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The M & M Industries, Inc. Life-Latch® Sharps & Biohazard Containers are indicated for single use containment of medical waste, including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in a variety of health settings, such as hospitals, physician offices, dental offices, patient rooms, laboratories, home health and other generators of contaminated sharps or infectious waste. The sizes of containers that are the subject of this submission are the 3.5 gallon, 5.0 gallon and 6.5 gallon, in either white or black color.

The Life Latch Sharps & BioHazard Container is a round white high density polyethylene (HDPE)) container. It has a flexible handle that rests at the side when not in use. The top of the container has one inch ridges all around the top, which fit into a slot around the inside of the lid. The container is fitted with an insert that snaps into four slots on the container near the top. This insert has a three inch opening in the center. Emanating from that opening are slots that remind one of six slices of pie. This allows the opening to be enlarged when necessary to add a large sharps product. I till and as a safety feature to allow visual checking of the extent that the container is filled while discouraging hands from touching the sharps. The lid has a safety lever to help prevent accidental opening of the container.

The provided text describes a 510(k) premarket notification for the "Life Latch® Sharps & BioHazard Container." This is a medical device application for substantial equivalence to a predicate device, not a study evaluating device performance against pre-defined acceptance criteria in the way a clinical trial or a novel technology assessment would.

Therefore, many of the requested points, such as sample size for test sets, expert adjudication, MRMC studies, and standalone performance, are not applicable in this context. The document focuses on demonstrating that the new device is "substantially equivalent" to an already legally marketed device by meeting relevant industrial standards.

Here's a breakdown of the information that can be extracted and a clear statement of what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• International Maritime Dangerous Goods (IMDG) Code
• International Civil Aviation Organization (ICAO) Technical Instructions
• International Air Transport Association (IATA) Dangerous Goods Regulations | The Life Latch® Sharps & BioHazard Container is certified in accordance with the requirements set forth in these regulations. |
  | Indications for Use (Equivalence) | Substantially equivalent to Sage Products, Inc. Sharps Disposal Containers with Screw Top Caps (K980490) for single-use containment of medical waste (hypodermic needles, syringes, lancets, blood needles) in various healthcare settings. | The device's indications for use are stated to be substantially equivalent to the predicate device. |
  | Technological Characteristics (Equivalence) | Substantially equivalent in all areas impacting safety and effectiveness and technological characteristics to Sage Products, Inc. Sharps Disposal Containers with Screw Top Caps (K980490). | The conclusion states the device meets appropriate standards and raises no safety/efficiency issues or claims that differ from the predicate device. |

2. Sample size used for the test set and the data provenance

• Not Applicable. This document is a premarket notification (510(k)) demonstrating substantial equivalence to an existing device. It does not describe a study involving a particular "test set" of patient data or samples to evaluate clinical performance in the way a diagnostic or therapeutic device might. The "testing" referred to is against engineering standards for the physical product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth established by experts is mentioned or required for this type of device submission, which focuses on manufacturing standards and equivalence to a predicate device.

4. Adjudication method for the test set

• Not Applicable. As no "test set" in the sense of patient data is described, there is no adjudication method.

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 device (a sharps container) does not involve AI or human readers, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a physical container, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. The "ground truth" in this context is the adherence to established industry and transport standards (ASTM, DOT, U.N., IMDG, ICAO, IATA) for sharps disposal containers and the demonstration of substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not Applicable. There is no "training set" or corresponding ground truth.

Summary of the Study/Evidence:

The "study" in this context is the demonstration by M & M Industries, Inc. that their "Life Latch® Sharps & BioHazard Container" meets a series of established engineering and safety standards and is substantially equivalent to a predicate device.

• Predicate Device: Sage Products, Inc. Sharps Disposal Containers with Screw Top Caps (K980490).
• Demonstration Method: The manufacturer submitted evidence (implied through the 510(k) summary) that their product's characteristics and performance align with:
  • ASTM F2132-01 (Puncture Resistance)
  • DOT Title 49 CFR Section 178.603 (Impact Resistance)
  • U.N. Recommendations on the Transport of Dangerous Goods
  • International Maritime Dangerous Goods (IMDG) Code
  • International Civil Aviation Organization (ICAO) Technical Instructions
  • International Air Transport Association (IATA) Dangerous Goods Regulations
• Conclusion: The FDA reviewed this evidence and determined that the device is "substantially equivalent" to the legally marketed predicate device, meaning it is as safe and effective and can be marketed.

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