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510(k) Data Aggregation
(148 days)
EQ Balance is intended to assess body tilt as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Interpretation of EQ Balance results should only be made by a healthcare professional, as part of a multifaceted assessment of balance. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. EO Balance should be used in an indoor setting free from obstructions and free from excessive noise or visual distractions. EQ Balance should be only be used as directed by your healthcare practitioner. EQ Balance may be used on mobile devices running iOS or Android operating systems.
EQ Balance is a mobile balance test to be used on mobile phone and tablet devices with iOS version 10.3 or later, or Android OS version 6 or later. EQ Balance measures balance using the accelerometer within the device.
EQ Balance utilizes an algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device held to the chest by the user. Users follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. EQ Balance does not function as a diagnostic test, and EQ Balance results should be interpreted by qualified individuals only.
The provided text details the 510(k) summary for the EQ Balance device, which is intended to assess body tilt as an indicator of balance. The study's primary goal was to demonstrate substantial equivalence to the predicate device, Sway Balance.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the performance testing verified that "EQ Balance and the Sway™ Balance System (Sway) are in statistical agreement." The agreement was primarily assessed using Spearman's analysis and Deming Regression Model.
| Acceptance Criteria / Performance Metric | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Statistical Agreement (3-pose average) with Predicate (Sway Balance) | Not explicitly stated, implied to be demonstrable statistical agreement | Spearman's analysis: "the 3-pose average measures calculated by EQ Balance were in statistical agreement with the 3-pose average obtained with Sway Balance for both normal and balance-impaired groups, and for all three stances (double leg, tandem right and left)."Deming Regression Model: "showed agreement between the 3-pose average balance measures (the primary device output), as well as 23 of the 27 additional analyses that were conducted." | The study aimed to show agreement rather than a specific statistical threshold for acceptance. |
| Intraclass Correlation (ICC) for consistency of EQ Balance measure | Not explicitly stated. Implied to be strong consistency. | ICC for the cohort was 0.75 (p<0.001) | This indicates strong consistency of the task output between test sessions. |
| Poorer balance scores for subjects with balance impairments | Not explicitly stated, but expected for clinical relevance. | "Poorer balance scores were observed for subjects with balance impairments." | This demonstrates the device's ability to differentiate between healthy and impaired balance. |
| Conformance to product specification (Nonclinical/Bench Testing) | Met specification | "EQ Balance met specification." | Verified accuracy of tilt angles from the accelerometer. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 70 subjects (25 males; 45 females).
- Data Provenance: Prospective. The clinical testing was conducted under an IRB-approved study at a "sports medicine and concussion clinic in Mississauga, Ontario." Mississauga is in Canada.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated for specific ground truth establishment. However, the study was conducted under the "oversight of a principle investigator from the Department of Neurosurgery at the University of Toronto."
- Qualifications of Experts: The ground truth for balance impairment was "determined by failure of the modified Balance Error Scoring System (mBESS) test." The mBESS test itself is administered by trained individuals, implying expert involvement in the assessment that defined the ground truth. While explicit expert count or detailed qualifications for establishing mBESS ground truth aren't given, the involvement of a "principle investigator from the Department of Neurosurgery" suggests qualified oversight.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly described as a multi-reader adjudication process (e.g., 2+1, 3+1). The balance impairment ground truth was determined by the "failure of the modified Balance Error Scoring System (mBESS) test," implying a standardized test administered and interpreted by trained personnel. The simultaneous testing of EQ Balance and Sway Balance on the same subjects suggests a direct comparison where each device's output was against the other and against the mBESS-determined impairment status, rather than a multi-expert adjudication of the device outputs themselves.
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
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described.
- Effect Size of Human Reader Improvement: This study focused on the statistical agreement between two device outputs (EQ Balance and Sway Balance) and their ability to correlate with balance impairment as determined by mBESS. It did not involve comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The study "Performance testing verified that EQ Balance and the Sway™ Balance System (Sway) are in statistical agreement." Both EQ Balance and Sway Balance are described as software applications that "utilizes an algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer." The clinical study involved subjects holding the mobile device and the applications calculating scores; there's no mention of a human-in-the-loop directly interpreting the raw accelerometer data or refining the algorithm's scores for the purpose of the study.
7. The Type of Ground Truth Used
The ground truth for balance impairment in the clinical study was established by the "failure of the modified Balance Error Scoring System (mBESS) test." This is a clinical assessment method.
8. The Sample Size for the Training Set
The document does not provide information about the sample size used for the training set for the EQ Balance algorithm. The provided clinical study appears to be solely for validation/performance testing.
9. How the Ground Truth for the Training Set was Established
As no information is provided regarding a specific training set or its sample size, details on how its ground truth was established are also not available in the provided text.
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