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The Steri-Cassettes and Steri-Cages are intended to contain dental instruments for cleaning, sterilization, organization, storage and handling. The Steri-Cassettes and Steri-Cages are suitable for pre-vacuum and gravity displacement steam sterilization methods. The cassettes and cages are not intended to maintain sterility; they are intended to be used in conjunction with validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices.

The validated steam sterilization cycle parameters are as follows:

| Steam Sterilization
Cycle | Minimum Exposure
Temperature | Minimum
Exposure Time | Minimum Dry Time |
|-------------------------------------------------------------|---------------------------------|--------------------------|------------------|
| Gravity
Displacement
(wrapped) | 250°F (121°C) | 30 Minutes | 15 Minutes |
| Gravity
Displacement
(wrapped) | 270°F (132°C) | 15 Minutes | 15 Minutes |
| Gravity
Displacement
(wrapped) | 275°F (135°C) | 10 Minutes | 30 Minutes |
| Gravity
Displacement
(unwrapped for
immediate use) | 132°C (270°F) | 3 Minutes | None |
| Pre-Vacuum
(wrapped) | 270°F (132°C) | 4 Minutes | 30 Minutes |
| Pre-Vacuum
(wrapped) | 275°F (135°C) | 3 Minutes | 16 Minutes |
| Pre-Vacuum
(unwrapped for
immediate use) | 273°F (134°C) | 3 Minutes | None |

Steri-Cassettes and Steri-Cages are used to hold instruments in a secure way for cleaning, sterilization and presentation at point of use. They keep instrumentation organized in an efficient way. They are available in a variety of sizes to accommodate instruments of various sizes and are offered in an assortment of colors to aid in office organization.

Steri-Cassettes and Steri-Cages have perforations consisting of open-slots on the lid and the base which allows exposure of the device to the sterilant during sterilization. All the five variations of the stackable Steri-Cassettes and Steri-Cages have the same design of open-slot perforations on their lid and base (1) Steri-Cassette AA - Shallow - High Heat, (2) Steri-Cassette AA - Shallow - Standard Heat, (3) Steri-Cassette AB - Medium -High Heat, (4) Steri-Cassette BB - Deep - High Heat and (5) Steri-Cage - Standard Heat. Steri-Cassettes include instrument holder inserts, which are removable and individually hold instruments.

Cassettes and cages are manufactured by Injection Molding process from either high-heat resin or polypropylene with color - materials widely used in the medical field. The colors are already pre-mixed and vary by color in the supplier's proprietary resin mixtures: Steri-Cassettes High-Heat: RoHs-compliant, high-heat resin - Ultem Resin 1000 and Steri-Cassettes Standard Heat and Steri-Cages: polypropylene with color.

The cassettes and cage have a latching lid to contain the products. The proposed devices are designed to fit any standard autoclave and ultrasonic machine, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles. Since the proposed cassettes and cages have open slots, a legally-marketed and FDA-cleared sterilization wrap must be used for sterilization purposes to maintain the sterility of the contents.

The proposed Steri-Cassettes and Steri-Cages are packaged in non-sterile, plastic shrinkwrap, which is then appropriately labeled and includes a validated Cleaning and Sterilization/ Dry Time Instructions for use.

Here's an analysis of the acceptance criteria and study information for the Steri-Cassette and Steri-Cage Sterilization Packaging System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving absolute safety and effectiveness through extensive standalone studies typical for novel devices. Therefore, the information regarding "acceptance criteria" and "studies" will primarily relate to demonstrating that the new device performs as well as or in a similar manner to the legally marketed predicate device, especially in terms of sterilization parameters and material compatibility. The document often references standards rather than detailed study protocols and results.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format with direct performance metrics in the way one might expect for a novel performance claim (e.g., "X% accuracy"). Instead, the substantial equivalence is demonstrated by aligning the device's capabilities and validated parameters with recognized standards and the predicate device's performance. The key "performance" for this device relates to its ability to withstand and facilitate sterilization effectively.

The closest we get to acceptance criteria are the validated steam sterilization cycle parameters and the general compatibility with cleaning and sterilization processes.

