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Microdent Sterlization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal.

When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used.

The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle:

• Temperature: 270°F/132°C
• Exposure time: 4 minutes.
• Drying time: 20 minutes.
• The cassettes are not to be stacked during sterilization.

KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively.

Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette.

Microdent Sterilization Cassette consists of different sizes of the same basic configuration (maximum weight 509 gr). All systems consist of a minimum of a plastic base and cover. Each cover can be fastened to its corresponding base by means of locking tab or guides. Accessories may be used with systems to organize or separate contents to be placed in them for use.

The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and cover have an evenly distributed hole pattern in relation to its size.

The provided text describes the "Microdent Sterilization Cassette" and its performance data. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

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Avinent Sterilization Cassettes are 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 the following cycle: Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time. -The trays are intended for sterilization of non-porous loads. -The trays are recommended not to be stacked during sterilization. -The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams. -Avinent Implant System SLU does not make any lumen claims for the Avinent Sterilization Cassettes.

The Avinent Sterilization Cassettes are 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 of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. The trays in this submission are Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. 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 them to be effective for 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 wrap must be used for sterilization purposes to maintain the sterility of contents. The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K191566. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired. The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.

The provided text is related to the FDA 510(k) premarket notification for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. The document details the device description, indications for use, comparison to a predicate device, and a summary of non-clinical testing.

However, the questions you've asked are typically relevant to studies evaluating the performance of AI/ML-driven medical devices (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details).

Since the Avinent Sterilization Cassettes are a physical medical device (sterilization trays), and not an AI/ML software or diagnostic tool, many of the requested data points (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, ground truth types related to expert consensus or pathology, etc.) do not apply to this type of submission.

The "studies" described are validation tests for the physical properties and functionality of the sterilization cassettes themselves (e.g., cleaning validation, steam sterilization validation, cycle life, cytotoxicity).

Let's adapt the answer based on the information available and the nature of the device:

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

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The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/ Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.

The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials which meet national or international specifications and are commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.

The document provided describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Medtronic Transportation/Sterilization Cassettes (K190840).

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 a distinct "test set" in the context of typical AI/ML medical devices (e.g., patient data). The testing performed seems to be for the physical characteristics and sterilization efficacy of the medical device (cassettes).

• Distribution Simulation Validation: The sample size for outer cases and inner trays is not explicitly mentioned, but the test involves subjecting these items to distribution cycles.
• Biocompatibility Testing: Not applicable to the cassettes themselves, but to the medical devices used in conjunction with them. No sample size for devices or data provenance (e.g., country of origin, retrospective/prospective) is provided for this aspect.
• ANSI/AMMI ISO 17665-1 (Sterilization Validation): The sample size refers to the "worst case" Medtronic Transportation/Sterilization Cassettes (22.75 x 11.26 x 5.5 inches), loaded with implants and common surgical instruments (total weight 28.6 lbs), including worst-case lumen dimensions. The number of cassettes or specific instruments tested is not quantified as a sample size.

Given the nature of the device (sterilization cassettes) and the tests conducted, the data provenance is likely from laboratory testing and engineering evaluations rather than clinical patient data. The document does not specify countries of origin or whether the data is retrospective or prospective, as these are not relevant to device performance for this type of product.

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 as the device is not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The ground truth for the performance testing is based on established industry standards (ASTM D4169-14, ISO 10993, ANSI/AAMI ISO 17665-1) and objective measurements.

4. Adjudication method for the test set

Not applicable, as this is not an AI/ML diagnostic device requiring expert adjudication of results. The "ground truth" is defined by the objective pass/fail criteria of the specified engineering and sterilization standards.

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

Not applicable. The device is a physical sterilization cassette, not an AI/ML diagnostic tool that assists human readers.

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

Not applicable. The device is a physical sterilization cassette, not an algorithm.

7. The type of ground truth used

The ground truth for the performance testing is based on:

• Objective Visual Inspection: For distribution simulation, assessing obvious damages.
• Compliance with Standards: For biocompatibility (ISO 10993) and sterilization efficacy (ANSI/AAMI ISO 17665-1), meeting defined performance metrics like an SAL of 10^-6. These are scientific and engineering benchmarks rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device, and therefore, does not have a 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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The Medtronic Transportation Cassettes are intended for use in healthcare facilities to organize, enclose, sterlize, transport, and store medical devices and other instrumentation between surgical uses. The Medtronic Transportation/Sterilization Cassettes are not intent own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.

