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Cala kIQ is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.

Cala kIQ is indicated to aid in the temporary relief of postural and tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.

Cala kIQ is a small, lightweight, wrist-worn stimulator device designed to aid in the relief of hand tremors by applying a calibrated Transcutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wrist.

The TAPS output pattern is calibrated to the individual patient's tremor frequency. During device setup, the patient performs a postural hold, during which the onboard sensors measure the tremor frequency which is then used to customize the TAPS output pattern to deliver therapy to the median and radial nerves at the appropriate, patient-specific, optimal stimulation frequency.

Cala kIQ is comprised of the following components:

• Stimulator: Contains sensors, electronics, and firmware for delivering TAPS therapy . and provides user interface
• Band: Contains multi-use, conductive electrodes spaced at intervals to align with . targeted nerves and attachment points for Cala kIQ Stimulator
• . Base Station: Provides charging function and contains an indicator light to alert the user to operating conditions.

The Cala kIQ Stimulator contains the electronics, sensors, and firmware for calibrating and delivering TAPS therapy. The patient uses the Cala kIQ Stimulator buttons to complete device calibration, adjust the stimulation amplitude, and initiate therapy sessions. The Cala kIQ Stimulator is attached to the Cala kIQ band, which includes embedded electrodes placed at appropriate intervals to properly target the median and radial nerves. To accommodate a broad distribution of wrist sizes, the band is available in three sizes (small, medium, and large).

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Cala kIQTM
Predicate Device: Cala Trio™

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define clear quantitative acceptance criteria for the Cala kIQ device across all metrics in the format you requested, especially for the Parkinson's Disease indication. Instead, it relies on demonstrating comparable effectiveness to the predicate device for Essential Tremor and provides descriptive results for Parkinson's Disease.

However, based on the provided clinical data, we can infer performance and the study's findings directly:

2. Sample Size Used for the Test Set and Data Provenance

Study 1 (Parkinson's Disease - standalone performance):

• Sample Size: 40 patients were enrolled.
• Data Provenance: Not explicitly stated, but the submission is for a US FDA clearance, implying results relevant to a US or general population. The study was described as a "single-arm, non-significant risk study," suggesting it was prospective.

Study 2 (Comparative Effectiveness - Cala kIQ vs. Cala Trio):

• Sample Size: 19 subjects completed the study, 6 of whom had Parkinson's Disease.
• Data Provenance: Prospective, single-center study. Country of origin not explicitly stated, but again, implied to be relevant to a US FDA clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth was established through clinician-rated and subject-rated assessments:

• Clinician-rated assessments: MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) and TETRAS (Tremor Essential Tremor Rating Assessment Scale) were used. The document does not specify the number or qualifications of the clinicians who performed these assessments. However, these are standardized scales typically administered by neurologists or movement disorder specialists.
• Subject-rated assessments: BF-ADLs (Bain and Findley Activities of Daily Living) were used, representing patient self-reported outcomes.
• Global Impression: CGI-I (Clinical Global Impression – Improvement) and PGI-I (Patient Global Impression – Improvement) were also used, which involve clinician judgment and patient self-perception, respectively.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for reconciling disagreements between experts. The assessments are presumably taken as direct measurements by the administering clinicians or self-reported by patients. This indicates that assessments were likely unadjudicated for the purposes described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done in the traditional sense of evaluating multiple readers' interpretations of diagnostic images or data. The studies involved:

• Study 1: A single-arm physiological intervention study assessing the device's direct effect on tremor and ADLs.
• Study 2: A crossover study comparing the Cala kIQ directly against the Cala Trio device in the same subjects, with assessments made by clinicians and subjects. This is a head-to-head device comparison, not an MRMC study related to interpretation.

Therefore, there is no discussion of the "effect size of how much human readers improve with AI vs. without AI assistance."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, Study 1 indirectly represents a standalone performance assessment of the Cala kIQ device (though not an "algorithm-only" assessment in the context of interpretation, rather a direct clinical effect). In this study, the device was used to deliver therapy, and its effect on patients' tremors and ADLs was measured. The device itself (Cala kIQ) functions autonomously in delivering calibrated TAPS therapy based on the patient's tremor frequency measured by onboard sensors. The reported results are the direct outcome of the device's therapy application.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's effectiveness was a combination of:

• Expert Clinical Assessment: Clinician-administered standardized scales (MDS-UPDRS, TETRAS, CGI-I) which reflect expert observation and rating of tremor severity and overall improvement.
• Patient-Reported Outcomes (PROs): Subject-rated scales (BF-ADLs, PGI-I) which reflect the patient's direct experience of symptom relief and functional improvement.

There was no pathology or specific outcomes data (like long-term mortality or disease progression) used as ground truth for this temporary relief indication.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size of a "training set" for the Cala kIQ device or its underlying algorithm. The device's TAPS output pattern is "calibrated to the individual patient's tremor frequency" during device setup using "onboard sensors." This suggests a patient-specific calibration rather than a broad, pre-trained algorithm in the AI/ML sense that would require a large training dataset. The studies described are for clinical validation, not algorithm training. Previous predicate devices (DEN170028, K182706, K203288 for Cala Trio) likely contributed to the iterative development and refinement of the TAPS technology, but specific training set information is not provided.

9. How the Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" with ground truth in the traditional AI/ML sense is not described. The device calibrates to each individual patient's tremor frequency. The underlying science and engineering of Transcutaneous Afferent Patterned Stimulation (TAPS) and the ability to measure tremor frequency would have been developed and validated through initial research and development phases, but the details of this are not provided in this 510(k) summary. The clinical studies (Study 1 and Study 2) served as validation, not training.

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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:

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.

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