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The intended use of this (single patient use) safety strap set is to act as a positioning aid and to prevent accidental falls of the pre-term (

The STATStrap™ Neonatal Incubator Safety Strap is a soft closed cell foam material covered with a laminate of soft fabric that allows Hook (Velcro® style) fabric to attach to it along the straps entire length. The end of each strap incorporates a hook fabric wing tab or a wire spring hook, so as to attach each strap to the infant incubator tray. These 13 inch straps are positioned in four positions altation our carp to the menthess tray so as to fit the patient's size. Once the straps are in place and securely fastened to the mattress tray, the straps cross over the neonate ( infant's ) body in a "X" pattern and attach to each other so as to provide positioning aid, prevent gross body movement or falls of the patient. A hook "tie strap" is included on both models to secure the two main straps together into a single unit. These straps are single patient use disposable items. Labeling states the disposable nature of the strap, precautions and the use instructions.

The provided text describes a 510(k) premarket notification for the STATStrap™ Neonatal Incubator Safety Strap. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove safety and effectiveness.

Therefore, many of the typical acceptance criteria and study components usually associated with a novel device's performance evaluation (like specific accuracy metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance studies) are not applicable in this context. The focus here is on comparing the new device's characteristics and intended use to an existing, approved device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for the device itself. Instead, the "acceptance criteria" are implied by the demonstration that the STATStrap™ shares the same fundamental design, materials, chemical composition, intended purpose, and attachment mechanism as the identified predicate devices, with only minor differences such as single-patient use labeling. The reported "performance" is that it functions in the same manner as existing safety straps.

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable. No test set in the traditional sense of a performance study was conducted. The equivalence was based on a comparison of device characteristics to predicate devices.
• The "study" is a comparison to legally marketed predicate devices, not a clinical trial with a test set of patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not applicable. There was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or expert adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. This type of study is not typically required for a 510(k) substantial equivalence submission for a physical accessory device like this.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

• Not applicable. This device is a passive physical accessory, not an algorithm or software. Its function inherently involves human interaction (placement by a user).

7. The Type of Ground Truth Used:

• Not applicable. No ground truth in the sense of clinical outcomes or pathology was established for the STATStrap™ as part of this submission. The "truth" considered by the FDA in a 510(k) is whether the new device is "substantially equivalent" to an existing, approved predicate device in terms of safety and effectiveness.

8. The Sample Size for the Training Set:

• Not applicable. No training set for an algorithm was used.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set or ground truth for a training set was established.

Summary of the "Study" and Its Findings:

The "study" or evidence provided is a comparison to predicate devices (K031096/K850496A by International Bio Medical / Airborne Life Support, and K001019/K941106 by Hill-ROM Airshield / Draeger Medical Inc.).

• Conclusion from Testing: The submission explicitly states "Clinical Data: Not applicable" and "Summary / Conclusion from Testing: Not applicable." This indicates that no new clinical or performance testing was conducted or submitted with this 510(k).
• Proof of Meeting Acceptance Criteria: The device met the "acceptance criteria" by demonstrating that its characteristics (design, materials, intended use, function) are substantially equivalent to those of the legally marketed predicate devices. The minor differences (single-patient use labeling, specific attachment mechanisms for different incubator types, and being labeled with the company name) were deemed not to raise new questions of safety or effectiveness. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

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