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reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating mild to moderate inflammatory acne.

The reVive Light Therapy® LED Cleansing system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The reVive Light Therapy® LED Cleansing System components include the unit containing the LED module, USB power cord, and power adapter. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC). It is intended for users 13 years or older.

The provided FDA 510(k) summary for the reVive Light Therapy® LED Cleansing System (K180447) does not contain a typical acceptance criteria table with reported device performance metrics in the way a clinical study for diagnostic or prognostic devices would.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Clear Bi-Light K153081) through comparison of technological characteristics and performance testing related to safety and functionality. The "acceptance criteria" can be inferred from the comparisons made to the predicate device and the pass/fail nature of the safety and usability tests.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since there isn't a direct table in the document, I will construct one based on the information provided, inferring acceptance criteria from the comparisons to the predicate and the documented test results.

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

• Usability Study Test Set: 15 participants.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This was a usability study, often conducted in a controlled environment, likely in the US where the submitter is located.

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

This type of information is not applicable to the studies presented for this device.

• For the usability study, "ground truth" was about successful execution of tasks and demonstrating light sensitivity, not clinical diagnosis. The performance was measured by participant action, not expert judgment.
• For the safety and functional performance testing, "ground truth" was established by adherence to international standards (e.g., IEC, ISO) and internal testing protocols, not by expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The usability study involved observing participants' actions (e.g., "100% of the participants were able to demonstrate the light sensitivity test."). Safety and performance tests against standards have pass/fail criteria, not adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is for diagnostic devices where human readers interpret medical images or data. The reVive Light Therapy® LED Cleansing System is a direct treatment device, not a diagnostic tool requiring human interpretation with or without AI assistance.

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

Yes, in a sense. The "performance testing" described (functional performance testing, software validation, safety testing, thermal performance testing) essentially represents standalone performance of the device's physical and software aspects against defined specifications and standards, without real-time human intervention influencing its core operation during the test.

7. The Type of Ground Truth Used

• Usability Study: User performance metrics (ability to demonstrate a test, successful device use).
• Safety and Functional Testing: Adherence to established international consensus standards (IEC, ISO) and internal performance specifications (e.g., thermal limits, software functionality).
• Substantial Equivalence: Comparison to the technological characteristics, intended use, and treatment parameters of a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is an LED therapy system, not an AI/machine learning algorithm that requires a training set in the typical sense. The software validation is likely for operational logic and safety features, not for learning from data.

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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The ALVUE™ Balloon Dilation System is indicated for patients undergoing surgical procedures requiring tissue retraction including the following procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery; spine surgery; orthopedic surgery; thoracoscopic surgery; and procedures in the extraperitoneal space. The system is intended to create an operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal, subcutaneous extremity, or thoracic space.

The ALVUE™ Balloon Dilation System is a surgical instrument that consists of an inflatable nylon balloon attached to the distal end of a dilator. ALVUE™ is used to dilate soft tissue to gain access to the surgical site and is available in a variety of sizes to accommodate the anatomical needs of the patient. The system includes accessories for inflation. ALVUE™ is a sterile single use device.

This device is a physical medical device (ALVUE™ Balloon Dilation System) and not an AI/ML powered device, so acceptance criteria and studies are based on mechanical and biocompatibility testing rather than AI model performance metrics. Therefore, many of the requested fields are not applicable.

Here's the relevant information from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary (as these are physical device tests, not clinical data from patients).

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

• Not Applicable. This is not an AI/ML device relying on expert-established ground truth from clinical data. The "ground truth" for mechanical testing is compliance with established engineering standards (ISO 10555-1, ISO 10555-4) and biocompatibility standards (ISO 10993-1).

4. Adjudication Method:

• Not Applicable. This is not an AI/ML device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not an AI/ML device.

6. Standalone (Algorithm Only) Performance Study:

• Not Applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• For mechanical testing: Engineering standards (ISO 10555-1:2013, ISO 10555-4:2013).
• For biocompatibility: Biocompatibility standards (ISO 10993-1).

8. Sample Size for the Training Set:

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. This is a physical medical device.

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