(53 days)
Is intended for over-the-counter (non-prescription) use by the consumer.
Provides moist heat therapy to temporarily relieve minor muscle and joint aches and pain associated with over-exertion, strains, sprains, arthritis, stiffness, and muscle spasm.
Temporarily relieves minor menstrual pain.
Temporarily increases local blood circulation.
BENGAY™ Heat Therapy is a disposable, single-use, airactivated pain relieving patch which adheres to the skin by means of a hydrogel adhesive and generates heat by the oxidation of iron powder.
The device consists of 6 components:
- Oxygen-impermeable, primary packaging; .
- . Breathable fabric sachet containing the heating element mixture;
- Heating element mixture; .
- Backing sheet which separates the heating element . mixture from the hydrogel layer;
- . Hydrogel layer to provide adhesion to the skin surface; and,
- Release liner to protect the adhesive hydrogel laver . prior to consumer use
When the air-tight, protective packaging is opened, the heating element mixture reacts with oxygen in the air, and the patch begins to warm up. It takes up to 30 minutes for the patch to reach its target temperature range. The patch stays warm for at least 8 hours.
BENGA Y™ Heat Therapy reaches its target temperature range in 30 minutes or less, and remains in this temperature range for a minimum of 8 hours.
BENGAY™ Heat Therapy provides moist heat as demonstrated by user perception and laboratory experiments.
The provided document is a 510(k) summary for a medical device (BENGAY™ Heat Therapy heat patch) and an FDA clearance letter. It is not a study report or clinical trial document that would typically include detailed acceptance criteria tables and performance metrics for an AI/algorithmic device. The information requested (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is standard for AI/ML device evaluations, but is not present in this type of regulatory submission for a heat therapy patch.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will answer based on the information that is present, noting where information is missing or not applicable to this type of device.
Acceptance Criteria and Device Performance for BENGAY™ Heat Therapy
This submission is for a heating patch, not an AI/ML device. Therefore, the "acceptance criteria" and "device performance" are focused on the physical characteristics, safety, and functionality of the heat patch itself, rather than diagnostic accuracy or algorithmic performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional/Safety) | Reported Device Performance |
|---|---|
| Heat Generation & Duration: | |
| Reaches target temperature range | Reaches target temperature range in 30 minutes or less. |
| Time to reach target temperature | 30 minutes or less. |
| Stays warm for a minimum duration | Stays warm for a minimum of 8 hours. |
| Moist Heat Delivery: | |
| Provides moist heat therapy | Demonstrated by user perception and laboratory experiments. |
| Safety - Biocompatibility: | |
| Safe for body contact surface | Demonstrated by relevant biocompatibility testing (in vitro cytotoxicity, sensitization, dermal irritation studies). |
| Safety - Clinical (Skin effects): | |
| Low potential for cumulative irritation | Demonstrated in a clinical study comparing with predicate device. |
| Low potential for thermal-related injury | Demonstrated in a clinical study comparing with predicate device. |
| Acceptable change in skin surface temperature | Demonstrated in a clinical study comparing with predicate device. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the studies mentioned (clinical safety study, biocompatibility tests, or moist heat demonstration studies).
- Data Provenance: Not explicitly stated (e.g., country of origin). The document implies the studies were conducted by Johnson & Johnson Consumer Products Company, likely in the US, but this is not confirmed.
- Retrospective or Prospective: The clinical safety study suggests a prospective design (comparing BENGAY™ Heat Therapy with the predicate device). Biocompatibility and laboratory experiments are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/mentioned. This device is not an AI/ML diagnostic system where expert-established ground truth is typically required for evaluation. The "ground truth" for this device relates to physical properties (temperature, duration) and biological responses (skin irritation, circulation), which are measured objectively or through clinical observation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/mentioned. Adjudication methods are typically relevant for resolving disagreements among multiple human readers/experts in diagnostic imaging or clinical assessment, which is not the context for this device.
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. This is not an AI-assisted device, so MRMC studies are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical heat patch, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Moist heat: User perception and laboratory experiments.
- Biocompatibility: Results from standardized in vitro and dermal irritation studies.
- Clinical Safety (irritation, thermal injury, skin temperature): Direct clinical observation, measurements of skin temperature, and assessment of skin reactions by medical professionals involved in the clinical study.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for a machine learning model.
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.