical Study (Secondary Outcomes)	Absence of secondary reintervention; time to hospital discharge.	All Test Samples Passed Primary and Secondary Outcomes.
Electromagnetic Compatibility (EMC)	Complies with relevant EMC standards (e.g., Radiated Emissions, Electro-Static Discharge Immunity, Radiated, Radio Frequency, Electromagnetic Immunity, Proximity Fields from RF Wireless Communications Equipment, Power Frequency Magnetic Field Immunity Test, Radiated fields in close proximity - Immunity Test, IEC 60601-1-2 Clause 5 Worksheet).	Complies (for all applicable tests based on battery operation).
Electrical Safety (ES)	Complies with relevant ES standards (e.g., Humidity Preconditions, Accessible Parts, Leakage Current Test, Dielectric Strength Means, Ball Pressure Test, Excessive Temperature, Push, Drop (Hand-held and Body-worn), Molding Stress Relief).	Pass (for all applicable tests).
Biocompatibility (Sensitization)	No irritation noted at any test site 24 or 48 hours after challenge patch removal (physiological saline or sesame oil extract).	Non-sensitizer.
Biocompatibility (Irritation)	Primary irritation index (PII) of the test article was 1.0 or less.	Non-irritant.
Biocompatibility (Acute Systemic Toxicity)	No gross abnormalities noted for any animals when necropsied at the conclusion of the 3-day observation period.	Non-cytotoxic.
Biocompatibility (Systemic Toxicity - ISO Materials Mediated Rabbit Pyrogen)	No rabbit administered with the test article extract had a temperature rise ≥0.5℃ at required observation time points during the 3-hour observation period, meeting USP limits.	Non-pyrogenic.
Shelf Life	All acceptance criteria met after 2-year accelerated aging. Device performs as intended to Design Specification.	All acceptance criteria were met. Device will perform as intended. Labeled for 2-year shelf life.
Packaging Validation	Acceptance criteria met for adequate and effective protection and sterile barrier requirements after 2-year accelerated aging.	Acceptance criteria were met. Packaging will provide adequate and effective protection and sterile barrier.
Sterilization Validation	Sterilization process achieves a minimum Sterility Assurance Level (SAL) of 10^-6, with BI results confirming acceptable lethality for fractional, half, and full cycles; subject device successfully adopted to original sterilization validation.	The validation study demonstrated that the sterilization process and equipment are capable of reliably and consistently sterilizing the devices to a minimum SAL of 10-6. The BI results confirm the acceptable lethality of the sterilization cycle to achieve the required SAL of 10-6. Fractional cycles, half cycles, and full cycles met the acceptance criteria. The subject device was successfully adopted to the original sterilization validation.
EO and ECH Residuals	Residual traces of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) are below limits specified in ISO 10993-7.	The residual traces of EO and ECH for the subject device are below the limits specified in ISO 10993-7.
EO and ECH Tolerable Contact Limit (TCL)	TCL of EO and ECH are below limits specified in ISO 10993-7.	The TCL of EO and ECH for the subject device are below the limits specified in ISO 10993-7.
Bacterial Endotoxin Levels	Bacterial endotoxins are not present above the endotoxin limit specified in FDA guidance document (June 2012), USP, and European Pharmacopeia BET 2.6.14.	The test results demonstrated that the bacterial endotoxins were not present above the endotoxin limit specified in FDA guidance document (June 2012), USP, and European Pharmacopeia BET 2.6.14.

2. Sample Sizes Used for the Test Set and Data Provenance

Physical, Surface Contamination, Time-Temperature, Tensile Tests: The document states "All test samples passed testing," but the specific number of samples for each bench test is not provided.
Animal Testing (Usability & Histopathology): "an acute swine model" (number of animals not specified). "four porcine tissue types" (liver, lung, kidney, skeletal muscle) with "triplicated sites" for histopathology.
US Clinical Study: Up to 30 participants. Prospective, non-randomized feasibility study. Data provenance is US (United States).
OUS Clinical Study: Up to 30 participants. Prospective, non-randomized feasibility study. Data provenance is OUS (Outside United States), specific country not mentioned.
EMC, ES, Biocompatibility, Shelf Life, Packaging, Sterilization, Residuals, Endotoxin Tests: "All test samples passed" or "results confirmed," but specific sample sizes for these tests are generally not detailed in this summary.

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

Bench Tests (Physical, etc.): No information about experts or their qualifications is provided; these tests rely on objective measurements.
Animal Testing (Usability): Mentions "All Usability Evaluation Ratings scored ≥3 (acceptable)" but does not specify the number or qualifications of evaluators/experts.
Animal Testing (Histopathological Assessment): Implies evaluation by qualified personnel for histopathological analysis, but the number and specific qualifications are not stated.
Clinical Studies (US & OUS): Clinical outcomes (hematoma formation, blood loss, need for ultrasound, reintervention, hospital discharge) would be assessed by medical professionals, likely physicians. However, the number and specific qualifications of these "experts" (e.g., attending physicians, surgeons, radiologists) who evaluated the outcomes or contributed to the ground truth are not specified in this document.

4. Adjudication Method for the Test Set

No specific adjudication method (e.g., 2+1, 3+1, none) is mentioned for any of the studies or tests. The clinical studies evaluated "Primary Study Outcomes" and "Secondary Study Outcomes" which would imply clinical assessment by treating physicians.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The studies performed (bench, animal, clinical) primarily focused on demonstrating the safety and performance of the Kronos Electrocautery Device itself, and its substantial equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance. The device in question is an electrocautery tool, not an AI software.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not done. This device is a physical electrocautery tool, not an AI algorithm, so a standalone algorithm-only performance study would not be relevant.

7. Type of Ground Truth Used

Physical/Bench Tests: Objective measurements against pre-defined specifications.
Animal Testing: In vivo performance in swine model, and histopathological analysis of porcine tissue. This is a form of objective test data and expert histological assessment.
Clinical Studies (US & OUS): Clinical observations and outcomes data (e.g., absence of hematoma, amount of blood loss, need for ultrasound, reintervention, time to hospital discharge). This is a form of clinical outcome data and physician assessment.

8. Sample Size for the Training Set

Not applicable/Not mentioned. This device is hardware for electrocautery, not a software or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a non-AI device, there is no training set or ground truth establishment method for a training set.

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