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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 Guided Surgery Kit is designed to hold various dental surgical drills and instruments to organize, steam sterilize, and transport between uses. The guided surgical drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.

The kit is to be enclosed in a FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in a FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minute dry time.
(2) Gravity Steam At 132°C for 15 minutes with a 30 minute dry time.
· The kit is intended for sterilization of non-porous loads.
· Do not stack kits during sterilization.
· Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Sterilizable Guided kit.

The Guided Surgery Kit is offered in 2 complete kit variations for 3 implant systems: Legacy, Simply lconic, and InterActive as a reusable perforated tray for purposes of transport, steam sterilization and storage of dental instruments, similar to the reference device Standard Sterilizable Tray (K202524). The kit is sold non-sterile and contains site preparation instruments, dental driving tools, prosthetic driving tools and ratchet tool which can be used for implant placement. The proposed Guided Surgical Drills are reusable surgical instruments designed to prepare an osteotomy for a dental implant procedure. The features remain unchanged from the predicate Surgical Drills (K200265) except for the addition of a Guide Body and Shoulder Stop. The addition of a Guide Body allows the proposed drills to function with guide sleeves which can be integrated into an existing surgical quide template to assist in the drilling sequence and placement of dental implants.

The provided document, an FDA 510(k) clearance letter for a "Guided Surgery Kit," does not describe a study involving an AI/Artificial Intelligence device that requires the detailed information requested in the prompt.

The device in question, a "Guided Surgery Kit," is a collection of dental surgical drills and instruments to organize, steam sterilize, and transport between uses, including drills intended to cut into maxilla or mandible for dental implant placement. The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily regarding biocompatibility, cleaning, and sterilization validation.

Therefore, many of the requested categories related to AI/ML device performance studies, such as "acceptance criteria for device performance," "sample sizes for test set," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set," are not applicable to the content of this regulatory submission.

The document explicitly states: "Clinical performance data is not required to establish substantial equivalence for the subject device." This further indicates that no human-in-the-loop or AI-specific performance study was conducted or reported in this submission for this particular device.

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