(281 days)
The GD-P-E Enhanced Handheld Pain Relief Laser Instrument generally indicated:
- adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin;
- adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS)
The GD-P-E Enhanced Handheld Pain Relief Laser Instrument consists of a LCD, button, battery, power charger jack. Accessories include a power cords, a power adapter. It is a handheld, non-invasive, non-heating infrared cold laser instrument designed to be used as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. A key feature of the device is its ability to produce multiple laser wavelengths (808nm and 650nm).
A key feature of the device is its ability to emit dual laser wavelengths (808nm and 650nm), providing targeted low-level light therapy to the affected area. This "cold" laser therapy enables body tissue to absorb the light, facilitating a temporary reaction within the cells that promotes minor pain relief.
The provided FDA 510(k) summary (K241057) for the "Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)" does not include information about acceptance criteria and a study proving device performance in the context of AI/ML or clinical efficacy.
This document is primarily focused on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with recognized standards. It explicitly states: "No clinical study is included in this submission." and "Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA guidance 'Content of Premarket Submissions for Device Software Functions'".
Therefore, I cannot extract the requested information regarding acceptance criteria and a study that proves the device meets them from the provided text for the following reasons:
- No clinical study: The document explicitly states that no clinical study was included in the submission. This means there is no data on human patient outcomes or diagnostic performance against a ground truth.
- Focus on substantial equivalence: The primary aim of this 510(k) is to show that the new device is as safe and effective as previously cleared predicate devices through technical comparisons and non-clinical testing, not to provide novel clinical performance data.
- Device type: The device is an "Infrared Lamp" (a physical medical device), not an AI/ML imaging analysis or diagnostic software device, which would typically involve the type of acceptance criteria and studies you are asking about (e.g., sensitivity, specificity, reader studies, etc.). The software validation mentioned is likely for the control functions of the laser device, not for an AI/ML diagnostic or assistive function.
The "Performance Testing" section refers to compliance with electrical safety, EMC, and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-1-11) and verification of output parameters (wavelengths, power, energy fluence, irradiance, beam focus, and energy distribution). These are technical acceptance criteria for the device's physical and electrical characteristics, not clinical performance or AI performance.
Without a clinical study or an AI/ML component seeking to demonstrate clinical or diagnostic performance, the questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to the information provided in this 510(k) summary.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.