(126 days)
Nitta M&T Safety Boxes are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.
Nitta M&T Safety Boxes are disposable and non-sterile sharps container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1.0L, 1.5L, 3.2L and 7.6L containers in locking and non-locking variations. Equipped with visible final lock mechanism. A design that allows you to determine and clearly differentiate the permanent and temporary closure engagement by the position of final lock claws.
The document describes the Nitta M&T Safety Box, a disposable and non-sterile sharps container, and its compliance with relevant standards. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Objective | Acceptance Criteria (ISO 23907-1:2019 Requirements) | Reported Device Performance |
|---|---|---|
| Container Stability | No more than 0 failures per container were observed when placed at a 15° inclination. | Meets ISO23907-1:2019 Requirements - No more than 0 failures per container were observed. |
| Handle Strength | No failures were observed when suspended for at least 60 minutes. | Meets ISO23907-1:2019 Requirements - No failures were observed. |
| Puncture Resistance | Average force required to be a minimum of 16N and an average of 18N or greater. | Meets ISO23907-1:2019 Requirements - All Nitta M&T products were found to meet the acceptance criteria. Testing resulted in a minimum force of 18.6 N was observed (presumably average). |
| Resistance to Damage (Drop/Impact Test) | No evidence of leakage or damage resulting in a breach of the sharps containment area after a 1m drop. | Meets ISO23907-1:2019 Requirements - No evidence of leakage or damage resulting in a breach of the sharps containment area were observed. All Nitta M&T products met the acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for each test. The testing was performed on the "subject device" (Nitta M&T Safety Box) which comprises various models. The data provenance is not explicitly mentioned with respect to country of origin, but Nitta M&T (Thailand) Co., Ltd. is based in Thailand. The studies appear to be prospective, laboratory-based performance tests as opposed to retrospective data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a physical medical device (sharps container), not an AI or diagnostic device that requires expert evaluation for ground truth. The acceptance criteria are based on objective, quantifiable metrics defined by international standards (ISO 23907-1:2019). Therefore, expert consensus for ground truth is not applicable in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is objective performance testing against a standard, not a subjective evaluation requiring adjudication.
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 not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is conformance to the objective, measurable requirements outlined in the international standard ISO 23907-1:2019. This involves physical measurements and observations of the device's behavior under specific test conditions.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not a machine learning model.
§ 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).