Search Results
Found 1 results
510(k) Data Aggregation
(90 days)
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.
Not Found
Here's an analysis of the provided information, focusing on the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for a hair removal device. Notably, it does not explicitly state specific numerical acceptance criteria (e.g., "X% hair reduction"). Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a previously legally marketed device.
Therefore, the acceptance criteria here are implicitly:
- Demonstrating similar clinical effectiveness (hair removal) as predicate devices.
- Demonstrating similar safety profile (adverse effects) as predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Effectiveness: Achieve hair removal in skin type VI patients comparable to predicate devices (IPL devices for skin types I-V). | A multi-center study was conducted to examine the clinical effectiveness of IPL™ devices in the removal of unwanted hair. The study documented the clearance rate obtained when treating skin type VI patients. The conclusion states that "IPL™ devices used to treat skin type VI patients are substantially equivalent in their level of safety and effectiveness to that obtained when using the same devices to treat patients with skin types I - V." While specific clearance rates are not quantified in this summary, the claim of substantial equivalence implies that the performance met the expected standard, based on the predicate devices. |
| Safety: Demonstrate a safety profile (adverse effects) comparable to predicate devices. | The study documented the adverse effects obtained when treating skin type VI patients. The conclusion states that "IPL™ devices used to treat skin type VI patients are substantially equivalent in their level of safety and effectiveness to that obtained when using the same devices to treat patients with skin types I - V." Again, specific adverse effect rates are not detailed, but the claim of substantial equivalence implies an acceptable safety profile. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The document mentions "A multi-center study was conducted," but the number of patients included in this study ("test set") is not provided in this summary.
- Data Provenance:
- Country of Origin: Not explicitly stated. Multi-center studies could involve various locations.
- Retrospective or Prospective: Not explicitly stated, but the phrasing "A multi-center study was conducted to examine..." suggests a prospective study where data was collected specifically for this purpose.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the summary. For hair removal studies, "ground truth" often involves visual assessments by clinicians or photographic documentation, but the details of who performed these assessments and their qualifications are not included.
4. Adjudication Method for the Test Set
- This information is not provided in the summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not explicitly stated or implied. The study focused on the performance of the IPL device for hair removal on skin type VI patients compared to existing data/predicate devices for skin types I-V. There's no mention of human readers evaluating cases with and without AI assistance (as AI is not the primary focus here, rather it's a device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in a sense, the study describes a standalone device performance. This is an Intense Pulsed Light (IPL) device, not an AI algorithm. The device operates independently to deliver treatment, and the study evaluated its clinical effect directly. There is no "human-in-the-loop" component in the context of an AI algorithm interacting with human interpretation.
7. The Type of Ground Truth Used
- The ground truth for effectiveness would likely be based on:
- Clinical observation/assessment of hair clearance (reduction in hair count or density) by trained personnel.
- Adverse event reporting for safety.
- This is inferred as the study "documented the clearance rate and the adverse effects."
8. The Sample Size for the Training Set
- Not applicable / not provided. This device is an IPL device, not an AI/machine learning model that typically requires a "training set." The clinical study evaluated the device's performance directly.
9. How the Ground Truth for the Training Set was established
- Not applicable / not provided. As this is not an AI/ML device, there isn't a "training set" in the conventional sense that would require establishing ground truth for machine learning. The data from the multi-center study would serve as the "test set" to confirm the device's performance against the implicit acceptance criteria of substantial equivalence.
Ask a specific question about this device
Page 1 of 1