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Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

Hospital size sterilizer cycles

• Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
• Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time

Tabletop sterilizer cycles:

• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time

Ethylene Oxide sterilization cycles:

• Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:

Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.

Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).

Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).

The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.

The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".

The Chex-All® Sterilization pouches and tubes are made from a medical grade porous paper thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open to insert medical devices to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.

The pouches also contain chemical process indicators used to demonstrate that the pouches have been a subject of either a steam or ethylene oxide sterilization process.

All Chex-All sterilization pouches and tubes are flat and include the following products: Chex-All Heat-seal sterilization pouch, flat; Chex-All Heat-seal sterilization tube, flat, sold in rolls; Chex-All II Self-seal sterilization pouch, flat; Chex-All III Self-seal sterilization pouch, flat.

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The TunnelVision Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow

The HBL Blade Assembly is indicated for use with the TunnelVision Endoscopic Soft Tissue Release System, the 3M Agee Inside Job Carpal Tunnel Release System, or the MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow

Hand Biomechanics Lab's TunnelVision Endoscopic Soft Tissue Release System is a surgical system designed for minimally invasive soft tissue release procedures. The system includes the TunnelVision Endoscope, TunnelVision Handpiece, reusable manual surgical instruments (small and medium dilators, synovium elevator, coequal dilator), an instrument sterilization tray, and the HBL Blade Assembly.

The HBL Blade Assembly (Model CTR-455) was previously cleared under 510(k) K222490 for use with the 3M® and MicroAire® SmartRelease® systems. This submission expands indications for use to include compatibility with the TunnelVision platform. No changes were made to blade assembly materials, design, or sterilization method.

Reusable components (handpiece, endoscope, surgical instruments, sterilization tray) are supplied non-sterile, to be cleaned and steam sterilized by the end user. The HBL Blade Assembly is a sterile, gamma-irradiated, single-use device.

The subject device is comprised of two components:

1. TunnelVision Endoscopic Soft Tissue Release System – includes the endoscope, handpiece, manual surgical instruments, and sterilization tray. These components are reusable following validated cleaning and sterilization processes.
2. HBL Blade Assembly – a gamma-sterilized, single-use disposable device containing the cutting blade. The blade cuts in a retrograde direction to safely release the targeted soft tissue.

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Guided DAS Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Guided DAS Surgical Kit is intended to allow sterilization of the enclosed medical devices.

Guided DAS Surgical Kit requires the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kit is to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: dynamic air removal steam sterilization- Exposure at 132 °C for 4 minutes and 30 minutes dry time.

Guided DAS Surgical Kit is intended for sterilization of non-porous loads.

Guided DAS Surgical Kit is recommended not to be stacked during sterilization.

The combined weight of the Guided DAS Surgical Kit and the associated instruments is 760 grams.

The weight of the empty Guided DAS Surgical Kit is 600 grams.

This tray is designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the trays by the healthcare provider.

The provided text is a 510(k) clearance letter and summary for the "Guided DAS Surgical Kit," which is a sterilization wrap/container. It outlines the device's indications for use, classification, and a comparison to a predicate device.

However, the provided document does not contain information relevant to AI/ML device performance, such as:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for AI/ML test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes of AI assistance on human readers.
• Standalone (algorithm-only) performance metrics.
• Type of ground truth used (expert consensus, pathology, outcome data).

The "Summary of Nonclinical Testing Table" on page 8 focuses on validation tests typical for medical devices related to cleaning, sterilization, dry time, life cycle, and biocompatibility, which are hardware-related and not AI/ML performance metrics. The conclusion explicitly states, "No clinical data were included in this submission."

Therefore, based solely on the provided text, it's impossible to describe the acceptance criteria and the study that proves an AI/ML device meets them, as the document is about a physical medical device (sterilization kit) and not an AI/ML algorithm.

If the request assumes this document should or would contain information about an AI/ML component, then the answer is that the document explicitly does not provide such information.

To answer your request within the confines of the provided text, I must state that the document does not contain the information needed to describe the acceptance criteria and study for an AI/ML device.

The document describes the testing performed for a physical medical device (sterilization kit). The listed tests are for material and functional validation, not for an AI/ML algorithm's analytical or clinical performance.

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The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.

The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.

(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.

(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.

The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.

The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.

The provided FDA 510(k) clearance letter and summary describe a Sterilization Pouch and Roll device, which is a Class II medical device. This is NOT an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as effect size of human readers improving with AI, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document details various performance tests such as sterilant penetration, biocompatibility, package integrity, and chemical indicator testing. However, it does not explicitly state the sample sizes used for each of these test sets. The tests are "bench testing" (non-clinical) and do not involve human subjects.

