(119 days)
ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization.
The Hip Arthroscopy Master Tray is intended for use only with the following instruments and/or other instruments of similar type and size: (list of instruments provided)
Sterilize the Hip Arthroscopy Master Tray using the following parameters: (steam sterilization parameters provided)
The PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) are designed to hold a variety of powered ConMed Linvatec handpieces as well as attachments and/or accessories that may be used with the powered handpieces.
Cannulated handpieces or attachments with an internal diameter not less than 0.031 inches (0.079cm) and a cannulated length no greater than 5.75 inches (14.61cm) and/or handpiece accessories such as pneumatic air supply hoses with a lumen not less than 0.187 inches (0.475 cm) in diameter and a cannulated length no greater than 15 feet (4.6 m) may be sterilized in this tray along with other non-cannulated, non-porous instruments.
Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) using the following parameters. (steam sterilization parameters provided)
ConMed Linvatec Anodized Aluminum Sterilization Trays are constructed of metal with perforations to facilitate sterilant penetration, evacuation and drying, These trays are designed to fit any standard autoclave and are manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the trays are perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. Although these trays are reusable they will not be serviced or repaired.
ConMed Linvatec Anodized Aluminum Sterilization Trays are available under various trade names and in various sizes and tray configurations. Interior structures of the trays have the ability to separately hold each individual instrument during the entire duration they are in contact with the trav.
This document is a 510(k) Summary for ConMed Linvatec Anodized Aluminum Sterilization Trays. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
Based on the provided text, a "study" in the traditional sense (e.g., a clinical trial with acceptance criteria and reported performance metrics like accuracy, sensitivity, specificity, etc.) was not conducted or reported. This document is a premarket notification for a medical device (sterilization trays), and the "acceptance criteria" and "device performance" described are related to the sterilization parameters and physical characteristics of the trays, rather than a diagnostic or AI-driven system.
Therefore, many of the questions regarding sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the content provided.
However, I can extract information related to the performance parameters defined for the sterilization process.
1. Table of Acceptance Criteria and Reported Device Performance
For the ConMed Linvatec Anodized Aluminum Sterilization Trays, the key acceptance criteria and performance are related to the sterilization cycles they can withstand. The "device performance" here refers to the validated sterilization parameters for using the trays.
| Acceptance Criteria (Sterilization Parameters) | Reported Device Performance (Validated Parameters for Use) |
|---|---|
| Hip Arthroscopy Master Tray (ST7900) | |
| Steam (wrapped), Pre-vacuum Cycle: | |
| Minimum Temperature | 270°F (132°C) |
| Minimum Exposure Time | 4 minutes |
| Minimum Dry Cycle | 20 minutes |
| Steam (wrapped), Gravity Cycle: | |
| Minimum Temperature | 270°F (132°C) |
| Minimum Exposure Time | 15 minutes |
| Minimum Dry Cycle | 25 minutes |
| PowerPro® Small System Sterilization Case (PRO5095) & Hall® Sterilization Tray (PRO6000) | |
| Steam (wrapped), Pre-vacuum Cycle: | |
| Minimum Temperature | 270°F (132°C) |
| Minimum Exposure Time | 4 minutes |
| Minimum Dry Cycle | 25 minutes |
| Steam (wrapped), Gravity Cycle: | |
| Minimum Temperature | 270°F (132°C) |
| Minimum Exposure Time | 15 minutes |
| Minimum Dry Cycle | 35 minutes (with a caution specifically noting this is required to prevent wet packs) |
| Material Compatibility | Constructed from durable, biocompatible, corrosion-resistant materials, compatible with repeated steam sterilization. |
| Sterilant Penetration | Perforated design to facilitate sterilant penetration, evacuation and drying. |
| Maintenance of Sterility | Requires use of an FDA cleared sterilization wrap to maintain sterility of contents (due to perforations). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document does not describe a test set or data provenance in the context of an AI/algorithmic study. The "testing" mentioned refers to the validation of the sterilization parameters for the physical device. The exact sample size for this physical testing (e.g., number of sterilization cycles, number of trays tested) is not specified. The origin of the testing data would likely be from ConMed Linvatec's internal testing labs, based in Largo, Florida, USA.
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. This is a submission for a physical medical device (sterilization trays), not an AI/diagnostic system requiring expert readers for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method described as there's no diagnostic or interpretative output from the 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 a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is the
- Physical and chemical properties of the materials used in the trays (biocompatibility, corrosion resistance).
- Effectiveness of sterilization cycles as demonstrated through standardized microbiological indicator tests (e.g., biological indicators, chemical indicators) and physical monitoring. These tests would confirm that the parameters listed achieve sterility and that "wet packs" are avoided. This is an engineering/biology-based ground truth, not an expert consensus or pathology on a patient case.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI system that undergoes training.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI system.
§ 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).