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The Shaw Scalpel System Controller (Model SG6) is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional stainless steel scalpel and to minimize blood loss by sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated temperature blade.

The Shaw Scalpel System Controller (Model SG6) is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade. The system utilizes a razor-sharp blade coated with proprietary thick-film inks which when used with the handle and controller heat the blade to precisely controlled temperature levels to achieve the desired levels of hemostasis during surgery. The temperature of the Shaw Scalpel System's blade can be adjusted from 70° C to 300° C at the touch of button on the handle or the controller. The Shaw Scalpel System is intended to provide hemostasis as the surgeon incises. The sharpness of the steel blade and scalpel pressure provides the incising action. The steel blade is covered with a black non-stick coating. Below the non-stick coating surface and a layer of insulation is temperature-controlled micro- circuitry which transfers heat uniformly to the entire blade. The Shaw Scalpel System consists of the following main components: a) Controller An electronic power supply/controller that energizes the blade and provides various automatic calibration, sensing, and control functions. It has user controls with visual and audible indications of instrument status. The controller includes software installed on a PCBA. The software monitors the resistance of the blade which it uses to calculate the amount of power needed to be applied to the blade to maintain the temperature setting on the controller. b) Disposable Handle and Blade Both the subject and the Predicate Controllers utilize a sterile disposable scalpel handle and blade, connected to the controller with a light- weight, flexible electrical cable for use with disposable blades. Handles and blades were cleared via 510 (k) K002021. c) Footswitch An optional footswitch is available for use with the Controller which allows the user to increase/decrease the blade temperature and to switch from CUT and COAG modes. The footswitch was cleared via K091107.

The provided text describes the Shaw Scalpel System Controller (Model SG6) and its comparison to a predicate device, the Hemostatix Model P8400 Thermal Scalpel System Controller. The submission focuses on demonstrating substantial equivalence rather than a new clinical study. Therefore, the information typically requested for AI/ML device studies (such as MRMC, standalone performance, training set details, and specific ground truth provenance for complex algorithms) is not directly applicable or available in this document.

However, I can extract information related to the device's performance verification and usability testing, which include acceptance criteria and study details.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Electrical Safety & Blade Temperature Tests: The sample size is not explicitly stated for these engineering tests. It would typically involve multiple units tested under various conditions to ensure compliance. Data provenance is implied to be from the manufacturer's internal testing or an independent laboratory dedicated to device performance verification.
• Human Factors Usability Testing:
  • Sample Size: 30 participants (15 in the non-sterile group, 15 in the sterile group).
  • Data Provenance: Prospective, conducted as part of the device's development and validation. The study was conducted by C2Dx, Inc.

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

• Electrical Safety & Blade Temperature Tests: N/A. Ground truth for these engineering tests is based on predefined technical specifications and standards (e.g., IEC standards, temperature tolerances). Expert interpretation for ground truth is not applicable in the same way it would be for diagnostic AI.
• Human Factors Usability Testing:
  • Number of Participants (representing users): 30 participants.
  • Qualifications (not "experts" in ground truth, but representative users):
    • Non-sterile group: 15 circulating nurses.
    • Sterile group: 11 scrub techs and 4 surgeons.
  • These individuals acted as the "ground truth" in terms of user interaction and usability of the device for its intended purpose.

4. Adjudication Method for the Test Set

• Electrical Safety & Blade Temperature Tests: N/A. These tests involve direct measurement against established quantitative thresholds rather than expert adjudication.
• Human Factors Usability Testing: The document does not specify an "adjudication method" in the typical sense of resolving disagreements among experts for ground truth. Instead, it describes a usability study where participants' interactions and feedback are assessed against predefined usability parameters and safety criteria. The "acceptance criteria" for usability were met, implying that user performance and feedback were deemed satisfactory without requiring a separate adjudication panel.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for a hardware device, focusing on demonstrating substantial equivalence to a predicate device through engineering verification and usability testing, not on comparing diagnostic or treatment effectiveness of human readers with vs. without AI assistance. The device is an electrosurgical scalpel system, not an AI/ML diagnostic aid.

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

Yes, in essence, the pure "standalone" performance relates to the intrinsic functioning of the device's control software and hardware.

• The Electrical Safety tests and Actual Blade Temperature vs. Controller Set-point tests demonstrate the standalone performance of the device's electrical systems and temperature control algorithms without human intervention beyond activating the device and setting parameters.
• The software within the controller is responsible for monitoring temperature sensors and controlling power to maintain the set temperature. This functionality operates autonomously in a "standalone" fashion.

