(233 days)
The Orbit Inserter is indicated to aid the user with the insertion of the cannula into the subcutaneous tissue for compatible infusion sets listed on the labeling.
The Orbit Inserter is intended to be used to assist patients and their caregivers by providing a mechanism to automate the insertion of compatible Ypsomed Infusion Sets primarily in a home setting.
The Orbit Inserter is a manually operated, spring-loaded insertion aid for automatic insertion of compatible Orbit infusion sets. It assists the user with insertion of the infusion set cannula into the subcutaneous tissue. The device is non-invasive, non-sterile and intended for multiple uses by the same patient. The Orbit Inserter is made of plastic and is powered by a stainless-steel spring.
This document is a 510(k) Summary for the Orbit Inserter, a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or algorithms, nor does it present data from diagnostic imaging studies or multi-reader multi-case studies typically associated with AI performance evaluations.
Therefore, many of the requested points in your prompt are not applicable to the content of this document. I will answer the applicable questions and explain why others do not apply based only on the provided text.
Here's a breakdown of the acceptance criteria and study information for the Orbit Inserter based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensional | Devices must meet Dimensional Specification | Pass |
| Visual Inspection | No cracking; No gross discoloration | Pass |
| Functional Testing | Meets Functional Specifications for: • Activation Torque • Button Activation force • Insertion Force • Reset Torque | Pass |
| Biological | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Usability | Successful Summative HF Validation | Pass |
| Life-cycle Testing | Meets Visual and Functional requirements after 550 activations | Pass |
2. Sample size used for the test set and the data provenance
The document mentions "after 550 activations" for Life-cycle Testing, which implies a sample size of at least one device tested for 550 activations. It doesn't explicitly state the number of devices or the data provenance (country of origin, retrospective/prospective). However, the company, Ypsomed AG, is based in Switzerland.
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 device is a mechanical inserter, not an AI or diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" here is the device's physical performance according to engineering and usability specifications.
4. Adjudication method for the test set
This is not applicable. As it's a mechanical device performance test, there's no need for adjudication by multiple experts in the sense of agreeing on a diagnosis or marking a lesion. The results are objective measurements and observations against pre-defined specifications.
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 is not applicable. This document describes a mechanical medical device, not an AI system. Therefore, no MRMC study, human readers, or AI assistance is relevant to its performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical inserter; there is no algorithm or AI component to test in a standalone manner.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications and ISO standards for mechanical, visual, functional, and biological properties, as well as summative user validation for usability. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic performance.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a mechanical device. This concept applies to machine learning models.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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).