(243 days)
No
The description explicitly states that the device "does not create new information through analysis or interpretation, nor does it offer any diagnostic or treatment recommendations." It focuses on providing summary statistics and comparing scores to a normative database, which are not indicative of AI/ML processing.
No
The device is described as a computerized cognitive assessment aid for concussion, not a treatment or therapy device. It provides an indication of cognitive function and does not offer diagnostic or treatment recommendations.
No
The device description explicitly states multiple times that "The Sway System is not intended as a stand-alone diagnostic device" and "Sway Sports+ does not .... offer any diagnostic or treatment recommendations." It is described as an "assessment aid."
Yes
The device description explicitly states that Sway Sports Plus is a "software solution (SaMD)" and operates on existing mobile device hardware (Apple iPhone, iPad, iPod Touch, or Android mobile devices) which is not provided by the manufacturer. It accesses the internal accelerometer of the mobile device but does not include any proprietary hardware.
Based on the provided information, the Sway System Sports Plus is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Sway System Sports Plus Function: The Sway System Sports Plus is a software solution that provides a computerized cognitive assessment. It uses an individual's performance on cognitive tasks and balance tests to provide an indication of their current level of cognitive function. It does not analyze biological samples.
- Intended Use: The intended use is for computerized cognitive assessment and management of concussion, not for analyzing biological samples to diagnose or detect a condition.
- Device Description: The description explicitly states it's a "software solution (SaMD)" and uses the device's internal accelerometer to analyze motion during testing. It does not mention any analysis of biological specimens.
- Lack of Biological Sample Analysis: There is no mention of collecting or analyzing any type of biological sample from the patient.
Therefore, the Sway System Sports Plus falls outside the scope of an In Vitro Diagnostic device. It is a software-based assessment tool used to evaluate cognitive function and balance.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
POM
Device Description
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 batterv 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18-24 years old
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Normative Database
- Study type: Normative Database collection
- Sample size: Over 126,000 users aged 18 to 24 years old.
- Data source: De-identified baseline test data.
- Annotation protocol: Subjects were selected based on inclusion criteria: Completed a baseline test in English, completed a baseline test in the United States of America, primary language was English, did not report a concussion within the last 6 months, did not report neurological conditions, did not report learning disability, had valid scores on all tests. Data were stratified across age and gender. Mann-Whitney U statistical tests were used to assess inter- and intra-sex and age differences. Descriptive statistics (mean, standard deviation, median, and interquartile range [10th, 25th, 75th, and 90th]) were calculated. Statistical significance was set a priori at a p-value of 0.05. Age/gender group samples required minimal size of 50 profiles.
- Key results: Results indicate an increase in performance in Sway Sports+ modules with age, with scores peaking in the early to mid-20's. Specific tests also show gender-based normative value differences.
Validity
- VanRavenhorst-Bell et al., 2021:
- Study type: Construct Validity
- Sample size: 88 healthy adults aged 18 to 48 years (mean 22.09 ± 4.47 years).
- Key results: Sway Reaction Time module was statistically significantly correlated (r = -0.46 to 0.22, p ≤ 0.05) with several ImPACT QT reaction time measures. Sway Impulse Control and Inspection Time measures were also statistically significantly correlated (r = -0.25 to -0.46, p ≤ 0.05) with five ImPACT QT reaction time measures. Overall, these findings suggest that Sway Sports+ cognitive test battery is clinically comparable to the FDA-cleared concussion management system.
- Clark & VanRavenhorst-Bell, 2022:
- Study type: Construct Validity
- Sample size: 85 adults (mean age 23.1 years; 68% female).
- Key results: Significant correlations between Sway Sports+ and both 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.
