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Indications for Use for Neodent Complement Kit Cases:

Neodent Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. 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 using one of the following cycles:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-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 Complement Case and the associated instruments is 75,7 g. The weight of the empty Kit Case is 53.62 grams.

Neodent Instrument Kit Cases should not be stacked during sterilization.

Indications for Use for Nuvo Complement Kit Cases:

Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ 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 using one of the following cycles:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.

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

Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.

Nuvo™ Instrument Kit Cases should not be stacked during sterilization.

The subject devices Complement Kit Cases consist of a storage case for Neodent and Nuvo instruments set. They are made of autoclavable polymer, the case has silicone holders to store and hold each instrument securely during sanitization and surgical procedures. The case can be equipped according to the procedure.

The provided text is a 510(k) summary for a medical device (Complement Kit Cases), focusing on the device's substantial equivalence to a predicate device. It details non-clinical performance data.

Here's the information extracted and organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "Six simulated use cycles" for manual cleaning validation and refers to "the tested worst case devices" for life cycle validation. It does not explicitly state the number of individual devices or test runs beyond these general descriptions for all tests.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. These are non-clinical (laboratory) tests, not clinical studies involving patient data.

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

This document describes non-clinical performance testing for a medical device (sterilization kit cases), not a diagnostic AI/ML device that requires expert-established ground truth from images or clinical data. Therefore, this section is not applicable. The "ground truth" here is based on validated laboratory methods and established material/sterilization standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. Performance is measured against physical and biological criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a non-clinical performance study for a physical medical device (sterilization kit cases), not an AI/ML clinical study. Therefore, no MRMC study was performed, and no effect size for human readers improving with AI assistance is provided.

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

Not applicable. This is not an AI/ML device; it is a physical medical device. The performance evaluated is of the device itself (e.g., its ability to withstand sterilization cycles, its biocompatibility).

7. The Type of Ground Truth Used

The "ground truth" in these non-clinical performance tests is based on:

• Established Standards: ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, AAMI TIR30:2011, ISO 10993-1, ISO 10993-5, and FDA Guidance documents.
• Physical and Biological Parameters: Visual inspection for soil, quantifiable levels of hemoglobin and protein (for cleaning), sterility assurance level (SAL) of 1 x 10⁻⁶ (for sterilization), structural integrity after 100 cycles, and cell proliferation inhibition percentages (for biocompatibility).

These are objective, measurable criteria defined by regulatory and industry standards.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as no training set was used.

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