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The 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 container, 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 Select™ TC PureSet™ Tray) and 1202 grams (NobelZygoma 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

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 surgical 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.

This is a 510(k) Pre-Market Notification for a medical device called the "NobelZygoma PureSet™ Tray," a type of sterilization wrap. The document is primarily concerned with demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a groundbreaking study with novel acceptance criteria and deep dives into AI performance statistics.

However, I can extract the relevant information regarding acceptance criteria and the types of studies performed, as described in the provided text, recognizing that these are not clinical studies in the typical sense for AI devices.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the NobelZygoma PureSet™ Tray (a sterilization tray), acceptance criteria are typically related to its functionality in terms of cleaning, sterilization, biocompatibility, and durability, ensuring it performs as intended and is safe for patient contact.

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

This document describes validations for a physical medical device, not an AI/ML model for diagnostic or prognostic purposes involving patient data. Therefore, the concept of a "test set" and "data provenance" in the context of country of origin or retrospective/prospective data as it applies to software or AI is not directly applicable here.

• Sample Size for Testing: The document refers to "representative worst-case devices" for all non-clinical tests. It doesn't specify a numerical sample size (e.g., N=3, N=50) for these physical device tests. The selection of "worst-case" implies that a specific configuration or condition that would pose the greatest challenge to cleaning, sterilization, or durability was chosen for testing.
• Data Provenance: Not applicable in the context of clinical/patient data for AI. The tests are laboratory-based, non-clinical evaluations of the device itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not explicitly provided in the document. For physical device validations like these, "ground truth" is established through adherence to recognized international and national consensus standards (e.g., ISO, AAMI) and testing protocols, rather than expert consensus on diagnostic images or pathology. The testing laboratories performing these validations would employ qualified personnel, but their specific roles or number are not detailed.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective, laboratory-based validations against predefined physical/mechanical and microbiological criteria defined by recognized standards. There isn't a need for expert adjudication in the way it's used for interpreting ambiguous clinical data or establishing ground truth for AI model outputs.

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 specifically designed for evaluating the impact of AI on human reader performance for diagnostic tasks, usually involving medical images or clinical data. The NobelZygoma PureSet™ Tray is a physical sterilization tray, not an AI/ML diagnostic or therapeutic device.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone study in the context of an "algorithm only" or AI performance was not done. This device is not an algorithm. The non-clinical tests described were "standalone" in the sense that they evaluated the device's intrinsic characteristics (cleaning, sterilization, durability) without human intervention in the performance of the device itself, but not in the AI-specific meaning.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by adherence to and successful completion of recognized international and national consensus standards for sterilization, cleaning, biocompatibility, and durability. These standards incorporate scientific principles and validated methodologies to empirically determine if a device meets safety and effectiveness requirements.

• Examples of such standards cited: AAMI TIR12, AAMI TIR 30, ISO 15883-1, ISO 15883-5, ISO 10993-1, ISO 10993-5, ISO 10993-12, AAMI ST79, AAMI ST77, ISO 17665-1, ISO14161, ISO14937, AAMI ST8, ISO 11737-2, AAMI TIR17, FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, ISO 17664-1, ANSI/AAMI ST77.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML model that requires a "training set" of data.

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

Not applicable, as there is no training set for a physical medical device.

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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 |

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.

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

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.

Ask a specific question about this device

The 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. The 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 wrap. Sterilization wap. Sterlization validations for the worstcase PureSet Tray included surgical/prosthetic instruments such as torque wrenches, implant drivers, drills, screw taps, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelParallel CC PureSet Tray), 945 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet) and 486 grams (Prosthetic PureSet).

The PureSet Trays are reusable trays to be used in combination with Nobel Biocare surgical/prosthetic instruments and components. The PureSet Trays are used to store and organize the instruments and components during both the surgical, restorative and reprocessing procedures. The 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. Each PureSet Tray consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, and storage. All the components of the PureSet Tray are perforated with an evenly distributed hold pattern, and are designed to be used for sterilization via steam sterilization. Since the PureSet Trays are perforated, an FDA cleared wrap or pouch must be used for sterilization purposes and to maintain the sterility of the contents. The PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities. The PureSet Tray consists of three parts: 1) a base with holders to accommodate the different surgical/prosthetic instruments, 2) a removable PureSet Plate (spare part) to indicate the surgical workflow (in case of the surgical tray) and the position of the instruments and components within the tray, and 3) a lid to securely contain the instruments and components during reprocessing and transportation

The Nobel Biocare PureSet Trays underwent several non-clinical performance tests to demonstrate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not explicitly state a specific "sample size" in terms of number of devices for each test. However, it mentions quantities in the context of repeated reprocessing:
  • Legibility: 500 cleaning and sterilization cycles.
  • Plate Reprocessing: 250 cycles of cleaning and sterilization.
  • Worst-case product was used for shipping simulation.
• Data Provenance: The tests were conducted by Nobel Biocare AB, presumably in a laboratory setting, to evaluate the device's performance against established standards. The document does not specify the country of origin of the data beyond Nobel Biocare's location. The testing appears to be prospective as it was performed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• This device is a sterilization tray, and the testing focuses on its physical and functional performance (biocompatibility, cleaning efficacy, sterilization efficacy, durability, transport integrity, packaging). These tests typically rely on standardized methods and laboratory measurements rather than human expert opinion to establish ground truth. Therefore, the concept of "experts used to establish ground truth" as it would apply to diagnostic AI is not directly relevant here. The ground truth is established by the objective measures defined by the standards (e.g., SAL 10-6 for sterilization).

