(273 days)
NFANT® Feeding Solution is intended to measure movement of the nipple during non-nutritive suck (NNS) or nutritive suck (NS).
NFANT® Feeding Solution is comprised of a portable multi-use electronics unit (NFANT SSB Sensor) powered by a non-rechargeable coin cell battery, single use bottle coupling (NFANT Coupling) and mobile application which acts as a user interface and data display (NFANT App). Nipple movement data during Non-Nutritive Suck or Nutritive Suck is transmitted to a mobile device and displayed for clinician interpretation from past feedings can also be securely transferred, stored and retrieved by authorized users from a cloud based database (NFANT DBMS) for comparisons between feedings.
When in use, the NFANT Coupling has a commercially available or prescribed bottle or pacifier nipple placed on one end and a normal bottle on the other. The NFANT SSB Sensor is snapped in place to mate with the NFANT Coupling. The user "wakes-up" (activates) NFANT SSB Sensor for streaming and data collection. An infant then undergoes normal nonnutritive sucking with a pacifier (no liquid swallow) and/or nutritive sucking with a bottle nipple during normal feeding sessions (liquid swallow). Nipple movement data is garnered and displayed on the mobile application for clinical interpretation. Safe oral feeding requires coordination of sucking, swallowing and breathing which involves integration, maturation and coordination of multiple sensorimotor systems. NFANT provides clinicians with objective data reqarding nipple movement during non-nutritive (NNS) and nutritive sucking (NS).
As the infant sucks, the NFANT Coupling allows bottle fluid (when applicable) to flow from the bottle to the nipple. The NFANT Coupling maintains a plug insert that provides a two compartment membrane sealing the NFANT Coupling and separating the bottle fluid from pressure sensors contained in the NFANT SSB Sensor housing. With assembly, ports on the NFANT SNAP housing engage each respective membrane creating a seal between the NFANT SSB Sensor and NFANT Coupling while also creating two sealed chambers between the membrane and a respective pressure sensor.
NFANT has one disposable component, the NFANT Coupling that comes in contact with the fluid. After a single use by a patient, the NFANT Coupling is disposed of in waste. The NFANT SSB Sensor does not come in contact with the feeding fluids and is reused specific to the infant with each NFANT Coupling usage. The NFANT App component is software only. NFANT is sold non-sterile.
The provided text is a 510(k) summary for the NFANT® Feeding Solution. It describes the device, its intended use, and its similarities and differences to a predicate device. However, it does not contain detailed information about specific acceptance criteria for device performance or a comprehensive study report proving the device meets those criteria in the way typically expected for a clinical trial or performance study focusing on diagnostic accuracy.
The document primarily focuses on demonstrating substantial equivalence to a predicate device by:
- Bench testing: Verifying seals, calibrating pressure inputs, measuring nipple dynamics, and validating accelerometer tilt readings.
- Biocompatibility testing: As per ISO 10993-1.
- Software verification and validation: For firmware, mobile app, and web portal.
The "Summary of Testing" section is very high-level and only states that "All of the testing results for the NFANT Feeding Solution passed within the acceptance parameters." It does not report specific quantitative acceptance criteria or the numerical performance results against those criteria. It also doesn't detail clinical performance metrics like sensitivity, specificity, or accuracy in relation to a specific clinical outcome or ground truth established by experts.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not explicitly mentioned or detailed in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing: | |
| Verify proper seals of NFANT SSB Sensors and NFANT Assembly to enable pressure measurements | Passed |
| Calibrate known pressure inputs to NFANT SSB Sensor output | Passed |
| Measure nipple dynamics for clinical interpretation | Passed |
| Validate accelerometer tilt readings to known angular inputs to determine NFANT Assembly orientation | Passed |
| Biocompatibility: | |
| ISO 10993-1 requirements | Passed |
| Shelf Life Testing (accelerated aging): | Passed (real-time aging to continue) |
| Software Verification and Validation: (for embedded firmware, NFANT App, and Web Portal) | Passed |
Note: The document states that "All of the testing results for the NFANT Feeding Solution passed within the acceptance parameters" but does not provide the specific quantitative acceptance parameters themselves (e.g., "pressure measurements should be within X% of true pressure").
2. Sample size used for the test set and the data provenance
Sample Size for Test Set: Not specified. The document mentions "preliminary tests" and "bench testing" but does not provide the number of units or data points used in these tests.
Data Provenance: Not specified. These appear to be laboratory/bench tests, not clinical data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. The ground truth for the bench tests appears to be established by known physical inputs (e.g., "known pressure inputs," "known angular inputs"), rather than expert interpretation of clinical data. There is no mention of experts establishing a clinical ground truth for device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not specified. This pertains to clinical ground truth establishment, which isn't detailed in the provided bench testing summary.
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 done / Not specified. This document describes a device that measures physical parameters (nipple movement via pressure sensors) for clinician interpretation, not an AI-assisted diagnostic tool that would typically undergo an MRMC study. The device provides "objective data regarding nipple movement" for clinicians to interpret, but it does not claim to offer AI-driven interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The NFANT Feeding Solution is described as a "passive measurement system" that displays data "for clinician interpretation." It's not an algorithm that produces a diagnostic output on its own; rather, it provides data to a human clinician for their assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the ground truth was "known inputs" for pressure and angular measurements. For other aspects like biocompatibility and software, the ground truth would be compliance with established standards and specifications. There is no mention of a ground truth based on expert consensus, pathology, or outcomes data related to disease diagnosis or clinical prognosis.
8. The sample size for the training set
Not applicable/Not specified. This device is not described as a machine learning/AI algorithm that requires a training set. It is a sensor-based measurement device.
9. How the ground truth for the training set was established
Not applicable/Not specified. As it's not an AI/ML device with a training set, this information is not relevant.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.