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510(k) Data Aggregation
(226 days)
The Surgical Trays are intended for organizing, sterilizing and storing of instruments.
The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Sterilization parameters:
Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time
The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load:
| Product name | ArticleNumber | Max Load (g) | Vent to VolumeRatio (in-1) |
|---|---|---|---|
| OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |
The proposed Surgical Tray is a reusable perforated container that is intended to store and organize the instruments needed before, during and after implant surgery as well as holding instruments during sterilization.
The Surgical Tray is a container composed of three main components: a lid, a base and an overlay, all made of polyphenylsulfone (Radel R5000). The overlay has co-molded silicone tooling supports. The base has silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the surgical workflow and the position of the instruments within the tray for the different product lines.
The proposed Surgical Tray is available in one size with outer dimensions of 7.3 x 5.5 x 2.4 inches and offered in 2 inner tray configurations with varied instrument loads, see Table 5.1.
| Table 5.1- Surgical Tray configurations | ||||
|---|---|---|---|---|
| Product name | Model number | Max no of instruments | Max load (g) | Vent to volume ratio (in-1) |
| OmniTaper Surgical Tray | 68015282 | 51 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 45 | 513.7 | 0.033 |
This document describes the premarket notification (510(k)) for Dentsply Sirona Inc.'s "Surgical Trays" (K212281). The acceptance criteria and the study proving the device meets these criteria are detailed in section 5.7 "Non-Clinical Performance Data" and related subsections.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization cycle validation | Sterility assurance level (SAL) of < 10^-6 | Pass |
| Drying validation | No visible moisture≤ 3% weight gain of packaging and absorbable materials | Pass |
| Reprocessing of trays (cleaning and sterilization) | No signs of flush rust, rust corrosion, deformation or damage | Pass |
| Simulated use of trays | - No significant wear of the holders- The instruments must have safe seating in the holders after the shake test | Pass |
| Cytotoxicity | Inhibition of cell proliferation must be at or below 30% compared to untreated cultures | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the numerical sample sizes for each test in the non-clinical performance data section. It indicates that the "tested Surgical Tray represents the worst-case validated load of 513.7g." This implies at least one tray was tested for each condition, likely with replicates to satisfy validation requirements, though specific numbers are not provided.
- Data Provenance: The studies are described as "Non-clinical testing data submitted, referenced, or relied upon." Given this is a 510(k) submission by Dentsply Sirona Inc., the data is internally generated by the manufacturer or by third-party labs on their behalf. The studies were performed to validate the device's performance characteristics. It's prospective in nature, as the testing was conducted specifically to gather data for regulatory submission. The country of origin of the data is not specified, but the manufacturer is based in York, Pennsylvania, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The tests described are performance validations based on established standards and internal test methods. They do not involve "experts" establishing a clinical "ground truth" in the way an AI medical device for diagnosis would. Instead, the "ground truth" is determined by the objective and quantifiable outcomes of the physical and chemical tests (e.g., measuring SAL, visible moisture, weight gain, physical damage, cytotoxicity). The qualification of the personnel conducting these tests would be standard for laboratory and engineering testing, but specific details are not provided as they are not relevant for this type of device validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept (adjudication method for test sets) is primarily relevant for studies involving human interpretation of data, such as images for AI diagnostic devices. For the physical and chemical performance tests of a surgical tray, no human adjudication of ambiguous results is necessary. The acceptance criteria are objective. Therefore, the method is None in the context of expert consensus/adjudication.
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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI-assisted diagnostic or interpretative devices in a clinical setting with human readers. The "Surgical Trays" device is a reusable surgical instrument container, not an AI or diagnostic device, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. Again, this type of study is relevant for AI algorithms. The device in question is a physical medical device. The "performance" here refers to its physical characteristics and ability to be sterilized and reused, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's validation is based on objective, quantifiable physical, chemical, and microbiological measurements against predefined acceptance criteria from recognized standards (e.g., ANSI/AAMI/ISO 17665-1, ISO 10993-5, AAMI TIR12) and internal test methods. For example:
- Sterilization validation: Ground truth is the achievement of an SAL of < 10^-6, verified by biological indicators.
- Drying validation: Ground truth is the absence of visible moisture and a weight gain of ≤ 3%.
- Reprocessing/Simulated use: Ground truth is the absence of visual damage, deformation, rust, or compromised instrument seating.
- Cytotoxicity: Ground truth is cell proliferation inhibition at or below 30% compared to controls.
8. The sample size for the training set
Not applicable. This device is a physical medical instrument tray, not a machine learning model or AI device. Therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no training set for this type of device.
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