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The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

The GRP Sharps Container is a blow molded HDPE bottle with a spun-weld iris at the opening. The iris acts as an aperture, allowing a vertical sharps drop. The device has a yellow safety ring which prevents the cap from locking closed during use. The device has a white 2.5″ cap which contains a sealing gasket. Once the GRP Sharps Container is full, the safety ring is removed prior to pacing the cap on. When the safety ring has been removed, the cap locks down for a tight seal. The device is available in four sizes: 1.5 quart, 1 gallon, 2 gallon and 3 gallon. The containers are identical except for capacity.

The provided text describes a 510(k) premarket submission for a medical device: GRP Sharps Container. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria, ground truth, and expert adjudication in the way an AI/ML device would.

Therefore, many of the requested categories (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this submission, as it is for a physical device (sharps container) and not an AI/ML diagnostic or prognostic tool.

However, I can extract the acceptance criteria based on compliance with standards and the reported performance as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the context of typical AI/ML studies. The testing would have involved a sufficient number of physical GRP Sharps Container units to ensure compliance with the specified standards for each model size.
• Data Provenance: The tests conducted are non-clinical, laboratory-based physical and mechanical performance tests on the manufactured device itself, rather than data from human subjects or clinical settings. The provenance is from these specific laboratory tests against recognized standards.

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

• Not applicable. This submission is for a physical medical device (sharps container) and not an AI/ML algorithm that requires expert-established ground truth from data for diagnostic or prognostic purposes. Compliance is determined by objective physical testing against established international and national standards.

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

• Not applicable. See point 3. Ground truth is derived from objective performance against engineering standards.

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 physical device, not an AI-assisted diagnostic tool.

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

• Not applicable. See point 5.

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

• Objective performance against established engineering standards and regulatory requirements. For example, puncture resistance is directly measured against the criteria specified in ASTM F 2132-01. Leak resistance is measured against CSA Z316.6-95.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. See point 8.

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The Noble Sharps container is a disposable over the counter sharps container that is intended for the safe disposal of used medical sharps. It is intended for use in offices, exam and patient rooms of small quantity healthcare providers such as medical doctors, dentists, and veterinarians. The size of the Sharps Container is 6 7/16" in height x 4 15/16" in width x 2 7/16" in depth. It is designed with 4- individual single use chambers with each holding 1-sharp, with a maximum sharp length of 6 1/8″.

The Noble Sharps Container are intended to be used at healthcare facilities, including nursing stations, medication carts, laboratories, emergency rooms, treatment rooms, and other small quantity waste generators for the safe disposal of hazardous sharps.

The Nobles Sharps Container is a single use device designed for the safe disposal of hazardous sharps. It is designed with 4-chambers, each chamber will hold one sharps. After each chamber is filled with a sharp, a locking lid is closed by pressing downward, thus permanently sealing the sharps inside the container. All materials including the bottom, sides, and locking lid are manufactured using PP7726 (polypropylene) the same material used in the predicate device, the GongDong disposable sharps container cleared under K082042. The size of the Noble Sharps Container is 6 7/16" in height, 4 15/16" in width and 2 7/16" in depth.

The Noble Sharps Container is a medical device designed for the safe disposal of hazardous sharps. The submission refers to performance testing under recognized standards to demonstrate substantial equivalence to its predicate device.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the sample sizes for the performance tests (ASTM F 2132, CSA Z316.6-07, BS 7320:1990). Given that these are standard tests for physical properties, the sample sizes would typically be defined by the respective standards. The data provenance is not specified beyond the fact that the tests were conducted for the Noble Sharps Container. It's implied to be prospective testing specific to this device.

3. Number of Experts and Qualifications:

Not applicable. This is a medical device focused on physical performance rather than diagnostic accuracy that would require expert human review. The evaluation relies on standardized engineering tests.

4. Adjudication Method:

Not applicable. The performance is assessed through objective physical and mechanical testing as per established standards, not through human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The device is a sharps container, not an imaging or diagnostic device that would involve human readers or AI assistance in interpretation.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the sense that the Noble Sharps Container was subjected to specific performance tests (puncture resistance, topple resistance, leakage) independent of human interaction for its intended function.

7. Type of Ground Truth Used:

The ground truth for the performance testing is implicitly defined by the pass/fail criteria and methodologies outlined in the referenced standards: ASTM F 2132, CSA Z316.6-07, and BS 7320:1990. These standards establish objective criteria for puncture resistance, topple resistance, and leakage, respectively.

8. Sample Size for Training Set:

Not applicable. This device is a physical medical device and not an AI/machine learning model, so there is no training set in the conventional sense.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set for this type of device.

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The sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps.