0
February 15, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Sway Medical, Inc. % Robert Steurer Consultant Steurer Consulting Group, LLC 800 Blue Quail Rd Keller, Texas 76248
Re: K241737
Trade/Device Name: Sway System Sports Plus Regulation Number: 21 CFR 882.1471 Regulation Name: Computerized Cognitive Assessment Aid For Concussion Regulatory Class: Class II Product Code: POM Dated: January 15, 2025 Received: January 15, 2025
Dear Robert Steurer:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name Sway System Sports Plus
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
| Date Prepared: | February 12, 2025 |
|---|---|
| Submitter: | Sway Medical, Inc. |
| 32 S. Lewis Ave. | |
| Tulsa, OK 74101 | |
| Submitter Contact: | Sway Medical, Inc. |
| 32 S. Lewis Ave. | |
| Tulsa, OK 74101 | |
| Name: Alex Pettigrew | |
| Sway Medical Inc | |
| Phone: (281) 726-3820 | |
| Email: alex.pettigrew@swaymedical.com | |
| Application | |
| Correspondent: | Robert Steurer |
| Principal Consultant | |
| Steurer Consulting Group | |
| 800 Blue Quail Rd. | |
| Keller, TX 76248 | |
| steurerbob@gmail.com | |
| +1 (425) 358-1072 | |
| Manufacturing | |
| Site: | Sway Medical, Inc. |
| 32 S. Lewis Ave. | |
| Tulsa, OK 74101 | |
| Trade Name: | Sway Sports+ |
| Common Name: | Neurological Diagnostic Device |
| Classification | |
| Name: | |
| Device Class: | Computerized Cognitive Assessment Aid for Concussion |
| Class II | |
| Primary | |
| Classification | |
| Regulation: | 21 CFR §882.1471 |
5
Primary Product Code:
POM
Predicate Device: Impact Applications, Inc. ImPACT Quick Test, K170551
Reference
Predicate Device: Impact Version 4, K202485
| Substantially
Equivalent
Devices: | New Device | Predicate
Device | Reference Predicate
Device |
|-----------------------------------------|--------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------|
| | Sway Sports Plus (Sports+)
Sway Medical, Inc. | ImPACT Quick Test
K170551
Impact Applications, Inc. | ImPACT Version 4
K202485
ImPACT Applications, Inc. |
6
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 Description: cognitive assessment aid for concussion. This prescription device uses an individual's score(s) on a batterv 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).
7
| Intended Use: | The Sway System Sports Plus is intended for use as a computerized cognitive assessment test to aid in the 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 |
|---|---|
| Summary of Substantial Equivalence: | The Intended Use of Sway Sports+ is the same as the predicate device, ImPACT QT, and the reference predicate device, ImPACT. The patient age range for Sway Sports+ is contained within that of the predicate and reference devices. Sway Sports+ and the predicate device function on mobile devices incorporating Apple iOS; Sway Sports+ also functions on Android OS devices. |
| Sway Sports+, the predicate device, and the reference device all enable the administration of neuropsychological tests to evaluate a test taker's cognitive state. All devices are similar in terms of technological characteristics, as they administer neurocognitive test modules using standard off-the-shelf computing devices and record objective cognitive performance measurements as the test taker responds to stimuli presented on the screen. Sway Sports+ also includes balance assessments; balance has been documented in the scientific literature as a potential indicator of the effects of concussion. | |
| Sway Sports+ differs from the predicate and reference devices in the content and design of the cognitive tasks. However, both Sway Sports+ and the predicate device provide the same reporting on the mobile application, on a web portal, and in .pdf format. The reference device also has reporting available on a web portal and in .pdf format. Both summary and raw data are available as an export for all devices. | |
| Sway Sports+ uses internal accelerometer and gyroscope data from mobile devices as well as touch input to record patient responses. The predicate device relies solely on touch input, and the reference device uses input from computer peripherals. This is not a significant difference, as all devices include a response signal to the underlying operating system as part of their algorithms. | |
| Technology Comparison: | The Sway Sports+ employs the same technological characteristics as the predicate device and the reference device. |
8
| Table 1 - Substantial Equivalence Comparison | |||
|---|---|---|---|
| Characteristic | Sway Sports Plus | ||
| (Sports+) | Predicate Device | ||
| ImPACT Quick Test | |||
| (K170551) | Reference Device | ||
| ImPACT Version 4 | |||
| (K202485) | |||
| Operating System | Apple iOS and Android | ||
| mobile devices | Apple iOS mobile | ||
| devices | Desktop/laptop | ||
| computers | |||