The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices, which meet national or international standards. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation / Sterilization Cassettes design consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, sterilization, and storage. These components consist of: an outer base, internal individual trays with or without lids, caddies and an outer locking lid. The components if the Medtronic Transportation/Sterilization Cassettes are fabricated from intrinsically stable metals and thermoplastic polymers. All of the components of the Medtronic Transportation/Sterilization Cassettes are perforated with an evenly distributed hole pattern, and are designed to be used for steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA-cleared wrap must be used for sterilization and to maintain the sterility of the contents. The Medtronic Transportation/Sterilization Cassettes are designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the Medtronic Transportation/Sterilization Cassettes are effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description. The document is a 510(k) summary for a medical device (Medtronic Transportation/Sterilization Cassettes) that states no changes were made to the device itself, only to the labeling to add manual cleaning instructions.

Therefore, the document explicitly states that the original biocompatibility and verification/validation data still applies, and it does not provide new, detailed acceptance criteria and performance data for the device's primary function of sterilization and transport. It mentions a cleaning validation study was performed for the new manual cleaning instructions, but provides no details on its methodology, sample size, or specific acceptance criteria and results beyond stating it was "effective."

Without specific acceptance criteria and reported device performance (e.g., sterilization efficacy rates, barrier properties, mechanical durability under specific tests), and details on the study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, etc.), I cannot fulfill your request.

Ask a specific question about this device

The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.

The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices which meet national or international specifications. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation/Sterilization Cassettes design consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, sterilization, and storage. These components consist of: an outer base, internal individual trays with or without lids, caddies and an outer locking lid. The components of the Medtronic Transportation/Sterilization Cassettes are fabricated from intrinsically stable metals and thermoplastic polymers. All of the components of the Medtronic Transportation/Sterilization Cassettes are perforated with an evenly distributed hole pattern, and are designed to be used for sterilization via steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA cleared wrap must be used for sterilization purposes and to maintain the sterility of the contents. The Medtronic Transportation/Sterilization Cassettes are designed to be used with standard autoclaves used in hospitals and healthcare facilities. Thus allowing the Medtronic Transportation/Sterilization Cassettes to be effective for sterilization and are designed such that they withstand the environment of repeated steam sterilization cycles.

The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation. They are not intended to maintain sterility on their own but are to be used with an FDA-cleared sterilization wrap. The device was evaluated for its ability to withstand the distribution environment, achieve sterility, and for biocompatibility.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

Gravity Displacement:

• 250°F (121°C) for 30 minutes, 30 minutes dry time
• 270°F (132°C) for 15 minutes, 30 minutes dry time
• 275°F (135°C) for 10 minutes, 30 minutes dry time

Dynamic-Air-Removal (4 Pre-conditioning pulses):

• 270°F (132°C) for 4 minutes, 30 minutes dry time
• 275°F (135°C) for 3 minutes, 30 minutes dry time |
  | Durability (Distribution Environment) | The Medtronic Transportation/Sterilization Cassettes were able to withstand the distribution environment. Testing was conducted in accordance with ASTM D4169: 2009 – "Standard Practice for Performance Testing of Shipping Containers and Systems". |
  | Biocompatibility | Materials used in the Medtronic Transportation/Sterilization Cassettes are biocompatible, including thermoplastic polymers, aluminum, and stainless steel. An assessment based on ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process" concluded that if substances were to transfer, they would not present a chemical hazard. The device does not have direct patient contact. |

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

The document does not specify a distinct "test set" sample size for the performance validation in the way a clinical trial would. Instead, the validation involved a "worst case" Medtronic Transportation/Sterilization Cassette configuration. This configuration was described as:

• Dimensions: 22.75 x 11.26 x 5.5 inches
• Total Weight: 28.4 lbs (including implants and common surgical instruments)
• Lumen Dimensions (worst case): 363 x 1.575mm and 247.5 x 4.1mm

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission, the testing was prospective and conducted by the manufacturer, Medtronic Sofamor Danek, likely in the USA where the company is located.

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. The ground truth for sterilization validation is established through recognized and standardized microbiological and physical testing methods (e.g., biological indicators, chemical indicators, physical monitoring) designed to demonstrate a specific Sterility Assurance Level (SAL). It does not involve human expert consensus in the same way a diagnostic imaging study would.

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

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments. The performance testing for this device (sterilization validation, durability, biocompatibility) relies on objective, standardized laboratory measurements and methodologies.

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. A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic AI devices where human readers interpret medical images or data. The Medtronic Transportation/Sterilization Cassettes are physical medical device accessories for sterilization and transportation, not an AI-powered diagnostic tool.

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

Yes, the performance testing was effectively "standalone" in that the device's ability to maintain sterility, withstand distribution, and its biocompatibility were evaluated directly through standardized physical and microbiological tests. There is no "algorithm" or "human-in-the-loop" component to the function of this medical device. The validation confirmed the device's inherent design capabilities.