The data provenance is from non-clinical bench testing. The tests were performed to evaluate the performance and functionality of the device against a requirement specification. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies or data collection in human populations.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a physical sterilization pouch and roll, and its performance is evaluated through standardized laboratory and bench testing against established physical, chemical, and biological criteria, not by human expert interpretation of data or images. Ground truth is established by objective measurements and standardized test methods.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective measurements and established standards rather than expert interpretation requiring adjudication.

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 relevant for AI/ML devices where human performance with and without AI assistance is being compared. This document is for a physical sterilization product.

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

Not applicable. This device is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The ground truth for this device's testing is based on:

• Standardized Test Methodologies and Acceptance Criteria: As outlined in the "Test Methodology" and "Acceptance Criteria or End Point" columns in Table 3 of the 510(k) summary. These include standards like ISO 17665-1, ISO 10993 series, ASTM F1886, ASTM F2251, ISO 1924-2, ASTM F1140, ASTM F1929, ASTM F88, ASTM D3078, DIN 58953-6, ISO 11140-1, and ASTM F1980.
• Physical and Chemical Measurement: For properties like thickness, tensile strength, burst strength, seal strength, and the color change of the chemical indicator.
• Microbiological Evaluation: For the microbial barrier test (e.g., 0 CFU No growth).
• Biocompatibility Testing: Evaluating potential toxicity, irritation, and sensitization in laboratory settings (e.g., L-929 cells).
• Sterilization Effectiveness: Meeting a specified Sterility Assurance Level (SAL 10-6).

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component described for this device, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set.

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The PAL Sterilization Case is a reusable sterilization case intended to provide storage for the PAL handpiece, the PAL cable, and 4 PAL cannulas during sterilization, storage, and transportation within the hospital environment. The PAL Sterilization Case is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with FDA-cleared sterilization wraps. The PAL Sterilization Case has only been evaluated for a non-stacked configuration. The validated steam sterilization parameters are listed below:

The MicroAire PAL Sterilization Case is a non-surgical, non-patient contacting, accessory to the already existing PAL (Power-Assisted Liposuction) System (cleared for market under K212024, K171286 and K220318), designed to contain reusable surgical instruments during steam sterilization. The case is designed to contain four (4) PAL Multi-Use Cannulas, one (1) PAL Electric Handpiece, and one (1) PAL Handpiece Cable. The subject product scope only includes the sterilization case, constructed of a separable base and lid, as illustrated in Figure 11-A.

The PAL Sterilization Case (subject device) is a stainless-steel case comprised of a separable lid and base. These two components latch together via the latch mechanisms on either side of the base which mate with the flanges on either side of the lid. Inside the case there are silicone mounts for a PAL handpiece, cable, and 4 cannulas (30 cm or less in length). The sterilization case is used to steam sterilize its contents via standard gravity or dynamic air removal autoclave processes. The subject device is a non-surgical, non-patient contacting, accessory device to the MicroAire PAL System. The subject device allows a user to organize and transport PAL reusable surgical instruments before, during, and after steam sterilization. The case is provided non-sterile and contains silicon mounting brackets to keep the devices in place, and a perforated stainless-steel enclosure to allow penetration of steam. The case has an overall footprint of approximately 16" x 6" x 2". Its construction of 1mm thick stainless steel and silicone make it lightweight and easy to transport when fully loaded with instruments. The lid also has two carrying handles on its lid for easy transport.

The provided FDA 510(k) clearance letter and summary describe a "PAL Sterilization Case," which is a reusable case for sterilizing surgical instruments. This is a medical device, but it is not an AI/ML powered medical device. Therefore, the questions about acceptance criteria for AI algorithms, such as sample size for test sets, data provenance, expert adjudication, MRMC studies, and standalone algorithm performance, do not apply to this submission.

The document focuses on the performance validation of a physical sterilization case and its ability to maintain sterility under specific sterilization parameters.

Here's an analysis of the available information regarding its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sterilization Validation: The document does not explicitly state the specific sample size (e.g., number of test runs or sterilization cycles) for the gravity and pre-vacuum steam sterilization validations. However, it indicates that the tests were conducted according to recognized standards (ANSI/AAMI ST77, AAMI TIR12, ISO 17665, and FDA guidance), which would prescribe appropriate sample sizes and methodologies for achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
• Cleaning Validation: The sample size for cleaning validation is not explicitly stated. It adheres to AAMI ST98 requirements.
• Weight Verification: The document states "ANSI/AAMI ST77:2013/(R)2018 (for sample size)," implying that the sample size for weight verification was derived from this standard. The outcome states a mean weight of 5.582 lb ± 0.026 lb, which suggests multiple measurements were taken to achieve 90% confidence, but the exact number of cases or measurements isn't provided.

