(108 days)
The Reza Band and the Reflux Band are for people 18 years and older to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. The devices are worn by the user while sleeping.
The Reza Band and Reflux Band are proposed for over the counter (OTC) use.
The proposed devices are non-invasive and non-sterile worn by the user while sleeping. As with the predicate device (Reza Band), the proposed Reza Band and Reflux Band were designed as a treatment for LPR symptoms.
The mode of operation of these devices is to provide slight external pressure, typically in a range of 20-30 mmHg, at the cricoid cartilage region. This external pressure increases the luminal pressure within the upper esophageal sphincter (UES). It has been shown that when the UES is subjected to the increased external pressure, it reduces stomach contents from coming up into the larynx, pharynx and lungs.
The user positions the device around their neck. For the Reflux Band, the user uses an application (App) installed on an iOS or Android mobile device to fit the Reflux Band to the desired externally applied pressure. The electronics of the Reflux Band have been incorporated into its cushion (SmartCushion) so that the Reflux Band can interact with the App. For the Reza Band, the user utilizes the accessories External Manometer and Pressure Sensor to properly fit the device. A typical range is also 20-30mmHg of applied pressure.
The components of the Reflux Band and Reflux Band are identical of a Cushion, Comfort Band, Frame, Comfort Dial and Clasp.
The provided text describes the Reza Band and Reflux Band, external upper esophageal sphincter (UES) compression devices, and their substantial equivalence to a predicate device for the reduction of laryngopharyngeal reflux (LPR) symptoms. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting detailed acceptance criteria and studies in the format requested.
Therefore, the available information is insufficient to fully complete the requested table and details regarding acceptance criteria and performance data as per your prompt. However, I can extract what is explicitly stated in the document.
Here's a summary of the available information and an explanation of what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in terms of numerical thresholds for outcomes. Instead, it mentions various tests performed and concludes substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-Clinical Performance: | |
| Electrical Safety (IEC 60601-1 compliance) | Tested to IEC 60601-1 (Compliance implies meeting the safety standards) |
| Electromagnetic Compatibility (IEC 60601-1-2 compliance) | Tested to IEC 60601-1-2 (Compliance implies meeting the EMC standards) |
| Software Functionality (Software Verification and Validation) | Software Verification and Validation performed (Successful completion implies software functions as intended) |
| Manometer Accuracy (Bench Testing) | Bench Testing for Manometer Accuracy performed (Successful completion implies manometer provides accurate pressure readings) |
| Device Stability (Shelf Life Testing) | Shelf Life Testing performed (Successful completion implies device maintains its properties over its designated shelf life) |
| Clinical Performance: | |
| Usability for OTC use | Usability testing performed (Successful usability suggests users can properly operate the device without medical supervision) |
| User Comprehension of LPR symptoms (Reflux Symptom Index - RSI) | Comprehension testing of a tool commonly used for the population with LPR symptoms is the Reflux Symptom Index (RSI) (Successful comprehension suggests users can understand and report their symptoms using the common tool, supporting proper self-assessment and device usage in an OTC setting, and presumably demonstrating the device's ability to reduce symptoms as measured by this index). The document mentions "comprehension testing of a tool" which implies testing if users can understand symptoms measurement, not necessarily a direct measure of device effectiveness via RSI reduction in a clinical trial. However, the overall conclusion of "substantial equivalence" and "can be used safely and effectively as OTC devices" suggests that the clinical tests supported the device's ability to reduce LPR symptoms. |
Missing Information:
The document does not provide specific numerical acceptance criteria (e.g., "RSI score reduction by X points" or "accuracy of manometer within +/- Y mmHg"). The "Reported Device Performance" column above is based on the implication of successfully performing the tests mentioned, rather than specific quantitative results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated for either usability testing or comprehension testing.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
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):
This information is not provided. For non-clinical tests like electrical safety or bench testing, "ground truth" is typically established by engineering standards and measurement equipment. For clinical/usability tests, the "experts" or evaluators are not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This type of study is not relevant to the device described (an external UES compression device) which is not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This concept is not applicable to the device described as it is a physical, user-operated device, not a standalone algorithm. The "software" mentioned for the Reflux Band (an app) supports device fitting, not a standalone diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For non-clinical tests (IEC standards, bench testing, shelf life): Ground truth is typically derived from established engineering and safety standards, validated measurement equipment, and defined material properties.
- For usability and comprehension testing: Ground truth would likely be based on expert observation of user interaction, user feedback, and pre-defined criteria for successful task completion or correct understanding. The mention of the Reflux Symptom Index (RSI) suggests that symptom reduction, as reported by patients using this validated tool, would be a key outcome for efficacy (though the text only mentions comprehension of the tool, not direct efficacy results). However, specific details on how "ground truth" for efficacy was established for substantial equivalence are not provided in this summary.
8. The sample size for the training set:
This device is not an AI/machine learning model that typically relies on a "training set" in the computational sense. Therefore, this concept is not applicable to the information provided.
9. How the ground truth for the training set was established:
As mentioned above, the concept of a "training set" with associated ground truth is not applicable to this physical device submission.
Conclusion based on provided text:
The provided document is a 510(k) summary focused on demonstrating "substantial equivalence" of the Reza Band and Reflux Band to a predicate device (Reza Band, DEN130046). It lists various non-clinical and clinical tests performed, but it does not provide the detailed quantitative acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or adjudication methods that would typically be found in a comprehensive study report. The intent of a 510(k) summary is to summarize findings that support a claim of substantial equivalence for regulatory purposes, rather than being a full scientific publication of detailed study results.
§ 874.5900 External upper esophageal sphincter compression device.
(a)
Identification. An external upper esophageal sphincter compression device is a prescription device used to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
(i) Mechanical integrity testing (
e.g., tensile strength testing, fatigue testing) and(ii) Shelf life testing.
(3) The technical specifications must include pressure measurement accuracy to characterize device performance.
(4) Clinical performance testing must document any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.
(5) Labeling must include the following:
(i) Appropriate warnings and precautions,
(ii) A detailed summary of the clinical testing pertinent to use of the device including a detailed summary of the device-related complications or adverse events,
(iii) Detailed instructions on how to fit the device to the patient, and
(iv) Instructions for reprocessing of any reusable components.
(6) Patient labeling must be provided and must include:
(i) Relevant warnings, precautions, and adverse effects/complications,
(ii) Information on how to correctly wear the device,
(iii) The potential risks and benefits associated with the use of the device,
(iv) Alternative treatments, and
(v) Reprocessing instructions.