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510(k) Data Aggregation
(46 days)
The Surgical and Prosthetic Trays are intended for organizing, sterilizing and storing of instruments. The Surgical and Prosthetic Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
The proposed Surgical and Prosthetic Trays are reusable perforated containers that are intended to store and organize the instruments needed before, during and after implant surgery and the prosthetic procedure as well as hold instruments during sterilization.
The Trays are containers composed of three main components: a lid, a base and an overlay, which are all made of polyphenylsulfone (Radel R5000NT). The trays have co-molded silicone tooling supports and silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the guided surgery or prosthetic procedure workflow and the position of the instruments within the tray for the different product lines.
The proposed Surgical and Prosthetic Trays are available in two tray sizes. The Surgical trays are available in medium size with outer dimensions of 7.3 x 5.5 x 2.4 inches and the Prosthetic trays are available in small size with outer dimensions of 5.4 x 3.9 x 2.4. Each tray size is offered in 2 inner tray configurations with varied instrument loads, see Table 1.
The provided text describes the acceptance criteria and the studies that prove the device meets these criteria for "Surgical and Prosthetic Trays" (K220791).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization cycle validation | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ISO 17665-2:2009 | Sterility assurance level (SAL) of ≤ 10-6 | Pass |
| Drying validation | AAMI TIR12:2020, ANSI/AAMI/ISO 17665-2:2009 | No visible moisture, ≤ 3% weight gain of packaging and absorbable materials | Pass |
| Cleaning (Manual Pre-Cleaning and automated Cleaning) | AAMI TIR 30:2011, ISO 15883-1:2014 | No visible soil.Protein and TOC content Limit < 5 [µg/cm²] Protein and TOC content Limit < 95 [µg/device] | Pass |
| Reprocessing of trays (cleaning and sterilization) | Internal Test Method | No signs of flush rust, rust corrosion, deformation or damage | Pass |
| Simulated use of trays | Internal Test Method | No significant wear of the holders | Pass |
| Packaging testing | ISTA 2A(2011) | No signs of cracks or ruptures on the surgical trays | Pass |
| Cytotoxicity | ISO 10993-5:2009 | Inhibition of cell proliferation must be at or below 30% compared to untreated cultures | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for individual tests (e.g., number of trays tested for sterilization, drying, or cleaning). It refers to the "Proposed device" for sterility and drying validation, and the "Predicate device" for cleaning, reprocessing, simulated use, packaging, and cytotoxicity.
The data provenance is from non-clinical performance data, meaning these are laboratory or bench tests, not involving human subjects. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA, and the company is Dentsply Sirona Inc., with an address in York, Pennsylvania, USA. The testing methodologies are based on international standards (ANSI/AAMI/ISO, ISO, AAMI TIR) which are widely recognized.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For these types of non-clinical, performance-based tests (sterilization, drying, material properties), the "ground truth" is typically established by adhering to referenced international standards and specifications, rather than expert consensus on individual cases. The "experts" would be the personnel performing and analyzing these standardized tests, whose qualifications are usually governed by quality management systems within the testing facilities.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests, which are objective measurements against predefined criteria (e.g., SAL ≤ 10-6, ≤ 3% weight gain, specific chemical limits), an adjudication method in the sense of multiple expert reviews is not typically applicable. The results are usually a direct outcome of the test protocol.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging devices or algorithms where human readers interpret medical images. The device in question is a surgical tray for sterilization and storage, which does not involve human interpretation of data in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a physical sterile processing tray, not a software algorithm. Therefore, "standalone algorithm performance" is not a concept that applies to this device.
7. The Type of Ground Truth Used
The "ground truth" for these tests is based on objective criteria and methodologies defined by recognized international and national standards (e.g., ANSI/AAMI/ISO, ISO, AAMI TIR, ISTA). For example:
- Sterilization: Sterility Assurance Level (SAL) ≤ 10-6.
- Drying: No visible moisture, ≤ 3% weight gain.
- Cleaning: Absence of visible soil and specific limits for protein and TOC content.
- Material Biocompatibility (Cytotoxicity): Defined inhibition of cell proliferation percentage.
- Mechanical Performance (Reprocessing, Simulated Use): Absence of visible damage, deformation, significant wear.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product (surgical tray), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
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