(303 days)
AP Medical sharps containers are intended for use by healthcare providers such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities for safe disposal of sharps such as Needles, Scalpels, Lancets and other Sharp Instruments.
Three different lines are offered to our customers and end users: PBS line - disposable round containers with access inlets on the lid, for sharps disposal CS line - disposable square containers with rotating lid for sharps disposal NURSY line - disposable square containers with hermetic permanent closure for sharps disposal
Our sharps containers are made of Polypropylene resin and coloured using Masterbatch which contains no heavy metals or cadmium. These materials allow us to produce a very safe, high quality puncture resistant container. Each container is comprised of a Body (either square or round) and a lid. The lids are a very safe and secure fit. All containers are vertical entry. All containers have the maximum filling level line as well as required labelling in accordance with current legislation. These containers are equipped with a permanent closure system, that is the final method of closure. Once the container is closed permanently it is locked closed. It can not manually re-open. This is a very safe method of preventing injury. Once the container is full it is locked and then disposed of. It is safe for anyone coming into contact with the container.
The provided text is a 510(k) premarket notification for AP medical sharps containers. It details a comparison to predicate devices and presents results from non-clinical mechanical tests to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study as requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from Predicate Performance) | Reported Device Performance (AP MEDICAL) |
|---|---|
| Impact Resistance: Pass (no damage after dropping from 1 meter) | No damage after dropping from 1 meter |
| Puncture Resistance (base, sides, closure, top): Pass (average > 18 N, min > 12.5 N) | Average > 18 N, min > 12.5 N |
| Leak Resistance (sides and bottom): Pass (leak proof on sides and bottom) | Leak proof on sides and bottom (Nursy line is also leak proof on top) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each mechanical test. It states "The summary data derived from mechanical tests are as follows," implying tests were conducted. The data provenance is from AP Medical Italia S.p.A., presumably at their manufacturing facility in Roncadelle di Ormelle, ITALY. The study appears to be prospective as it involves new testing of their products against established criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study involves mechanical performance testing of physical devices against objective, quantitative criteria (e.g., force in Newtons for puncture resistance, visual inspection for impact/leakage). It does not involve human interpretation or expert-established ground truth in the way a diagnostic AI study would.
4. Adjudication method for the test set
Not applicable. See point 3.
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 applicable. This is a 510(k) submission for physical medical devices (sharps containers), not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. The performance demonstrated is for the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests is based on objective, verifiable mechanical properties and performance benchmarks established by the predicate devices and possibly relevant industry standards for sharps containers (though specific standards are not cited in this excerpt, they are implied by the performance criteria). For example, puncture resistance is measured in Newtons, and impact resistance is determined by whether damage occurs after a specific drop height.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).