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Our Horizontal Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.

Our Horizontal Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a snap-on, leakresistant, poly-propylene lid. The lid has a "mail-box" style raised opening into which the sharps are dropped horizontally. When the container is full, a unique butterfly closure system closes to prevent over-filling and to prevent access to the sharps inside.

This document describes a 510(k) submission for a Horizontal Entry Sharps Container, focusing on its substantial equivalence to existing devices rather than a detailed study proving performance against acceptance criteria. There is no information in the provided text that describes the actual acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters requested in your prompt.

The 510(k) summary (Attachment 5, Rev. 1) and the FDA letter explicitly state that the device is being submitted for "substantially equivalent" status. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device, rather than providing new clinical or non-clinical study data to prove novel performance claims against specific acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions you've posed based on the provided text.

Here's what can be inferred from the document regarding the device's intended claims and comparison:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance are provided in the document. The submission is based on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No test set or data provenance from a performance study is mentioned.

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)

Not applicable. No ground truth determination or expert involvement for a study is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication is mentioned.

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/imaging device, and no MRMC study is mentioned.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. No ground truth for a study is mentioned.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable. No ground truth for a training set is mentioned.

Summary of Device and 510(k) Submission:

• Device Name: Horizontal Entry Sharps Container
• Manufacturer: Custom Medical Plastics, Inc.
• Intended Use: Provides a receptacle for used, contaminated medical sharps and for enclosure during transport to ultimate disposal.
• Classification: Class II accessory to a hypodermic needle (21 CFR Section 880.5570), Product Code: FMI.
• Basis for Marketing: Substantial equivalence to Horizontal Entry Sharps Containers manufactured by Sage Products Inc. and Sherwood Medical.
• Key Features (described in 510(k) summary):
  • Injection-molded polypropylene container with a snap-on, leak-resistant polypropylene lid.
  • "Mail-box" style raised opening for horizontal sharps insertion.
  • Unique butterfly closure system to prevent over-filling and access once full.
  • Wall mount bracket and locking mechanism (similar to predicates).
• Key Claim: "Our Horizontal Entry Sharps Container will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use." (This is a general quality statement, not a specific performance metric).
• Cautionary Statement: "container is puncture resistant, but not entirely puncture-proof. To avoid the possibility of accidental sticks, do not overfill, inspect unit before handling and handle with care."

The provided text focuses on the description of the device and the justification for substantial equivalence to existing devices, which is the core of a 510(k) submission. It does not contain the specifics of a detailed performance study as you've outlined. For physical devices like this, manufacturing specifications, material testing, and design validation (often demonstrated through comparison with predicate devices and adherence to relevant standards, though not explicitly detailed here) would form the basis of safety and effectiveness, rather than clinical study-style acceptance criteria.

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Our Vertical Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.

Our Vertical Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a tabs down, leakresistant, polypropylene lid. The lid has a chimney-type opening into which the sharps are dropped vertically.

The provided text describes a 510(k) submission for a "Vertical Entry Sharps Container." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a full-fledged study with detailed metrics like accuracy or sensitivity.

Therefore, the information requested in the prompt (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable or not present in this document. The 510(k) process for this device type primarily relies on comparing design, materials, and intended use to existing devices, and ensuring compliance with general controls (like Good Manufacturing Practices).

Here's a breakdown of why each section of your request cannot be fulfilled from the provided text:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The document does not describe specific quantitative acceptance criteria or performance metrics for this device beyond its intended function as a receptacle for sharps and its puncture-resistant property. The primary "performance" assessed is its substantial equivalence to predicate devices, implying it functions similarly and safely.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No specific test set or data from performance testing is mentioned. The submission is a comparison to predicate devices, not a study involving a test set of data.

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)

• Not Applicable. As there is no "test set" and no "ground truth" to establish in the context of a diagnostic or interpretive device, experts for this purpose were not involved and are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 passive medical device (a sharps container), not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this device.

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

• Not Applicable. This is not an algorithmic or AI device.

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

• Not Applicable. As this device collects sharps, there is no "ground truth" in the diagnostic sense. The "ground truth" for a sharps container would be its ability to safely contain sharps, which is often assessed through design verification, material testing, and compliance with standards, not diagnostic ground truth.

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. See point 8.

Summary of Device Information Provided:

• Device Name: Vertical Entry Sharps Container
• Manufacturer: Custom Medical Plastics, Inc.
• Intended Use: Provides a receptacle for used, contaminated medical sharps and for enclosure during transport to ultimate disposal.
• Material: Injection-molded polypropylene container and lid.
• Key Feature: Chimney-type opening for vertical sharps drop, designed to better protect user's fingers.
• Safety Statement: Puncture-resistant, but not entirely puncture-proof; warns against overfilling, inspect before handling, and handle with care.
• Disposal: Incineration in compliant medical waste incinerators.
• Regulatory Class: Class II accessory to a hypodermic needle (21 CFR Section 880.5570); Panel 80 FMI.
• Substantial Equivalence Claim: To Vertical Entry Sharps Containers manufactured by Sage Products Inc. and Sherwood Medical, based on similar materials (polypropylene), manufacturing process (injection molding), and design (chimney-type opening).
• Date of Submission: December 24, 1996 (Amended April 4, 1997)
• FDA Decision: Substantially Equivalent (July 3, 1997)

The 510(k) process for this device type primarily relies on comparing the device's design, materials, and intended use to existing legally marketed predicate devices, not on generating novel performance data against specific acceptance criteria.

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