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U&U Hydrogen Peroxide Gas Plasma Sterillzation Pouch / Roll are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD 100NX Hydrogen Peroxide Gas Plasma sterilizer.

The recommended Hydrogen Peroxide Gas Plasma cycle parameter: STERRAD 100NX STANDARD Cycle

Sterilization load claim:

STERRAD 100NX Sterilizer Standard cycle:

· General medical instruments (metal and nonmetal, including hinged devices)

· Instruments with single-channel stalniess steel lumens with an Internal diameter 3 mm or larger and length 150 mm or shorter.

· Polyethylene and Teflon lumentubing with an internal diameter of 3 mm or larger and length of 500 mm or shorter.

· These items must be sterilized without any additional load items

· Limit of 20 pieces of tubing per cycle

Load condition: One device per Sterilization Pouch.

Load chamber: Two shelves (total weight: 21.4 Ibs or 9.7 kg)

Load Pouch: Leave enough material beyond the seal for the opener to easily grasp (usually 1- 1 % inches).

SHELF LIFE: It is recommended that the products are put to their end use within 2 years of manyfacture. The recommended "best before" date and the manufacturing date are stated on the label. This device was demonstrated to maintain sterility of the contents for 30 days after Sterilization.

The U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll are manufactured from TYVEK and medical plastic film that are heat sealed on three sides. The fourth side has an adhesive tape that is used to seal the pouch or heat-sealed by the heat-seal machine. The TYVEK conforms to recognized material standards and can be sterilized by STERRAD 100 NX Hydrogen Peroxide Gas Plasma. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as these predicate devices. Substantial equivalent to the predicate device was established by physical testing of the TYVEK (pressure drop vs. flow and filtration efficiency) and film (thickness, tensile strength and elongation) from non-sterile, sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, dye migration).

The pouches are manufactured from TYVEK that is thermally sealed to laminated film on the left, right, and bottom of pouch. The fourth side has an adhesive tape that is used to that is used to seal the pouch or heat-sealed by the heat-seal machine prior to sterilization of the enclosed medical device.

This document describes a 510(k) submission for "U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll". The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing. Since this is a medical device for sterilization packaging, the "acceptance criteria" are related to the physical and biological integrity of the packaging material and its ability to maintain sterility, rather than AI model performance metrics. Similarly, there is no "study that proves the device meets the acceptance criteria" in the sense of a clinical trial for an AI system, but rather a series of laboratory tests.

Here's an analysis of the provided text based on your request, with the understanding that the nature of the "device" is a sterilization pouch/roll, not an AI system. Therefore, many of your requested items, such as expert-established ground truth, MRMC studies, standalone algorithm performance, and sample size for training sets, are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Performance Tests" and a "Comparison Table" to demonstrate substantial equivalence to the predicate device. The acceptance criteria for these tests are implied to be "PASSED" or "YES" to match the predicate device's characteristics.

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 explicitly state the sample sizes for the performance tests. It refers to "physical testing of the TYVEK... and film... from non-sterile, sterilized finished devices, as well as, performance of these finished devices." The provenance of the data is not specified beyond the manufacturer being based in China. The testing appears to be prospective, specifically conducted for this submission.

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

Not applicable. This is not an AI/diagnostic device that relies on expert consensus for ground truth. The "ground truth" here is established by standardized laboratory testing methods for material properties and sterility maintenance.

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

Not applicable. There is no human adjudication process described for these physical and biological tests.

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. This is not an AI device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for the device's performance is based on the results of standardized physical tests for material properties (e.g., pressure drop vs. flow, filtration efficiency, thickness, tensile strength, elongation, seal strength, package burst, dye migration) and biological tests for sterility maintenance, demonstrating equivalence to the predicate device. The specific standards or methodologies for these tests are not detailed in this summary but are implied by the "PASSED" results and the regulatory context of a 510(k) submission.

8. The sample size for the training set:

Not applicable. This is not an AI device. There is no "training set" in this context.

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

Not applicable. There is no "training set" in this context.

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Gas Plasma Sterilization is intended to be used for terminal sterilization of all Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products as follows:

• Trilogy® Acctabular System (acctabular liners) .
• t Nex Gento Complete Knee Solution (articular surfaces and patellas)

Sterrad 100 Sterilization System

The provided document describes the summary of safety and effectiveness for "Gas Plasma Sterilization" for Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products.

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

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 size used for the test set of the sterilization validation. It broadly mentions "Performance Testing/Sterilization Validation." It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective). Sterilization validations typically involve controlled laboratory experiments rather than patient data.

