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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 RxPeakFlow is a single patient use device to measure a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.

The RxPeakFlow is a device used to measure the peak expiratory flow of a patient. The Peak Expiratory Flow Rate is a recognized lung function value that is helpful in monitoring of respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.

Here's a breakdown of the acceptance criteria and the study details for the RxPeakFlow Meter, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Note: The document only provides the performance of the RxPeakFlow against these criteria, stating it "passed all testing and met the criteria for range, accuracy and precision of required by the American Thoracic Society's Standardization of Spirometry". It doesn't explicitly list a separate "acceptance criteria" column versus "reported device performance," but rather presented these as the requirements the device met.

2. Sample Size and Data Provenance for the Test Set

The document states that "bench testing" was performed. However, it does not provide specific details regarding:

• Sample size used for the test set (e.g., number of devices tested, number of individual measurements).
• Data provenance (e.g., country of origin, retrospective or prospective nature of the "bench testing").

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not provided in the document. Bench testing typically relies on standardized reference instruments or methods rather than human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1, none) are typically used when multiple human experts are involved in interpreting results, especially in imaging or diagnostic studies. Since the testing was "bench testing," and no human experts or interpretation are mentioned for establishing ground truth, information on an adjudication method is not applicable and not provided.

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

An MRMC comparative effectiveness study was not done. The device is a "Meter, Peak Flow," which measures a physical parameter directly, rather than providing an interpretation that a human would then use to make a decision. The performance evaluation was through "bench testing," not a clinical study involving human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document explicitly states: "The RxPeakFlow has been tested for performance through bench testing. The device passed all testing and met the criteria for range, accuracy and precision of required by the American Thoracic Society's Standardization of Spirometry, specifically the ATS 26 flow-time waveform testing." This describes the algorithm's (or device's mechanical) performance without human intervention.

7. Type of Ground Truth Used

The ground truth used was based on standards and requirements from the American Thoracic Society's Standardization of Spirometry, specifically the ATS 26 flow-time waveform testing. This implies that the device's measurements were compared against known, standardized flow-time waveforms or reference measurements adhering to these professional guidelines.

8. Sample Size for the Training Set

The document does not provide information on a separate "training set" or its sample size. This is common for mechanical devices that are calibrated and tested against physical standards, rather than "trained" using a dataset in the way a machine learning algorithm would be.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth was established. The device is a mechanical measurement tool rather than an AI/ML-driven diagnostic.

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