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The Therapik is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing localized blood flow.

The Therapik is a small, portable, hand-held, battery-powered device equipped with a carrying wrist strap. It measures approximately 3cm x 10cm and weighs less than 4 ounces, including the 9 volt battery. The heat is initiated by use of a simple, non-locking, finger-or thumb-activated on/off switch. Heat is produced by pressing the switch. The Therapik device delivers 50 - 60°C heat directly on the user's skin. The user is instructed to apply the device for as long as the heat is comfortable on the skin (approximately 20 - 30 seconds).

Here's a breakdown of the acceptance criteria and study information for the Therapik® device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated: The documentation does not provide a formal table of pre-defined acceptance criteria with specific thresholds (e.g., "must achieve X% efficacy"). Instead, the performance is reported descriptively based on clinical findings.

• Total/complete disappearance of pain: 61/69 users
• Distinct alleviation of pain: 7/69 users
• Slight alleviation of pain: 1/69 users
• Not effective: none
  Canadian Body-Pic Study (N=50, referenced):
• Reported effective by all 50 users for a variety of stings and bites. |
  | Effectiveness (Itching Relief) | Demonstrate effective relief of itching from insect stings/bites. | Venezuela and France/Italy/Reunion Studies (N=69):
  (Implied by overall effectiveness rating for "pain and inflammation" as "pain and itching" are grouped in the Indications for Use. Specific itching relief percentages are not broken out separately from pain.)
  Canadian Body-Pic Study (N=50, referenced):
  (Implied by overall effectiveness for stings and bites, which typically involve itching.) |
  | Safety | No serious adverse effects related to device use. | No serious side effects related to the use of the Therapik were reported in the Venezuela and France/Italy/Reunion studies. |
  | Operating Characteristics Comparability | Comparable Time/Temperature Profile and Maximum Operating Temperature to predicate devices. | Comparative performance testing was performed on the proposed Therapik device and the predicate National Health Care NH-202 device, establishing comparability of operating Time/Temperature Profile and Maximum Operating Temperature. Operating characteristics, recommended use time, operating temperature, and labeling were also compared to Li's Itch Stopper. (Specific data not provided, but comparability was established). |

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

• Sample Size for Test Set:
  • Therapik® Clinical Trials: 69 subjects (35 from Venezuela, 34 from France, Italy, and Reunion).
  • Referenced Body-Pic Study: 50 subjects from Canada.
• Data Provenance: Prospective clinical trials. The Therapik trials were conducted in Venezuela, France, Italy, and Reunion. The referenced Body-Pic study was conducted in Canada.

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

• Not Applicable. The "ground truth" for the clinical effectiveness studies was based on the subjective self-reporting of the users themselves ("Each user was asked to rate the effectiveness of the device"). There were no external experts establishing ground truth in terms of diagnosis or outcome.

4. Adjudication Method for the Test Set

• None. Since the "ground truth" was subjective self-reporting by the individual users, there was no independent adjudication of their responses.

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

• Not Applicable. This device is a therapeutic heating device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant to this submission.

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

• Yes (effectively). The clinical studies describe the performance of the device used directly by individuals without the need for interpretation or intervention by a human expert in terms of its therapeutic effect. The "performance" is the device alone, applied by the user.

7. The Type of Ground Truth Used

• Subjective User-Reported Outcomes. The "ground truth" in the clinical studies was the users' subjective ratings of pain alleviation. This is a common method for assessing the effectiveness of devices for symptomatic relief where objective measures are difficult or less relevant than the patient's experience.

8. The Sample Size for the Training Set

• Not Applicable. This device relies on physical principles (heat application) and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The "training" of the device is its design and manufacturing to produce the specific thermal output.

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

• Not Applicable. As explained above, there is no "training set" in the context of AI/ML for this device. The design and validation of the thermal output would be based on engineering specifications and physical measurements, rather than a "ground truth" derived from clinical data in the same way an AI model's training set would be.

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