(24 days)
The AG MASSTM Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.
The AG MASS™ is a sterile injection and draining device. The device is intended to deliver Saline fluid in order to dilute secretions accumulated above the cuff of an Endotracheal Tube and drain out all fluids. The AG MASS™ contains two syringes of 35 CC and 10 CC that are enclosed within MASS main body and is designed for use with Hospitech's AnapnoGuard ETT. The AG MASSTM is provided sterile for single use.
The provided document is a 510(k) summary for the AG MASS™ Suction Pump System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on bench testing. However, the document explicitly states that clinical studies were not required and therefore not performed to determine the safety and efficacy of the device.
As a result, I cannot provide the information requested regarding acceptance criteria and a study proving device performance in the context of clinical or comparative effectiveness studies with human readers. The information you are asking for, such as sample size, data provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this document because such studies were not deemed necessary for this device's market clearance.
The document focuses on "Performance Bench Tests" and demonstrates compliance with relevant standards:
1. Table of acceptance criteria and reported device performance:
Based on the provided document, the "acceptance criteria" were primarily compliance with specific standards and successful completion of bench tests to demonstrate the device is "as safe and effective as the cleared predicate devices."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Standards Compliance | Complies with: |
| Sterilization (ANSI/AAMI/ISO 11137-1: 2006) | Passed |
| Biological Evaluation (ISO 10993-1:2003(E)) | Passed |
| Bench Tests | Demonstrated performance: |
| Draining Validation | Demonstrated intended function. (Specific metrics not provided) |
| Prefilled Saline Syringe Chemical/Toxicological Assessment | Found safe. |
| Chemical/Toxicological Assessment (Leachable/Extractable post-sterilization) | Found safe. |
| Equivalence to Predicate Devices | "As safe and effective as the cleared predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document states, "Hospitech believes that clinical studies are not required to determine the safety and efficacy of the device." Performance was demonstrated through bench testing, not a clinical test set with a patient sample size.
- Data Provenance: Not applicable for clinical data. The data provenance described relates to engineering bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for medical imaging or AI performance (e.g., radiologist consensus) was not established because clinical trials were not performed. The "ground truth" for the bench tests would have been engineering specifications and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring human adjudication was utilized.
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:
- No. An MRMC comparative effectiveness study was not conducted. This device is a mechanical suction system, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (suction pump system), not an algorithm or software. Its performance is inherent to its mechanical function, not an algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench tests, the "ground truth" was compliance with established engineering standards (e.g., ISO for sterilization and biocompatibility) and successful demonstration of the physical functionalities (e.g., draining validation). There was no clinical ground truth (like pathology or outcomes data) established as no clinical studies were performed.
8. The sample size for the training set:
- Not applicable. This device is a mechanical product, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as no training set was used.
§ 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.