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The Hemostatix Thermal Scalpel System Handles and Blades are a surgical instrument designed to retain the precise. clean cutting characteristics of a traditional stainless 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 Hemostatix Thermal Scalpel System (HTSS) 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 Hemostatix handle and controller heat the blade to precisely controlled temperature levels to achieve the desired levels of hemostasis during surgery. The temperature of the HTSS's blade can be adjusted from 70°C to 300°C at the touch of button on the handle or the controller.

HTSS 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 HTSS 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 EPROM on the control 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) Footswitch An optional footswitch is available for use with the Model P8400 Controller which allows the user to increase/decrease the blade temperature and to switch from CUT and COAG modes.
c) Handle A disposable scalpel handle, connected to the controller with a lightweight, flexible electrical cable for use with disposable blades.
d) Blades Various sizes of sterile disposable scalpel blades similar in size, shape and sharpness to conventional #10, #12, and #15 scalpel blades.

Here's a breakdown of the acceptance criteria and study information for the Hemostatix Thermal Scalpel System Handles and Blades, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Electrical Safety & Patient Contacting Material Identification: No specific sample sizes are mentioned for these tests, implying they were likely type tests or extensive material characterization rather than statistical sampling of many devices. The data provenance is internal testing by the manufacturer.
• Actual Blade Temp vs. Controller Set-point: Not explicitly stated, but the phrase "original and newly modified blades" suggests at least two distinct units were tested. The data provenance is internal testing by the manufacturer.
• Non-stick Performance (Egg Yolk): 10 samples of Krytox coated blades and an unstated number (likely 10) of ShieldSys coated blades. Data provenance is internal testing by the manufacturer.
• Cutting Performance (Flank Steak): 10 samples of Krytox coated blades and an unstated number (likely 10) of ShieldSys coated blades. Data provenance is internal testing by the manufacturer.
• Country of Origin: Not explicitly stated, but given the US FDA submission, it's presumed to be from within the US or compliant with US standards. The study appears to be entirely prospective as it involves direct testing of the modified device components.

3. Number of Experts and Qualifications for Ground Truth

• None stated. The performance tests described (electrical safety, biocompatibility, temperature accuracy, non-stick, and cutting performance using egg yolk and flank steak) are objective, quantitative, or qualitative assessments that do not rely on expert interpretation for establishing ground truth in the way medical imaging or clinical diagnoses would.

4. Adjudication Method

• None. The described tests are based on objective measurements or qualitative assessments with clear grading criteria (e.g., 1-10 scale), not on expert consensus or adjudication.

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

• No. This type of study is not applicable to the device being described. The Hemostatix Thermal Scalpel System is a surgical instrument for cutting and hemostasis, not a diagnostic imaging device or an AI algorithm that assists human readers. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only) Performance Study

• No. This device is a physical surgical instrument; it is not an algorithm, and thus, a standalone algorithm performance study is not relevant or applicable.

7. Type of Ground Truth Used

• The ground truth for the performance tests was based on:
  • Objective Measurement/Standard Compliance: For Electrical Safety and Actual Blade Temperature, adherence to specified international standards and a defined temperature range.
  • Laboratory Testing: For Biocompatibility, standard ISO tests and an elemental extraction study/toxicological risk assessment.
  • Empirical Performance Metrics: For Non-stick Performance and Cutting Performance, a comparative evaluation against a predicate device using a defined grading scale for specific test materials (egg yolk, flank steak).

8. Sample Size for Training Set

• Not Applicable. This is a hardware device undergoing performance testing, not a machine learning model requiring a training set.

9. How Ground Truth for Training Set was Established

• Not Applicable. As there is no training set, there is no ground truth for it.

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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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