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

The document does not mention the use of experts or the establishment of "ground truth" in the context of a test set for this sterilization validation. Sterilization validations typically rely on established microbiological testing methods rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are usually relevant for studies involving human interpretation or subjective assessment, which is not the case for a sterilization validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not applicable as this is a sterilization validation, not a study evaluating human readers' performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in principle. A sterilization validation is inherently a standalone performance assessment of the sterilization process itself, without human intervention in the sterilization efficacy. The "device" in this context is the sterilization process.

7. Type of Ground Truth Used

The ground truth used for a sterilization validation is based on microbiological testing, specifically demonstrating the inactivation of a predefined number of highly resistant microorganisms (biological indicators) to achieve the specified Sterility Assurance Level (SAL). This is an objective, quantitative measure.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to a sterilization validation. Sterilization validations are based on established scientific principles and experimental protocols, not machine learning models that require training data.

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

Not applicable, as there is no training set for a sterilization validation.

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The intended use of this additional style of System 12® acetabular inserts is identical to that of previously released System 12® inserts: they are intended to be used with Osteolock/Vitalock acetabular shells in primary or revision total hip arthroplasty.

The purpose of this submission is to describe an additional style of System 12® acetabular inserts which are stabilized/sterilized using a process called Duration® II Stabilization. The purpose of the Duration® Il process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The acetabular insert is packaged in air, and terminally sterilized by the gas plasma sterilization process. The System 120 Acetabular Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA guidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices.

These System 12® inserts are identical in design to previously cleared System 12® inserts: they are available in a range of outer diameter sizes to mate with the respective acetabular shell, and 22.0, 22.2, 26, 28, and 32mm inner diameters to mate with Howmedica femoral heads. These inserts are available in a neutral, 10°, and 15° hooded design. The locking mechanism of this style of acetabular insert is identical to previously released System 12® acetabular inserts.

The provided text summarizes a 510(k) submission for the Duration® II System 12® Acetabular Inserts. This device is an additional style of acetabular insert intended for use in total hip arthroplasty, and the submission focuses on its manufacturing process (Duration® II Stabilization and gas plasma sterilization) and its substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "marketing claims" in the document, which are essentially performance standards the device aims to meet.

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

The document does not explicitly state the sample sizes for the individual tests (e.g., FTIR, tensile modulus, ESR). It refers generally to "Testing was performed in accordance with the draft FDA guidance on UHMWPE."

• Data Provenance: The studies appear to be prospective laboratory/in vitro testing conducted by Howmedica. The country of origin of the data is not specified beyond being generated by the applicant (Howmedica, located in New Jersey, USA). There is no mention of human clinical data or retrospective patient data.

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

This section is not applicable to this submission. The "ground truth" for the tests described is based on established engineering and materials science standards (ASTM, FTIR, ESR, hip wear simulation) rather than expert clinical consensus or interpretation of patient data. The results are objective measurements.

4. Adjudication Method for the Test Set

This section is not applicable. As the tests are objective material property and wear measurements, there is no need for an adjudication method by human observers.

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

This section is not applicable. The device is a medical implant (acetabular insert), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI performance is irrelevant.

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

This section is not applicable. As mentioned above, the device is a medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

• Objective material property measurements against established industry standards (ASTM F-648, modified ASTM D2765-90).
• Quantitative analytical techniques such as FTIR (Fourier-transform infrared spectroscopy) for oxidation and ESR (Electron Spin Resonance) for free radicals.
• Standardized in vitro wear simulation using a hip wear simulator.

Essentially, the "ground truth" is derived from scientific and engineering measurements and established test methods.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set." The materials themselves are manufactured and tested, not "trained."

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

This section is not applicable, as there is no training set for this device.

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The intended use of this additional style of Duracon® Condylar and A-P lipped tibial inserts is identical to that of previously released Duracon® tibial inserts: they are intended to be used with Duracon® femoral and patellar components, and tibial baseplates in primary or revision cemented total knee arthroplasty.

The purpose of this submission is to describe an additional style of Duracon® Condylar and A-P lipped tibial inserts which are stabilized/sterilized using a process called Duration® II Stabilization. The purpose of the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the gas plasma sterilization process. The Duracon® Condylar and A-P lipped Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA quidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices. As will be discussed later, this additional style of insert demonstrated significantly less wear when compared to air irradiated UHMWPE.

These Duracon® Condylar and A-P lipped inserts are identical to those previously released. They are available in peripheral sizes extra-small through extra-large in thicknesses from 6mm to 25mm. These inserts have a three point locking mechanism that is identical to those Duracon® inserts which have been previously released.

