(145 days)
The Gyrus ACMI Telescope Storage-Sterilization Tray (TEL-GT) is intended to be used to enclose and protect Gyrus ACMI telescopes during Steam Sterilization using the following parameters:
STEAM Sterilization Parameters:
| PreVacuum | |
|---|---|
| Temp: | 275°F |
| 132°C | |
| Pressure | 26psigs |
| Exposure | 3 minutes |
| Dry Time | 20 minutes |
The trays are to be double wrapped with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI telescopes. Telescopes without lumens up to 31 cm in length may be sterilized in the tray with a diameter between 2.7mm to 4mm. Two telescopes can be sterilized at one time.
Maintenance of Sterility is dependent on the sterilization wrap shelf life and not the tray. User must follow the instructions for use supplied with the approved sterilization wrap and follow recommended storage conditions and timeframes for shelf life of the sterilization wrap.
The Gyrus ACMI Telescope Storage-Sterilization Trav is a two-piece container made of a plastic lid containing 14 holes, and a plastic trav containing 18 holes that permit ready ingress of Steam. The tray provides protection to the telescopes during sterilization and storage.
The provided document, K120474, describes the Gyrus ACMI Telescope Storage-Sterilization Tray. This is a medical device, and the information presented is for a 510(k) premarket notification. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report with performance metrics in the way one would for a diagnostic or AI-driven decision support system.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of device submission. The "study" described is a validation of the sterilization process through parameters, not a clinical performance study.
Here's an attempt to populate the table and answer the questions based on the available information:
Acceptance Criteria and Device Performance for Gyrus ACMI Telescope Storage-Sterilization Tray (K120474)
The Gyrus ACMI Telescope Storage-Sterilization Tray is intended for use in steam sterilization. The "acceptance criteria" for this device are fundamentally linked to its ability to facilitate effective steam sterilization and protect the enclosed telescopes. The "performance" is demonstrated by its compatibility with specific sterilization parameters and its design features that allow for proper steam ingress.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Compliance |
|---|---|---|
| Sterilization Effectiveness | The tray must permit steam sterilization of Gyrus ACMI telescopes using defined PreVacuum steam parameters (Temp: 275°F/132°C, Pressure: 26psigs, Exposure: 3 minutes, Dry Time: 20 minutes) when double-wrapped with FDA cleared sterilization wrap. | Validation performed. The device was validated to sterilize Gyrus ACMI telescopes using Steam with the specified parameters. The plastic lid and tray contain 14 and 18 holes, respectively, "that permit ready ingress of Steam." The conclusion states "performance data" supports substantial equivalence. |
| Device Protection | The tray must enclose and protect Gyrus ACMI telescopes (without lumens, up to 31 cm length, 2.7mm to 4mm diameter) during sterilization and storage. | The tray provides "protection to the telescopes during sterilization and storage." |
| Biocompatibility | Materials must be compatible with testing identified in ISO10993-1. | "Materials are compatible with testing identified in ISO10993-1." The DEVICE does not come into contact with patients. |
| Material Equivalence | Materials used must be the same as the predicate devices, or other legally marketed devices by Gyrus ACMI. | "The Gyrus ACMI Telescope Storage-Sterilization Tray is composed of the same materials as the predicates..." as well as other legally marketed devices. |
| Maintenance of Sterility | Maintenance of sterility is dependent on the sterilization wrap shelf life, not the tray. Users must follow IFU for wrap. | Explicitly stated: "Maintenance of Sterility is dependent on the sterilization wrap shelf life and not the tray. User must follow the instructions for use supplied with the approved sterilization wrap..." |
| Compliance to Standards | Design must comply with relevant voluntary standards. | "The design of the DEVICE complies with the following standards: ISO10993-1, AAMI/ANSI ST77, AAMI/ANSI ST79." |
| Substantial Equivalence | The device must be substantially equivalent to legally marketed predicate devices. | "In summary, based on intended use, technological characteristics and performance data, the Gyrus ACMI Telescope Storage-Sterilization Tray is substantially equivalent to previously cleared Gyrus ACMI storage-sterilization trays." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of statistical analysis of a diagnostic or AI device. The validation described is for the sterilization process parameters using the tray. While specific numbers of sterilization cycles or tests are implied by "validation," the sample size and data provenance (country of origin, retrospective/prospective) are not detailed in this 510(k) summary. This is typical for a device like a sterilization tray where the focus is on process validation rather than clinical outcome studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of experts establishing a "ground truth" for a test set in the context of this device. The "ground truth" for sterilization effectiveness would be defined by standard microbiological testing and physical indicators during the validation process, which is established by established protocols and regulatory standards, not expert consensus on individual cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set requiring expert adjudication for this type of device.
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 a diagnostic device or an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the sterilization effectiveness, the "ground truth" is established by adherence to validated sterilization parameters, successful inactivation of biological indicators if used, and sterility assurance levels as defined by relevant standards (e.g., AAMI/ANSI ST77, ST79). For biocompatibility, the ground truth is established by material testing against ISO10993-1. These are physical/microbiological truths, not expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
§ 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).