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To remove excessive hair prior to placement of defibrillator electrodes.

The Rapid Hair Removal Pads ("RHRP") are intended to be used by medical professionals prior to the placement of DC-Defibrillator, Low Energy electrodes to remove excessive chest and side torso hair from a victim of sudden cardiac arrest. This hair can significantly impede the defibrillator's performance in analyzing the heart's rhythm and delivering an appropriate shock. The primary mechanism of the RHRP is a high-tack adhesive that removes hair from the sites on the chest and side torso on which these electrodes are to be placed, prepping the site for optimal electrode-to-skin contact. RHRP is a single-use product and can be disposed of with other emergency single-use equipment.

To use the RHRP, the user removes the pads from the outer packaging, peels the pads sequentially off the non-stick PET liner backing, and places the adhesive side of the pad at two sites—on the chest and side torso-where the defibrillator electrodes will be placed. The user presses the pads on firmly to adhere them to the hair and skin at those sites. The user then pulls the pads quickly away from the skin in the opposite direction of hair growth. The resulting area is left substantially cleared of hair, decreasing impedance and increasing electrode-to-skin contact.

The provided document describes the FDA 510(k) premarket notification for the "Rapid Hair Removal Pads" (RHRP) and its substantial equivalence determination to a predicate device. The document details performance testing conducted to support this claim, which includes Human Factors/Usability testing, Impedance testing, and Biocompatibility studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with numerical targets, but rather describes the successful outcomes of the tests. Based on the reported findings, we can infer the implicit acceptance criteria met by the device.

• RHRP labeling effectively directs users.
• Application and removal of RHRP can be completed within a reasonable timeframe (implied performance goal).
• No user confusion or error identified. | - Training of ALS personnel and RHRP labeling effectively directed users on proper application and removal.
• Proposed labeling changes will further enhance the user interface.
• Timed simulation: ALS personnel were able to properly place and remove RHRP in under 15 seconds.
• No user confusion or user error identified based on simulation and questionnaire responses. |
  | Impedance Testing | - RHRP application should substantially decrease impedance at electrode placement sites.
• This decrease in impedance should optimize electrode-to-skin contact and aid defibrillation therapy. | - The hair removal accomplished by the RHRP adhesive substantially decreases impedance, thereby optimizing the electrode pad-to-skin contact and aiding defibrillation therapy.
• Impedance readings were taken before and after RHRP application to demonstrate this effect. |
  | Biocompatibility | - No detectable interaction with human cells (cytotoxicity).
• Minimal or temporary skin irritation (human use testing).
• No chemical irritation of the skin.
• The adhesive materials coming into contact with the skin are non-toxic, do not contain color additives, and have no adverse environmental effects (based on manufacturer records). | - Cytotoxicity test results show no detectable interaction between RHRP and human cells, with a reactivity grade of "O".
• Human Use Testing showed only minor and temporary mechanical irritation of the skin.
• No chemical irritation of the skin was experienced after application and removal.
• Analysis of the RHRP adhesive material (based on manufacturer records) deemed them non-toxic, free of color additives, and with no adverse environmental effects. |

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

• Human Factors/Usability Testing:
  • Sample Size: 15 Advanced Life Safety (ALS) trained professionals.
  • Data Provenance: Prospective, conducted in a simulated emergency setting with live human subjects. The country of origin is not specified but is implied to be within the jurisdiction of the FDA submission (USA).
• Impedance Testing:
  • Sample Size: 26 total chest pulls (implying the RHRP was used 26 times, likely on different subjects or areas).
  • Data Provenance: Prospective, as impedance readings were taken before and after RHRP application. Country of origin not specified (implied USA).
• Biocompatibility Studies:
  • Cytotoxicity Test: Sample size not explicitly stated for the test itself, but performed on the device material.
  • Human Use Testing: Sample size not explicitly stated, but implies observation on human subjects.
  • Adhesive Material Analysis: Based on manufacturer records (no specific sample size for a test set provided here).
  • Data Provenance: Assumed prospective for cytotoxicity and human use testing, retrospective/document review for adhesive material analysis. Country of origin for tests not specified (implied USA).

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

• Human Factors/Usability Testing: The "ground truth" here is the ability of ALS personnel to correctly and efficiently use the device without confusion or error. This was established through observation and questionnaire responses from 15 ALS trained professionals. Their specific qualifications are stated as "Advanced Life Safety trained professionals (ALS personnel)".
• Impedance Testing: The "ground truth" is the change in impedance. This was measured objectively using a "CheckTrode Ohm meter" by presumably study personnel, not through expert consensus on images or outcomes.
• Biocompatibility Studies:
  • Cytotoxicity: Measured objectively in a lab setting by trained personnel following established protocols.
  • Human Use Testing: Based on observation of skin reactions, likely by trained medical observers.
  • Adhesive Material Analysis: Based on manufacturer records, implying expert analysis of material composition and safety data by the manufacturer's qualified personnel.

The document does not detail a process of using a specific number of "experts" to establish ground truth in the sense of image interpretation or medical diagnosis for these types of tests.

4. Adjudication Method for the Test Set

• Human Factors/Usability Testing: No explicit adjudication method (like 2+1 or 3+1) is mentioned. User performance was assessed through direct observation during a simulated environment and through post-testing questionnaire responses from the 15 ALS personnel. "No user confusion or user error was identified" suggests a consensus or clear determination from the observed data.
• Impedance Testing: No adjudication method. It relies on objective meter readings.
• Biocompatibility Studies: No adjudication method. Based on laboratory test results and observations.

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

• No MRMC comparative effectiveness study was done or reported. The device is a physical hair removal pad, not an AI or digital diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. As the device is a physical hair removal pad, there is no "algorithm only" performance separate from its interaction with a human user applying it.

7. The Type of Ground Truth Used

• Human Factors/Usability Testing: Observational data (user performance, task completion time) and self-reported feedback (questionnaire responses) from trained professionals.
• Impedance Testing: Objective quantitative measurements (impedance readings in ohms) from a testing device (CheckTrode Ohm meter).
• Biocompatibility Studies: Laboratory assay results (cytotoxicity grade), clinical observation of skin reactions (human use testing), and material composition analysis (manufacturer records).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve AI/machine learning algorithms that require a "training set" in the context of data. The "training" mentioned in the Human Factors study refers to training the ALS personnel on how to use the device.

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

• Not applicable. (See point 8).

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