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510(k) Data Aggregation
(216 days)
Caerus Corporation
The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.
The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.
The provided text is a 510(k) summary for the Caerus Active System and Avenue8, seeking substantial equivalence to predicate devices. It describes performance data and a clinical study conducted.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that non-clinical performance testing and a clinical study were conducted to verify device performance and satisfy special controls. However, it does not explicitly state specific acceptance criteria values (e.g., "The device must achieve X% pain reduction to be considered effective") and then report the results against those criteria in a tabular format. Instead, it reports outcomes from the clinical study and compliance with standards.
We can infer "performance" from the clinical study's outcome in terms of pain reduction effect.
| Acceptance Criteria (Implied from Clinical Study Goal) | Reported Device Performance (Active System + SOC group) |
|---|---|
| Significant pain reduction compared to Standard of Care (SOC) alone | 36% reduction in pain (compared to 10% reduction in SOC group) using the Mankowski scale over 2 weeks. |
| Low incidence of adverse events and no serious adverse events | 3.3% minor complications (4 out of 120 participants), distributed equally between groups, with no serious or unanticipated adverse events. |
2. Sample Size Used for the Test Set and Data Provenance
The text describes a clinical study which serves as the "test set" for demonstrating clinical performance.
- Sample Size: 120 patients enrolled.
- 48 in the Active System (Shortwave Diathermy + Heating Therapy) group.
- 43 in the SOC group. (Note: The sum of these two groups is 91, not 120. There's a discrepancy in the provided numbers, as 120 is the total. This could imply other groups or just a rounding/reporting discrepancy. Assuming the reported group sizes are correct for the Active System and SOC groups, the remaining 29 participants are unaccounted for in this specific breakdown).
- Data Provenance: Not specified, neither country of origin nor retrospective/prospective. However, a clinical study implies prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. For a clinical study measuring pain, the "ground truth" is typically the patient's self-reported pain score (Mankowski scale in this case), not an expert consensus on interpreting data like images. Therefore, expert consensus in the traditional sense (e.g., radiologists interpreting images) is not applicable here.
4. Adjudication Method for the Test Set
- This information is not applicable as the "ground truth" is patient-reported pain scores, not adjudicated data. There's no mention of an adjudication process for these scores.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This device involves direct patient treatment and pain measurement, not interpretation of data by multiple human readers (e.g., radiologists) with or without AI assistance. The study described is a clinical trial comparing the device's efficacy against standard of care.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. The device (Active System) is a physical medical device that delivers therapy, not a standalone AI algorithm for diagnosis or interpretation. The clinical study evaluates the device's performance as a treatment.
7. The Type of Ground Truth Used
- The "ground truth" for the clinical study was patient-reported pain assessment scores, specifically using the Mankowski scale, measuring the change from baseline at the end of 2 weeks.
8. The Sample Size for the Training Set
- This information is not applicable or not provided. This document describes a medical device for treatment, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The clinical study serves to validate the device's effectiveness, not to train an algorithm. There is no mention of an algorithm or AI component that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable or not provided as there is no "training set" in the context of an AI/ML algorithm for this device.
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