(81 days)
The handLITE is intended to emit energy in the red and near infrared region of the light spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat contact dermatitis of the hand and wrist.
The handLITE device consists of:
- Flexible silicone glove with integrated controller (contains rechargeable lithium-ion polymer battery)
- Power supply and country specific adaptors
handLITE is a home use wearable light emitting diode (LED) phototherapy device.
The device consists of a flexible silicone glove that contains red (630nm) and near infrared (830nm) light emitting diodes (LEDs) and an integrated controller. The LEDs generate the light at an intensity of 30mW/cm², delivering 18J/cm² per treatment.
The power supply is used to charge the integrated Lithium battery in the handLITE.
The provided document contains information on the handLITE (TN19S) device, but it does not contain acceptance criteria or a study that specifically proves the device meets predefined acceptance criteria for a new and complex AI/ML device.
The document describes a 510(k) clearance, which largely focuses on demonstrating substantial equivalence to a predicate device. While a clinical study was performed to support safety and effectiveness, it's not structured as a typical AI/ML validation study with pre-defined performance metrics and acceptance thresholds.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred or directly stated, and clearly mark what information is not present.
Acceptance Criteria and Device Performance (Not Applicable in the traditional AI/ML sense)
The FDA 510(k) clearance process for this device, a light-emitting device for dermatological conditions, focuses on demonstrating substantial equivalence to predicate devices. There are no explicitly stated numerical "acceptance criteria" for the device's performance in the way one might define them for an AI/ML diagnostic algorithm (e.g., "sensitivity must be >X% AND specificity >Y%").
Instead, the clinical performance testing aims to show the device is safe and effective for its intended use, analogous to how a new drug might demonstrate efficacy and safety in trials. The "performance" is articulated as an improvement in contact dermatitis symptoms.
Table of Performance (Based on Clinical Study Results):
| Metric | Acceptance Criteria (Not Explicitly Stated for Performance) | Reported Device Performance |
|---|---|---|
| Effectiveness: Mean improvement in SCORAD index (Treated Hand vs. Untreated Control Hand) | (Implicitly: Statistically significant improvement and clinically meaningful difference between treated and untreated hands) | Treated Hand: 12.2 mean improvement |
| Untreated Hand (Control): 3.5 mean improvement | ||
| Safety: Adverse Events | (Implicitly: No unacceptable adverse events) | No adverse events reported |
| Patient Reported Improvement (Dermatitis) | (Implicitly: High percentage of subjects reporting improvement) | 18 of 23 subjects (78%) reported an improvement in their dermatitis |
| Patient Reported Itch/Scaliness Reduction | (Implicitly: High percentage of subjects reporting reduction) | 15 of 23 subjects (65%) responded their dermatitis was less itchy and scaly |
| Patient Reported Satisfaction ("not at all unhappy") | (Implicitly: High percentage of subjects reporting satisfaction) | 18 of 23 subjects responded they were "not at all unhappy" about their contact dermatitis |
| Ease of Use | (Implicitly: High percentage of subjects finding it easy to use) | All subjects responded the handLITE LED device was either "easy" or "extremely easy" to use |
Study Details
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Sample sizes used for the test set and the data provenance:
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Clinical Study (Effectiveness & Safety):
- Enrollment: 25 subjects
- Completed Full Treatment: 23 subjects
- Data Included in Evaluation: All available data from 25 subjects (including the 2 who did not complete the full course).
- Data Provenance: Not explicitly stated, but the submission is from a UK company ("iSMART Developments LTD, Birmingham, B73 5LT United Kingdom"). The clinical study likely took place in the UK or a region where the sponsor operates, but this is an inference, not directly stated.
- Retrospective/Prospective: Prospective (clinical study undertaken to support safety and effectiveness).
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Usability/Human Factors Study:
- Sample Size: 19 subjects
- Data Provenance: Not explicitly stated.
- Retrospective/Prospective: Prospective (study conducted to assess label comprehension).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not an AI/ML device requiring expert consensus for ground truth on images or other diagnostic data.
- The "ground truth" for the clinical effectiveness study was objective measurement of dermatitis signs and symptoms using the SCORAD index, likely performed by clinical investigators. The qualifications of these investigators are not detailed in this summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a diagnostic AI/ML device that requires adjudication of interpretations. The SCORAD index is a standardized scoring system.
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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 study was performed. This is not an AI/ML diagnostic or assistive device for human readers. It is a light therapy device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a treatment device, not a standalone diagnostic algorithm. Its performance is measured directly by its effect on the patient's condition.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the effectiveness study: Clinical Assessment (SCORAD index) of the signs and symptoms of contact dermatitis. This is a standardized, objective scoring system. Patient-reported outcomes were also collected.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. Its "training" would be device design and engineering.
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How the ground truth for the training set was established:
- Not applicable as no AI/ML training set is mentioned or implied for this device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.