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Nobel Biocare PureSet Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic instruments and components during cleaning/sterilization and during implant/prosthetic treatment.

Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA cleared sterilization pouch, or sterilization wrap.

Sterilization validations for the worst-case PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screwdrivers, and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1122 grams (NobelActive / NobelParallel CC PureSet Tray), 1063 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet Tray), 486 grams (Prosthetic PureSet Tray), 1143 grams (NobelActive Guided PureSet Tray), 1146 grams (NobelParallel CC Guided PureSet Tray), 1176 grams (NobelReplace CC Guided PureSet Tray), and 1035 grams (NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray).

| Method | Steam Sterilization (Moist Heat Sterilization)
for Wrapped Instruments | |
|--------------------------------------------------|---------------------------------------------------------------------------|-------------------------|
| Cycle | Dynamic-Air-Removal
(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C (270°F) | 132°C (270°F) |
| Exposure time for a single-use
pouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) |
| Minimum drying times | 20 minutes | 30 minutes |

Device Description

PureSet Trays are reusable surgical trays to be used in combination with Nobel Biocare surgical instruments and components. PureSet Trays are used to organize and store the instruments and components during both surqical and reprocessing procedures.

PureSet Trays are not intended to maintain sterility on their own; they are intended to be used in conjunction with an FDA cleared sterilization wrap, pouch, or container.

All components of the PureSet Tray are perforated with an evenly-distributed hole pattern and are designed to be used for sterilization via steam sterilization. Because the PureSet Trays are perforated, an FDA-cleared sterilization wrap, pouch, or container must be used during sterilization and storage to maintain the sterility of the contents.

PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.

Principle of Operation / Mechanism of Action:

PureSet Trays consist of multiple components (tray base, lid, and plate) integrated into a single unit which is used to organize instruments during surgical procedures and to protect the instruments during transportation, reprocessing, and storage.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Nobel Biocare PureSet Trays), which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness. Therefore, the device does not have acceptance criteria in the traditional sense of a clinical trial (e.g., meeting a certain sensitivity/specificity threshold for a diagnostic device). Instead, the "acceptance criteria" here refers to the successful completion of non-clinical performance tests designed to show that the device is as safe and effective as its predicates for its intended use.

Here's an analysis based on the provided text, adapted to the requested format where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Test Scope / Objectives	Acceptance Criteria	Reported Device Performance
Durability of Tray Handle and Closing Mechanism: Demonstrate that the tray handle and closing mechanism can withstand at least 4 times the maximum weight of a fully loaded tray.	• The tray closing mechanism does not open while the tray is lifted with 4 times maximum weight of a fully assembled tray (4140 grams).
• The handle does not break loose from the tray, and there is no permanent distortion, cracking or other evidence of failure to the handle or closing mechanism.	• Tested to 250N of force (25 kg of weight) without opening.
• Handle did not break loose from the tray, and there was no permanent distortion, cracking or other evidence of failure to the handle or closing mechanism.
Packaging Performance: Demonstrate that the packaging system adequately protects the tray against the hazards associated with global distribution.	• Product shall be damage free.
• The cardboard box and the LD-PE bags containing the PureSet Tray shall be intact.
• All box labels shall be present and legible.	• Product was damage free.
• The cardboard box and LD-PE bags were intact.
• All box labels were present and legible.
Simulated Intrafacility Transportation: Demonstrate that the subject PUR0900 PureSet tray retains all instruments in their designated holders during simulated transport of a fully-loaded tray throughout a typical healthcare facility.	• The instruments shall stay in the designated location within the tray after each test sequence of each test run.
• The assembled Torque Wrench does not become disassembled after transport during each test sequence.	• All instruments remained in their designated locations after each sequence during each test run.
• The torque wrench remained assembled after each sequence during each test.
Repeated Reprocessing: Demonstrate that the tray and plate components of the PureSet Tray can withstand repeated reprocessing cycles (500 cycles for the tray and 250 cycles for the plate) without unacceptable degradation to the laser marking and printing.	• All laser marking on the trays and plates shall remain legible, and the colors on the plate shall remain identifiable and with no detected discoloration or corrosion.
• PureSet trays and plates shall remain biocompatible after repeated reprocessing following the methods established by Nobel Biocare.	• The PureSet plates met all acceptance criteria after 250 reprocessing cycles.
• The PureSet trays met all criteria after both 250 and 500 cycles.
• No cytotoxic effects were observed in any of the tested samples.

2. Sample Size Used for the Test Set and the Data Provenance

Durability of Tray Handle and Closing Mechanism: The testing was performed on the "worst-case (heaviest) fully-loaded tray in the PureSet Tray family (PUR0100; 1633 grams fully loaded)". The specific number of individual trays tested for this is not explicitly stated, but it implies at least one representative sample.
Packaging Performance: "Two group of five sample trays" were packaged and sent for testing. So, a total of 10 trays were tested.
Simulated Intrafacility Transportation: A "single example of a fully-loaded PUR0900 PureSet tray" was used. Three test runs were performed for each method by a single operator.
Repeated Reprocessing: One plate was subjected to 250 cycles. Two trays were tested; one was subjected to 250 cycles and the other to 500 cycles.
Data Provenance: The document does not specify the country of origin for the data collection, but given Nobel Biocare has offices in Sweden and Switzerland, and the FDA submission is for the U.S. market, it's likely conducted in Europe or a certified testing facility globally. The tests are non-clinical (laboratory/simulated), not retrospective or prospective clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable. The device is a sterilization wrap accessory (surgical tray). The "ground truth" for its performance is established through engineering and biological performance testing against recognized standards, not through expert clinical consensus or interpretation of medical images. For example, "Pass/Fail Criteria" are defined by engineering specifications (e.g., "tray closing mechanism does not open", "product shall be damage free", "laser marking... shall remain legible").

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth from ambiguous or complex data (like interpreting medical images). For the non-clinical testing of this device, the pass/fail criteria are objective and directly measurable.

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

This information is not applicable. The device is a surgical tray for sterilization and organizing instruments, not an AI-powered diagnostic or assistive tool for human readers/clinicians.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device has no algorithmic or AI component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

Engineering Specifications and Standards: Defined physical properties (e.g., ability to withstand a specific force, dimensions) and adherence to industry standards (e.g., DIN 58952-3, ASTM D4169-16, ANSI/AAMI ST77:2013, EN ISO 10993-1, EN ISO 17664:2017).
Visual Inspection: For integrity, damage, legibility of markings.
Functional Testing: To ensure instrument retention and continued functionality after repeated processing.
Biocompatibility Testing: To ensure no cytotoxic effects.

8. The Sample Size for the Training Set

This information is not applicable. The device does not involve machine learning or AI, and therefore does not have a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this device.

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