(173 days)
The LAPEX BCS is intended to emit energy in the visible and 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 LAPEX BCS has a hand-held treatment probe, is noninvasive, low level visible and infrared lamp that provides continuous heat therapy at fixed frequency. The System consists of a Drive Unit, Power Supply and controls and optional treatment probes that contain the visible and infrared radiating elements. Various Cluster Probes are available accessories with the Drive Unit. The LAPEX BCS generator operates automatic calculation of energy output in relation to set treatment parameters and the parameters(treatment time, output power delivered) can be adjusted by using key and treatment specifications and menus as well as treatment progressing are displayed on a LCD display in real time. And the LAPEX BCS generator operates simultaneous and independent management of outputs for connecting probes with laser sources of different wavelength. The LAPEX-BCS generator supplied with 2 completely independent outputs for using two treatment probes and simultaneously, even with laser sources of different wavelengths. The LCD displays operating parameters of both channels. 'This allows two operators to carry out laser therapy independently; just like having two separate instruments.
Here's an analysis of the provided text regarding the LAPEX BCS device, focusing on acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the LAPEX BCS device, as described in the provided document, primarily relate to its ability to generate a specific skin temperature.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Generate a skin temperature of 40°C ± 0.8°C for 5 minutes. | The LAPEX BCS "can generate a skin temperature 40°±0.8° for 5min" |
| Generate a skin temperature of 40°C ± 0.8°C for 20 minutes. | The LAPEX BCS "can generate a skin temperature 40°±0.8° for ... 20min respectively." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 50 subjects.
- Data Provenance: The document states "50 subjects of various ages and races (Oriental, Black, and Caucasian)". This suggests it was likely a prospective clinical test conducted by Meridian Co., Ltd. The country of origin of the data is not explicitly stated beyond the company's location in Seoul, Korea. It is not specified as retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts or the establishment of ground truth by experts for the clinical testing. The study focuses on measuring the device's physical effect (skin temperature elevation) rather than expert interpretation of clinical outcomes for ground truth.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The study appears to be a direct measurement of skin temperature.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study described focuses on the device's physical performance, not on how it assists human readers or improves their performance.
6. Standalone Performance Study
Yes, a standalone study was performed. The "clinical testing using thermography on 50 subjects" measured the device's ability to generate a specific skin temperature on its own. This is a standalone performance metric for the LAPEX BCS device.
7. Type of Ground Truth Used
The ground truth used in this context is the measured skin temperature. The acceptance criteria are based on achieving a specific, quantifiable physical change (temperature elevation) rather than an expert consensus, pathology, or direct patient outcomes (though pain relief is the ultimate intended use, the study provides a physiological basis for it).
8. Sample Size for the Training Set
No training set is mentioned. This device is an infrared lamp, not an AI or machine learning algorithm that typically requires a training set. The study described is a direct performance measurement.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set or an AI/ML algorithm involved.
§ 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.