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The Isolyser Sharps Management System (SMS) is a disposable overthe-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS sharps containers are designed to safely and securely contain used medical sharps prior to removal and subsequent disposal. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800. .98 liters: (2) Sharps Management System (SMS) 2400, 3.3 liters; (3) Sharps Management System (SMS) 4000, 5.97 liters; and (4) Sharps Management System (SMS) 10000, 10.47 liters. Each SMS model includes a water-based acrylamide solution that, when mixed with the provided catalysts, creates a polymer that encapsulates used medical sharps. Once the polymer has formed, the entire SMS container, including its contents, may be disposed in a user's ordinary trash in most states. It is the user's responsibility to dispose of the SMS container in accordance with Federal. State and Local regulations. The SRS 800, SMS 2400, SMS 4000, SMS 10000 are intended for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMS sharps containers are not intended for reuse.

The Isolyser SMS is a disposable over-the-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800. .98 liters: (2) Sharps Management System (SMS) 2400, 3.3 liters; (3) Sharps Management System (SMS) 4000, 5.97 liters; and (4) Sharps Management System (SMS) 10000, 10.47 liters. The SMS containers are marketed for use in the offices, exam, and patient rooms of small quantity healthcare providers such as medical doctors, dentists, veterinarians, and laboratories. The SMS sharps containers are not intended for reuse. The SMS's container is stable, puncture resistant, and leak-proof on the sides and bottom. Used medical sharps are placed vertically into the opening on the top of the container and dropped into an acrylamide solution that is contained inside the container. Once the SMS container has been filled with used medical sharps. users: add the provided catalyst packages to the acrylamide solution inside the container; securely place the lid onto the container; shake the container for ten (10) seconds; and allow the polymer to form overnight. Once the polymer has formed, the entire SMS container, including its contents, may be disposed in a user's ordinary trash in most states. It is the user's responsibility to dispose of the SMS container in accordance with Federal, State and Local regulations. The overall design and specifications for the Isolyser SMS meet OSHA Bloodborne Pathogens Standard as well as the American Society for Testing and Materials Puncture Resistance Standard F2132-01(2008). All SMS containers have BIOHAZARD warning labels clearly visible with lettering in contrasting color and are affixed by adhesives to the sides of the SMS container.

The provided document describes a medical device, the Isolyser SMS Sharps Container, and its 510(k) submission to the FDA. However, the document does not contain specific information about acceptance criteria, efficacy studies, or performance metrics in the way that would typically be presented for a diagnostic or AI-powered device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. This means the manufacturer is asserting their device is as safe and effective as a device already legally marketed, rather than presenting a novel study proving efficacy against specific performance targets.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will address what can be extracted or inferred:

Here's an analysis based on the provided document:

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

The document does not specify quantitative acceptance criteria with corresponding reported device performance metrics in the way a clinical trial or performance study would. Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to existing predicate devices and compliance with relevant standards.

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 describe a "test set" in the context of device performance evaluation with a specific sample size. This 510(k) is based on descriptive data and comparison to a predicate device, rather than a clinical or performance study with a test dataset. Therefore, there is no information about data provenance.

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 described above, there was no "test set" requiring ground truth establishment by experts in the context of device performance in the provided document.

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

Not applicable. There was no "test set" or adjudication method described.

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 is a physical sharps container, not an AI-powered diagnostic tool, and therefore 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 sharps container, not an algorithm.

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

Not applicable. For this type of device, "ground truth" relates to compliance with engineering standards (e.g., puncture resistance, leak-proof design) and regulatory requirements, rather than a diagnostic accuracy assessment. The "ground truth" for the claim of substantial equivalence is based on the characteristics and performance of the legally marketed predicate device (K943626).

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of physical medical device in the context of performance study described in the document.

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

Not applicable.