Data Provenance: The data is from "non-clinical testing" performed by MicroAire Surgical Instruments, LLC, the device manufacturer. The tests are laboratory-based validations rather than observational studies, so concepts like "country of origin of the data" or "retrospective/prospective" are not directly applicable in the same way they would be for patient data.

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 question is not applicable. For physical sterilization validation, "ground truth" is established through standardized microbiological testing (such as biological indicators and physicochemical parameters) and subsequent lab analysis to confirm the absence of viable microorganisms or the attainment of a specified Sterility Assurance Level (SAL), not by human expert interpretation in the medical imaging sense.
• For cleaning validation, "visible evidence of test soil" is typically assessed by trained personnel using visual inspection criteria.
• For weight verification, it's a direct measurement.

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

• This question is not applicable to the non-clinical performance data presented for this physical sterilization case. Adjudication methods are typically used in clinical studies or AI/ML performance evaluations where there is subjective interpretation of findings by multiple experts.

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 question is not applicable. The PAL Sterilization Case is a physical device, not an AI/ML system, and therefore, an MRMC study related to AI assistance for human readers was not performed.

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

• This question is not applicable. The PAL Sterilization Case is a physical device, not an algorithm.

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

• Sterilization Validation: The ground truth for sterilization effectiveness is based on microbiological assay results (confirming a Sterility Assurance Level (SAL) of 10⁻⁶) and physicochemical parameters (temperature, time, pressure, and dryness) as defined by established sterilization standards (e.g., ANSI/AAMI ST77, ISO 17665). This is an objective, laboratory-derived ground truth.
• Cleaning Validation: The ground truth for cleaning effectiveness is the absence of visible test soil after cleaning, as assessed by visual inspection from a specified distance according to AAMI ST98, and potentially measured levels of residual soil.
• Weight Verification: The ground truth for weight is direct measurement using calibrated scales.

8. The sample size for the training set:

• This question is not applicable. The PAL Sterilization Case is a physical device and does not involve AI/ML algorithms that require a "training set."

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

• This question is not applicable, as there is no "training set" for this physical device.

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GCI Sterilization Wrappers are intended to be used to enclose reusable textile-based medical devices, such as surgical gowns, towels, and drapes, for sterilization by a health care provider. They are designed to allow effective steam sterilization of the enclosed textile items and to maintain sterility until use, for up to 28 days.

GCI Sterilization Wrapper sizes and validated load limitations are as follows:

GCI Sterilization Wrappers are reusable through 38 wash, dry, and sterilization cycles. Pack assembly should follow established folding, assembly, and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. Closure can include autoclave tape and elastomer closures.

Sterilization: A prevacuum steam sterilization cycle (4 minutes exposure at 132°C, Dry Time: 30 minutes) has been validated.

GCI Sterilization Wrappers are intended to enclose a textile-based medical device for sterilization and maintain sterility of the enclosed device until used.

The proposed devices are medical devices that are provided non-sterile. They may be reused up to 38 times. They are available in multiple sizes to accommodate textile-based medical devices, ranging from 18"x18" to 60"x60". The size is indicated by color coding of the wrap borders for easy identification.

Load sizes should be large enough to prevent too much overlapping of the wrapper material (such that all but one side of the wrapper should be a single layer when properly folded) to allow appropriate sterilant penetration. Load sizes should be small enough to overlap by at least 2 inches on the remaining side to ensure there are no gaps.

This document pertains to the 510(k) clearance for GCI Sterilization Wrappers, a Class II medical device. The information provided outlines the non-clinical performance data used to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Discussion of Study Proving Device Meets Acceptance Criteria:

The document states that performance testing was conducted in alignment with FDA guidance documents "Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities" and "Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities."

Testing was also conducted to relevant standards including:

• ASTM D5587: Tearing Strength
• 16 CFR 1610: Flammability
• AATCC 127: Water Resistance: Hydrostatic Pressure
• AATCC 42: Water Resistance: Impact Penetration
• ISO 10993-5: Biocompatibility - Cytotoxicity
• ISO 10993-10: Biocompatibility - Irritation and Sensitization
• ISO 9073: (Not directly referenced in table, but listed as a standard used for testing)
• ASTM D5034: Breaking Strength
• AAMI TIR 12: Use Life and Reprocessing Effectiveness
• AAMI TIR 30: Use Life and Reprocessing Effectiveness
• ANSI/AAMI/ISO 17665-1: Sterilization Validation and Sterility Maintenance

All testing results are reported to have "passed pre-determined acceptance criteria," supporting the performance of the subject device.

