(260 days)
The myNeWT system is indicted for patients who would benefit from Negative Pressure Wound Therapy as it may promote wound healing by removing low to moderate levels (
The myNeWT Negative Pressure Wound Therapy System is a portable, body worn, Single Use system for patients who have hard to heal wounds. Therapy is accomplished by the electronically controlled pump unit delivering a continuous negative pressure at -80 mmHg ±20mmHg to the wound surface, which draws the exudate into a flexible exudate canister, creating an environment that promotes wound healing via the removal of low to moderate amounts (
Here's an analysis of the provided text regarding the acceptance criteria and study for the myNeWT Negative Pressure Wound Therapy System, structured according to your request:
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed report of a new clinical study with specific performance metrics against pre-defined acceptance criteria for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment in a clinical context is generally not present in this type of regulatory submission. The studies reported are primarily non-clinical (electrical, biocompatibility, mechanical, etc.) and aim to show the device meets design specifications and is safe and effective when compared to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary focused on substantial equivalence rather than a de novo clinical trial, specific numerically defined "acceptance criteria" for a primary endpoint and "reported device performance" in a clinical human context are not explicitly stated in a tabular format. The document generally states that the device "passed all the verification and validation testing," indicating it met its internal design specifications and relevant standards.
Here's an interpretation based on the non-clinical tests conducted, where the "acceptance criteria" are implied by compliance with standards and successful completion of tests:
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety | Passed AAMI ES 60601-1:2005/R 2012, IEC 60601-1-6: Ed 3.1 2013-10, ANSI/AAMI HA 60601-1-11:2011, and IEC 62366-1:2015. |
| Electromagnetic Compatibility | Passed IEC 60601-1-2: Ed 4.0 2014-02 and IEC 60601-1-11: Ed 2.0 2015-01. |
| Software Verification & Validation | Conducted and documentation provided as recommended by FDA guidance. |
| Biocompatibility | Passed ISO10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-10 (Primary skin Irritation). |
| Sterility | Passed Sterility Validation using Ethylene Oxide to ANSI/AAMI/ISO 11135:2014. |
| Sterile Packaging | Passed BS EN ISO 11607-1:2009 + A1:2014, including ISTA 2A distribution testing and accelerated/real-time aging. |
| Mechanical Performance | Passed tests for compressor life, valve performance, battery life, pump noise, display visibility, canister strength, exudate containment, cleaning, and tube/connector mis-connection. |
| Therapy Performance | Passed tests for vacuum levels (at pump and wound bed) and exudate removal performance. |
| Stability/Shelf Life | Passed stability testing to support shelf life claims. |
| Usability | Developed using a usability process conforming to IEC 62366-1:2015 and FDA Guidance. |
| Distribution Testing | Passed ISTA Procedure 2A (2011) for final packed kit. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of human clinical data for this 510(k) submission. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the myNeWT System to the predicate devices."
- Data Provenance: The reported "test" data primarily comes from bench testing of the device components and system to engineering specifications and international standards. This is not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided as the "test set" primarily refers to non-clinical engineering and laboratory tests, not a clinical dataset requiring expert ground truth.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring adjudication by experts is mentioned.
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 information is not applicable. The device is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (a pump system), not an AI algorithm. Its performance is inherent in its mechanical and software operation.
7. The type of ground truth used
- For the non-clinical tests, the "ground truth" is defined by established engineering specifications, international performance standards (e.g., ISO, IEC, AAMI), and documented test protocols. For example, for vacuum levels, the "ground truth" would be the target vacuum range as measured by calibrated equipment.
8. The Sample Size for the Training Set
- Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as this is not an AI/machine learning device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.