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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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Esthetic Abutment Nobel Biocare N1™ TCC: The Esthetic Abutment Nobel Biocare N1™ TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation. Esthetic Abutment Nobel Biocare N1TM Base: The Esthetic Abutment Nobel Biocare N1™ Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.

Esthetic Abutments Nobel Biocare N1™ are pre-manufactured dental implant abutments, intended for use as an aid in prosthetic rehabilitation. Esthetic Abutments Nobel Biocare N1™ are intended for use in the upper and/or lower jaw in combination with Nobel Biocare's Nobel Biocare N1™ implant system in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The abutments are made from titanium vanadium allov. Esthetic Abutments Nobel Biocare N1 ™ is composed of two device lines: Esthetic Abutment Nobel Biocare N1™ TCC and Esthetic Abutment Nobel Biocare N1™ Base.

The acceptance criteria and device performance for the Nobel Biocare N1™ Esthetic Abutments are described based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test. However, it mentions that dynamic loading (fatigue) testing was conducted in saline at 37 °C. The data provenance is from non-clinical testing, therefore not involving human subjects or data from a specific country of origin in the context of clinical studies. The testing was performed in a laboratory setting.

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

Not applicable. The reported performance data for this device (dental abutments) is based on non-clinical, laboratory-based testing (mechanical, MRI compatibility, biocompatibility, cleaning/sterilization), rather than expert assessment of clinical data or images to establish a "ground truth."

4. Adjudication Method for the Test Set

Not applicable. As the testing mentioned is non-clinical and laboratory-based, an adjudication method in the context of human assessment is not relevant.

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. The device is a physical dental abutment, not a diagnostic or AI-assisted interpretation system.

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

Not applicable. This device is a physical dental abutment, not an algorithm or software. The performance evaluations are of the physical product's characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria is established by adherence to recognized international and FDA standards for medical device testing. For example:

• Mechanical strength: Conformance to force/stress limits defined by ISO 14801.
• MRI compatibility: Conformance to safety and performance specifications outlined in ASTM F2052, F2213, F2119, F2182.
• Biocompatibility: Conformance to safety requirements defined by ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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· NobelProcera® Zirconia Abutment/Implant Crown N1™ Base:

The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.

· Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:

The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.

NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines:

• NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and -
• -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base

The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following:

a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration

b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design

The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing.

NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3.

The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).

The provided document is a 510(k) premarket notification for a dental device, specifically the NobelProcera® Zirconia N1™ Base and its associated Prosthetic Screw. The notification aims to demonstrate substantial equivalence to previously marketed predicate devices, rather than establishing de novo acceptance criteria or proving performance against novel criteria through clinical studies. Therefore, much of the requested information regarding a device meeting specific acceptance criteria and the nature of the study that proves it, as it would apply to a new classification or a device with new indications requiring extensive clinical validation, is not directly available or applicable in the provided context of a 510(k) submission for substantial equivalence.

However, I can extract information related to the performance data used to support substantial equivalence, which serves a similar purpose to demonstrating acceptance criteria in this regulatory pathway. The acceptance criteria here are implicitly alignment with the performance of the predicate and reference devices.

Here's a summary based on the provided text, addressing what can be inferred or directly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a quantitative table format that a device must meet to be considered "safe and effective." Instead, it focuses on demonstrating substantial equivalence by comparing its characteristics and performance to legally marketed predicate and reference devices. The "reported device performance" is primarily comparative in nature.

Implicit Acceptance Criteria (Demonstrated Equivalence) & Reported Performance:

Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: Principle of operation, compatible Implant/Base platforms (NP/RP), device material (Ti6Al4V ELI), thread design, and screw interfaces (Omnigrip Mini) are the same as Reference Device No. 1. DLC coating applied to screw body, similar to Reference Device No. 1. Differences in screw body dimensions, anodization (subject device is not anodized), and packaging do not raise new concerns. |
| Performance (Non-clinical) | Performance as good as predicate/reference devices for intended use, as demonstrated by recognized standards (e.g., ISO 14801, ISO 10993-1, ASTM). | Fatigue Performance: Dynamic loading testing performed according to ISO 14801. Testing found acceptable, including evaluation of removal torque and no screw-loosening for run-out samples.
Biocompatibility: Demonstrated according to ISO 10993-1.
Wear Assessment: Light optical and SEM imaging following ISO 14801 fatigue loading showed similar wear patterns to reference device systems (NobelProcera® Zirconia Implant Bridge (K202452) and NobelProcera® ASC Abutment CC (K132746)).
Packaging System Performance: Tested per ASTM D4169.
Magnetic Resonance Compatibility: Tested according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182.
Cleaning and Sterilization Validation: End user cleaning and sterilization validation in accordance with ISO 17665-1 and AAMI TIR12. |
| Performance (Clinical/Real-World Evidence) | No evidence of new safety/effectiveness concerns with differences in materials or design. | Post-Market Surveillance (PMS) Data:

