Search Results

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 kinetic hand 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 temporary relief of hand tremors for patients with essential tremor and to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease. Cala kIQ is made up of three (3) components:

• 1. Cala kIQ Stimulator
• 2. Cala kIQ Band
• 3. Cala kIO Base Station

Cala kIQ detects the frequency of a patient's tremor using on-board motion sensors and applies transcutaneous afferent patterned stimulation (TAPS), a constant current, charge-balanced waveform that alternates between the medial nerves of the wrist. The TAPS pattern is customized to the individual user through an automated device calibration, performed at device set-up.

Cala kIQ is only available via prescription. When Cala kIQ is prescribed for a patient, the ordering physician identifies a prescribed "tremor task," a tremor-inducing postural hold for the patient. The prescribed tremor task is performed by the patient during device callbration. Initial calibration is completed either in a patient's home or physician's office and is operated thereafter by the patient in a home-use setting. Calibration is completed only once for the initial set-up of the device. In addition, the tremor task is performed before and after sessions to measure changes in the patient's tremor amplitude. The patient is prompted on the device for these measurements for the first forty sessions and every seventh session thereafter.

The Cala kIQ device is a wrist-worn stimulator intended to provide temporary relief for hand tremors in adults with essential tremor or Parkinson's Disease. The current submission (K243848) aims to demonstrate substantial equivalence to a previously cleared version of the Cala kIQ (K242259), despite a change in the electrode material formulation and a temporary reduction in the wristband shelf-life.

Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Set stimulation intensity
3. Therapy available on demand | 1. Calibration (completed at device setup only)
4. Set stimulation intensity
5. Therapy available on demand |
   | Treatment Time | 40 minutes | 40 minutes |
   | Wristband life | 90 days | 90 days |
   | Shelf-life | Cala kIQ Band: 18 months | Cala kIQ Band: 3 months (reverting due to new electrode material, pending further testing) |
   | Waveform | Biphasic | Biphasic |
   | Shape | Rectangular | Rectangular |
   | Maximum Output Voltage | 4 @ 500Ω; 80 @ 10kΩ | 4 @ 500Ω; 80 @ 10kΩ |
   | Maximum Output Current | 8 @ 500Ω; 8 @ 10kΩ | 8 @ 500Ω; 8 @ 10kΩ |
   | Duration of primary (depolarizing) phase | 300 µsec | 300 µsec |
   | Pulse Duration | 650 µsec | 650 µsec |
   | Frequency | 150 Hz | 150 Hz |
   | Symmetrical phases? | Yes | Yes |
   | Phase Duration | 300 µS each phase | 300 µS each phase |
   | Net Charge | 0 @ 500Ω | 0 @ 500Ω |
   | Maximum Phase Charge | 2.4 @ 500Ω | 2.4 @ 500Ω |
   | Maximum Current Density | 1.29 @ 500Ω | 1.29 @ 500Ω |
   | Maximum Average Current | 0.72 @ 500Ω | 0.72 @ 500Ω |
   | Maximum Average Power Density | 2.18 @ 500Ω (0.0022 W/cm²) | 2.18 @ 500Ω (0.0022 W/cm²) |
   | Electrical safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety |
   | Compatibility with intended environments | Conforms to EMC requirements | Conforms to EMC requirements |
   | Mechanical safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety |
   | Chemical safety | Not applicable. | Not applicable. |
   | Thermal safety | Conforms to IEC 60601 Electrical Safety | Conforms to IEC 60601 Electrical Safety |
   | Radiation safety | Not applicable. | Not applicable. |

Study Proving Acceptance Criteria:

The current submission (K243848) for the Cala kIQ device primarily relies on demonstrating substantial equivalence to its predicate device (K242259). The core argument is that the only difference between the subject device and the predicate device is the formulation of the proprietary electrode material.

Therefore, the study focuses on validating the safety of this new electrode material and asserting that all other performance aspects remain identical to the predicate device, for which performance data was previously reviewed and accepted.

