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

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

Cala Trio is a small, lightweight, wrist-worn stimulator device designed to aid in essential tremor symptom relief by applying Transcutaneous Afferent Patterned Stimulation (TAPS) to the median and radial nerves of a patient's wrist. The Cala Trio system includes three main components: (1) a rechargeable stimulator, (2) a wrist-worn electrode band, and (3) a base station that charges the device.

The stimulator component contains the electronics for delivering TAPS to the patient's wrist. There are three buttons on the stimulator that are used for calibration and stimulation amplitude adjustments, among other functions. Text prompts, stimulation delivery parameters, timer, and other messages are provided on the stimulator's full color display to provide instructions and stimulation delivery information.

To deliver therapy, the stimulator is attached to the wrist band, which includes integrated electrodes placed at appropriate intervals around the inner diameter of the band 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). Each band size is also available in right or left-handed versions to target the appropriate nerves of the prescribed hand.

The provided text describes a 510(k) premarket notification for a medical device called Cala Trio. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, Cala ONE, rather than establishing de novo performance criteria for an entirely new device. Therefore, the "acceptance criteria" discussed are primarily about demonstrating that the modified device (Cala Trio) is as safe and effective as the predicate device (Cala ONE), despite some changes.

Here's an analysis of the provided information concerning the "acceptance criteria" and the study that proves the device meets them, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not absolute performance targets set for a new device type, but rather the demonstration that the Cala Trio performs equivalently to the Cala ONE. The performance here is primarily about achieving similar clinical outcomes and meeting non-clinical safety/electrical standards.

Study 2 (Yu et al., 2020 - single session): 70-80% of TAPS users demonstrated tremor relief for 60 minutes after stimulation in a study of 15 participants. |
| Non-clinical & Technical Equivalence: | |
| Biocompatibility in accordance with ISO 10993-1. | Demonstrated Biocompatibility in accordance with ISO 10993-1:2018 (Cala ONE was 2009 version). |
| Meets IEC60601-1 and collateral standards (EMC & Electrical Safety). | Meets all requirements of IEC60601-1 and relevant collateral and particular standards. |
| Stimulation waveform conforms to internal standard. | Stimulation waveform conforms to requirements of internal standard test method and acceptance criteria. |
| Electrode performance and shelf life. | Electrode performance conforms to requirements of internal standard test method and acceptance criteria at T=24 months. |
| Sensor performance and associated algorithms. | Non-clinical performance testing demonstrated that the measurements obtained from the Cala Trio sensor (triaxial accelerometer only) are equivalent to those obtained from the Cala ONE sensors (gyroscope and triaxial accelerometer). |
| Electrical stimulation characterization. | The therapy pattern parameters are unchanged, and clinical evidence demonstrates that changes in maximum output voltage, maximum output current, maximum phase charge, maximum current density, maximum average current, and maximum average power density do not impact safety or effectiveness of the device. The functionality of the output channel and therapy parameters are unchanged despite going from 1 channel with 2 alternating outputs to 2 alternating channels. |

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

• Isaacson et al. (2020) Study:
  • Sample Size: 263 enrolled subjects, with 205 subjects completing the study.
  • Data Provenance: Not explicitly stated, but described as a "prospective, multi-center, single-arm three months study of repeated home use." Given the authors and typical clinical trial landscapes for such devices, it's highly likely to be US-based, and it is prospective.
• Yu et al. (2020) Study:
  • Sample Size: 15 participants.
  • Data Provenance: Described as "an in-office, single session study." Not explicitly stated, but likely also prospective and US-based given the authors.

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

The document does not describe the establishment of a "ground truth" by experts in the way it might for an AI image analysis device (e.g., radiologists labeling images). Instead, the performance is assessed via:

• Patient self-reported outcomes: PGI-I (Patient Global Impression of Improvement).
• Clinician-reported outcomes: CGI-I (Clinical Global Impression of Improvement).
• Standardized tremor assessment scales: TETRAS (The Essential Tremor Rating Assessment Scale) and BF-ADL (Bain and Findley Activities of Daily Living Scale).
• QUEST (Quality of Life in Essential Tremor) scale.

For the clinician-reported outcomes, while not specified, it's presumed that the clinicians involved in the multi-center study were qualified medical professionals, likely neurologists or specialists in movement disorders, who are trained to assess these scales. The number of such "experts" would correspond to the number of clinicians participating in the study who performed these assessments. The document does not specify the exact number of clinicians or their precise qualifications beyond what is implied by their role in a clinical study for essential tremor.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus) is described for the clinical outcome measures. These measures (TETRAS, BF-ADL, CGI-I, PGI-I, QUEST) are often collected directly by study staff, clinicians, or patients, and then analyzed statistically. It is not an image review or labeling task that typically requires adjudication.

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

No MRMC study was performed or is relevant here, as this device (Cala Trio) is a therapeutic device for tremor relief, not an AI diagnostic imaging tool interacting with human readers.

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

The Cala Trio is a physical therapeutic device. Its core function is to deliver transcutaneous afferent patterned stimulation (TAPS). Its performance is inherently "standalone" in the sense that the device itself delivers the therapy. There is no human-in-the-loop performance being evaluated in the context of an algorithm's output needing interpretation by a human. The patient uses the device, but the device's therapeutic action is direct.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context refers to the assessment of tremor relief and improvement in daily living and quality of life. This was established using:

• Clinical Assessment Scales: TETRAS, BF-ADL (Likely assessed by clinicians).
• Patient-Reported Outcomes: PGI-I, QUEST (Self-reported by patients).
• Clinician Global Impression of Improvement: CGI-I (Assessed by clinicians).
• Self-reported duration of tremor relief from patients.

This is a combination of subjective patient feedback and objective (clinical scale scores) assessments.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a device modification, relying on clinical evidence of its direct predecessor (Cala ONE) and clinical studies of the modified device (Cala Trio) for substantial equivalence. It does not refer to a machine learning context where a separate "training set" would be used to develop an algorithm for diagnosis or image analysis. The "training" for the device's therapeutic protocol was established in prior research for the Cala ONE and maintained for the Cala Trio.

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

As above, this context is not applicable. The device's therapeutic mechanism (TAPS) is based on established neurophysiological principles, not on a machine learning model trained on a dataset with a defined "ground truth" in the AI sense. The clinical studies establish the device's effectiveness, not a training ground truth for an algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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