(75 days)
The OriGen tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues.
Not Found
This looks like a 510(k) submission for a medical device (OriGen Tissue Storage Bags) where the primary change is the sterilization method. The provided documents focus on the regulatory approval process and the substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria for an AI/machine learning device.
Therefore, most of the information requested in your prompt (about AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in these documents.
However, I can extract the following information related to acceptance criteria and the "study" demonstrating the change:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (after radiation sterilization) |
|---|---|
| Product Characteristics | No change |
| Product Performance | No change |
| EtO Residues | Eliminated (benefit of new sterilization) |
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly stated for the "physical testing," but the submission indicates "Physical testing has demonstrated..." This implies a test dataset was used, but the size, specifics, and provenance are not detailed in these regulatory summary documents. This is a change in manufacturing process for an existing device, not a new device with a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "study" here is physical testing of the device itself (likely material properties, integrity, functionality), not an assessment requiring expert human interpretation of results in the way an AI/ML diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable. The assessment would likely involve laboratory tests and measurements against predefined specifications, not expert adjudication.
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 not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The ground truth for the physical testing would be established by the pre-change device's characteristics and performance, likely through engineering specifications and quality control standards. The "physical testing" aimed to show that the new sterilization method did not alter these established characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and there is no mention of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned.
Summary of what can be inferred from the document:
The core "study" cited is "Physical testing" which aimed to demonstrate that changing the sterilization method from Ethylene Oxide (EtO) to radiation did not change the product characteristics or performance of the OriGen Tissue Storage bags. The acceptance criteria essentially were that the characteristics and performance remain the same as the original EtO-sterilized device (approved under K915471), with the added benefit of eliminating EtO residues. The details of this physical testing (e.g., sample size, specific tests, quantitative results) are not provided in this 510(k) summary letter.
N/A