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

• Sample Size for Test Set: The document does not explicitly state the specific number of samples used for each individual test. It mentions that "All testing results passed pre-determined acceptance criteria," suggesting that sufficient samples were tested to meet the statistical requirements of the respective standards.
• Data Provenance: The document indicates that George Courey Inc. is located in Laval, Quebec, Canada. While the testing itself is described as "Performance testing was conducted," the specific location or country of origin where these tests were physically performed is not detailed. The data is retrospective in the context of the 510(k) submission, as these tests were completed prior to the submission for clearance.

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

This information is not applicable to this type of device and study. The "ground truth" for the performance characteristics of sterilization wrappers is established by objective, standardized laboratory tests and international/national standards (e.g., ISO, ASTM, AAMI). Expert consensus by medical professionals is not typically used to establish the ground truth for properties like tearing strength, flammability, or water resistance of a material. For "Sterilization Validation" (SAL of 10-6), the "ground truth" is a measurable scientific endpoint achieved through validated sterilization cycles, not expert opinion.

4. Adjudication method for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation tasks where human readers make subjective assessments that might require a tie-breaking or consensus mechanism. For materials testing and performance validation of a sterilization wrapper, the results are objective measurements against defined acceptance criteria, not subjective interpretations requiring 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:

This is not applicable to this device. An MRMC study is relevant for diagnostic imaging AI or other applications where human interpretation is involved. GCI Sterilization Wrappers are a physical barrier device, and their performance is evaluated through laboratory-based physical, chemical, and microbiological testing, not human reader assessments.

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

This is not applicable. This is not an AI-powered diagnostic algorithm or software device. The product is a physical sterilization wrapper, and its performance is evaluated through material science and sterilization efficacy tests.

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

The "ground truth" for the performance of the GCI Sterilization Wrappers is based on objective measurements and adherence to established industry standards and regulatory guidance documents. This includes:

• Physical Property Measurements: Tearing strength, breaking strength, water resistance, linting, flammability are all quantifiable physical properties measured using standardized test methods.
• Biocompatibility Testing: Cytotoxicity, irritation, and sensitization are evaluated using established in vitro and in vivo models according to ISO 10993 standards, yielding objective results (e.g., "Non-Cytotoxic").
• Sterilization Efficacy and Maintenance: Sterilization validation (achieving SAL of 10-6) and sterility maintenance are determined through microbiological testing and barrier integrity assessments under controlled conditions, adhering to ANSI/AAMI/ISO 17665-1.
• Use Life and Reprocessing Effectiveness: Confirmed through repeated cycling and performance evaluation according to AAMI TIR12 and TIR30.

There is no subjective "ground truth" derived from expert consensus, pathology, or outcomes data in the traditional sense for this product.

8. The sample size for the training set:

This is not applicable. The GCI Sterilization Wrappers are a physical product, not a software algorithm that requires a "training set" in the context of machine learning or AI. The rigorous testing described is a validation process, not a training process.

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

This is not applicable for the same reasons as #8. There is no training set for this type of medical device.

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The AESCULAP Aicon® Container is a reusable rigid sterilization container intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container is compatible for use in the following sterilization modalities in the configurations listed below:

• Ethylene Oxide (EtO)
• STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex
• STERIS V-PRO 60: Lumen, Non- Lumen, Flex
• STERIS V-PRO S2 Non-Lumen
• STERRAD 100NX: Standard, Express, Flex, Duo
• STERRAD NX: Standard, Advanced
• STERRAD 100S
• STERIZONE VP4
• PreVac Steam

The AESCULAP Aicon® consists of two different container styles: a solid bottom container and enhance drying system (EDS) container.

The AESCULAP Aicon® Container is compatible with accessories such as baskets, trays, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. Prevac cycles without dry times are Immediate Use Sterilization Cycles (IUSS).

The AESCULAP Aicon® Container System is a reusable rigid container system used for the packaging, transportation, and storage of instruments prior to, during, and after sterilization. It consists of the various sizes of container bottoms, container lid, and basket options, and should only be used with designated Aesculap® filters, locks and indicator cards identified in this IFU.

The AESCULAP Aicon® Container System is provided non-sterile and will undergo sterilization by the end user. The AESCULAP Aicon® Container System can be identified by its JJ Series part number.

