(253 days)
MAUSER PG II Sharps Container is intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, veterinarian offices and other waste generators for the safe collection and disposal of hazardous sharps.
MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access.
MAUSER PG II Sharps Container is a single-use device, which consist of rectangular body and available in three sizes 30 liter, 50 liter and 60 liter. Each container has two parts, the body and the lid, which assemble together to form a unit. Two lid styles are available: grip, and click with port hole.
MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access.
Manufacturer offers a stainless steel pedal frame cart that offers a hands free collection process and integrates with all sizes of container and lid type.
The container is designed for safe collection and disposal of sharps, i.e. items that can cause puncture wounds, cuts or tears in skin or mucous membranes, including, but not limited to hypodermic, surgical, suture, and IV needles; Pasteur pipets, lancets, razors, scalpels, and other blades.
This document is a 510(k) summary for a medical device called the MAUSER PG II Sharps Container. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to predicate devices. It is not a document describing the acceptance criteria and study proving a device meets acceptance criteria for an AI/ML powered medical device, which is what your request implies by asking about ground truth, training sets, adjudication, MRMC studies, and expert qualifications.
The provided text focuses on the physical and mechanical properties of a sharps container, not on an AI's performance. Therefore, I cannot extract the information required for an AI/ML device study, such as sample size for test sets (as there isn't one in the context of AI), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth (outside of physical test results), training set size, or how ground truth for training was established.
However, I can extract the acceptance criteria and performance data for the physical device as presented in the document:
Acceptance Criteria and Device Performance for MAUSER PG II Sharps Container
The MAUSER PG II Sharps Container is a physical medical device designed for the safe collection and disposal of sharps. The performance data presented in the 510(k) summary focuses on demonstrating that the device meets physical and mechanical safety standards, primarily through various engineering tests. No AI/ML component is mentioned or evaluated in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Test Method | Acceptance Criteria (Implied by "Pass" result and standard) | Reported Device Performance |
|---|---|---|---|
| Puncture resistance | ASTM F2132-01 (Reapproved 2008) | Force required to puncture container > 15 N | Pass (All sections > 15 N) |
| Drop test | §178.603¹ (United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199) | No release of contents after drops from 1.2 meters at -18°C. | Pass |
| Leak resistance test | §173.197¹ (CFR Title 49) | No leakage observed for 60 minutes when positioned upside down. | Pass |
| Stack Test | §178.606¹ (c) (CFR Title 49) | No deterioration or release of contents after being subjected to total weight of identical packages stacked 3 meters high. | Pass |
| Vibration Test | §178.608¹ (CFR Title 49) | No rupture, leak, or deterioration after 60 minutes of vibration. | Pass |
| Stability | ISO 23907³ (Sharps Injury Protection - Requirements and test methods - Sharps Containers) | Container did not slide or topple on a 15° incline. | Pass |
| Strength of handles | ISO 23907³ (Sharps Injury Protection - Requirements and test methods - Sharps Containers) | Handles remained intact, no rupture, tear, crack, or separation from container when suspended at 150% authorized gross mass for 1 hour. | Pass |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Puncture Resistance: "Various sections of container" were tested. The exact number of sections or containers is not specified.
- Drop Test: Six containers (each of the three sizes) were tested.
- Leak Resistance: Individual containers were tested (number not specified).
- Stack Test: Individual containers were tested (number not specified).
- Vibration Test: Individual containers were tested (number not specified).
- Stability: Individual containers were tested (number not specified).
- Strength of Handles: Individual containers were tested (number not specified).
- Data Provenance: The tests were conducted internally by MAUSER USA, LLC. The document does not specify the country of origin of the data beyond the company's US address. The nature of these tests is clearly prospective, as they are performed to demonstrate compliance for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to the type of device and testing described. The "ground truth" here is established by standardized physical engineering test methods (ASTM, CFR, ISO), not by human expert consensus on medical images or diagnostic interpretations. The tests are objective measurements of physical properties.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication is typically relevant for subjective assessments, especially in clinical studies or for determining ground truth in image analysis. For objective physical tests, the results are based on direct measurement against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable. An MRMC study is relevant for evaluating the impact of a new technology (like AI) on human performance in diagnostic tasks. This document describes a physical sharps container, not a diagnostic or AI-enabled device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. There is no algorithm or software component for which standalone performance would be relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurements derived from adherence to established engineering standards and regulations (ASTM F2132-01, DOT CFR Title 49, ISO 23907). For instance, for puncture resistance, the ground truth is the force measured in Newtons; for drop test, it's the observation of content release; for leak resistance, it's the observation of leakage.
8. The Sample Size for the Training Set
This information is not applicable. There is no AI/ML component described, and therefore no "training set" in the context of machine learning. The device's design is validated through the physical tests listed, not through a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI/ML model. The "ground truth" for the device's design and manufacturing is derived from the established engineering standards and safe design principles for sharps containers.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).