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510(k) Data Aggregation
(456 days)
Pain TB and Pain TJ Laser systems are indicated for adjunctive use in the temporary relief of low-back pain and wrist pain associated with Carpal Tunnel Syndrome.
PainTB and PainTJ can be used repeatedly and uses semiconductor lasers to generate three wavelengths of light at 670nm, 830nm and 910nm. In general, this device irradiates to the pain area with a laser beam to relieve pain. It can also be controlled via a dedicated app on your smartphone, allowing you to monitor when and how much you have used it.
The information provided describes the PainTB/PainTJ Laser systems. Here's a breakdown of the acceptance criteria and study details based on the input:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific numerical acceptance criteria for performance like a certain percentage reduction in pain score with a corresponding confidence interval. Instead, it relies on demonstrating statistical significance in pain reduction compared to a mock device and claiming substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | No adverse effects observed during the clinical study. Complies with general safety, EMC, usability, home healthcare, medical laser equipment, and laser product safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-22, IEC 60825-1). Biological evaluation (cytotoxicity, skin sensitization, skin irritation) meets ISO 10993 standards. |
| Effectiveness for Pain Relief (Low-back pain) | The difference in VAS scores before and after treatment for Group B (Active Laser + exercise treatment) and Group C (Mock Laser + exercise treatment) was statistically significant (p-value |
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(394 days)
The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
The LAPEX-2000 is a low level laser therapy device.
This 510(k) submission (K034009) for the LAPEX-2000 low-level laser therapy device asserts substantial equivalence to predicate devices rather than providing a new clinical study with defined acceptance criteria and performance metrics. Therefore, many of the requested details are not available.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the submission. The submission relies on demonstrating substantial equivalence to predicate devices, implying that if it is equivalent, it meets the inherent safety and effectiveness standards of those previously cleared devices. There are no explicit acceptance criteria or reported performance metrics (like sensitivity, specificity, or improvement effect size) for the LAPEX-2000 itself in this document.
The comparison table provided focuses on technical specifications and intended use to show similarity to predicate devices:
| Feature | LAPEX-2000 | Predicate: THOR DDII 830CL3 Laser System (K030226) | Predicate: MicroLight 830 (K010175) |
|---|---|---|---|
| Probe | |||
| Source | Diode GaAlAs | Diode GaAlAs | Diode GaAlAs |
| Type | Continuous & Modulated Continuous | Continuous & Modulated Continuous | Continuous & Modulated Continuous |
| Wavelength | 830nm | 830nm | 830nm |
| Output Power | 30mW x 3 | 30mW x 3 | 30mW x 3 |
| Intended Use | Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome | Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome | Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome |
The conclusion states that the device is "as safe and effective as the predicate device" based on "bench, electrical safety, EMC, and user testing data," but the details of this testing (acceptance criteria, performance results) are not elaborated upon.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. This submission does not include a clinical study with a "test set" in the context of device performance metrics. The mention of "user testing" is too vague to determine sample size or data provenance. The focus is on demonstrating technical equivalence and shared intended use with existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. As there is no clinical study with a test set requiring ground truth establishment, this information is not relevant to this submission type.
4. Adjudication Method for the Test Set
Not applicable/Not provided. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study was not conducted or reported in this submission. The submission does not discuss human reader performance or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a therapeutic laser, not an algorithm, so a standalone performance study in the context of AI is not relevant.
7. The Type of Ground Truth Used
Not applicable/Not provided. For a substantial equivalence claim, the "ground truth" is largely established by the regulatory clearance of the predicate devices for their indicated uses and the technical similarity of the new device. No specific ground truth type (like pathology or outcomes data) for a novel clinical study is detailed for the LAPEX-2000.
8. The Sample Size for the Training Set
Not applicable/Not provided. This device is hardware, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. This information is not relevant for this type of device and submission.
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