The provided text describes the acceptance criteria and the study results for the Duration® II Duracon® Tibial Inserts - Gas Plasma Sterilization Device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: The excerpt specifically mentions a "Duracon® A-P lipped tibial insert (large, 19mm)" being tested. While it provides an average wear rate with a standard deviation, it does not explicitly state the number of samples (n) used to calculate this average for both the Duration® II and the conventionally gamma sterilized inserts.
• Data provenance: The data is described as "in vitro tests" using a "multiaxial knee joint simulator." This indicates the data is from prospective laboratory testing rather than human clinical data. The country of origin of the data is not specified, but the submission is to the FDA in the USA, implying the testing likely adheres to U.S. or international standards.

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

• This question is not applicable to this study. The "ground truth" for this device is not established by expert consensus on images or clinical outcomes, but by objective physical measurements (e.g., wear rate, material properties) conducted in a laboratory setting according to engineering standards (ASTM).

4. Adjudication method for the test set

• This question is not applicable to this study. Adjudication methods (like 2+1, 3+1) are typically used in studies where human experts are making judgments, often in medical imaging or clinical trial outcome assessment. The reported study involves direct measurement of material properties and wear in a simulator.

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 MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is irrelevant to the evaluation of a physical orthopedic implant.

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

• This question is not applicable to this study. This device is a physical implant, not an algorithm. The "standalone performance" here refers to the physical properties and wear characteristics of the material itself, which were tested in a simulator without human intervention in the 'reading' process.

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

• The ground truth for this study is based on objective, quantitative physical measurements of material properties (e.g., conformance to ASTM F-648, gel content, tensile modulus, ESR for free radicals) and in vitro wear testing in a knee simulator.

8. The sample size for the training set

• This question is not applicable to this study. This is a direct physical device evaluation, not a machine learning model, so there is no "training set."

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

• This question is not applicable for the same reason as above; there is no training set for a physical device evaluation.

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The Kimberly-Clark™ Gas Plasma Indicator Strip is a chemical sterilization process indicator as defined in 21 CFR Part 880.2800(b). The indicator strip is intended to be used by a health care provider to accompany products being sterilized via a low temperature (STERRAD) sterilization process. The indicator strip is used to differentiate between product that has been exposed to hydrogen peroxide and product that has not been exposed to hydrogen peroxide. The strip will change color, from blue to green, upon exposure to the low temperature sterilant (hydrogen peroxide).

The Kimberly-Clark Gas Plasma Indicator Strip (KCGPIS) is manufactured from a Tyvek® material or other synthetic substrate. The indicator is approximately 34 " wide by 4 inches long and is flexographically printed with a hydrogen peroxide sensitive ink.

This document describes the validation of the Kimberly-Clark™ Gas Plasma Indicator Strip (KCGPIS).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text, but rather implied by the description of the tests and successful outcomes. The device performance is reported as meeting these implied good manufacturing practice standards.

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

• Sample Size for Test Set:
  • Aging Study: Not explicitly stated, but implies a comparison between "control and aged samples."
  • Fading Properties: Not explicitly stated, but implies multiple strips were tested to yield percentage retention.
  • pH Buffer and Chemical Testing: 33 exposures for KCGPIS, 32 exposures for STERRAD strip.
  • EO/Steam Sterilization: Not explicitly stated, but implies multiple strips were tested for each sterilization method.
  • Indicator Efficacy: "All samples" showed complete color change when contained in pouches and wrapped trays, but the specific number of samples is not given.
• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective in nature, as they involve testing the newly developed Kimberly-Clark™ Gas Plasma Indicator Strip under controlled conditions to demonstrate its performance.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The validation relies on observable color changes and comparisons to a predicate device, which implies a direct assessment without the need for expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set

The document does not mention any formal adjudication method (e.g., 2+1, 3+1). The nature of the device (a chemical indicator with a clear visual color change) suggests that adjudication by multiple independent parties would likely not be necessary. The assessment of color change is typically straightforward.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation plays a significant role, and the AI's impact on human reader performance is being evaluated. The KCGPIS is a simple chemical indicator with a direct visual output, not an AI-powered diagnostic tool.

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

Yes, the testing described is effectively a standalone performance evaluation of the chemical indicator itself. The device's performance is determined purely by its physical and chemical properties (color change in response to sterilant or other conditions), without any human interpretation element that an "algorithm" might typically assist or replace. There is no AI algorithm involved in this device.

7. The Type of Ground Truth Used

The ground truth used is primarily objective physical/chemical reaction.

• For efficacy studies, the ground truth is whether the complete STERRAD sterilization cycle was actually performed (i.e., exposure to hydrogen peroxide sterilant). The indicator is then expected to change color.
• For stability and resistance studies, the ground truth is the controlled environmental condition (e.g., specific temperature, humidity, light exposure, pH, or exposure to other sterilants like EO/steam). The expected behavior (no change or a specific change) is then observed.

8. The Sample Size for the Training Set

This question is not applicable. The KCGPIS is a chemical indicator, not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm.

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

This question is not applicable, as there is no training set for an AI algorithm.

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