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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.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: 60 adult patients
• Data Provenance: Single-center study conducted in South Korea. The study was prospective and randomized.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number of experts or their qualifications for establishing ground truth regarding the patients' pain levels. It mentions "VAS measurement has used as pain level scale," which is a subjective patient-reported outcome. The study was "rater blind," meaning the individuals assessing the VAS scores were unaware of the treatment group, but it doesn't specify if these "raters" were experts.

4. Adjudication method for the test set:

Not explicitly mentioned. The study likely relied on patient-reported VAS scores as the primary outcome.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to the described device. PainTB/PainTJ is a therapeutic laser system, not an AI-powered diagnostic imaging tool involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. The PainTB/PainTJ is a medical device that delivers laser therapy; it is not an algorithm that performs a task autonomously. Its performance is evaluated through patient outcomes and safety.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The primary ground truth for effectiveness was outcomes data, specifically:

• Patient-reported Visual Analog Scale (VAS) scores for pain relief.
• Observation for adverse effects.

8. The sample size for the training set:

Not applicable. The PainTB/PainTJ device is a physical laser therapy system and does not involve AI or machine learning models that require a "training set."

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

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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:

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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