(113 days)
Pulsaderm ACE-All Blue is indicated to treat mild to moderate acne on the face.
The Pulsaderm ACE-All Blue is a device that uses Blue Light Emitting Diodes to provide LED Light therapy to the skin. Blue light is emitted for the treatment of mild to moderate acne.
The provided document is a 510(k) Pre-Market Notification for the Pulsaderm ACE-All Blue device, which is an LED light therapy system for treating mild to moderate acne. This type of document focuses on establishing substantial equivalence to existing legally marketed devices rather than presenting a standalone study with detailed clinical performance metrics against specific acceptance criteria.
Therefore, the document does not contain the requested information about acceptance criteria and a study proving the device meets those criteria in the typical sense of a clinical trial demonstrating efficacy against a defined endpoint. Instead, it relies on demonstrating equivalence in technological characteristics and safety to predicate devices.
However, I can extract the information that is present concerning performance testing and a lay-user study, and explicitly state what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pulsaderm ACE-All Blue Technical Specifications | ||
| Wavelength (nm) | N/A (Compared to Predicates) | Blue light 415 +/- 5 nm |
| Dose Rate (mW cm2) | N/A (Compared to Predicates) | Blue light: 25 mW cm2 |
| Dose (J/cm2) | N/A (Compared to Predicates) | 12 J/cm2 |
| Lay-User Study | ||
| Lay users able to properly use device by reading instructions without assistance | Not explicitly stated as a numerical acceptance criterion, but implied goal is high success rate. | 98% of lay users were able to properly use the device by reading instructions in the user manual without any assistance. |
| Lay users able to read and comprehend user manual and package labeling. | Not explicitly stated, but implied goal is successful comprehension. | The conclusion was that an average lay user can read and comprehend correctly the user manual and package labeling. |
| Safety and Conformity | ||
| Compliance with IEC 60601-1:2012 | Yes | Conforms |
| Compliance with IEC 60601-1-2:2014 | Yes | Conforms |
| Compliance with IEC 62471:2006 | Yes | Conforms |
| Biocompatibility testing to ISO 10993 | Yes | Tested to ISO 10993 |
| Risk Management System conforming to ISO 14971:2007 | Yes | Designed and developed under a Risk Management System conforming to ISO 14971:2007 |
Missing Information: The document focuses on technical specifications comparison, safety standards compliance, and a lay-user study for usability, rather than clinical efficacy against a pre-defined acceptance criteria for acne treatment effectiveness.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the "lay-user study". It only mentions "study data was collected".
- Data Provenance: The lay-user study was described as being conducted "with Institutional Review Board (IRB) approval and oversight." No specific country of origin is mentioned, but the company is based in Fort Myers, FL, USA, suggesting a US-based study. The study was prospective in nature, as it involved observing users reading instructions and attempting to use the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided as the "ground truth" for the lay-user study was based on observed successful use of the device by the participants themselves, as per the instructions. There were no "experts" establishing a disease-related ground truth, as the study was about usability of instructions.
4. Adjudication Method for the Test Set
- This information is not provided. Given the nature of the lay-user study (observing proper usage based on instructions), an adjudication method in the traditional sense (e.g., 2+1 reads of medical images) would not be applicable. The assessment was likely direct observation of user interaction with instructions and the 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, an MRMC comparative effectiveness study was not done. This type of study is irrelevant for this device, which is a standalone light therapy device, not an AI-assisted diagnostic or interpretation tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device itself is a "standalone" light therapy device. The non-clinical testing included a "lay-user study" which assessed the ability of users to follow instructions to operate the device correctly. This is a form of standalone performance assessment in terms of usability and safety, but not clinical efficacy. No "algorithm only" performance was assessed as it's not an AI/software device.
7. The Type of Ground Truth Used
- For the lay-user study, the "ground truth" was defined by the ability of participants to correctly follow the instructions and use the device as intended. This is an operational or usability ground truth, not a clinical one (like pathology or outcome data).
8. The Sample Size for the Training Set
- This information is not applicable and not provided. The Pulsaderm ACE-All Blue is an LED light therapy device; it does not involve machine learning algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no training set 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.