(52 days)
The MiniMed Sof-serter infusion set insertion system is intended to help make insertion of a Sof-set or Sof-set OR infusion set simpler and with minimal discomfort. Use of the device may improve the user's consistency of infusion set insertion.
The MiniMed Sof-serter infusion set insertion system is a manually operated, spring-loaded injection device. It is similar to most syringe needle introducer devices currently marketed, however, this device is used to insert two specific subcutaneous infirstration sets, the Sof-set® and Sof-set QR® infusion sets manufactured by MiniMed Inc. The device is contraindicated for use with other infusion sets.
This is a premarket notification (510(k)) for a medical device, not a study reporting on the performance of an AI/ML powered device. As such, most of the requested information (acceptance criteria, study details, ground truth, expert involvement, sample sizes, etc.) is not applicable to this document.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable: This document is a 510(k) summary for a mechanical device. It describes the device and its intended use, but it does not present a performance study with specific acceptance criteria and detailed results in the way an AI/ML device would. The "performance" here is implied by its similarity to a predicate device and its ability to simplify infusion set insertion.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: No clinical or performance study data with a test set is provided in this 510(k) summary.
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)
- Not Applicable: Ground truth establishment by experts is relevant for AI/ML performance evaluation, which is not the subject of this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication is not relevant for this type of device submission.
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 is a mechanical device, not an AI-powered system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This device is a manual, spring-loaded injection device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: Ground truth is not established for this type of device. The primary "ground truth" for a 510(k) submission like this revolves around demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness. The "proof" is the comparison provided.
8. The sample size for the training set
- Not Applicable: There is no training set for a mechanical device.
9. How the ground truth for the training set was established
- Not Applicable: There is no training set or ground truth for a mechanical device.
Summary based on the provided text:
The document describes the MiniMed® Sof-serter™ Model 300, a manually operated, spring-loaded injection device intended to simplify and improve consistency for inserting specific subcutaneous infusion sets (Sof-set® and Sof-set QR®).
Acceptance Criteria and Study:
The document does not explicitly state "acceptance criteria" in a quantitative sense as one would expect for an AI/ML device. Instead, the "acceptance" for this 510(k) is based on demonstrating substantial equivalence to a legally marketed predicate device, the AutoJect® 2 injection device (K945660).
The "study" that proves the device meets this (implied) acceptance criterion is the comparison of technological features presented in the 510(k) summary:
- Shared features: Both are spring-driven devices, require loading an infusion set/syringe, compressing a spring, and activating with a button. Both are made of plastic with metal springs.
- Differences and justification: The primary difference is the type of needle introduced – the Sof-serter introduces an infusion set needle and cannula, while the AutoJect 2 introduces an insulin syringe needle and delivers insulin. The submission states, "These modifications do not affect the safety or effectiveness of the device."
Essentially, the "acceptance criteria" are met by demonstrating that the new device is as safe and effective as the predicate device, despite minor differences in its specific application. The "study" is the analytical comparison of the device's design and function to the predicate.
§ 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).