(243 days)
The Sway System Sports Plus is intended for use as a computerized cognitive assessment and management of concussion in individuals ages 18-24. The Sway System Sports Plus is indicated for use when there is a suspected concussion or head injury.
Sway Sports Plus (referred to as Sway Sports+) is a licensed variant of the Device Sway System and is a software solution (SaMD) that provides a computerized cognitive assessment aid for concussion. This prescription device uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to a suspected concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. The examiner may have the patient complete the Sway Balance test to provide an additional indicator in their assessment of concussion. The Sway System is not intended as a stand-alone diagnostic device. After the patient completes the Sway Sports+ test(s), the examiner can view the summary statistics for each test such as mean reaction time (speed). Sway Sports+ does not create new information through analysis or interpretation, nor does it offer any diagnostic or treatment recommendations. The Sway Sports+ is not intended to be used as a standalone diagnostic device. Sway Sports+ operates in the Apple iOS or Android operating systems, enabling it to be used on the hardware of Apple iPhone. iPad, and iPod Touch. or Android mobile devices. The internal accelerometer is accessed to analyze motion of the device in response to stimuli during testing. The mobile device hardware is not provided by Sway Medical. Environments where Sway Sports+ may be used may include both clinical and non-clinical settings. Clinical settings may include physician offices, hospitals, physical or occupational therapy clinics, skilled nursing facilities, assisted living centers and other healthcare facilities where cognitive tests may be evaluated. In addition, non-clinical environments may include sports team's locations where the application may be used on the sideline to perform a cognitive assessment, e.g., fitness centers, gymnasiums, or stadiums. It is recommended that the tests be taken in a supervised environment for baseline and post-injury testing. Sway Sports+ consists of the Sway Balance (K121590) and the Sway Computerized Cognitive Assessment Aid. The Sway Computerized Cognitive Assessment Aid (PTY) is exempt from 510(k).
Here's a breakdown of the acceptance criteria and the study information for the Sway System Sports Plus, based on the provided text:
Acceptance Criteria and Device Performance
The provided text details the non-clinical and clinical performance testing results, and how they relate to the substantial equivalence claim rather than explicit "acceptance criteria" in a pass/fail table format. However, we can infer the acceptance criteria from the reported performance results and the comparison to predicate devices.
Table 1: Inferred Acceptance Criteria and Reported Device Performance
| Performance Metric | Inferred Acceptance Criteria (Based on Predicate/Reference Equivalence & Clinical Utility) | Reported Device Performance (Sway Sports Plus) |
|---|---|---|
| Software Validation | Compliance with IEC 62304 and FDA guidance for software V&V. Meeting predetermined specifications. | Designed and developed according to Sway Medical, Inc.'s internal software development process in accordance with IEC 62304. Tested using verification and validation methods. Results indicate compliance with specifications. All tests passed with no exceptions. |
| Construct Validity | Demonstrates construct validity with traditional neuropsychological tests and similar correlations to predicate devices. | VanRavenhorst-Bell et al., 2021: Sway Reaction Time, Impulse Control, and Inspection Time módulos correlated significantly (r = -0.46 to 0.22, p ≤ 0.05) with ImPACT QT reaction time measures. Clark & VanRavenhorst-Bell, 2022: Sway Sports+ modules exhibited correlation values ranging from 0.22 to 0.42 with traditional neurocognitive tests (WAIS-IV, WMS-IV, D-KEFS, CVLT-III). Demonstrated stronger correlation strengths with traditional neurocognitive tests compared to ImPACT. Significant correlations with ImPACT and traditional tests (p |
§ 882.1471 Computerized cognitive assessment aid for concussion.
(a)
Identification. The computerized cognitive assessment aid for concussion is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand-alone diagnostic device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed.
(2) Clinical performance data must be provided that demonstrates how the device functions as an interpretation of the current level of cognitive function in an individual that has recently received an injury that causes concern about a possible concussion. The testing must:
(i) Evaluate device output and clinical interpretation.
(ii) Evaluate device test-retest reliability of the device output.
(iii) Evaluate construct validity of the device cognitive assessments.
(iv) Describe the construction of the normative database, which includes the following:
(A) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.
(B) Statistical methods and model assumptions used.
(3) The labeling must include:
(i) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function in a patient that has recently received an injury that causes concern about a possible concussion. The summary of testing must include the following:
(A) Device output and clinical interpretation.
(B) Device test-retest reliability of the device output.
(C) Construct validity of the device cognitive assessments.
(D) A description of the normative database, which includes the following:
(
1 ) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.(
2 ) How normal values will be reported to the user.(
3 ) Representative screen shots and reports that will be generated to provide the user results and normative data.(
4 ) Statistical methods and model assumptions used.(
5 ) Whether or not the normative database was adjusted due to differences in age and gender.(ii) A warning that the device should only be used by health care professionals who are trained in concussion management.
(iii) A warning that the device does not identify the presence or absence of concussion or other clinical diagnoses.
(iv) A warning that the device is not a stand-alone diagnostic.
(v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.