(119 days)
The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container intended to allow for sterilization, by hospitals, surgery centers, and healthcare facilities, of the enclosed, compatible Stryker Sterile Battery Packs and maintain sterility of the enclosed device until used. The container is validated for use with compatible battery packs in low temperature hydrogen peroxide sterilization cycles.
The Stryker System 9 Sterile Battery Container is a rigid, reusable device intended to enclose compatible Stryker sterile battery packs for hydrogen peroxide sterilization. The container consists of a stainless-steel perforated lid with a stainless-steel filter retention plate and a plastic (Radel®) base. The Sterile Battery container utilizes single use polypropylene filters and indicator cards. The container base is designed to exclusively fit onto the Stryker sterile battery charger to allow the sterile battery pack to charge while maintaining a sterile barrier. The Stryker System 9 Sterile Battery Container encompasses one distinct configuration in two sizes, small and large.
The provided text describes a 510(k) premarket notification for a medical device (Stryker System 9 Sterile Battery Container). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials for novel devices.
Therefore, the study described is a non-clinical performance testing suite designed to show that the device performs as intended and is as safe and effective as its predicate, particularly in the context of sterilization efficacy and maintenance of sterility. It is not a clinical study involving human patients or complex AI algorithms requiring MRMC studies, expert consensus on images, or detailed ground truth establishment in a diagnostic context.
Here's an analysis based on the provided document, fulfilling the requested information where applicable. Many questions regarding AI/diagnostic device studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of device and submission, as it's a physical sterilization container, not a diagnostic imaging AI.
1. A table of acceptance criteria and the reported device performance
| Testing | Standard in compliance with | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy | ISO 14937:2009, ISO 22441:2022 | Confirms sterile efficacy | Pass |
| Toxicological Risk Assessment | ISO 10993-17 | Confirms acceptable residuals | Pass |
| Cleaning Validation | AAMI ST98:2022 | Cleaning instructions were validated and demonstrated that the subject devices could be visually and quantifiably cleaned | Pass |
| Maintenance of Sterility | AAMI ST77:2013/(R)2018 | Demonstrates that the subject device is capable of maintaining product sterility for the duration of the shelf life | Pass |
| Simulated Use Design Validation | ISO 17664-1:2021, AAMI TIR 12:2020, ST77:2013/(R)2018 | Confirms that the device can undergo repeated processing to support that the device's performance is maintained following a minimum number of exposures to the proposed sterilization methods | Pass |
| Human Factors Engineering | IEC 62366-1 Ed 1.1 b 2020 | Confirms safety and effectiveness of the subject device for the intended users, uses, and use environments | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of containers tested, number of sterilization cycles performed) for each non-clinical test. It generally states that "A suite of non-clinical testing was performed."
- Data Provenance: The data comes from the manufacturer's (Stryker Instruments) internal testing as part of their premarket notification. The country of origin of the data is implied to be the USA, given the manufacturer's address in Michigan. These were prospective tests specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the non-clinical performance testing of a sterilization container. "Ground truth" in the context of diagnostic devices (e.g., AI for medical imaging) involves expert interpretation or pathological confirmation. For this device, the "truth" is established by adherence to validated sterilization standards and measurable outcomes (e.g., sterility, absence of toxic residuals, successful cleaning). The expertise would lie with the engineers and microbiologists performing and validating these standard-driven tests, not a panel of clinical experts interpreting data for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth from multiple human readers for diagnostic AI, to resolve disagreements. Here, validation is against objective, measurable criteria defined by established standards.
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. MRMC studies are specific to evaluating diagnostic AI systems, comparing human performance with and without AI assistance. This device is a physical sterile battery container, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This concept applies to AI algorithms. The "performance" of this device is its physical and chemical properties and its ability to maintain sterility, which are evaluated through direct testing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is adherence to established international and national standards for sterilization, cleaning, biocompatibility, and human factors. This includes:
- Microbiological testing for sterility (e.g., confirming no microbial growth after sterilization cycles).
- Chemical analysis for residuals.
- Physical measurements and observations for cleaning effectiveness and structural integrity after simulated use.
- Usability testing according to human factors standards.
This is not a diagnostic device where pathology or expert consensus on images would define the ground truth.
8. The sample size for the training set
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).