(207 days)
The Omega Xp Laser System is indicated for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis.
The Omega Xp Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by either AC or battery power and can be used with a variety of laser probes. The Omega Xp Laser System is intended to emit energy in the infrared spectrum to provide temporary relief of pain associated with rotator cuff tendonitis.
The Omega Xp Laser System is comprised of a Base Unit and select Laser Probes. The Base Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Base Unit by an umbilical cord. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.
The provided text describes the Omega Xp Therapeutic Laser System, a Class II device for temporary relief of pain associated with rotator cuff tendonitis. However, it does not provide explicit acceptance criteria in a quantitative or tabular format for device performance. Instead, it relies on a determination of substantial equivalence to predicate devices and summarizes the safety and efficacy studies with general statements.
Below is an attempt to structure the information based on your request, highlighting where specific details are missing or implied:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit, quantified acceptance criteria are not provided in the document. The "reported device performance" is primarily the conclusion of substantial equivalence and a statement that the device performs as intended without new safety or efficacy issues.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Intended Use: | |
| "The Omega Xp Laser System is indicated for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis." | The clinical trial assessed the device's ability to provide temporary pain relief associated with rotator cuff tendonitis. Outcome was deemed sufficient to support the claim. |
| Safety: | |
| No new safety issues raised. | The device performs as intended and does not raise any new safety issues. |
| Efficacy: | |
| No new efficacy issues raised. | The device performs as intended and does not raise any new efficacy issues. |
| Technical Characteristics: | |
| Similar to predicate devices (Photo Thera, Inc. Acculaser Pro 4 (K023060) and Stargate International, Inc. Excalibur Light Therapy System (K041530)). | The Omega System and the named predicate devices have the same intended uses and similar technical and performance characteristics. |
| Compliance with Standards: |
- ISO 9000:2000
- EN46001
- Directive 89/336 (electromagnetic compatibility)
- 21 CFR 1010 and 1040 (applicable performance standards) | The device is manufactured to comply with these international standards and applicable FDA performance standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "the randomized, blinded clinical trial conducted."
- Data Provenance: Not explicitly stated. The documentation is from a US FDA submission, but the origin of the clinical trial data (e.g., country) is not specified. It is a retrospective summary for a 510(k) submission, confirming the clinical trial was completed prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the given text. For a device like a therapeutic laser, "ground truth" often refers to patient-reported pain scores or functional outcomes, not necessarily expert consensus on images.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? This type of study (MRMC) is typically relevant for diagnostic imaging devices where different readers interpret cases. For a therapeutic device like the Omega Xp Laser System, a "multi-reader multi-case" study in the traditional sense is not applicable or mentioned. The study was a "randomized, blinded clinical trial," which compares the device's effect to a control (e.g., sham treatment or standard care).
- Effect size of human readers with/without AI assistance: This is not applicable as the device is a therapeutic laser, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? This concept is also not applicable as the Omega Xp Laser System is a physical therapeutic device operated by a human, not an AI algorithm. Its "performance" is its ability to deliver light energy and the resulting clinical outcome in patients, which is always with human involvement for operation and patient interaction.
7. Type of Ground Truth Used
For a therapeutic device, the "ground truth" for efficacy is typically clinical outcomes data, such as:
- Patient-reported pain reduction (e.g., using a Visual Analog Scale - VAS or Numeric Rating Scale - NRS).
- Improvement in functional ability.
- Other subjective or objective measures of disease activity related to rotator cuff tendonitis.
The text states "Further evidence of the safety and efficacy of the Omega System was assessed by the randomized, blinded clinical trial conducted," implying that clinical outcomes were the "ground truth" for efficacy.
8. Sample Size for the Training Set
- Sample Size for Training Set: This information is not provided in the text. For a traditional medical device (non-AI), there isn't typically a "training set" in the machine learning sense. The clinical trial data would be the primary evidence for efficacy.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: This is not applicable in the context of this device. The efficacy of the device was established through a "randomized, blinded clinical trial," where the "ground truth" for participant outcomes would have been gathered during the trial (e.g., pain scores, functional assessments, etc.).
§ 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.