(205 days)
The LD-I-75 and LD-I-200 "" treatment heads are indicated for adjunctive use in the temporary relief of pain associated with rotator cuff tendonitis.
The BioFlex™ System and related Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, and low cost benefit to the patient, the practitioner and the health care system.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
This device (LD-I 75 and LD-I 200™) is a low-level laser treatment head, classified as a Class II device (21 CFR part 890.5500, Product Code NHN) for adjunctive use in pain therapy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Indication: Temporary relief of pain associated with rotator cuff tendonitis. | "The scientific concept on which this device is based is the principle that by stimulating a local area with low level laser, pain is relieved." |
| Functional Safety & Calibration | "A series of factory calibration tests are conducted to verify the device is accurate and calibrated (and can maintain calibration over its useful life). The BioFlex® System and related Treatment Heads has benefited from design, development, testing and production procedures that conform to Quality Systems." |
| Substantial Equivalence | The FDA determined the device is substantially equivalent to legally marketed predicate devices (K010175, K043353, K050342). |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific clinical study with a test set designed to evaluate the efficacy of the LD-I 75 and LD-I 200™ for pain relief or for its intended use. The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to quality systems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as no clinical study with a test set is described in the provided document.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical study with a test set is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. This type of study is more common for diagnostic imaging devices where human reader performance is a key metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device described is a physical medical device (low-level laser treatment heads) and not an AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product.
7. The Type of Ground Truth Used
The 510(k) summary does not describe the use of ground truth in the context of a clinical study for efficacy. The core of the submission for this device type typically relies on:
- Scientific Principle: The belief that stimulating with a low-level laser relieves pain.
- Predicate Device Comparison: Demonstration of substantial equivalence to already approved devices.
- Manufacturing Quality Assurance: Verification through factory calibration and quality system conformance.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI algorithm.
Summary of Missing Information and Context:
It's crucial to understand that for a physical therapy device like a low-level laser, the 510(k) pathway often relies heavily on demonstrating substantial equivalence to already legally marketed devices. This means that extensive new clinical studies to prove efficacy (like those with large test sets, ground truth establishment by experts, or MRMC studies) are often not required if the new device can show it's "as safe and effective" as a predicate device with similar indications for use and technological characteristics.
The provided document highlights the scientific concept behind the device and its adherence to quality systems. The FDA clearance is based on this substantial equivalence, rather than a detailed efficacy study with a specific test set.
§ 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.