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

• Sample Size for Test Set: Not explicitly stated as a separate clinical test set for performance on tremor relief was conducted for this specific submission. The submission states, "No other non-clinical or clinical testing was performed in support of a substantial equivalence determination." The performance data reviewed for the predicate device (K242259) are considered applicable.
• Data Provenance: Not applicable for new clinical performance data in this submission. The "acceptance criteria" table implies that the performance aspects derived from the predicate device are used as the benchmark.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable, as no new clinical performance study was conducted requiring expert ground truth in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable, as no new clinical performance study was conducted requiring adjudication in this submission.

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:

• Not applicable. This device is an external stimulator for tremor relief, not an AI-assisted diagnostic or interpretive tool that would involve multi-reader multi-case studies.

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

• The device performs a standalone function (tremor detection and stimulation delivery). The "performance data reviewed in previous submissions, including the predicate submission, are still applicable to the subject device since they are similar in technology, and, hence, the previously reviewed data supports that the subject device meets special controls." This indicates that the standalone performance of the system (including its tremor detection and stimulation algorithm) was assessed in previous submissions.

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

• For the predicate device's performance, the device's efficacy is to "aid in the temporary relief of hand tremors." This would typically be assessed through clinical outcomes data, likely involving tremor quantification (e.g., using accelerometers, clinical rating scales like the Fahn-Tolosa-Marin Tremor Rating Scale or the Unified Parkinson's Disease Rating Scale part III tremor scores), measured against baseline. The current submission does not provide new details on the ground truth used for the predicate's performance.

8. The sample size for the training set:

• Not applicable for this submission, as no new machine learning model or algorithm training is mentioned as being performed for this particular 510(k). The device's TAPS pattern is customized to the individual user through an automated device calibration, not a general training set for an AI model.

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

• Not applicable, as no new machine learning model training set is specifically discussed in this submission. The device uses individual patient "calibration" for customization, which is a process to adapt to the individual's tremor frequency, not a general training dataset for an AI model.

Ask a specific question about this device

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 kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease.

Cala kIQ Gen 2 is a small, lightweight, wrist-worn stimulator device designed to aid in the temporary 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 Gen 2 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 the Cala kIQ Gen 2 Stimulator
• Base Station: Provides charging function and contains an indicator light to alert the user to operating conditions.

The Cala kIQ Gen 2 Stimulator contains the electronics, and firmware for calibrating and delivering TAPS therapy. The patient uses the Cala kIQ Gen 2 Stimulator buttons to complete device calibration, adjust the stimulation amplitude, and initiate therapy sessions. The Cala kIQ Gen 2 Stimulator is attached to the Cala kIQ Gen 2 Band, which includes embedded electrodes placed at appropriate intervals to properly target the medial nerves. To accommodate a broad distribution of wrist sizes, the band is available in three sizes (small, medium, and large).

The provided document is a 510(k) premarket notification for the Cala kIQ device. While it establishes substantial equivalence to a predicate device, it explicitly states that no new performance or clinical data was collected or submitted for this specific 510(k) application (K242259).

The document indicates that the submission is primarily for "labeling updates" to an existing device (Cala kIQ Gen 2), which itself was released under a "note-to-file" and compared to a prior predicate device (Cala kIQ Gen 1, K222237). Therefore, the information you're requesting regarding acceptance criteria and study details would pertain to the original K222237 submission or earlier development phases, which are not detailed in this document.

Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested because the document explicitly states:

• "There was no performance testing conducted in support of Cala kIQ Gen 2 premarket application." (Page 13, Section VII. PERFORMANCE DATA)
• "There was no clinical testing conducted in support of Cala kIQ Gen 2 premarket application." (Page 13, Section VIII. CLINICAL DATA)

The concluding statement on page 13, Section IX. SUBSTANTIAL EQUIVALENCE, clarifies: "The performance data reviewed in previous submissions, including the predicate submission, are still applicable to the subject device since they are similar in technology, and, hence, the previously reviewed data supports that the subject device meets special controls."

To answer your request, information from the K222237 submission or the original developmental studies for Cala kIQ Gen 1 would be required, which are not part of this document.

Ask a specific question about this device

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.

Ask a specific question about this device