• NPr ASC Ab Zirconia CC (K132746): 8.1 years in patient, low complaint rates, no concerns regarding dissimilar materials (DLC-coated screw with Zirconia abutment).
• NobelProcera® Zr Implant Bridge (K202452): 1.7 years in patient, low complaint rates, no concerns regarding dissimilar materials.
  Clinical Data: Five clinical studies on NPr ASC Ab Zirconia CC (K132746) with mean follow-ups of 0.6-3.6 years, reporting on 277 devices. No reports of wear debris from Zirconia/DLC-coated screw contact or other adverse events raising concerns about dissimilar materials. A gap analysis was provided to support the relevance and reliability of this real-world evidence. |

2. Sample Size for the Test Set and Data Provenance

The document does not define a single "test set" in the context of a clinical trial for direct performance measurement. Instead, it refers to various non-clinical tests and real-world evidence.

• Non-clinical testing (Fatigue, Wear, MRI Compatibility, Packaging): The sample sizes for these specific tests are not provided in the summary. For example, ISO 14801 fatigue testing typically involves a certain number of samples (e.g., n=10-12 per group) but this detail is omitted.
• Real-World Evidence (PMS Data):
  • NPr ASC Ab Zirconia CC (K132746): Data collected from December 2013 up to January 2022. The longest time in a patient was approx. 8.1 years.
  • NobelProcera® Zr Implant Bridge (K202452): Data collected from May 2020 up to January 2022. The longest time in a patient was approx. 1.7 years.
  • Data Provenance: This is post-market surveillance data, likely originating from clinical use of the cleared predicate/reference devices, implicitly from various countries where Nobel Biocare products are marketed. It is retrospective in nature.
• Clinical Data (NPr ASC Ab Zirconia CC):
  • Sample Size: 277 NPr ASC Ab Zirconia CC (K132746) devices were reported across 5 clinical studies.
  • Data Provenance: The document states the studies were "included consecutively with no selection regarding study inclusion made besides the inclusion criterion that the NPr ASC Ab Zirconia CC had to be used in the study." The studies were published in international journals, suggesting prospective clinical studies from potentially diverse geographical origins, but specific countries are not mentioned (e.g., "[1] Greer, A.C., et al., Int J Prosthodont, 2017"). These are considered Real World Evidence in this submission.

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

This specific information is not provided in the document. For 510(k) submissions focusing on substantial equivalence, the "ground truth" for the test set is usually the performance of the predicate device as established by its clearance and recognized standards, rather than a new expert consensus process for the subject device. The clinical studies mentioned were about observing device performance in patients, not establishing a new ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for interpreting subjective endpoints in clinical trials or for establishing ground truth from multiple expert readings (e.g., in AI/imaging studies). The provided clinical evidence references published studies with their own methodologies, which are not detailed here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The studies cited are focused on the clinical performance and safety of existing devices (predicates/references) and a "gap analysis" for using that as real-world evidence for the subject device, or non-clinical engineering tests. There is no mention of comparing human readers with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical dental abutment and prosthetic screw, not an AI algorithm or software. Therefore, there is no "standalone" performance in the context of an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence is primarily:

• Engineering Standards: Compliance with ISO 14801, ISO 10993-1, ASTM F2052, F2213, F2119, F2182, ISO 17665-1, AAMI TIR12.
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate and reference devices (On1 Concept K161655, N1™ TiUltra™ TCC Implant system K211109, NobelProcera Angulated Screw Channel Abutment Conical Connection K132746, Nacera Pearl K143071).
• Outcomes Data/Real-World Evidence: Post-market surveillance data and clinical study outcomes for the predicate/reference devices, showing low complaint rates, good tissue health, and no unexpected adverse events related to material interactions. These outcomes serve as a proxy for acceptable performance.

8. The Sample Size for the Training Set

This concept is not applicable as the device is a physical dental component and not an AI/machine learning model that undergoes a "training" phase with a dataset.

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

This question is not applicable for the same reason as point 8.

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N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.

N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.

The provided text describes the regulatory clearance of a dental implant system (N1™ TiUltra™ TCC Implant system) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving the device meets those criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, indications for use, and comprehensive non-clinical and clinical testing. The concept of "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate, rather than meeting specific performance metrics for a diagnostic task.

Therefore, I will interpret "acceptance criteria" as the criteria for establishing substantial equivalence and "reported device performance" as the outcomes of the non-clinical and clinical studies conducted to support that equivalence.

Here's a breakdown of the information based on the provided text, addressing your specific questions, with explanations for what is not present:

1. Table of acceptance criteria and the reported device performance

Since this is a submission for substantial equivalence, the "acceptance criteria" are demonstrating similarity to predicate devices and acceptable performance in various non-clinical and clinical tests.

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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.

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