| Use Cases | Measures change over | ||
| time | Same | Same | |
| Patient Population | 18-24 years old | 12-70 years old | 12-80 years old |
| How Provided | Software only | Same | Same |
| Reporting Features | Report viewable on the | ||
| Sway Mobile Application | |||
| and on the Sway Web | |||
| Portal and in .pdf | |||
| format. Summary and | |||
| Raw Data is available as | |||
| csv export from the web | |||
| portal data. | Report viewable in PDF | ||
| format. Summary and | |||
| Raw Data available in | |||
| csv, xml, and html file | |||
| formats. | Same | ||
| Technology | Stand-alone software | ||
| application | Same | Same | |
| Stimulus Presentation | Mobile device screen | Same | Desktop or laptop screen |
| Stimulus Capture | |||
| (test taker response) | User input (motion | ||
| response) via mobile | |||
| device motion sensors | |||
| and via touch screen | User input (finger touch) | ||
| via mobile device touch | |||
| screen | User input via computer | ||
| peripherals. | |||
| Cognitive Tasks | |||
| Administered | Test battery consisting of | ||
| multiple test modules: | |||
| -Module 1: Reaction | |||
| Time | |||
| -Module 2: Impulse | |||
| Control | |||
| -Module 3: Inspection | |||
| Time | |||
| -Module 4: Memory Test, | |||
| including three letter | |||
| delayed recall and | |||
| working memory | Test battery consisting of | ||
| multiple test modules: | |||
| -Module 1: Symbol | |||
| Match | |||
| -Module 2: Three letter | |||
| memory and reverse | |||
| number counting | |||
| -Module 3: Attention | |||
| Tracker | Test battery consisting | ||
| of multiple test modules: | |||
| -Module 1: Word | |||
| Memory and Delayed | |||
| Memory Recognition | |||
| -Module 2: Design | |||
| Memory and Delayed | |||
| Design Recognition | |||
| -Module 3: X's and O's | |||
| -Module 4: Symbol | |||
| Matching | |||
| -Module 5: Color Match | |||
| Module 6: Three Letter | |||
| Memory | |||
| Additional Tests/Input | Balance Test; Symptom | ||
| Tracker; Patient | |||
| Demographics | Symptom Tracker; | ||
| Patient Demographics | Same as predicate | ||
| device | |||
| Results Interpretation | The Sway System does | ||
| not provide a | |||
| recommendation that | |||
| the patient is impaired | |||
| vs. unimpaired. Clinical | |||
| interpretation of the | |||
| results includes a | |||
| normative database for | |||
| Clinical comparison. | Same | Same | |
| Psychometric | |||
| Properties | Demonstrates construct | ||
| validity with traditional | |||
| neuropsychological test | |||
| and test-retest reliability | Same | Same | |
| Standards Used | ISO 14971 | ||
| IEC 62304 | |||
| IEC 62366 | ISO 14971 | ||
| IEC 62304 | Same | ||
| Key Clinical Outcomes | Validity: r values range | ||
| from 0.22 to 0.42 when | |||
| compared to traditional | |||
| neuropsychological | |||
| testing; similar small to | |||
| moderate correlations | |||
| when compared to the | |||
| predicate device. |
Reliability: ICC values
range from 0.68 to 0.92
for one-week test-
retests intervals | Validity: r values range
from 0.28 to 0.61 when
compared to traditional
neuropsychological
testing.
Reliability: r values
range from 0.18 to 0.83 | Validity: r values range
from 0.37 to 0.70 when
compared to traditional
neuropsychological
testing.
Reliability: ICC values
range from 0.50 to 0.88
for test-retest intervals
less than 30 days |
9
10
| Sterilization and
Shelf-life | Sway Sports+ is a software product. Sway Sports+ does not have a shelf-
life. Therefore, this section is not applicable. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Sway Sports+ is a software product and does not directly nor indirectly contact
the patient. Therefore, this section is not applicable. |
| Software Testing | Sway Sports+ was designed and developed according to Sway Medical, Inc.'s,
internal software development process in accordance with IEC 62304. Sway
Sports+ was tested using verification and validation methods, the results of
which indicate the Sway Sports+ complies with its specifications. |
| Electrical Safety | Sway Sports+ is a software product. Therefore, this section is not applicable. |
| Electromagnetic
Compatibility Testing | Sway Sports+ is a software product. Therefore, this section is not applicable. |
11
Sway Sports+ was developed and validated in accordance with IEC 62304, Medical Performance Devices – Software Life Cycle and the FDA Guidance documents "General Principles Testing — Bench of Software Validation" and "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" that are appropriate for software development. Software verification and validation activities, including design phase reviews, risk management, traceability and software testing for performance, were all executed to demonstrate compliance with predetermined specifications.
