Search Results

The SOFTINJECT is an auto-injector indicated for assisting in the subcutaneous or intracorpus cavernosa injection of approved pharmaceutical products with approved commercially available syringes and needles.

The SOFTINJECT is a syringe needle introducer, commonly known as an auto-injector. It is made of plastic molded parts and springs. The spring-loaded mechanism provides an injection with a hypodermic needle to a pre-determined depth below the skin surface. The SOFTINJECT is intended to be used with FDA-approved B-D 1 ml insulin syringes and approved needles filled with FDA-approved pharmaceutical products. The SOFTINJECT has been designed to assist in the subcutaneous or intracorpus cavernosa injection of pharmaceutical products.

This document is a 510(k) summary for the SOFTINJECT auto-injector, a device designed to assist in the subcutaneous or intracorpus cavernosa injection of pharmaceutical products. It compares the SOFTINJECT to a predicate device, the ID-300 auto-injector.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of acceptance criteria or specific reported device performance metrics. The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance testing with accept/reject criteria.

2. Sample Size Used for the Test Set and the Data Provenance

The provided text does not specify a sample size used for a test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective). The submission is a regulatory document seeking market clearance based on substantial equivalence to an existing device, not a clinical study report with detailed methodology.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The provided text does not mention any experts used to establish ground truth or their qualifications. This type of information would typically be found in a clinical or performance study report, which is not included here.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method for a test set.

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

The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Furthermore, the SOFTINJECT is a mechanical auto-injector, not an AI-powered diagnostic or assistive technology for human readers. Therefore, this type of study is not applicable.

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

The provided text does not mention any standalone performance testing for an algorithm. As stated above, the device is a mechanical auto-injector, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The provided text does not describe the type of ground truth used. This suggests that formal ground truth establishment, as would be done for a diagnostic device or AI, was not the primary focus of this 510(k) submission. The equivalence is based on device design and intended use.

8. The sample size for the training set

The provided text does not mention a training set sample size. This is not an AI/machine learning device, so the concept of a training set is not applicable.

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

The provided text does not mention how ground truth for a training set was established. Again, this is not an AI/machine learning device.

Summary of what the document does provide:

The document is a 510(k) Pre-Market Notification for a medical device (auto-injector). Its primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (ID-300, K961309).

• Acceptance Criteria & Performance: The document implies that the "acceptance criteria" for clearance was the demonstration of substantial equivalence to the predicate device in terms of design, intended use, and functioning (providing an injection to a pre-determined depth). Specific quantitative performance data against defined acceptance criteria are not provided in this summary.
• Study: The "study" here is essentially the comparison of the SOFTINJECT to the predicate device, the ID-300 auto-injector. This comparison would have likely involved engineering analysis, design documentation review, and perhaps some internal functional testing to confirm the mechanical operation, but the details of such tests are not included in this 510(k) summary. The FDA's letter indicates that the device was reviewed for its "clinical indications for use" and determined to be substantially equivalent.

Ask a specific question about this device