• 250°F (121°C) for 30 Min Exposure, 15 Min Dry Time
• 270°F (132°C) for 15 Min Exposure, 15 Min Dry Time
• 275°F (135°C) for 10 Min Exposure, 30 Min Dry Time
  Pre-Vacuum:
• 270°F (132°C) for 4 Min Exposure, 30 Min Dry Time
• 275°F (135°C) for 3 Min Exposure, 16 Min Dry Time |
  | Steam Sterilization Cycle Parameters (Unwrapped, immediate use) | Gravity Displacement:
• 132°C (270°F) for 3 Min Exposure, None Dry Time
  Pre-Vacuum:
• 273°F (134°C) for 3 Min Exposure, None Dry Time |
  | Reusable Life Cycle | "Yes, validated to be reused at least five (5) times." (Implies the device maintains its structural integrity and functionality for at least 5 sterilization cycles). |
  | Material Compatibility with Sterilization Method | "Yes - Materials are compatible with sterilization method" and "Materials of construction are compatible with steam sterilization." (Implies no degradation or adverse effects from sterilization). |
  | Sterilant Penetration | "Yes - Sterilant (steam) penetration through perforations in base and lid - Steam Sterilization Validation testing." (Implies effective sterilant access to contents). |
  | Microbial Barrier (Packaging Integrity) | "To be used with a validated, FDA-cleared sterilization wrap." (The device itself is not a microbial barrier; acceptance is based on its intended use with appropriate external packaging). |
  | Biocompatibility | "Yes - Materials are known to be biocompatible and do not come into direct contact with patient." (Implies non-toxic to patients and users under normal conditions, given the no-patient-contact nature). |
  | Heat Resistance | Standard Heat Steri-Cassettes and Steri-Cages: Withstand 275°F.
  High Heat Steri-Cassettes: Withstand 320°F. (As per performance and sterilization testing and resin specifications). |

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

The document is a 510(k) summary, which typically does not provide granular details about sample sizes for each validation test performed. The studies are described in a general manner by referencing standards.

• Sample Size for Test Set: Not explicitly stated for any specific test. The phrase "Cleaning Validations conducted," "Sterilization Validation testing," and "validation testing" implies that a sufficient number of units were tested to satisfy the requirements of the referenced standards (e.g., ISO 17665-1, AAMI ST77, etc.).
• Data Provenance: The studies were conducted by Sybron Dental Specialties (Kerr Corporation) for their product. It is implied the data is prospective as it's part of the premarket notification process for a new device. The location of the testing is not specified, but the manufacturing involves Mexico (SDS de Mexico S. de R.L. de C.V.) and the applicant is in the USA (Orange, CA).

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

This type of information is generally not applicable to the evaluation of a sterilization packaging system. "Ground truth" in this context would be established by validated scientific methods and measurements (e.g., temperature probes, biological indicators for sterility, chemical analysis for cleaning residuals, mechanical testing for durability), rather than expert consensus interpretations of medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "truth" is established by direct measurement and validated scientific methods, not by expert review or consensus.

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

No. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a sterilization packaging system and does not involve such an interface.

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

Yes, in essence. The performance evaluations (cleaning, sterilization efficacy, material compatibility, durability) are for the device itself as it functions in the sterilization process defined by its intended use, without human-in-the-loop performance measurement. The device's "performance" is its intrinsic capability to withstand and facilitate sterilization according to established parameters.

7. The Type of Ground Truth Used

The ground truth for the performance of this device is established through:

• Validated Sterilization Parameters: Achieving sterility (e.g., a Sterility Assurance Level, SAL of 10^-6) under the specified time, temperature, and pressure conditions using biological indicators (BIs) and physical monitors.
• Material Compatibility Testing: Demonstrating that the materials do not degrade, off-gas harmful substances, or otherwise interfere with the sterilization process or the instruments being sterilized. This is often based on adherence to ISO 10993 and ISO 7405 standards.
• Cleaning Efficacy Testing: Demonstrating that the device can be effectively cleaned to reduce organic and inorganic residues to predetermined acceptable levels.
• Physical Durability/Life Cycle Testing: Showing that the device maintains its structural integrity and functional requirements over a specified number of reprocessing cycles.
• Adherence to Recognized Industry Standards: The listed standards (e.g., AAMI ST77, ANSI/AAMI/ISO 17665-1) define the "ground truth" for how such devices should be tested and validated.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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