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Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

Disposable Insulin Pen Needle, could be divided into Model CT (normal type) and model ST(safety type) according to whether there is sharps protection features. Model CT consists of needle hub, needle container, needle tube, needle shield and seal (dialyzing paper). Model ST consists of needle hub, needle container, protective cap, needle tube, spring, slider, protective jacket and seal (dialyzing paper). The device is sterilized by EO gas and for single use. The shelf life is 5 years.

Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with needle shield or protective jacket before use, medical dialyzing paper is covered and sealed needle container to maintain sterile of the cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. When Disposable Insulin Pen Needle is connected to insulin pen operates on the principles of common piston syringes. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.

Model ST has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

The provided text is a 510(k) Premarket Notification for a Disposable Insulin Pen Needle. It focuses on demonstrating substantial equivalence to predicate devices through design comparisons and a summary of performance testing. The document does not describe a study that involves acceptance criteria for device performance based on AI or diagnostic accuracy. Instead, it details the physical and functional performance of the device based on established medical device standards.

Therefore, I cannot provide information about:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI.
• Sample size used for the test set and data provenance for an AI model.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract information regarding the device's general performance testing and criteria based on the provided document:

The device's performance is evaluated against recognized international standards for medical devices and sterility.

Here's a summary of the performance testing and criteria mentioned, which serves as the "acceptance criteria" in the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

• Maximum EO residual . | - Meets requirements of ISO 10993 series standards.
• All listed specific tests performed.
• Particulate matter for injections performed per USP . |
  | Sharps Protection Features | - For Model ST: Meet requirements of safe-lock guard activation and safety overriding/unlocking force after activation (triggering performance) as per ISO 23908:2011 (Sharps injury protection). | - Model ST meets the requirements of safe-lock guard activation and safety overriding/unlocking force after activation per ISO 23908:2011. |
  | Clinical Simulated Use | - For Model ST: Demonstrate sharps injury prevention feature through clinical simulated use testing, according to ISO 23908:2011 and FDA Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features. | - Clinical simulated use testing completed for Model ST. Test results show good sharps injury prevention feature. |
  | Hub/Needle Bond Strength | - Conform with ISO 11608-2. | - Conform with ISO 11608-2. |
  | Method of Attachment | - Screw structure, conform with ISO 11608-2. | - Screw structure, conform with ISO 11608-2. |
  | Needle Tip Configuration | - Tri-bevel edge needle. | - Tri-bevel edge needle. |
  | Endotoxin Limit | - 20 EU per device. | - 20 EU per device. |

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

The document does not specify a distinct "test set" in the context of diagnostic performance or AI. Instead, it refers to samples of the device being manufactured and subjected to various physical, chemical, and biological tests according to the standards listed above. The provenance of these test samples would be the manufacturer's production line (Ningbo Medsun Medical Co., Ltd., China). The tests are prospective in the sense that they are performed on the manufactured device models to demonstrate compliance.

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

Not applicable, as this is not a diagnostic device involving expert interpretation or AI. The "ground truth" here is compliance with established international and national medical device standards, which are defined by committees of experts in the field.

4. Adjudication Method for the Test Set

Not applicable. The criteria are objective measurements and validations against 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, as this is not a diagnostic device or AI-driven system.

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

Not applicable, as this is a physical medical device.

7. The type of ground truth used

The "ground truth" is defined by the technical specifications and performance requirements outlined in the cited international and national standards (e.g., ISO 11135, ISO 11608-2, ISO 9626, ISO 7864, ISO 10993 series, ASTM D4169-16, ASTM F1929-2015, USP , ISO 23908:2011). These standards represent established scientific and engineering principles for medical device safety and efficacy.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).

The HumaPen Luxura is a reusable mechanical pen-injector designed for use for the selfinjection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately). The pen injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.

Here's an analysis of the provided text regarding the HumaPen Luxura device, focusing on acceptance criteria and supporting studies:

This document is a 510(k) Premarket Notification from the FDA for the HumaPen Luxura, a reusable insulin pen. It primarily demonstrates substantial equivalence to a predicate device (HumaPen Luxura HD) rather than presenting a comprehensive study of a novel AI-powered device. Therefore, many of the requested categories for AI-specific studies and performance metrics are not applicable or cannot be extracted from this type of document.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the specific number of devices or test cycles used for each non-clinical performance test. It mentions "sample devices" for the life-cycle test without giving a number.
• Data Provenance: The data is generated from non-clinical performance testing conducted by the device manufacturer, Eli Lilly and Company. This is prospective testing related to device design and manufacturing, not clinical data from patients. The country of origin of the data is implied to be within the company's testing facilities, likely in the US (Indianapolis, IN, is the submitter's location).

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

This is not applicable. The referenced standards (ISO 11608-1:2012, ISO 10993-1:2009) define objective, quantifiable performance metrics, not expert-derived ground truth. Human Factors testing would involve users, but the document does not specify experts for "ground truth" establishment in the sense of AI evaluation.

4. Adjudication method for the test set:

Not applicable. The tests involve objective measurements against predefined criteria in international standards. There is no mention of an adjudication process for subjective assessments.

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 mechanical insulin pen and not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a mechanical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical performance tests is the defined limits and methodologies within the referenced international standards (ISO 11608-1:2012 for dose accuracy and functionality, ISO 10993-1:2009 for biocompatibility). These are objective, empirically verifiable standards.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

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

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