(315 days)
The Time Machine Series Lasers Model TTML-8102000 - 810/830 nm is intended for use in temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.
The TTML-8102000 hand held laser device operates in continuous wave mode at a fixed frequency. The Power is operated with lithium batteries. A cap covers the laser aperture and must be removed before treatment. Activating a mechanical button powers on the unit when operating by battery power. When a mechanical switch is pressed a LCD screen illuminates. The device can be operated in either of two modes which are selected by means of a mechanical switch: (1) a timer mode where treatment time is entered by means of a mechanical switch and time is displayed on the LCD screen. The device automatically shuts off when the set time is reached. (2) a manual mode where treatment continues until the device is manually shut off. The unit is powered down by pressing the power button (battery mode). None of these functions are controlled by software. The software controls only the timer and time display. Software is embedded into a single chip circuit which contains the CPU and memory. These chips are used in simple circuits. The device can maintain skin temperature of 40-45℃ for at least 10 minutes based on the study conducted on three live human subject.
The provided text describes the 510(k) premarket notification for "The Time Machine Series Lasers" (Model TTML-8102000). The document outlines the device's indications for use, its comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for clinical performance metrics (like sensitivity, specificity, accuracy for a diagnostic device). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to a predicate device and adherence to safety and performance standards.
The primary "clinical performance" reported is related to maintaining skin temperature.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical safety and non-harmfulness to end-users (implied by predicate equivalence and safety standards) | The skin temperature study "confirmed that the subject device passes the clinical test and it's safe and non-harmful to the end users." |
| Maintain skin temperature for therapeutic effect (40-45°C) for a specified duration | The device can maintain skin temperature of 40-45℃ for at least 10 minutes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "three live human subjects"
- Data Provenance: The study was conducted on "live human subjects," indicating a prospective human study for this specific aspect of performance. The country of origin is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish a "ground truth" for the skin temperature study. The measurement of skin temperature is an objective physiological metric.
4. Adjudication Method for the Test Set
Not applicable, as no subjective interpretation or consensus among experts was required for the objective temperature measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not relevant for a therapeutic laser device whose "clinical test" involved objective skin temperature measurement. The document focuses on demonstrating substantial equivalence to a predicate device based on indications for use and technical characteristics, and a small-scale human study for a specific physiological effect.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This device is a therapeutic laser and its performance is assessed by its physical output and direct physiological effect (skin temperature), not by an algorithm's classification or detection capabilities. The embedded software "controls only the timer and time display," and its performance is not evaluated in a standalone manner in the context of this FDA submission.
7. Type of Ground Truth Used
The "ground truth" for the skin temperature study was direct physiological measurement (skin temperature). The goal was to demonstrate that the device achieves and maintains a specific temperature range, not to diagnose a condition against a "true" diagnosis from pathology or expert consensus.
8. Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. The software's function is limited to controlling the timer and display, which are pre-programmed and do not learn from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning algorithm.
§ 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.