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Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument 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 (pre-vacuum) - Exposure at 132 °C for 4 minutes, 30-minute dry time (for GM Zygomatic Surgical Kit Case) or 20-minute dry time (for GM Helix LG Compact Surgical Kit Case)

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time (only for GM Helix LG Compact Surgical Kit Case)

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Zygomatic Surgical Kit Case and the instruments is 738.1 g. The weight of the empty kit case is 515 g.

The combined weight of the GM Helix LG Compact Kit Case and the instruments is 297.3 g. The weight of the empty kit case is 236 g.

Neodent Instrument Kit Cases should 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 devices include two (2) such kit cases. The lids are manufactured from injection molded polyphenylsulfone resin, the tray and base are manufactured from injection molded polysulfone resin. The designs include grommets and inserts of various geometries manufactured from molded silicone that retain the instruments within the tray and base. The subject device kit cases are provided nonsterile to the end-user.

The medical device in question is the Neodent Instrument Kit Cases, intended for use in sterilizing other medical devices by healthcare providers using moist heat (steam). The provided documentation details the acceptance criteria and the studies conducted to demonstrate its performance.

Here's a breakdown of the requested information:

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

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

The document does not specify the exact sample sizes used for each test. For instance, it doesn't state how many kit cases were subjected to manual cleaning validation or how many sterility tests were performed.

Regarding data provenance:

• The tests were nonclinical performance data.
• The document does not explicitly state the country of origin of the data, but the sponsor is "JJGC Indústria e Comércio de Materiais Dentários SA" located in Curitiba, Parana, Brazil. Therefore, the data likely originates from Brazil or a laboratory contracted by the sponsor.
• The tests as described (validation studies) are inherently retrospective in nature, as they involve testing the manufactured device against pre-defined criteria.

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

This information is not provided in the document. The studies are nonclinical performance tests and do not involve human expert interpretation of device performance in a medical context where ground truth needs to be established by experts (e.g., radiologists interpreting images). The "ground truth" for these tests is based on objective laboratory measurements and industry standards.

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

This is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers to resolve discrepancies in their interpretations. The tests described are laboratory-based performance validations against defined physical and biological criteria, not human-in-the-loop assessments.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which is not what the Neodent Instrument Kit Cases are. This device is a sterilization accessory.

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

No, a standalone algorithm-only performance study was not done. This device is a physical instrument kit case, not a software algorithm.

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

The "ground truth" for the nonclinical performance data is based on:

• Objective laboratory measurements and chemical/biological assays for manual cleaning validation (hemoglobin and protein levels).
• Sterility Assurance Level (SAL) of 10⁻⁶ which is a a quantitative measure of the probability of a single viable microorganism occurring on an item after sterilization. This is established through microbiological testing.
• Visual and functional inspection for life cycle testing, against manufacturing specifications.
• Measurement of cell proliferation inhibition percentage for cytotoxicity testing, an objective biological response measurement.

These are all objective, measurable criteria derived from recognized standards rather than subjective expert consensus, pathology reports, or patient outcomes data.

8. The sample size for the training set

This information is not applicable/not provided. The "Neodent Instrument Kit Cases" is a physical medical device, not an AI, machine learning, or software device that requires a training set.

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

This information is not applicable/not provided as the device is not an AI/ML system requiring a training set.

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Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument 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 (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 40-minute dry time.

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams.

Neodent Instrument Kit Cases should not to be stacked during sterilization.

Indications for Use for GM Helix Compact Surgical Kit Case:

Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument 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 (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams.

Neodent Instrument Kit Cases should 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 devices include two (2) such kit cases. The lids are manufactured from injection molded polyphenylsulfone resin, the tray and base are manufactured from injection molded polysulfone resin. The designs include grommets and inserts of various geometries manufactured from molded silicone that retain the instruments within the tray and base. The subject device kit cases are provided nonsterile to the end-user.

The provided text describes the acceptance criteria and a study proving the device meets these criteria for the Neodent Instrument Kit Cases (K192670).

Here's the breakdown of the information requested:

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 size for the test set" in terms of number of devices or data points used for each test. However, it indicates that testing was performed on the "subject devices" (plural), which refers to the two models: GM Surgical Kit Case (110.288) and GM Helix Compact Surgical Kit Case (110.297).

The data provenance is from Brazil, as the sponsor is "JJGC Indústria e Comércio de Materiais Dentários SA" located in Curitiba, Parana, Brazil. The study appears to be retrospective in the sense that the testing was conducted and results presented as evidence for the premarket notification.

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

This information is not provided in the document. The document refers to validation testing (e.g., manual cleaning validation, sterilization validation, life cycle testing, cytotoxicity) according to established standards (Custom, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff," ANSI/AAMI/ISO 10993-5). These tests rely on objective measurements against defined criteria rather than expert consensus on "ground truth" in the way an AI diagnostic study might.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device and testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data, and a robust method is needed to establish a "ground truth" diagnosis. The tests performed here are objective performance tests (e.g., chemical residue levels, sterility assurance level, physical integrity).

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 performed. This type of study is relevant for AI-assisted diagnostic devices, which is not the nature of the "Neodent Instrument Kit Cases."

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

A standalone performance study was not performed in the context of an AI algorithm. The device is a physical instrument kit case, not a software algorithm. The "standalone" performance here refers to the physical device's ability to meet performance criteria (e.g., cleaning, sterilization, durability) without human intervention beyond the standardized operating procedures for use.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective laboratory measurements and tests against predefined acceptance criteria derived from recognized industry standards and guidance documents (e.g., Hemoglobin concentration readings, protein concentration readings, Sterility Assurance Level of 10⁻⁶, visual and functional inspection results after simulated use, cytotoxicity inhibition percentage). It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. The "Neodent Instrument Kit Cases" is a physical medical device, not a machine learning or AI algorithm, therefore there is no "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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