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The Zap-It! is a hand held device, consisting primarily of housing, a push button (which the user de presses to excite the piezoelectric crystal), 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 summary of the acceptance criteria for Zap-It! and the study data proving it meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance for Zap-It!

Acceptance Criteria Category	Specific Criteria	Reported Device Performance / Study Findings
I. Effectiveness	Primary Outcome: Proportion of subjects whose itching at t=15 minutes decreased 40% or greater relative to baseline itching at t=5 minutes (Visual Analog Scale - VAS).	Achieved. 19 out of 27 (70.4%) active treatment subjects met the success criterion, compared to 3 out of 26 (11.5%) placebo subjects. The difference was statistically significant (p<0.05). Mean VAS score for the active group was statistically significantly lower than the placebo group at all time points after baseline.
II. Safety (General)	No adverse events reported during human performance study. Risks of cutaneous burns, adverse skin reactions, damage to sensitive tissue, infection, burns from flammable substances, interference with implanted devices, failure to identify correct population/condition, and device failure are appropriately mitigated.	Achieved. "Subjects were monitored for 24 hours and no adverse events were noted." All identified risks are mitigated through labeling, biocompatibility assessment, and non-clinical testing.
III. Device Performance	Electrical Output Specifications: Characterization of total charge delivered, maximum instantaneous output current, maximum instantaneous output voltage, pulse duration, charge density.	Achieved. Open circuit output measured as 13kV, 0.7mA, and 20 µS pulse duration. Specifics on total charge delivered and charge density are not explicitly detailed in the summary but fall under the general heading of characterization.
	Mechanical Bench Testing: Device withstands labeled number/duration of uses.	Achieved. Testing showed the device still conferred charge after 5000 actuations, though with a 34% decrease in measured open circuit voltage. Labeling advises users to replace the device after "several (e.g., 1,000) uses" if effectiveness degrades.
	Biocompatibility: All patient-contacting materials assessed to be biocompatible.	Achieved. Justification was provided supporting biocompatibility of the acrylonitrile butadiene styrene (ABS) patient-contacting material for an externally-contacting device.
IV. Labeling & Usability	Validated Instructions: Addresses appropriate/inappropriate body areas, conjunction with flammable materials, use near implanted devices, and identification of skin condition. Technical Parameters: Includes max output voltage, current, and pulse duration. Adverse Event Reporting: Directs users to manufacturer and MedWatch. Anticipated Uses: States anticipated number of uses prior to failure.	Achieved. The labeling addresses all these points: warnings against using with pacemakers, over open wounds, eyes, lips, inside mouth, over viral lesions; warnings regarding flammable materials; instructions on maximum 5 activations per bite to mitigate burns; stating the device's effectiveness degrades over time and to replace after "several (e.g., 1,000) uses"; explicit output parameters (13kV, 0.7mA, 10µS); and instructions for reporting adverse events to the manufacturer and MedWatch. The labeling comprehension study also demonstrated that 15 subjects understood the cautionary language and instructions for use.
V. Population	Safe and effective in the intended user population (adults and adolescents). Neonates, infants, and children excluded.	Achieved for adults; extrapolated for adolescents. The clinical trial enrolled healthy subjects 18-65 years of age. Data was extrapolated to adolescents "based on the similarities of skin between adults and adolescents." Labeling explicitly states safety and effectiveness "has not been established in neonates, infants and children."

Study Details:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: 53 healthy subjects (18-65 years of age) with a history of mosquito bite reaction. Randomized 1:1 into active treatment (n=27) and placebo (n=26) groups.
- Data Provenance: The study was a clinical trial, implying prospective data collection. The location/country of origin of the data is not explicitly stated in the provided text, but it’s a regulatory submission to the FDA (indicating likely a US-based study or one for US market approval).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / No external experts needed for ground truth. For this device, the "ground truth" for effectiveness was the subjects' self-reported itching via a Visual Analog Scale (VAS) and objective measurement of edema. The "ground truth" for safety was the monitoring of adverse events directly from subjects. There was no need for external expert consensus on an image or diagnostic finding.
Adjudication method for the test set:
- Not applicable. The primary outcome (reduction in itching) was a direct measurement from the subjects themselves (VAS scores), compared against a baseline. The secondary outcome (edema size) was also an objective measurement. There was no mention of an adjudication process involving multiple reviewers for subjective interpretation.
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. This was not an MRMC comparative effectiveness study. This study evaluated the direct effectiveness of a physical device (Zap-It!) on human subjects, not a diagnostic AI system assisting human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The study evaluated the " Zap-It!" device's performance standalone, meaning its direct effect on individuals without any human intervention or interpretation of its output needed for the primary outcome. The device itself is not an AI algorithm, but a non-AI medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Outcomes Data: The primary ground truth was self-reported itching severity (patient-reported outcome) using a Visual Analog Scale (VAS).
- Objective Measurement: A secondary outcome involved objective measurement of edema length and width from the mosquito bite.
- Safety Monitoring: Direct observation/reporting of adverse events served as the ground truth for safety.
The sample size for the training set:
- Not applicable. The Zap-It! device contains no software or AI algorithms, so there was no "training set" in the context of machine learning. The clinical trial described served as the primary performance evaluation.
How the ground truth for the training set was established:
- Not applicable. As there was no training set for an AI algorithm, this question is not relevant.

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K Number

DEN130019

Device Name

ZANZA-CLICK

Manufacturer

TECNIMED S.R.L.

Date Cleared

2014-11-07

(617 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Zanza-Click (or Disc-o-Click, or Mini-Click) is indicated for temporarily reducing the swelling and itching caused by mosquito bites.

Device Description

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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