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Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases requre the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterlization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Dynamic Air Removal (pre-vacuum) – Exposure at 132°C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132°C for 15 minute dry time. Ziroonia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The Zirconia Guided Surgery Kit Case and the associated instruments is 342.2 g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.

Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery Kit Cases require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum): exposure at 132°C for 4 minutes, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.

The Zirconia and Nuvo CF Guided Surgery Kit Cases subject to this submission are reusable rigid containers, composed by a case bottom, a removable inner tray and a lid, which are made of autoclavable polymer. They are indicated to hold various dental instruments (not subject of this submission) in order to organize, sterilize and protect them. Sterilization via moist heat (steam) is performed by the healthcare provider.

This document is a 510(k) Summary for the Zirconia and Nuvo CF Guided Surgery Kit Cases. It describes the non-clinical performance data used to evaluate the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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 sample sizes for each test set (e.g., number of kit cases tested for sterilization, cleaning, or life cycle). It mentions "representative samples" for biocompatibility.

The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer (JJGC Indústria e Comércio de Materiais Dentários S.A. dba Neodent, Brazil, and Straumann USA, LLC). The studies appear to be prospective, specifically designed to validate the new devices.

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

This document describes non-clinical performance data involving laboratory testing against established standards. Therefore, it does not involve "experts" in the sense of clinicians establishing ground truth for diagnostic accuracy. The ground truth is defined by the technical specifications and performance requirements established by the listed ISO and AAMI standards.

4. Adjudication Method for the Test Set:

Not applicable, as this is laboratory testing against objective criteria defined by standards, not subjective evaluation by human experts.

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

Not applicable. This is not a study assessing the effectiveness of an AI or diagnostic device with human reader interaction. It relates to the sterilization and reprocessing of medical device cases.

6. Standalone Performance Study:

Yes, the studies described are standalone performance studies of the device itself (the Zirconia and Nuvo CF Guided Surgery Kit Cases). The tests evaluate characteristics like sterilization effectiveness, cleaning efficacy, durability over multiple cycles, and biocompatibility, without human-in-the-loop performance being a factor.

7. Type of Ground Truth Used:

The ground truth used is based on established international and national medical device standards (ISO 17665-1, ISO 17665-2, AAMI TIR 30:2011, ISO 10993-5) and regulatory guidance documents (FDA Guidance document for ISO 10993-1). These standards define objective criteria for successful performance (e.g., specific microbial reduction, acceptable residual levels, physical integrity over cycles, cytotoxicity limits).

8. Sample Size for the Training Set:

Not applicable. These are non-clinical validation studies for physical devices, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set involved. The "ground truth" for the device's performance is established by its compliance with the specified performance standards in the validation testing.

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The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA Cleared sterilizer for one of the following cycles:

• · Pre-vacuum Steam At 132ºC for 4 minutes with a 20 minutes dry time.
• · Pre-vacuum Steam At 135°C for 3 minutes with a 20 minutes dry time.

The trays are not intended for sterilization of non-porous loads.

The trays are recommended not to be stacked during sterilization.

The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams).

Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays.

The device 'instrument trays' is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior Components during sterilization. Each tray consists of three components: a base tray, a lid and an internal individualized insert tray. All three the components are perforated for steam sterilization. The internal insert tray and base has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchets /wrenches.

The lid, base and insert are made of Radel R-5000. This material is a polymer resin.

The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools.

The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap mush be used for sterilization purposes to maintain the sterility of the contents

The provided text describes the acceptance criteria and the results of a study for the "Southern Implants Instrument Trays" device.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each test set. It mentions "The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams)." This implies testing was done on these configurations, but not specific sample numbers for individual tests. The data provenance (country of origin, retrospective/prospective) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of device and tests described. The "ground truth" here relates to objective performance criteria for sterilization, cleaning, biocompatibility, and physical durability, which are assessed through laboratory testing against established standards, not through expert human interpretation of medical images or conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 consensus are typically used for subjectively assessed data, such as in clinical trials or image interpretation. This is not mentioned and is not applicable to the engineering and biological performance tests described here.

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

An MRMC comparative effectiveness study is not relevant to this device. This type of study applies to diagnostic AI devices involving human readers. The Southern Implants Instrument Trays are physical medical devices for sterilization and organization.

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

This refers to the performance of an AI algorithm alone. The device in question is a physical instrument tray, not an AI algorithm. Therefore, this question is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on:

• Established scientific principles and standards: For sterilization effectiveness (6 log reduction), cleaning efficacy (protein and hemoglobin levels), cytotoxicity (morphological grade), and physical durability (no damage).
• Standardized test methods: Such as ISO 17665-1, ISO 17664, AAMI TIR 12, AAMI TIR 30, ISO 10993-5, and ASTM D 4169.
• Measurement of physical and biological parameters: e.g., bacterial reduction, chemical residue levels, cell viability, physical integrity, temperature readings.

8. The sample size for the training set

This device is not an AI algorithm that requires a training set. Therefore, this question is not applicable.

9. How the ground truth for the training set was established

This question is not applicable as there is no AI training set for this device.

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Indications for Use for Drill Stop Pre-Mounted Kit and Drill Stop Kit: Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Instrument Kits are intended to allow sterilization of the enclosed medical devices. Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minute dry time Gravity displacement -Exposure at 132 °C for 15 minutes, 30-minute dry time. Instrument Kits are intended for sterilization of nonporous loads. The combined weight of the Kit and the associated instruments is 194.90 grams. The weight of the 189.12 grams. Instrument Kits are recommended not to be stacked during sterilization.

The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in polymer. The design of the subject devices include grommets manufactured from polyphenylsulfone that retain the instruments within the tray. The subject device kit cases are provided nonsterile to the end-user.

The provided text describes the acceptance criteria and the study conducted for the NUVO Implant System - NUVO Instrument Kit Cases, a device intended for sterilizing other medical devices.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "The tested samples" for life cycle testing and "All Biological Indicators" for sterilization validation, without specifying the number.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information (number and qualifications of experts for ground truth establishment) is not applicable to the non-clinical performance data presented in the document. The tests performed are objective laboratory tests with defined acceptance criteria, not subjective interpretations requiring expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods are not applicable to the types of non-clinical, objective tests described in the document.

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

An MRMC comparative effectiveness study was not done. This device is an instrument kit case for sterilization, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.

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

This is not applicable as the device is not an algorithm or AI system. The tests evaluate the physical and functional performance of the instrument kit case itself.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed is based on established scientific and regulatory standards and objective measurements. For example:

• Manual cleaning validation: Objective measurements of residual hemoglobin and protein, and visual inspection against a "no visible soil" criterion.
• Sterilization validation: Growth or non-growth of biological indicators, indicating successful sterilization (achieving a sterility assurance level (SAL) of 10⁻⁶).
• Life cycle testing: Ability to withstand a specified number of cycles (100) without functional degradation.
• Cytotoxicity testing: Measured cell proliferation inhibition against a set threshold.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML model which requires a training set. The tests are for the physical device.

9. How the ground truth for the training set was established

This is not applicable as the device is not an AI/ML model and therefore does not have a training set or associated ground truth.

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