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The Isolyser Sharps Management Systems SMSm is a single-use, disposable, over-the-counter sharps container intended for use in clinical and non-clinical settings for the disposal of contaminated sharps and/or medical/red-bag wastes. The SMSm is marketed in five (5) different models: (1) Home Sharps Management (HSM) 800m, .98 liters, 3.45 x 2.72 x 7.29 (in.); (2) Sharps Management System (SMS) 2400m, 3.3 liters, 5 x 5x 10 (in.); (3) Sharps Mariagement System (SMS) 4000m, 5.97 liters, 8.47 x 5.99 x 8.87 (in.); (4) Sharps Management System (SMS) 10000m, 10.47 liters, 8.51 x 5.99 x 14.32 (in.); and (5) Sharps Management System (SMS) 5.3m, 21.1 liters, 11.93 x 9.87 x 14.68 (in.). Each SMSm model is designed to safely and securely contain used medical sharps and/or medical/red-bag wastes prior to removal and subsequent disposal. The SMS 5.3m is intended only for the storage and disposal of filled approved sharps containers and/or medical/red-bag wastes. Once an empty SMSm container has been filled with used medical sharps and/or medical/red-bag wastes, the entire SMSm container is intended to be packaged and mailed-back to WCM Waste and Compliance Management, Inc. for proper disposal. The HSM 800m, SMS 2400m, SMS 4000m, SMS 10000m, and SMS 5.3m are intended for home use by home health care providers and for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMSm sharps containers are not intended for reuse.

The Isolyser Home Sharps Management (HSM) 800m; Sharps Management System (SMS) 2400m; Sharps Management System (SMS) 4000m; Sharps Management System (SMS) 10000m are disposable non-reusable sharps containers that are intended to provide for safe and effective disposal of medical sharps and/or medical/red-bag wastes. The Isolyser Sharps Management System (SMS) 5.3m is intended only for the storage and disposal of filled approved sharps containers and/or medical/red-bag wastes. The SMS 5.3m is not intended for the direct disposal of used medical sharps. The HSM 800m, SMS 2400m, SMS 4000m, SMS 10000m, and SMS 5.3m are marketed for home use by home healthcare providers and for use in the offices, exam. and patient rooms of small quantity generators such as medical doctors, dentists, veterinarians, and laboratories.

The SMSm container is stable, puncture resistant (SMS 5,3m not tested) and leak-proof on the sides and bottom. Used medical sharps and/or medical/red-bag wastes are placed vertically into the opening on the top of the container. Once placed into the container, the SMSm does not require users to reach by hand into the container to retrieve contaminated sharps and/or medical/red-bag wastes. Once the container is full, the SMSm is intended to be mailed back to WCM Waste and Compliance Management, Inc. for proper disposal. The overall design and specifications for the Isolyser SMSm meet OSHA Bloodborne Pathogens Standard as well as the American Society for Testing and Materials Standard F2132-01(2008) (SMS 5.3m not tested). All SMSm containers have BIOHAZARD warning labels clearly visible with lettering in contrasting color and are affixed by adhesives to the sides of the SMSm container.

The provided text describes a 510(k) submission for Isolyser SMSm Sharps Containers. This is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance through a detailed clinical study with acceptance criteria.

Therefore, many of the requested elements (acceptance criteria, specific study design, sample sizes, ground truth establishment, MRMC studies, standalone performance) are not applicable in the context of this 510(k) application. This submission aims to show that the new device is as safe and effective as a legally marketed predicate device, primarily through descriptive data and compliance with standards, rather than generating new performance data in a clinical trial setting.

Here's a breakdown of the information that is available and a clear statement regarding what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A): This submission does not describe a traditional "test set" from a clinical or performance study with a defined sample size. The substantial equivalence is based on engineering design, material properties, and comparison to predicate devices and standards.

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

• Not Applicable (N/A): No ground truth establishment by experts for a test set is described. The evaluation is based on design specifications, material properties, and compliance with recognized standards.

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

• Not Applicable (N/A): No test set requiring expert adjudication is described.

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 (N/A): This device is a physical sharps container, not an AI-powered diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not Applicable (N/A): This device is a physical sharps container, not an algorithm, so standalone performance in this context is irrelevant.

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

• Not Applicable (N/A): As explained, traditional "ground truth" derived from clinical data is not applicable here. The "truth" or validation relies on:
  • Compliance with recognized industry standards: OSHA Bloodborne Pathogens Standard and ASTM F2132-01(2008).
  • Comparison to predicate device characteristics: Identity or similarity in intended use, function, basic composition, size, and design.

8. The sample size for the training set

• Not Applicable (N/A): There is no "training set" as this is not an AI/machine learning device. The development process would have involved engineering design, prototyping, and testing of physical units to ensure compliance with standards, but not a data-driven training set in the computational sense.

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

• Not Applicable (N/A): No training set as per explanation in point 8.

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