(28 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.
As described in DEN170028, the Cala ONE is a small, lightweight, wrist-worn stimulator designed to aid in transient essential tremor symptom relief by applying transcutaneous afferent patterned stimulation (TAPS) to the median and radial nerves of a patient's wrist. The Cala ONE device system consists of a charger, the stimulator, and a set of removable electrodes (gels) that work together to transcutaneously deliver electrical stimulation to the nerves.
The Cala Health, Inc. Cala ONE device is an external upper limb tremor stimulator indicated for the transient relief of hand tremors in adults with essential tremor. This 510(k) submission (K182706) for the Cala ONE focuses on a modification to the electrodes: changing from single-use to multi-use (30-day durability) electrodes.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, it indicates that the "change does not significantly affect the safety or effectiveness of the device" concerning the electrode material and that "the present Premarket Notification documents the substantial equivalence including electrical safety, energy transfer, biocompatibility, and shelf-life." This implies that the device maintained its performance for these parameters, which would have been established in the predicate device (DEN170028).
The key performance aspect reported for the modification is the multi-use durability of the electrodes to 30 days.
Based on the information provided, we can infer the following:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Maintained (Substantially Equivalent) |
| Energy Transfer | Maintained (Substantially Equivalent) |
| Biocompatibility | Maintained (Substantially Equivalent) |
| Shelf-Life | Maintained (Substantially Equivalent) |
| Electrode Durability | Multi-use for 30 days |
| Safety and Effectiveness | Not significantly affected by the change as demonstrated by the predicate device performance. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance for the studies conducted for this particular 510(k) submission (K182706). This submission focuses on a modification to an already cleared device (predicate DEN170028). The studies referenced (electrical safety, energy transfer, biocompatibility, shelf-life) were likely comparative and focused on demonstrating that the new multi-use electrode maintains the performance of the single-use electrode. The original studies for the predicate device (DEN170028) would contain the clinical efficacy data, which is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. As this is a 510(k) for a device modification (electrode change), the primary evidence provided focuses on engineering and bench testing rather than clinical expert evaluation of diagnostic accuracy.
4. Adjudication method for the test set
This information is not provided in the document.
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
An MRMC study is not applicable to this device. The Cala ONE is a therapeutic device (tremor stimulator), not a diagnostic device involving human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation in the context of an algorithm is not applicable here as this is a physical medical device (tremor stimulator) and not an AI/algorithm-based diagnostic tool. The device itself operates autonomously to deliver stimulation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this modification submission, the "ground truth" would be the established performance characteristics of the original single-use electrode (e.g., electrical properties, biocompatibility) from the predicate device (DEN170028). The studies for this modification aimed to demonstrate that the new multi-use electrodes perform equivalently to the predicate device's electrodes in terms of safety and functional characteristics (electrical safety, energy transfer, biocompatibility, shelf-life). Clinical efficacy (outcomes data regarding tremor relief) likely relies on the studies conducted for the predicate device, which are not detailed in this specific document.
8. The sample size for the training set
This information is not applicable/not provided. As this is a physical medical device (tremor stimulator) and not an AI/machine learning algorithm, there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no "training set" for this device.
§ 882.5897 External upper limb tremor stimulator.
(a)
Identification. An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must assess the following:
(i) Characterization of the electrical stimulation, including the following, must be performed: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(ii) Impedance testing, current distribution across the electrode surface area, adhesive integrity, and shelf life testing of the electrodes and gels must be conducted.
(iii) Simulated use testing of sensor performance and the associated algorithms that determine the stimulation output must be conducted.
(2) Patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface components;
(iv) Instructions on how to clean the device;
(v) A shelf life for the electrodes and gel; and
(vi) Reuse information.