7. The Type of Ground Truth Used

• Electrical Safety: Ground truth is based on engineering standards and regulatory requirements (e.g., IEC 60601-1, IEC 60601-1-2).
• Actual Blade Temperature vs. Controller Set-point: Ground truth is defined by specific quantitative temperature tolerances (+10°, -20° C) relative to the set-point. These are engineering specifications.
• Human Factors Usability Testing: Ground truth relates to "safe and effective use" as determined by established usability practices (ANSI AAMI HE75) and user performance/feedback during simulated use.

8. The Sample Size for the Training Set

N/A. This product is a hardware device with embedded control software, not a machine learning model that requires a "training set" in the conventional sense of AI/ML development. The software capabilities are determined by traditional programming and control algorithms, not by learning from large datasets.

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

N/A, as there is no "training set" for an AI/ML model for this device. The software logic and control parameters are designed and validated through engineering principles and testing, not learned from data.

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The Model P8400 Hemostatix Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

The Model P8400 Hemostatix Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade. The Model P8400 Hemostatix Thermal Scalpel System has the same intended use; the same technological characteristics; power modality; mode of operation: utilizes the same scalpel blades; has many of the same audible sounds and alarms; handles that are sterilized the same way (EO gas); same operating temperature ranges (70° C to 300° C), and, utilizes the same blades as the predicate device, the Hemostatix Model 2400Z Thermal Scalpel System cleared via 510(k) No .: K033089. The Model P8400 Hemostatix Thermal Scalpel System differs from the predicate device in that the Model P8400 Hemostatix Thermal Scalpel System features an aluminum enclosure vs. a thermoplastic enclosure for the Hemostatix Model 2400Z Thermal Scalpel System; requires a different handle with a unique plug-in connector which is not compatible with the Hemostatix Model 2400Z Thermal Scalpel System; will accommodate an optional footswitch to control the functions of the handle and blade; will mount on an IV pole unlike the Hemostatix Model 2400Z Thermal Scalpel System; has one multi-color 4.6 in x 3.4 in TFT display vs. two displays (1.5 in x 3 in - three color and 0.5 in x 3 in monochromatic message center); and is designed to be UL 60601-1 Type BF versus a Type B for the Hemostatix Model 2400Z Thermal Scalpel System.

Here's a breakdown of the acceptance criteria and study information for the K091107 Thermal Scalpel System, based on the provided documents:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Blade Temperature Test: Not explicitly stated as a "sample size" in terms of number of devices or blades, but measurements were taken over a range of set points (150°C and 300°C) with a thermocouple. The test was conducted in "still air without load applied to the blades," implying a controlled laboratory setting.
   • Hemostasis Test: Involved "controlled animal testing." The specific number of animals or trials is not provided.
   • Data Provenance: The tests were conducted internally by Hemostatix Medical Technologies, LLC, likely in a laboratory or preclinical setting. No information on country of origin for the data is provided beyond the company's location in Bartlett, TN, USA. The studies appear to be prospective for the purpose of demonstrating substantial equivalence.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Blade Temperature Test: Ground truth was established through direct temperature measurements using a thermocouple. No human experts were involved in establishing this ground truth directly for the test.
   • Hemostasis Test: Hemostasis was "judged on a 0 to 5 scale." The number and qualifications of the individuals who performed this judgment (i.e., established the ground truth) are not specified in the provided summary.

3. Adjudication Method for the Test Set:

   • Blade Temperature Test: Not applicable (direct instrumental measurement).
   • Hemostasis Test: The summary states hemostasis was "judged," but it does not describe an adjudication method (e.g., whether multiple graders were used, if there was a consensus process, or a tie-breaking rule).

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:

   • No MRMC study was reported. This device is a thermal scalpel, not an AI/software device that assists human readers.

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

   • Not applicable. This is a hardware medical device; it's not an algorithm or AI. The performance studies describe the device's inherent functional capabilities.

6. The Type of Ground Truth Used:

   • Blade Temperature Test: Instrumental measurements (thermocouple readings) served as the ground truth.
   • Hemostasis Test: Expert judgment on a 0-5 scale, based on controlled animal testing.

7. The Sample Size for the Training Set:

   • Not applicable. This device is a thermal scalpel, not a machine learning model. There is no "training set."

8. How the Ground Truth for the Training Set Was Established:

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

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