(122 days)
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
| Acceptance Criteria (from ISO 11608:2000 as applicable) | Reported Device Performance |
|---|---|
| Activation Force | Met all requirements and specifications |
| Needle Extension | Met all requirements and specifications |
| Injection Time | Met all requirements and specifications |
| Completeness of Injection | Met all requirements and specifications |
| Functionality | Met all requirements and specifications |
| Robustness | Met all requirements and specifications |
| Safety mechanism to prevent inadvertent activation | Design feature of DAI™ |
| Automatic recovering of the used needle | Design feature of DAI™ |
| Cutout window for syringe inspection | Design feature of DAI™ |
| Locking tabs to prevent disassembly | Design feature of DAI™ |
| Self-disabling after use | Design feature of DAI™ |
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.
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).