Search Results
Found 1 results
510(k) Data Aggregation
(344 days)
The Cala ONE device is indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
The Cala ONE is a small wrist-worn stimulator system that consists of a charger, the stimulator (including a (b) (4) within a housing and attached via a wristband, and a set of single use removable electrodes (gels) that work together to transcutaneously deliver electrical stimulation to the nerves. The Cala ONE stimulation pattern (referred to as transcutaneous afferent patterned stimulation (TAPS)) is tremor-customized (based on the patient's measured tremor frequency) and is delivered transcutaneously to the median and radial nerves of a patient's wrist. The patient specific TAPS is determined by the physician through a calibration process performed using the gyroscopes and microprocessor on the device. The stimulation output is described in Table 1 below. The Cala ONE electronics are powered by a lithium-ion rechargeable battery within the device.
The provided text details the regulatory information, device description, non-clinical/bench studies, and clinical study results for the Cala ONE external upper limb tremor stimulator. However, it does not explicitly state "acceptance criteria" for the device's performance in the clinical study. Instead, it describes the primary and secondary effectiveness endpoints of the study, and whether they were met. The outcome of the primary endpoint was that it was not met, as there was no statistically significant difference between the treatment and sham groups in the primary measure of tremor reduction.
Therefore, the response below will present the intended effectiveness endpoints as if they were acceptance criteria, and then report the device's performance against those endpoints.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not mentioned, the primary and secondary effectiveness endpoints of the study are used as a proxy for what the device would need to demonstrate to be considered effective.
| Acceptance Criteria (Study Endpoint) | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: Significantly greater change in the treatment group compared to the sham group in the TETRAS Archimedes spiral rating after stimulation compared to baseline. | Did NOT meet. The treatment group improved by an estimated 0.56 points, and the sham group by 0.39 points. The improvement in the treatment group was not statistically significantly greater than the improvement in the sham group (p = 0.263). The observed difference (0.17 points) was not considered clinically meaningful. |
| Secondary Effectiveness Endpoint 1: Significantly greater change in the treatment group compared to the sham group in the TETRAS Archimedes spiral rating during stimulation compared to baseline. | Not formally tested due to the hierarchical statistical analysis plan (primary endpoint not met). However, descriptively, both treatment and sham groups improved similarly by an estimated 0.37 points during stimulation. |
| Secondary Effectiveness Endpoint 2: Significantly greater self-reported improvement in the treatment group (CGI-I scale) compared to the sham group. | Not formally tested due to the hierarchical statistical analysis plan (primary endpoint not met). Descriptively, a greater percentage of subjects in the treatment group (88%, 35/40) reported an improvement after stimulation compared to the sham group (62%, 23/37). No treatment group subjects reported worsening, compared to 1 in the sham group. |
| Additional Effectiveness Analyses (Responder Rate - TETRAS Archimedes Spiral): % of subjects with a ≥ 0.5-point improvement. | After stimulation: Treatment group: 50.0% (95% CI: 33.8% - 66.2%); Sham group: 38.9% (95% CI: 23.1% - 56.5%). (Note: No statistical comparison reported for these rates). |
| Additional Effectiveness Analyses (Responder Rate - TETRAS Upper Limb Tremor): % of subjects with a ≥ 0.5-point improvement in Average TETRAS Upper Limb tremor. | After stimulation: Treatment group: 65.0% (95% CI: 48.3% - 79.4%); Sham group: 32.4% (95% CI: 18.0% - 49.8%). (Note: There was a "difference in the responder rates between the treatment and sham groups for the average TETRAS Upper Limb score," implying a positive trend for the treatment group, but no p-value is provided). |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Effectiveness Analysis Population (EAP): 77 subjects (40 in treatment group, 37 in sham group) for the primary and secondary effectiveness endpoints.
- Enrolled Population: 93 subjects initially enrolled (48 treatment, 45 sham) for sensitivity analyses.
- Per-Protocol (PP) Analysis Population: 60 subjects (30 treatment, 30 sham) for sensitivity analyses.
- Data Provenance: The study was a "multi-center, prospective, randomized, double-blinded, and sham-stimulation controlled" clinical study. The text does not specify the country of origin of the data, but it is a FDA De Novo submission, implying it primarily involved data relevant to US regulatory standards.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: 3 independent blinded raters.
- Qualifications: Board certified neurologists trained in movement disorders.
4. Adjudication Method
- For the TETRAS Archimedes spiral task, scores from all three independent blinded raters were averaged to get the final rating for each spiral, which served as the ground truth for this specific endpoint.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The study was a MRMC study in the sense that multiple readers (the 3 blinded neurologists) evaluated multiple cases (spirals from subjects). However, it was not a comparative effectiveness study designed to assess how much human readers improve with AI vs. without AI assistance. The "readers" (neurologists) were establishing ground truth for human subject performance with and without device intervention. The device itself is a stimulator, not an AI diagnostic tool that assists human readers.
6. Standalone (Algorithm Only) Performance
The study was not a standalone (algorithm only) performance study. The Cala ONE device is directly involved in physically stimulating the patient to reduce tremor. While it contains algorithms for tremor customization and motion sensing, the clinical study assessed the device with human subjects in the loop, measuring the effect of the stimulation on their tremor. The motion sensor and algorithm testing mentioned in the "Additional Testing" section were bench tests to confirm the device's adherence to specifications, not a standalone clinical performance evaluation.
7. Type of Ground Truth Used
- For the primary and secondary effectiveness endpoints related to the TETRAS Archimedes spiral, the ground truth was established by expert consensus (average score from 3 independent, blinded, board-certified neurologists trained in movement disorders).
- For other assessments (TETRAS Upper Limb Tremor, Bain & Findley ADL, CGI-I), the ground truth was established by investigator ratings (TETRAS ULT) and subject self-assessments (ADL, CGI-I).
8. Sample Size for the Training Set
The provided text does not mention a training set for the clinical study. The study described is a clinical trial evaluating the effectiveness of the device itself (Cala ONE) on human subjects with essential tremor, not a study of an AI algorithm that requires a separate training set. The device's internal algorithms (e.g., for tremor customization) would have been developed and "trained" during the device's engineering and pre-clinical stages, but details on that process and sample sizes are not provided here.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned for the clinical study in the provided text, this information cannot be provided.
Ask a specific question about this device
Page 1 of 1