(449 days)
Personal Injector is intended for use by patients to self-administer or by care-givers for injection of FDA approved drugs or biologics. Personal Injector is intended to introduce the needle below the skin surface.
Personal Injector is designed to accommodate two different and replaceable syringeholders. Personal Injector is intended for the use with FDA approved fixed or non-fixed needle syringes supplied with specific injection reqimens.
Personal Injector is intended to be used in any setting including the home.
Personal Injector is designed for the user - by a user, and here for a lot of emphasis has been put on functionality and injection comfort, appearance, surface, materials, weight, balance, and sound. Personal Injector is an injection system allowing the user to have maximum control and comfort while injecting.
Personal Injector differs from commonly known Auto-injector. Until today, marketed Autoinjectors are only for subcutaneous injections, and introduce both the needle and the drug in one motion. The injections are associated with discomfort, such as pain, blue marks, drug accumulation and swelling at the injection site. Personal Injector has a spring-loaded mechanism that only serves to introduce the needle to a pre-determined depth, either subcutaneous or intramuscular. Hereafter the patient can check for air bobbles and vein penetration, and perform a safe traditional manual injection of the drug, by slowly and steady pushing the plunger down. Personal Injector minimises pain and support the patient perform the manual drug introduction, avoiding almost all discomfort.
Personal Injector two unique Syringe-Holders is designed to accommodate FDA approved syringes with fixed and non-fixed needles. Personal Injector is suitable for many injection regimes, including multiple sclerosis patients treatment with interferon beta, cancer treatment, children receiving growth hormone treatment, men injecting local vasodilators to treat erectile dysfunction, and injections of heparin, adrenaline, insulin, apomorphine, and many others medications.
The provided document is a 510(k) summary for the Personal Injector device. It describes the device, its intended use, and provides contact information. However, it does not contain the results of a formal study with acceptance criteria and specific performance metrics in the way a clinical trial or a validation study for a diagnostic device would.
Based on the information provided, here's what can be extracted and what is missing:
Acceptance Criteria and Study Information for Personal Injector
The provided 510(k) summary (K033696) for the Personal Injector device does not include a formal study with quantitative acceptance criteria and reported device performance metrics that are typically found in validation studies for medical devices, particularly those involving diagnostic accuracy or functional performance against specific benchmarks.
The document primarily focuses on demonstrating substantial equivalence to a predicate device and describing the design and intended use of the Personal Injector. It mentions a "Focus Group Study" but provides very limited details about its methodology or quantitative results in relation to pre-defined acceptance criteria.
Here's an attempt to answer the requested points based on the available information, noting significant gaps:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, no quantitative acceptance criteria or specific device performance metrics (e.g., success rate of needle insertion, pain reduction scores, etc.) are explicitly stated in a table format or otherwise reported as part of a formal study aimed at proving the device meets said criteria.
The closest statement regarding performance is: "The results were outstanding, and Personal Injector has received wide praise from Patients and Healthcare Professionals alike." This is a qualitative, subjective statement and not a measurable performance metric against defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the "Focus Group Study."
- Data Provenance: The "Focus Group Study" was conducted in Denmark ("Rigshospitalet, the largest MS hospital in Denmark"). It appears to be a prospective study in the sense that patients "using the Injector" participated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document mentions "Healthcare Professionals" providing "wide praise," but it does not specify the number or qualifications of these experts involved in establishing any formal "ground truth" or evaluative criteria for the focus group study. The focus group participants were primarily patients.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None specified. The nature of the "Focus Group Study" suggests qualitative feedback collection rather than a formal adjudication process involving multiple expert reviewers.
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 MRMC study was performed or mentioned. This type of study is typically relevant for diagnostic imaging devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Personal Injector is a physical injection device, not a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The Personal Injector is a physical medical device designed for human interaction (patient or caregiver) during injection. It does not involve an algorithm or a standalone 'AI-only' performance component in the context of typical standalone device evaluations for AI-powered systems. Its function is to facilitate manual drug injection.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" equivalent in the "Focus Group Study" would be patient and healthcare professional feedback/satisfaction regarding "functionality and injection comfort, appearance, surface, materials, weight, balance, and sound," and minimizing "discomfort, such as pain, blue marks, drug accumulation and swelling at the injection site." This is primarily subjective experience and qualitative feedback, not an objective "ground truth" like pathology for a diagnostic device.
8. The sample size for the training set
- Not applicable. The Personal Injector is a mechanical device, not an AI/ML model that requires a "training set" in the computational sense. The document describes a "Focus Group Study" which is an evaluation, not a training phase.
9. How the ground truth for the training set was established
- Not applicable. As a mechanical device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning.
Summary of Limitations:
The provided 510(k) summary is for a device seeking substantial equivalence based on its physical and functional characteristics compared to predicate devices, rather than an AI-driven or diagnostic device requiring extensive performance studies with quantitative acceptance criteria, large training/test sets, or MRMC studies. The "Focus Group Study" mentioned is qualitative and lacks the detailed methodological reporting (sample size, expert qualifications, clear metrics) common in formal clinical validation studies that establish performance against pre-defined acceptance criteria.
§ 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).