(273 days)
The iTotal Family Reusable Instrument Tray is intended to house the reusable instrumentation associated with ConforMIS knee implant systems and define their organization during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 17lbs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration.
The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:
Cycle Type: Pre-vacuum Temperature: 132°C (270°F) Exposure Time: 4 minutes Dry Time: 30 minutes
The iTotal Family Reusable Instrument Tray is a sterilization tray with perforations and brackets to hold ConforMIS knee implant reusable instrumentation. Label plates are provided to indicate where specific reusable instrumentation should be placed within the tray. The sterilization tray consists of two layers. The base layer of the tray is a full tray which includes an accessory box to hold small items. The top layer of the sterilization tray is made up of one removable tray that is ¾ the length of the overall tray and a second removable tray that is ¼ the length of the overall tray. A lid is provided with the tray and is equipped with handles to allow the user to carry the tray.
The provided text describes a medical device, the "iTotal Family Reusable Instrument Tray," and its substantial equivalence to predicate devices based on non-clinical testing. However, it does not contain the specific details required to fully address your request in the format of acceptance criteria, device performance, and study characteristics.
Here's an attempt to extract and infer the information based on the provided text, while highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical targets and corresponding "reported device performance." Instead, it discusses "similarity" to predicate devices, which implies that the device must perform adequately in the tested areas, consistent with the predicates.
Based on the "Testing was performed to establish similarity" section and the "Device Comparison Table," we can infer the tested characteristics and the implicit performance required (i.e., demonstrated to be similar or meet functional requirements for a sterilization tray).
| Acceptance Criteria (Implied) | Reported Device Performance (Inferred from "similarity" and testing) |
|---|---|
| Cleaning and Disinfection Validation: The device must withstand and be effectively cleaned through the validated methods. | Testing demonstrated the device is similar to predicate devices, indicating it withstands and is effectively cleaned. |
| Sterilization and Dry Time Validation: The device must allow for effective steam sterilization and drying within specified parameters. | Testing demonstrated the device is similar to predicate devices, indicating successful sterilization and drying. |
| Shelf Life Testing: The device must maintain its integrity and functionality over its intended shelf life. | Testing demonstrated the device is similar to predicate devices, implying its durability over time. |
| Reprocessing Fatigue Simulation: The device must withstand repeated reprocessing cycles without compromising functionality. | Testing demonstrated the device is similar to predicate devices, indicating its ability to endure repeated reprocessing. |
| Indication for Use: Must align with stated purpose of housing instruments for sterilization, transport, and storage. | The device meets its defined indication for use. |
| Maximum Load Capacity: Must safely hold up to 17 pounds of instruments. | Demonstrated to hold up to 17 pounds, which is comparable to or exceeds predicate devices. |
| Sterilant Penetration: Must allow for adequate sterilant penetration. | Confirmed to allow sterilant penetration ("Yes"). |
| Microbial Barrier Properties: Must function effectively with an FDA cleared sterilization wrap to maintain sterility. | Confirmed for use with an FDA cleared wrap ("For use with an FDA cleared wrap"). |
| Material Compatibility with Sterilization Method: Materials must be compatible with steam sterilization. | Confirmed as compatible ("Yes"), and materials (Aluminum, Radel R5000, Silicone Medical Grade Class 6) are noted. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document states that "non-clinical testing was conducted," but it does not specify the number of units or cycles tested for each of the validations (Cleaning, Sterilization, Shelf Life, Reprocessing Fatigue).
- Data Provenance: The testing was conducted by the submitter, ConforMIS, Inc., located in Billerica, MA, USA. The studies are retrospective in the sense that they are conducted on a manufactured device to demonstrate its performance against established standards and predicate devices, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/Not mentioned. This information is typically relevant for studies involving human interpretation or subjective assessments. For a physical device like a sterilization tray, "ground truth" is established through standardized laboratory testing (e.g., measuring sterilization efficacy, material degradation, and mechanical integrity) against engineering specifications and regulatory guidelines, rather than expert consensus on interpretive data.
- Qualifications of Experts: Not applicable/Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not mentioned. As noted above, this kind of testing does not typically involve adjudication in the medical imaging or diagnostic sense. The results of the non-clinical tests would be objectively measured and reported.
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
- MRMC Study: No. This type of study is completely irrelevant to the device described, which is a physical sterilization tray, not an AI-powered diagnostic or interpretive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This terminology applies to AI algorithms. The device is a physical product, and its "standalone performance" refers to its functional characteristics (like holding instruments, allowing sterilization) as validated by the non-clinical tests.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this device's performance is based on objective, measurable criteria established by:
- Regulatory standards and guidance for sterilization and reprocessing.
- Engineering specifications for material properties, structural integrity, and validated sterilization cycle parameters.
- Performance data from legally marketed predicate devices (Signia™ Sterilization Tray K161347 and iDrive™ Ultra Sterilization Tray K130532), which serve as benchmarks for "similarity."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not mentioned. This device does not involve machine learning or AI, and therefore no "training set" of data would be used. The design and validation are based on engineering principles and regulatory compliance.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable/Not mentioned. As there is no training set, there is no ground truth for it.
In summary: The provided document is an FDA 510(k) clearance letter and summary for a physical medical device (sterilization tray), focusing on demonstrating "substantial equivalence" through non-clinical performance testing. It does not involve AI, image analysis, or clinical studies with human readers, which are the contexts for many of your questions.
§ 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).