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The DAI-R™ Autoinjector is a hand-held mechanical device intended for the automated, selfadministration of FDA-approved drugs and biologics. The DAI-R™ Autoinjector is designed to be used with a standard Glass Barrel 1mL Long Syringe with Luer Lock Tip that has been prefilled prior to an injection. The DAI-R™ Autoinjector is for use in the home environment to aid and support prescribed treatment and therapy.

The DAI-R is an automatic drug delivery device that is used for the injection of drugs and biologics from standard Glass Barrel 1mL Long syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R. The DAI-R is a single-use, disposable, syringe needle introducer device. It is spring-powered and designed to administer the entire contents of the prefilled syringe in one dose. The DAI-R injection has three operational steps: 1) the automatic insertion of the syringe needle to a predetermined depth into the body, 2) the automatic delivery of the syringe contents, and 3) the withdrawal of the needle from the body.

The DAI-R consists of a main body and a syringe carrier assembly. The syringe carrier is used to load the prefilled syringe into the main body to make a complete DAI-R delivery system. The complete DAI-R is a plastic tube with the loaded prefilled syringe, a front needle shield and a rear power assembly. The components of DAI-R are made of plastic and steel. The DAI-R does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.

The provided text describes the acceptance criteria and a study for the DAI-R™ Autoinjector.

1. Table of Acceptance Criteria and Reported Device Performance

The device was assessed using sections and methods specified in ISO 11608:2000 "Pen injectors for medical use-Part 1: Pen injectors - Requirements and test methods."

2. Sample Size and Data Provenance

The provided document does not specify the exact sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the DAI-R met the requirements of ISO 11608:2000.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable and not provided in the document. The device is a mechanical autoinjector, and its performance evaluation against ISO standards typically involves engineering and functional testing rather than expert-established ground truth in a clinical or diagnostic sense.

4. Adjudication Method

This information is not applicable and not provided. Performance against an ISO standard for a mechanical device does not typically involve an adjudication method in the way medical imaging or clinical studies do.

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

No. An MRMC comparative effectiveness study is not applicable and was not done for this type of mechanical device.

6. Standalone (Algorithm Only) Performance

No. This concept is not applicable to a mechanical autoinjector. The performance described is inherently "standalone" in a functional sense, as it refers to the device's ability to meet its operational specifications.

7. Type of Ground Truth Used

The "ground truth" for evaluating the DAI-R's performance was the requirements and specifications identified in ISO 11608:2000. This standard sets objective, measurable criteria for pen injectors.

8. Sample Size for the Training Set

This information is not applicable and not provided in the document. Mechanical devices are typically developed and validated through engineering design, testing, and adherence to standards, not through "training sets" in the context of machine learning or AI.

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

This information is not applicable and not provided. The development and validation process for this mechanical device would not involve establishing ground truth for a training set in the way AI models are trained.

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DAI™ is a hand-held mechanical device intended for the automated, subcutaneous, selfadministration of FDA-approved drugs and biologics. DAI™ is designed to be used with the standard 1.0mL Long (glass) Syringe with Needle that has been prefilled prior to an injection. DAI™ is for use in the home environment to aid and support prescribed treatment and therapy.

DAI™ is an automatic drug delivery device that is used for the subcutaneous administration of drugs and biologics from standard 1.0mL long glass syringes with staked needle from 25g to 27g and 12.7mm in length that are prefilled prior to use in DAI™ is a single-use, disposable, syringe needle introducer device that is spring-powered and designed to administer the entire contents of the prefilled syringe during one injection. A DAI™ injection consists of the automatic insertion of the syringe needle to a predetermined depth into the skin, followed by the automatic delivery of the syringe contents.

DAT™ consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self injection. The assembled DAI has a tubular design with a needle end and a power assembly with activation button end. DAI™ components and subassemblies are made of plastic and metal. DAI™ does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.

The provided 510(k) summary for the SHL DAI™ auto-injector does not contain a detailed study meeting all the requested criteria for an AI/ML device. This is a clearance for a medical device (auto-injector), not an AI/ML diagnostic or predictive tool, and thus the structure of the provided information is different.

However, I can extract the relevant information from the document that pertains to performance assessment and acceptance criteria for this type of device, as much as possible, and note where information specific to AI/ML studies is not applicable or not provided.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "DAI™ was assessed using the sections and methods specified in ISO 11608:2000 'Pen injectors for medical use-Part 1: Pen injectors - Requirements and test methods' as they apply to injection devices with non-replaceable prefilled cartridges." This standard would define the sample sizes for various tests.
• Data Provenance: Not explicitly stated. It's implied to be data generated from testing the physical device according to ISO 11608:2000. It's a prospective testing process following the standard. Country of origin not specified, but the applicant is SHL Medical, USA.

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

• Not Applicable in the context of an auto-injector. Ground truth for this type of device is established through objective physical measurements and functional tests, not expert interpretation of diagnostic images or data.

4. Adjudication method for the test set

• Not Applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective assessments (e.g., image interpretation). The performance of an auto-injector is measured objectively against predefined specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size

• No, not applicable. MRMC studies are used to assess the impact of a diagnostic aid (like AI) on human reader performance. This device is an auto-injector, not a diagnostic aid.

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

• Yes, in spirit. The "device performance" described is inherently "standalone" in that it refers to the physical device's automated function (needle insertion, drug delivery, safety features) without human interpretative input once activated. However, this is not an "algorithm only" study as it pertains to a mechanical device.

7. The type of ground truth used

• Objective physical measurements and functional test outcomes. For example, needle extension would be measured directly, injection time would be timed, and completeness of injection verified. The ground truth is the physical reality of the device's operation against its design specifications and the requirements of ISO 11608:2000.

8. The sample size for the training set

• Not Applicable in the context of an AI/ML device. This device is not AI/ML based and does not have a "training set" in that sense. Its design is based on engineering principles and validated through physical testing.

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

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

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