4. Adjudication Method:

• Not applicable. As described in point 3, the evaluation of a sterilization tray's performance against physical and biological standards does not involve expert adjudication in the way diagnostic image review might.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This device is a medical accessory (sterilization tray), not an AI-powered diagnostic tool. Therefore, an MRMC study to compare human reader performance with and without AI assistance is irrelevant.

6. Standalone Performance Study:

• Yes, a standalone performance study was conducted. The non-clinical performance tests mentioned in the table (biocompatibility, cleaning/sterilization, repeated reprocessing, tool movement during transport, shipping simulation) represent the standalone performance evaluation of the Nobel Biocare PureSet Tray itself, without human intervention in the primary function being tested (beyond, for example, loading/unloading for cleaning/sterilization tests).

7. Type of Ground Truth Used:

• The ground truth used for these tests is based on objective, standardized measurements and criteria defined by consensus standards (e.g., ISO 10993-1, ISO 10993-5, AAMI TIR 30, ISO 17665-1, AAMI ST79, AAMI TIR 12, ASTM D4169-16, ISO 14971). For example, achieving a Sterility Assurance Level (SAL) of 10-6 in sterilization validation is an objective ground truth.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm. Therefore, there is no "training set."

9. How Ground Truth for the Training Set was Established:

• Not applicable, as there is no training set for this type of medical device.

Ask a specific question about this device

The Nobel Biocare PureSet Tray is used in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; it is 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, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray) and 945 grams (NobelReplace CC PureSet Tray).

The PureSet Tray is a reusable surgical tray to be used in combination with Nobel Biocare surgical instruments and components. The PureSet Tray is used to store and organize the instruments and components during both the surgical and reprocessing procedures. The 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.

Each PureSet Tray consist of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, and storage. All the components of the PureSet Tray are perforated with an evenly distributed hold pattern and are designed to be used for sterilization via steam sterilization. Since the PureSet Trays are perforated, an FDA cleared wrap or pouch must be used for sterilization purposes and to maintain the sterility of the contents. The PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.

This document is a 510(k) premarket notification for the Nobel Biocare PureSet Tray, a Class II medical device. It's not a study proving the device meets acceptance criteria for an AI/ML product or diagnostic tool. Instead, it demonstrates the substantial equivalence of the PureSet Tray to legally marketed predicate devices, primarily regarding its function as a sterilization tray for surgical instruments.

Therefore, the requested information (acceptance criteria for an AI/ML product, study design for AI/ML performance, ground truth establishment for a diagnostic AI, etc.) cannot be extracted from this document because it pertains to a different type of medical device entirely. The document focuses on performance data related to material compatibility, sterilization effectiveness (for the tray itself, not its contents' sterility), durability, and reprocessing, which are relevant to a physical medical device like a surgical tray.

Here's why the specific questions cannot be answered based on this document:

1. Table of acceptance criteria and reported device performance (for an AI/ML product): This document references acceptance criteria for physical and sterilization performance (e.g., handle durability, cleaning/sterilization effectiveness for the tray), not for AI/ML model performance metrics like sensitivity, specificity, AUC, etc.
2. Sample size for the test set and data provenance: No "test set" in the context of AI/ML is mentioned. The testing involves physical prototypes of the tray.
3. Number of experts used to establish ground truth and qualifications: "Ground truth" in the AI/ML sense (e.g., diagnosed diseases) is not applicable here. Ground truth concerns the physical properties and performance of the tray.
4. Adjudication method for the test set: Not applicable to a physical device's performance testing.
5. MRMC comparative effectiveness study: Not applicable to a physical device. There are no "human readers" or "AI assistance" in this context.
6. Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" used for this device would be established by physical testing standards and validated sterilization methods, not medical expert consensus on diagnostic images or pathology.
8. Sample size for the training set: Not applicable. There is no AI/ML model being trained.
9. How ground truth for the training set was established: Not applicable. There is no AI/ML model being trained.

In summary: The provided document is a 510(k) premarket notification for a physical medical device (sterilization tray), not an AI/ML-based device. Therefore, the specific questions related to AI/ML product acceptance criteria and study design cannot be answered from this content.

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