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The UltiCare disposable pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

The UltiCare Disposable Pen Needles are sterile, single-use, type A, hypodermic single lumen needles designed for use with insulin pen injector devices. The UltiCare Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needle primary container. The UltiCare Disposable Pen Needles are non-toxic and nonpyrogenic, and are available in a variety of needle sizes (29 gauge to 31 gauge) and lengths (3/16" to 1/2").

The provided text is related to a 510(k) submission for UltiCare Disposable Pen Needles and discusses substantial equivalence, not detailed acceptance criteria or a study proving device performance in the way typically required for AI/ML-based diagnostic devices.

The document states that the UltiCare Disposable Pen Needles are "substantially equivalent in intended use, function and basic composition" to predicate devices, and that they "meet the following standards: ISO 11608-2, ISO 9626, ISO 7864." These ISO standards themselves contain specific requirements and test methods that, if met, serve as the de facto acceptance criteria and the "study" demonstrating their fulfillment.

However, the 510(k) summary does not provide the detailed results of these tests, sample sizes, ground truth establishment, or expert involvement as would be required for a performance study of a device that requires image analysis or complex expert interpretation. This is because pen needles are physical medical devices with established performance characteristics defined by international standards for manufacturing and materials, rather than devices that use algorithms to process and interpret data.

Therefore, for your current request format, much of the information you've asked for is not applicable or not explicitly detailed in this type of regulatory submission for this specific physical device.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly the requirements outlined in the specified ISO standards. The "reported device performance" is the statement that the device "meets" these standards, indicating compliance.

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

• Sample Size: Not specified in the provided document. The sample sizes would be determined by the testing protocols within the ISO standards, but the specific numbers for this submission are not given.
• Data Provenance: Not applicable in the context of clinical data for AI. For physical device testing against ISO standards, the tests are typically performed in a laboratory setting by the manufacturer or a certified testing facility to evaluate manufacturing quality and material properties. The country of origin of the data would be the location of the manufacturing or testing facility.

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

• This is not applicable for this type of device and regulatory submission. "Ground truth" in the context of expert consensus is relevant for diagnostic devices interpreting complex data (e.g., medical images, pathology slides). For pen needles, the "ground truth" is established by direct physical measurements, material science tests, and sterility tests performed according to the ISO standards. There isn't a need for expert consensus on an interpretation.

4. Adjudication method for the test set

• This is not applicable as there is no expert interpretation or consensus-based ground truth being established. The "adjudication" is whether the device's physical and material properties meet the objective, quantifiable requirements of the ISO 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

• No, this was not done. This type of study is completely irrelevant for a physical medical device like a pen needle. MRMC studies are designed for diagnostic support systems, particularly those involving human interpretation of complex data with or without AI assistance.

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

• No, this was not done. Again, this concept applies to AI/ML algorithms, not to a physical medical device like a pen needle.

7. The type of ground truth used

• The "ground truth" for pen needles is based on objective, quantifiable physical and material properties, and sterility parameters as defined by the referenced ISO standards (e.g., needle gauge, length, material composition, penetration force, cannula integrity, sterility). It is not pathology, outcomes data, or expert consensus in the diagnostic sense.

8. The sample size for the training set

• Not applicable. This device does not involve an AI/ML algorithm that requires a "training set."

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

• Not applicable. As there is no training set, there is no ground truth to be established for it.

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The Ulti Guard Home Insulin Syringe Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin syringes in the home. After use the syringes are to be deposited into the container for safe storage and eventual disposal according to local regulations.

The Ulti Guard Home syringe contains 100 UltiCare insulin syringes. Syringes can be selectively removed as needed, and used syringes conveniently deposited back into the top of the container for safe storage. Ulti Guard syringes and container are single use only.

The provided 510(k) summary for the UltiGuard Home Insulin Syringe Dispenser and Sharps Container describes a device designed for the safe dispensing, storage, and disposal of insulin syringes in the home.

Here's an analysis of the acceptance criteria and the study as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for each test (Impact Resistance, Puncture Resistance, etc.). It only mentions that the device "has been tested."

The data provenance is not specified. It is presumed to be from Ulti Med Inc.'s internal testing labs, but the country of origin is not mentioned, nor is it explicitly stated whether the tests were retrospective or prospective, though performance testing for a 510(k) is typically prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the type of device and study being described. For a physical medical device like a sharps container, "ground truth" is established by performance against pre-defined engineering and safety standards, not by expert interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving expert review of medical images or other clinical data where there might be inter-reader variability. For physical device performance testing, the results are typically objectively measured against established criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret medical cases. The UltiGuard is a physical sharps container and dispenser, not a diagnostic device.

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

No, a standalone study was not done. This concept applies to AI algorithms. The UltiGuard is a physical device, and its performance is assessed directly, not through an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective engineering and safety standards related to the physical properties of a sharps container. These standards dictate how a container must perform under specific conditions (e.g., what force it must withstand without puncturing, how much liquid it can contain without leaking). The document states that the device was tested for "Impact Resistance, Puncture Resistance, Leak Resistance Sharps Access and Stability," implying that these tests were conducted against established regulatory or industry benchmarks for such devices.

8. The Sample Size for the Training Set

This is not applicable. The UltiGuard is a physical medical device, not an AI model or algorithm that requires a training set.

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

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

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