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

The ground truth used for the performance evaluation was established through adherence to recognized industry standards and scientific principles for sterilization, durability, and biocompatibility.

• For Sterilization: The ground truth for sterility was defined by achieving a Sterility Assurance Level (SAL) of $10^{-6}$, which is a universally accepted standard for terminally sterilized medical devices. This is demonstrated through biological indicator (BI) and physical parameter monitoring as per AAMI and ISO standards.
• For Durability: The ground truth for durability was the successful completion of distribution testing as per ASTM D4169: 2009, indicating the device's ability to withstand simulated shipping environments without damage affecting its function.
• For Biocompatibility: The ground truth for biocompatibility was compliance with ISO 10993-1:2009, demonstrating that the materials are suitable for their intended use and do not pose a chemical hazard.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical device accessory, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.

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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The Oticon Medical Sterilization Cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use.

The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles:

The Oticon Medical Sterilization Cassette is a stainless steel cassette consisting of a base tray, a lid and an insert with instrument holders made of silicone. The lid is locked to the base tray by a locking tab. Once the lid is closed and locked, enclosed instruments are kept in place by the holders and a silicone rail in the lid.

The Sterilization Cassette is designed using materials that can be reused with steam sterilization methods. The base tray, lid and insert have evenly distributed perforations to allow for penetration of sterilant during steam sterilization. For the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap.

This document is a 510(k) summary for the Oticon Medical Sterilization Cassette, demonstrating its substantial equivalence to predicate devices. It focuses on the device's intended use and performance in cleaning and sterilization.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

• 132°C (270°F) for 4 minutes exposure, 20 minutes drying
• 134°C (273°F) for 3 minutes exposure, 16 minutes drying
• 135°C (275°F) for 3 minutes exposure, 16 minutes drying. | Showed that under the selected processing parameters, excellent steam penetration was achieved within the wrapped cassettes. Sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶ of the cassette and its contents when handled according to the recommended instructions. |
  | Wear Following Re-use and Processing | Testing for wear following re-use and repeated processing (no specific quantitative criteria mentioned, but implied satisfactory performance). | The Sterilization Cassette functioned as intended, and the performance observed was as expected. The document concludes that "further testing will not raise new issues of safety or efficacy," implying acceptable wear characteristics over repeated use. |
  | Material Compatibility | Material compatibility with sterilization process (based on comparison table). | "Yes" (stated in the comparison table, indicating compatibility). |
  | Microbial Barrier Properties | To be used in conjunction with a legally marketed sterilization wrap to maintain sterility (based on comparison table). | Confirmed that for the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap. |

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

The document does not specify the exact sample sizes (e.g., number of cassettes, number of cleaning cycles, number of sterilization cycles) used for the performance testing. It generally refers to "Testing... includes" and "The testing demonstrated."

The data provenance is from Oticon Medical AB, Sweden, as indicated by the submitter's address and manufacturer information. The testing is prospective, conducted specifically for the purpose of demonstrating the device's performance for this 510(k) submission.

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 performance data section describes the outcomes of the tests (efficiency, steam penetration, SAL of 10⁻⁶), but does not detail the methodology for establishing ground truth or the involvement of experts in that process. For a sterilization cassette, the "ground truth" would typically be established by validated test methods (e.g., biological indicators for sterility assurance) rather than expert consensus on subjective observations.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or subjective assessments by multiple readers. For performance testing of a sterilization cassette, the results are derived from objective physical and microbiological measurements/assays, not from human interpretation that requires adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a sterilization cassette. The document does not describe any AI component in this device.

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

Not applicable. This device is a physical medical device (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently tied to its physical design and the validated processes it enables.

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

The ground truth for the performance tests would be based on objective scientific measurements and validated industry standards. For example:

• Cleaning and Disinfection: Ground truth would be the reduction of specific microbial loads or removal of simulated soil to predefined levels, typically measured quantitatively in a lab setting according to standards (e.g., ASTM, ISO).
• Sterilization Validation: Ground truth is achieved when test results (e.g., from biological indicators or physical monitoring) demonstrate a sterility assurance level (SAL) of 10⁻⁶, meaning a one-in-a-million chance of a non-sterile unit, as per relevant sterilization standards (e.g., ANSI/AAMI ST79).
• Wear Testing: Ground truth would be the maintenance of physical integrity and functionality after a specified number of reprocessing cycles, conforming to design specifications or acceptable wear limits.

The document states "sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶," which is a key ground truth metric for sterilization.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As mentioned above, there is no AI/ML algorithm or training set for this device.

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