The Sharps Container is a piece of equipment used in hospitals, physicians' offices, dental offices, laboratories, home health areas, patient rooms and other locations of medical waste. The sharps container is designed to safely contain used needles or syringes and prevent accidental needle sticks from used syringes or needles.
The device is made of injected molded polypropylene material. The material . is made of molded plastic into a specific shape. The actual shape is designed to sit on the floor or a desk.
On the outer casing of all the sharps containers is the Biohazard Warning label in Orange, noticeably displayed.
The molded plastic container is designed and manufactured such that there . will be no leakage during storage, handling or transport.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Sharps Container, Model Lns-T1

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the standards used for performance testing (BS7230:1990, ASTM F2132:2008, OSHA 29CFR1910). The reported device performance is that the "product passed all tests."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample size for the test set or the exact data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Mechanical, environmental safety and performance testing have been accomplished according to BS7230:1990, ASTM F2132:2008 and OSHA 29CFR1910." and that the "product passed all tests." This suggests that the testing was conducted in a laboratory setting to meet these specific standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and is not provided in the document. The device is a physical sharps container, and its performance (e.g., impact, puncture, leak resistance) is evaluated through standardized mechanical and environmental testing against established engineering standards, not through human expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. As mentioned above, the evaluation is based on objective measurements against engineering standards, not expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is involved. This device is a physical container, and its effectiveness is determined by its physical properties.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable to a physical device like a sharps container. "Standalone" performance usually refers to an algorithm's ability to perform a task without human intervention, which doesn't fit the context of this product. The device's performance is inherently "standalone" in that it performs its function (containing sharps) without human "in-the-loop" interaction for its core function evaluation beyond its initial use.

7. The Type of Ground Truth Used

The ground truth for the performance testing was established by recognized industry and safety standards: BS7230:1990, ASTM F2132:2008, and OSHA 29CFR1910. These standards define the parameters and methodologies for evaluating the safety and effectiveness of sharps containers (e.g., impact, puncture, and leak resistance).

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The development and testing of a physical product like a sharps container do not typically involve "training sets" in the context of algorithms or machine learning. The design implicitly relies on engineering principles and material science, which are validated through physical testing.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. There is no "training set" in the context of this device. The design principles and manufacturing processes are likely informed by engineering best practices, prior product development, and regulatory requirements (e.g., those found in the referenced standards).

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

The Biodex Sharps Container consists of an injection molded polypropylene container fitted with an injection-molded snap on cover with a connected lid to the cover. The lid snaps onto the cover when the container is filled. The cover and lid are shipped not installed on the container bottom so the containers can be nested to save space. The cover is snapped onto the cover before use. The cover has an oval opening into which the Sharps are dropped vertically into the container.

The provided text is a 510(k) Summary for a Sharps Container. It describes the device, its classification, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert involvement, or AI-related assessments.

The document explicitly states: "The Biodex Sharps Container will be manufactured to the product specifications." but it does not detail what those specifications are beyond general descriptions like being "puncture resistant" and having a "fill line."

Therefore, I cannot fulfill your request as the required information is not present in the provided text. This document is a regulatory submission for a medical device that does not appear to involve AI or require complex performance studies beyond meeting basic safety specifications, which are not itemized here.

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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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This container is for use by Law Enforcement Agencies. Law Enforcement Officials who frequently ancounter syringes and other sharps during searches of suspects, vahicles, property or location.

A ans piece aluminum container designed for the wate and examinated needles and syringes. Container is designed of thin walled puncture resistant 6081 aluminum with a screw on leak proof lld. Container is designed to held up to two (2) 1cc syringes and is completely disposable in accordance with local and state regulations.

The provided text describes a 510(k) summary for the SC001 Sharps Container, not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device studies, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable.

However, I can extract information related to the device's acceptance criteria and the "study" (referring to the testing performed) that supports these criteria based on the provided text.

Here's a breakdown of the requested information, adapted for a non-AI/ML medical device submission:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The text mentions "a 1cc Insulin syringe with a .5 inch needle of .014 OD thickness." It then states, "It was found that in every situation that the needle bent..." This suggests multiple tests were performed with at least one representative needle, but a specific number of tests or needles is not quantified as a "sample size" in the way it would be for a statistical study. The "shake test" also implies testing with contained needles.
• Data Provenance: Not explicitly stated, but the testing was conducted by or for Imagination Medical Inc. in the context of a 510(k) submission to the FDA. The tests appear to be laboratory-based and conducted specifically for this submission. There is no information regarding country of origin for data or if it was retrospective/prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable. For this type of physical device testing, "ground truth" is established through direct measurements and observations of the device's physical properties and behavior under specified conditions, not through expert consensus on interpretations. The "truth" is the physical outcome of the test.

4. Adjudication Method for the Test Set

• Not applicable. Evaluation was based on direct physical testing outcomes (e.g., did the needle penetrate? did it leak? did it bend?). There's no indication of multiple observers or a need for adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not relevant for a sharps container. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess changes in diagnostic accuracy or efficiency.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This refers to AI algorithm performance and is not applicable to a physical sharps container.

7. The Type of Ground Truth Used

• Observed Physical Properties and Test Outcomes: The ground truth was established by directly observing the outcomes of engineered tests. For example, the force required to bend a needle, the force required to penetrate the container, and whether needles penetrated the container during a shake test.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, there is no training set for this type of device.

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