(105 days)
The ZX2 Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
The ZX2 Laser System is a non-invasive, low energy, infrared therapeutic medical laser. The ZX2 Laser incorporates an AC Control Unit and a variety of hand-held laser probes. The Control Unit has two (2) completely independent probe outputs which allow use of the device by two operators at once and/or treatment using two probes at once.
The Control Unit houses the power supply, electronics and user interface panel. The Control Unit is connected to a suitable grounded outlet. The Control Unit is equipped with a key which when inserted into the switch the Unit can be activated. The ZX2 has an emergency stop button that, when pressed, will deactivate the device. The device houses a split screen panel on the face of the control unit and dual control buttons for use with two independent probes.
The hand-held probes that are optional with the ZX2 Laser System include:
- 750 mW Deep Probe 808 nm GaAlAs Semiconductor laser
- 1.5 W Deep Probe 808 nm GaAlAs Semiconductor laser
- 6.1 W Multi Probe 808 nm GaAlAs Semiconductor laser / 658 nm Ga Aa InP
- SP4 Probe 904 nm Ga As Semiconductor Laser Pulsed
The above laser probes incorporate laser diode/s at 658nm, 808nm and 904nm diodes, classifying it under 21 CFR 890.5500, ILY infrared lamp for adjunctive use in pain therapy.
The provided document is a 510(k) summary for the ZX2 Laser System, an infrared lamp device. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing of its ability to generate therapeutic heat.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achieve a therapeutic heat temperature range of 40 - 45 degrees Celsius. | The device demonstrated a topical heating increase of at least 5°C reached within 3-4 minutes. The therapeutic temperature range was maintained for the 10-minute testing time. Specific examples: For a male, 52 years old (Table 1), low back temperature reached 40°C at 3 min and 45°C by 6 min. For a female, 44 years old (Table 2), knee temperature reached 40°C at 4 min and 45°C by 10 min. For a male, 41 years old (Table 3), shoulder temperature reached 41°C at 4 min and 45°C by 7 min. |
| Maintain the therapeutic temperature range for the recommended treatment time (stated as 10 minutes). | The achieved therapeutic temperature range was maintained until the device was turned off, and specifically, for the 10-minute testing time. |
| Not exceed a maximum acceptable therapeutic heat temperature (implied to be slightly above 45°C, with an automatic shut-off at 44°C). | The device incorporates a heat sensor with an automatic shut-off feature once the device exceeds a temperature of 44°C. While some reported temperatures touched or slightly exceeded 45°C briefly, the system's safety mechanism is noted. |
| Compliant with FDA recognized consensus standards for electrical safety and functional performance. | The device was compliant with EN 60601-1: 2006 Ed. 3, EN 60601-1-2:2012, and EN 60601-2-22:1996. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 3 individuals.
- Data Provenance: Retrospective bench testing on various body areas (knee, shoulder, neck, low back) of the 3 individuals. The document does not specify country of origin for the data itself, but the company is based in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Experts: Not applicable. The "ground truth" for this technical performance study was direct temperature measurements from the device during a controlled bench test.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This was a non-clinical, direct measurement study, not an expert-based review needing adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. This device is not an AI-assisted diagnostic or interpretive tool; it is a therapeutic device that generates heat.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Study: No, this device is a physical therapeutic laser system, not an algorithm. The testing described is of its physical performance (heating capabilities).
7. The Type of Ground Truth Used:
- Type of Ground Truth: Empirical temperature measurements taken on the skin of human subjects during a controlled bench test (
THERAPEUTIC HEAT TEMPERATURE DATA). The acceptance criteria for the target temperature range (40-45°C) are "as accepted by the FDA."
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The study describes non-clinical performance testing.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.
§ 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.