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The Comfort EZ™ disposable sterile insulin syringes are intended for injection of U100 insulin only.

The Comfort EZ™ insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle. The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 28 through 31 gauge needle sizes, in 0.3 ml/cc and 1 ml/cc capacities. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.

The provided document is a 510(k) summary for the Comfort EZ™ Insulin Syringe, which is a medical device for the injection of U100 insulin. The submission aims to demonstrate substantial equivalence to a predicate device, the Feel-ject 2. Insulin Syringe.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device (Feel-ject Insulin Syringe) and relevant international standards. The Comfort EZ™ Insulin Syringe aims to be "identical" in these aspects to achieve substantial equivalence.

The overall performance criterion is "substantially equivalent" to the predicate device due to identical technological characteristics, materials, manufacturing methods, and conformance to relevant standards.

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

The document states that "Bench and standards compliance testing was performed." However, it does not specify the sample size for any of these tests.

Regarding data provenance:

• Biocompatibility: Conforms to ISO 10993-1. The list of tests (Cytotoxicity, Maximization, Intracutaneous Toxicity, Hemolysis, Systemic toxicity, Pyrogen Testing) implies lab testing.
• Mechanical testing: Hub/needle bond strength (ISO 7894:1993).
• Sterility testing: ISO 11607 and ISO 11135, including EO residues testing (ISO 10997-7).
• Standards Compliance: ISO 8537:1991(E).

The document is a US FDA 510(k) submission, and the predicate device is from Korea (Feel Tech). The location where the "bench and standards compliance testing" for the Comfort EZ™ syringe was performed is not explicitly stated, but it would typically be conducted by the manufacturer (Simple Diagnostics, based in Florida, USA) or a contracted lab. The data is retrospective in the sense that the tests were performed to demonstrate equivalence for the 510(k) submission.

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

This question is not applicable to this type of device and submission. The "ground truth" for a mechanical device like an insulin syringe is based on objective measurements against established international consensus standards (like ISO standards) and material science, not expert interpretation of subjective data like images. Therefore, clinical experts or radiologists are not involved in establishing ground truth for performance testing.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in subjective assessments, which is not the nature of the bench and standards compliance testing performed for this device.

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

This question is not applicable. This submission is for a physical medical device (insulin syringe), not an AI algorithm or a diagnostic tool that involves human readers or image interpretation. Therefore, no MRMC study was conducted or is relevant.

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

This question is not applicable as it pertains to AI algorithms, not physical medical devices like syringes.

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

The "ground truth" for the test set in this context is based on:

• International Standards: e.g., ISO 8537 for syringes, ISO 10993 for biocompatibility, ISO 7894 for mechanical testing, ISO 11607 and ISO 11135 for sterility.
• Predicate Device Specifications: The characteristics, materials, and performance of the legally marketed Feel-ject 2. Insulin Syringe (K070917) form a primary basis for equivalence, implying its validated performance constitutes a "ground truth" for comparison.
• Objective Bench Test Results: Direct physical, chemical, and biological measurements demonstrating compliance with the above standards and equivalence to the predicate.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a physical medical device like an insulin syringe. Training sets are relevant for machine learning algorithms.

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

This question is not applicable as there is no training set.

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These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.

The Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and protected by blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected to the pen. The needle cap cover is intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.

This document describes a 510(k) submission for the Comfort EZ Pen Needle, a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of AI-based diagnostic performance. Therefore, many of the requested elements for describing a study proving a device meets acceptance criteria related to AI or diagnostic accuracy are not applicable.

Based on the provided text, the device in question is a Comfort EZ Pen Needle, which is a medical device for drug delivery (insulin) and not a diagnostic AI system. Therefore, the typical acceptance criteria and study designs relevant to AI/diagnostic performance (such as sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this document.

The "study" described in this 510(k) summary is a set of bench tests and demonstrations of substantial equivalence to existing predicate devices, as is standard for many medical devices, particularly those for which equivalence can be shown based on design and performance characteristics rather than complex diagnostic interpretation.

Here's an attempt to address the points based on the provided text, noting where the requested information is not relevant to a pen needle:

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

Since this is a non-AI, non-diagnostic device, the acceptance criteria are based on physical and functional properties, and the performance is reported against these.

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

• Sample Size: Not explicitly stated for each bench test. Bench tests typically involve a specific number of units to ensure statistical significance for the particular test being conducted (e.g., a certain number of needles for mechanical force testing, or samples for sterility testing). The document does not provide these specifics.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is standard for internal product development and testing of a device rather than a clinical study with patient data. The tests would be performed in a controlled laboratory environment.

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

• Not Applicable. This device does not involve diagnostic interpretation or "ground truth" established by human experts in the way an AI diagnostic device would. Bench tests follow established laboratory protocols and standards (e.g., ISO standards for pen compatibility, AAMI standards for sterility). Compliance with these standards serves as the "ground truth" for device performance.

4. Adjudication method for the test set:

• Not Applicable. There's no human interpretation or subjective assessment that would require adjudication.

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 is not an AI or diagnostic device, so an MRMC study is not relevant.

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

• Not Applicable. This is not an algorithm or AI device. The "performance" described is the physical and functional performance of the pen needle itself.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by international standards (e.g., ISO "Type A" for pen compatibility), manufacturing specifications, and industry best practices for medical device safety and efficacy (e.g., biocompatibility standards, sterility assurance levels). It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic device's ground truth would be.

8. The sample size for the training set:

• Not Applicable. This device does not involve machine learning or a "training set."

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

• Not Applicable. There is no training set for this type of device.

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