Non-Clinical A summary of the Non-Clinical Performance Bench Testing is included in Table 2.
Table 2 - Summary of Non-Clinical Performance Testing Documents: Software Testing as part of Verification and Validation; Documents: Test PRJ-2303-02 Verification and Validation Report . Performed PRJ-2211-04 Usability Validation Protocol ● . PRJ-2303-03 Usability Validation Results Device The Sway Sports+ is a software product capable of running on Android v9.0 Description or later and Apple iOS v13 or later. The software was tested on both platforms. The Sway Sports+ was tested per Verification and Validation protocol and Test Method/ criteria to ensure product meets product requirements. The results of the Applicable testing are included in PRJ-22303-02 Verification and Validation Report Standards along with Usability Testing Acceptance The actual (observed) results conform to the specified expected results. Criteria Unexpected Results/ None Significant Deviations Results All tests pass with no exceptions. System meets requirements specifications.
Testing
12
Performance Testing
– Clinical
This 510(k) submission includes a literature review of studies that demonstrate the validity, reliability, normative data, and clinical use of Sway Sports+. Data was collected to examine test-reliability in healthy controls, test-retest reliability in concussed patients, and the sensitivity & specificity of the product in the concussed population.
While Sway Sports+ is not intended to be used to classify a patient as having a concussion, it may be useful to create criteria based on the device's output to classify a patient as concussion positive or negative, to allow comparison to predicate devices to support a substantial equivalence determination. This information, along with additional data that demonstrate the device's test-reliability, construct validity, and reliability of outputs in patients with concussion, was used to support a determination of substantial equivalence.
Summary of Clinical Testing:
Normative Database
De-identified baseline test data was collected from over 126,000 users aged 18 to 24 years old. Subjects were selected based on the following inclusion criteria: Completed a baseline test in English, completed a baseline test in the United States of America, primary language was English, did not report a concussion within the last 6 months, did not report neurological conditions, did not report learning disability, had valid scores on all tests. Data were stratified across age and gender. Mann-Whitney U statistical tests were used to assess inter- and intra-sex and age differences in Sway balance and cognitive test module scores. Descriptive statistics (mean, standard deviation, median, and interquartile range [10th, 25th, 75th, and 90th]) were calculated for all Sway tests. Statistical significance was set a priori at a p-value of 0.05. Age/gender group samples were required to have a minimal size of 50 profiles to be considered for normative analysis. Results indicate an increase in performance in Sway Sports+ modules with age, with scores peaking in the early to mid-20's. Specific tests also show gender-based normative value differences. Thus, Sway Sports+ is designed to use both age and gender when relating individual scores to normative values.
Validity
- VanRavenhorst-Bell et al., 20214: This work demonstrated the construct validity of Sway Sports+ Reaction Time, Impulse Control, and Inspection Time modules compared to ImPACT QT. The sample included 88 healthy adults aged 18 to 48 years (mean 22.09 ± 4.47 years). Participants completed the ImPACT QT battery and Sway Sports+ tests during the same session, and scores from Sway Sports+ were compared to ImPACT QT composite and sub-test scores. The Sway Reaction Time module was statistically significantly correlated (r = -0.46 to 0.22, p ≤ 0.05) with several ImPACT QT reaction time measures. The Sway Impulse Control and Inspection Time measures were also statistically significantly correlated (r = -0.25 to -0.46, p ≤ 0.05) with five ImPACT QT reaction time measures. Overall, these findings suggest that Sway Sports+ cognitive test battery is clinically comparable to the FDA-cleared concussion management system.
- Clark & VanRavenhorst-Bell, 2022-: This study investigated the construct validity ●
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of Sway Sports+ in comparison to ImPACT and traditional neurocognitive assessments, including the Wechsler Adult Memory Scale-IV (WMS-IV), Wechsler Adult Intelligence Scale-IV (WAIS-IV), Delis-Kaplan Executive Function System (D-KEFS), and California Verbal Learning Test – 3rd Edition (CVLT-III). A total of 85 adults (mean age 23.1 years; 68% female) participated, with all tests administered by trained professionals in one session. Results indicated significant correlations between Sway Sports+ and both ImPACT and traditional tests, with significance at both p