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The New Era Laser is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, New Era, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

There is one model, FG 2000.

The main components of proposed device shown as following: Handpiece, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.

The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes Parameter one, two, three, four, five and six mode respectively for different preset parameter combination, and each particular parameter preset mode includes three submode as mode 1, mode 2 and mode 3.

The difference for each mode is only the default parameter, but all parameters for each mode can be adjustable in the parameter range.

The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);

The provided FDA 510(k) premarket notification for the "New Era" laser device aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a novel medical function. Therefore, the typical structure for reporting acceptance criteria and a study proving those criteria (as requested in the prompt) does not directly apply to this document.

The document primarily focuses on showing that the "New Era" laser is identical in all respects to an already cleared predicate device (K161692 Diode Laser Therapy Machine Model FG2000D). This means the "acceptance criteria" here are essentially proof of sameness to the predicate.

However, based on the information provided, I can construct a response that addresses the spirit of your request by interpreting the "acceptance criteria" as the shared specifications and safety standards that both the proposed and predicate devices meet, and the "study" as the non-clinical testing performed to show this equivalence.

Here's a breakdown of the requested information based on the provided text:

Key Takeaway: No independent clinical study data proving specific performance outcomes for the "New Era" laser is presented in this 510(k) submission. The entire premise is based on the device being identical to an already cleared predicate device, and thus inheriting its established safety and performance profile.

Acceptance Criteria and Device (Equivalence) Performance:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of traditional performance metrics like sensitivity/specificity for a diagnostic AI, the "acceptance criteria" for a 510(k) based on substantial equivalence revolve around matching the predicate device's specifications, intended use, and safety standards.

• Hair removal
• Permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin.
• Permanent hair reduction defined as long-term, stable reduction in hair regrowth at 6, 9, and 12 months post-treatment. | Identical. The New Era Laser is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Definition of permanent hair reduction is identical. |
  | Product Code Equivalence: GEX | Identical. GEX |
  | Regulation Number Equivalence: 21 CFR 878.4810 | Identical. 21 CFR 878.4810 |
  | Configuration Equivalence: Main Unit, Handpiece, Foot Control | Identical. Main Unit, Handpiece, Foot Control |
  | Principle of Operation Equivalence: Diode Laser | Identical. Diode Laser |
  | Laser Type Equivalence: Diode Laser | Identical. Diode Laser |
  | Laser Classification Equivalence: Class IV | Identical. Class IV |
  | Laser Wavelength Equivalence: 808 nm | Identical. 808 nm |
  | Spot Size Equivalence: 1.44 cm² | Identical. 1.44 cm² |
  | Fluence Equivalence: 2-120 J/cm² | Identical. 2-120 J/cm² |
  | Frequency Equivalence: 1-10 Hz | Identical. 1-10 Hz |
  | Pulse Duration Equivalence: 9-143 ms | Identical. 9-143 ms |
  | Power Supply Equivalence: AC 110V/50Hz-60Hz | Identical. AC 110V/50Hz-60Hz |
  | Dimension Equivalence: 5959146 cm | Identical. 5959146 cm |
  | Weight Equivalence: 49 kg | Identical. 49 kg |
  | Biocompatibility:
• No Cytotoxicity
• No Sensitization
• No Irritation | - Identical. No Cytotoxicity
• Identical. No evidence of sensitisation
• Identical. No evidence of irritation |
  | Electrical Safety Compliance:
• IEC 60601-1
• IEC 60601-2-22 | Compliant. Comply with IEC 60601-1, IEC 60601-2-22 |
  | EMC Compliance: IEC 60601-1-2 | Compliant. Comply with IEC 60601-1-2 |
  | Laser Safety Compliance:
• IEC 60601-2-22
• IEC 60825 | Compliant. Comply with IEC 60601-2-22, IEC 60825 |
  | Manufacturing Process/Components: Identical to predicate | Identical. Made by the same manufacturer, utilizing the same controls, components, and processes. |

Study Proving Acceptance Criteria:

The "study" here is a set of non-clinical tests designed to confirm that the "New Era" device meets the established design specifications and is indeed substantially equivalent to the predicate device.

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

• Sample Size: This is not a study with a "test set" in the sense of a dataset of patient images or clinical outcomes. Instead, it refers to the physical device (New Era, Model FG2000) itself, against which engineering and safety tests were performed.
• Data Provenance: Not applicable in the context of clinical data. The tests are performed on the device hardware. The document states the proposed device is "made by the same manufacturer" as the predicate.

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

• Not applicable. Ground truth for device specifications and compliance with engineering standards is established through validated testing procedures and compliance with international standards (e.g., IEC, ISO). These do not typically involve human expert interpretation in the way AI model ground truth is established.

4. Adjudication Method for the Test Set:

• Not applicable. This is not a clinical study requiring human reader adjudication.

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 study was not done. This 510(k) is for a laser device for hair reduction, not an AI-assisted diagnostic tool. No AI component is described.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No. This is not an AI algorithm. It is a standalone medical device (laser).

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is defined by:
  • Engineering Specifications: The design specifications of the device parameters (e.g., wavelength, fluence, spot size, power supply).
  • International Standards: Compliance with recognized consensus standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10). These standards themselves define the "ground truth" for safety and performance requirements.
  • Predicate Device Specifications: The "New Era" device's specifications were compared to those of the predicate device (FG2000D) to demonstrate identity.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. As there is no AI, there is no training set or associated ground truth establishment for a machine learning model.

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