(90 days)
The CrossRoads Modular Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during sterilization and during implant/prosthetic treatment. The CrossRoads Modular Tray System is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterlizations for the worst-case CrossRoads Modular Tray System included surgical instruments such as inserters, reamers, and ratcheting handles. The CrossRoads Modular Tray System is validated for a maximum load of 18.7 lbs (tray + instruments).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Drying time: 20 minutes
Dimensions do not exceed: 20.546" length x 10.022" width x 3.978" depth
The CrossRoads Modular Tray System is a reusable sterilization case with organizing trays intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects instruments during sterilization. All components are perforated for steam penetration. The tray can hold CrossRoads surgical instruments.
This document is a 510(k) Premarket Notification from the FDA for a medical device. It describes a sterilization wrap/case called the "CrossRoads Modular Tray System." The information pertains to the device's functional performance related to sterilization and handling, not to an AI/ML-driven diagnostic or image analysis system.
Therefore, the requested information elements such as "sample size for the test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable to this type of device and its regulatory review process. These questions are typically relevant for AI/ML-based diagnostic devices.
The document focuses on engineering and performance testing for mechanical and sterilization efficacy, not AI algorithm performance.
However, I can provide the acceptance criteria and reported device performance from the document based on the provided tables.
Acceptance Criteria and Reported Device Performance for CrossRoads Modular Tray System (K241050)
The device is a reusable sterilization case. The tests performed are standard engineering and sterilization validation tests, not AI/ML performance evaluations.
Table of Acceptance Criteria and Reported Device Performance
| Test | Standard / Method | Acceptance Criteria | Reported Performance / Results |
|---|---|---|---|
| Sterilization Efficacy | ISO 17665-1:2006(R)20013, ISO11138-1:2017, AAMI ST79:2017, AAMI TIR12:2020 | Sterilization Validation: All BIs processed in each half-cycle must be negative for microbial growth of the indicator organism after 7 days for the overkill method to be validated. Positive controls must show growth of the indicator organism. Negative controls must remain negative (no growth). |
Dry Time Validation: The dry time validation is successful if the weight differential of the wrapped case after sterilization does not increase by 0.2% of the pre-sterilization weight, and there is no evidence of moisture on or within the sterilized package, wrap, and instruments. | Pass |
| Cleaning Validation | AAMI TIR30:2011, ISO19227, AAMI TIR12:2020, AAMI ST98:2022, ASTM F2459 (2018), ASTM D4839-03 (2017) | Acceptance Criteria 1 (Visual Inspection): Visibly clean without evidence of discoloration, residue or particulate to the unaided eye without magnification under normal task lighting.
Acceptance Criteria 2 (Protein): ≤ 6.4 µg/cm²
Acceptance Criteria 3 (Hemoglobin): ≤ 2.2 µg/cm²
Acceptance Criteria 4 (TOC): ≤ 1000 mg/device (or 100 mg/cm² for devices larger than 50cm²) | Pass |
| Biocompatibility | ISO 10993-1:2018 | The materials are biocompatible. | Pass |
| Handle Strength Assessment | Shear and Tensile Strength Analysis - 501913762 | The lowest failure force determined in the assessment of handle assembly components must be greater than the maximum load of 18.7 lbs. | Pass |
Based on the provided document, the following requested information is not applicable or not provided, as the device is a sterilization tray and not an AI/ML diagnostic system:
- Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of an AI/ML model. The tests conducted (sterilization, cleaning, biocompatibility, handle strength) would involve specific numbers of units or samples as per the relevant standards, but this is not a "test set" for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of physical device testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is defined by physical/chemical measurements and standardized biological indicator responses, not expert human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for these tests is based on the results of validated physical and chemical tests (e.g., microbial growth/no growth, weight change, protein/hemoglobin/TOC levels, force measurements). Not based on expert consensus or pathology in a diagnostic sense.
- The sample size for the training set: Not applicable (no training set for a traditional engineering device).
- How the ground truth for the training set was established: Not applicable.
§ 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).