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The Zanza-Click (or Disc-o-Click, or Mini-Click) is a hand held device, consisting primarily of housing, a push button (which the user depresses to excite the piezoelectric crystal by means of a spring), a "Piezo unit" (containing piezoelectric crystal) and electrical output terminals (placed flush to the user's skin) intended to deliver electrical current to the skin.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety:
No cutaneous burns from appropriate use. (Mitigated by: Characterization of Electrical Output, Labeling)	The device output was characterized and determined to be 2.24 kV and up to 222.83mA, with a duration of 30 microseconds. Labeling includes instructions to limit activation (max 10 clicks for adults, 5 for children) and warnings about repeated excessive use on the same site to avoid burns.
Biocompatible patient-contacting materials to prevent adverse skin reactions. (Mitigated by: Biocompatibility Assessment)	Patient-contacting materials (acrylonitrile butadiene styrene (ABS), styrene butadiene copolymer (SBC), and polypropylene) have provided justification supporting biocompatibility for external, single-user contact.
No damage to sensitive tissue (eyes, lips, mouth, open wounds). (Mitigated by: Labeling)	Labeling includes warnings against use in or around sensitive areas (mouth, tongue, eyes, ear canal, etc.), over open wounds or rashes, infected areas, or if sensitive to electric stimulus. Also advises caution on areas lacking normal sensation.
No infection from appropriate use. (Mitigated by: Labeling)	Labeling states the device cannot be sterilized, is for single patient use, and if accidental contact with open wounds/blood occurs, it should be disposed of after disinfection.
No burns/injuries from ignition of flammable substances. (Mitigated by: Labeling)	Labeling warns against use with insect repellent and/or flammable substances containing alcohol, and advises waiting until such substances have thoroughly dried.
No interference with implanted devices or other patient care devices. (Mitigated by: Labeling)	Labeling includes warnings against use if the user has a cardiac pacemaker, implanted defibrillator, or other implanted electronic device, and against use in the presence of electronic monitoring equipment. Electromagnetic Compatibility testing was performed per IEC 60601-1-2:2007.
Accurate targeting of the correct patient population and condition (temporary reduction of itching and swelling from mosquito bites). (Mitigated by: Labeling)	The Indications for Use specify the device is for "temporarily reducing the swelling and itching caused by mosquito bites." Labeling includes warnings that the device was only found to temporarily remove itching and swelling, and advises seeking medical attention for infected bites, and not to use it to remove toxins or infection. A labeling comprehension study indicated users understood cautionary language and instructions.
Effectiveness:
Device must deliver at least 20,000 charges. (Mitigated by: Non-clinical (Bench) Testing, Labeling)	Mechanical degradation testing showed the device delivered at least 25,000 charges before failure. The labeling states, "Works for up to 20,000 clicks!"
Temporary reduction of itching and swelling caused by mosquito bites. (Mitigated by: Human Performance Testing)	At 1 hour (after first application):10% Swelling Reduction: Active Group: 86% (43 of 50) vs. Control (Sham) Group: 48% (24 of 50), with a Fisher's exact p-value < 0.0001 (statistically significant benefit in swelling reduction).75% Itch reduction (post-hoc analysis): Active Group: 96% (48 of 50) vs. Control (Sham) Group: 80% (40 of 50).(Note: For 40% Itch reduction at 1 hour, p=0.62, indicating no significant difference between active and sham for this specific threshold.)

Study Details

The study that proves the device meets the acceptance criteria is a prospective, double-blinded, placebo-controlled clinical study.

1. A table of acceptance criteria and the reported device performance: See table above.
2. Sample size used for the test set and the data provenance:
- Sample Size: 100 subjects (50 in the active group, 50 in the control group).
- Data Provenance: Prospective. The study was conducted in healthy subjects aged 18-65 years. The country of origin is not explicitly stated in the provided text, but Tecnimed S.r.l. is based in Italy, suggesting a European context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The study did not use external experts to establish ground truth in the typical sense of diagnostic image interpretation. Instead, the ground truth for the efficacy endpoint (itch and swelling reduction) was established by:
  - Subject-reported itch levels: On a scale of 0 (no itching) to 10 (severe itching).
  - Investigator-measured swelling: Using a caliper or small ruler to measure length, width, and height of erythema.
- The qualifications of the "investigator" are not specified beyond measuring swelling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- There was no explicit adjudication method described for the test set regarding conflicting interpretations, as the measurements were objective (swelling) or self-reported (itch). The study was double-blinded, meaning neither the subjects nor the investigators knew which device was active.
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, an MRMC comparative effectiveness study was not done. This device is a direct-use medical device, not an AI-powered diagnostic tool requiring human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, the primary efficacy data represents the standalone performance of the device itself (active device vs. sham device) without a human-in-the-loop as it's not a diagnostic system. The "algorithm" here is the piezoelectric stimulation mechanism.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for effectiveness was based on a combination of:
  - Patient-reported outcomes (PRO): Subject's self-assessment of itch level.
  - Direct objective measurements: Investigator's caliper measurements of swelling (erythema size).
8. The sample size for the training set:
- This device (Zanza-Click) does not contain software and therefore does not have a "training set" in the context of machine learning or AI. The performance was derived from the clinical study described.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

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