(112 days)
Paragon Medical's Surgical Instrument Delivery Systems are containment devices for medical device sterilization, The Systems are constructed of metal and/or plastic with perforations to facilitate steam penetration. They are to be used with an approved sterilization wrap. Sterilization Cycle: Prevacuum 132°C for 4 minutes Dry Time 20-40 minutes
Paragon Medical Surgical Instrument Delivery Systems consist of various sizes of metal, plastic, and combination cases and trays with removable lids. The devices are intended to hold and protect medical instrumentation or devices during steam sterilization processes and subsequent storage and transportation. The products are constructed of durable materials and designed with perforations or slots to allow for steam penetration. They are to be used with an appropriate sterilization wrap.
It looks like the provided text is a 510(k) summary for a medical device (Paragon Medical Surgical Instrument Delivery System), not a study report with detailed acceptance criteria and performance metrics for an AI/device algorithm.
Therefore, many of the requested items (sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of document, as it describes a physical sterilization container, not a diagnostic or AI-driven device.
However, I can extract the "performance testing" information that somewhat aligns with "acceptance criteria" for this specific type of device.
Here's an attempt to answer based on the provided text, focusing on the relevant sections:
Acceptance Criteria and Device Performance for Paragon Medical Surgical Instrument Delivery System
Given this is a 510(k) for a physical sterilization container, the "acceptance criteria" and "performance" relate to its ability to facilitate sterilization and protect instruments, rather than diagnostic accuracy.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effective sterilization during steam sterilization and drying cycles | "Various sizes of double wrapped Cases and Trays from the System, fully loaded with medical instrumentation including some with lumens(cannulae) of up to 15" in length x 0.093 dia. have been demonstrated to be effectively sterilized using bioindicators and thermocouples in a 132°C Prevacuum 4 minute cycle. Drying time is from 20-40 minutes." |
| Protection of medical instrumentation during sterilization and storage | (Implied by the device's main function and statement that "The devices are intended to hold and protect medical instrumentation or devices during steam sterilization processes and subsequent storage and transportation." The performance testing focuses on sterilization efficacy, suggesting protection is assumed if sterilization occurs effectively within the container.) |
| Compatibility with appropriate sterilization wrap | "They are to be used with an appropriate sterilization wrap." (This is a condition of use rather than a performance metric proved by the study itself, but essential for the system's function.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "Various sizes of double wrapped Cases and Trays from the System." It does not specify an exact number of cases/trays tested for sterilization efficacy.
- Data Provenance: The study was conducted by Paragon Medical, Inc. (device manufacturer) for the purpose of a 510(k) submission to the FDA. It is a prospective validation of the device's design and function. The country of origin of the data is implicitly the USA as the company and submission are based there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device. The ground truth (effective sterilization) was established through objective measurements using bioindicators and thermocouples, not expert human interpretation.
4. Adjudication method for the test set
This is not applicable as the ground truth was established by objective measurements (bioindicators and thermocouples) rather than human interpretation requiring 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
This is not applicable. This device is a physical sterilization container, not an AI-driven or diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical sterilization container and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing was objective measurement of sterilization efficacy using:
- Bioindicators: To confirm microbial kill.
- Thermocouples: To confirm temperature attainment during sterilization.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).