• The first digit of the model number designates the container length.
• The second digit designates the height.
• The last digit identifies the model and features.
  • Standard solid bottom container, designated by the "0" at the end of the product number.
  • Enhanced Drying System (EDS) solid bottom container, designated by the "1" at the end of the product number. The EDS container can also be identified by the Enhanced Drying Module, item 14 in the Product Component Diagram.

The JJ Series uses the same lids for the Standard and the EDS container bottoms.

The AESCULAP Aicon® Container System lid latches should remain in the closed position at all times except when installing on and removing the lid from the container bottom.

The JJ Series can be used with the perforated baskets and trays of both the AESCULAP Aicon® Container System and Aesculap® SterilContainer™ System. Non-Aesculap® pre-configured baskets that meet the clearance requirements, and can be properly aseptically presented may also be used. Medical device and container IFUs parameters (time and temperature) should be reconciled. Steam sterilization dry time performance may vary by facility based on water and steam quality and/or sterilization performance. Ensure you can achieve the same end result as identified in the instrument IFU. Follow facilities policies and procedures.

Notes:

• Thoroughly clean all Aesculap® container products, baskets, accessories and replacement parts prior to first use and after container repair service has been performed.
• Aesculap® baskets and accessories can be cleaned and sterilized following accepted industry guidelines and by using the same processes as Aesculap® sterile container bottoms.
• AESCULAP Aicon® Container System has ONLY been validated with Aesculap® filters, locks and indicator cards.
• Aesculap® only performed container testing with baskets and does not recommend using containers without baskets or with only mats.

Here's an analysis of the provided FDA 510(k) clearance letter for the Aesculap Aicon® Series Container System, focusing on the acceptance criteria and the studies that prove the device meets them.

It's important to note that this document is a 510(k) summary, which provides a high-level overview. Detailed study protocols, raw data, and comprehensive reports would be found in the full 510(k) submission, which is not publicly available here. The summary focuses on non-clinical performance data and does not involve AI or human readers for diagnostic interpretation, as this is a medical device for sterilization. Therefore, sections related to AI, multi-reader multi-case studies, and expert adjudication for ground truth are not applicable to this type of device and will be marked as "Not Applicable".

Acceptance Criteria and Reported Device Performance

Device: Aesculap Aicon® Series Container System (Sterilization Container Wrap)

Purpose of Studies: To demonstrate that the Aesculap Aicon® Series Container System is safe, effective, and performs as well as, or better than, the predicate device for its intended use of enclosing medical devices for sterilization and maintaining sterility.

Detailed Study Information

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

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of containers, number of sterilization cycles, number of biological indicators) for each test. For medical device sterilization studies, sample sizes are typically determined by relevant standards (e.g., AAMI, ISO) to achieve statistically significant results for sterility assurance. The phrasing "biological indicators must be negative for growth" implies that multiple indicators were used.
• Data Provenance: The document explicitly states "non-clinical tests" and does not mention clinical trials or human data. The tests are laboratory-based performance studies compliant with international and national standards (AAMI, ISO, EN). The country of origin of the data is not specified, but it would typically be from the manufacturer's labs or contracted testing facilities. The studies are prospective in nature, as they involve testing the device under controlled conditions to determine its performance.

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)

• Not Applicable. This is a medical device for sterilization, not an AI or diagnostic device that requires expert human interpretation of data for ground truth establishment. The ground truth for these performance tests is based on objective, measurable criteria defined by international and national technical standards (e.g., presence/absence of microbial growth, weight difference, visible moisture, protein/hemoglobin levels).

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

• Not Applicable. As there are no human experts establishing ground truth for diagnostic purposes, there is no adjudication method involved. The evaluation of test results against predefined, objective acceptance criteria constitutes the assessment mechanism.

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 a physical medical device (sterilization container) and does not involve AI, human readers, or diagnostic interpretation.

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

• Not Applicable. This is a physical medical device (sterilization container) and does not involve an algorithm or AI.

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

• The ground truth for this device's performance studies is based on objective, measurable physical and biological outcomes as defined by recognized standards (AAMI ST-77, ISO 10993-5:2009, TIR30, TIR17, ISO 11167-1). Examples include:
  • Absence of microbial growth in biological indicators (for sterilization efficacy and sterility maintenance).
  • Specific quantitative thresholds for weight difference (for dry time).
  • Absence of visible moisture.
  • Quantitative levels of protein or hemoglobin below predetermined amounts (for cleaning validation).
  • No degradation or impact to functionality (for material compatibility).
  • Cellular reactivity levels below a certain threshold (for cytotoxicity).

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set. The development of such devices relies on engineering design, material science, and iterative physical testing.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply here.

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The ONE TRAY® Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of the enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below:

• Prevac Steam
• 270°F, 4 min exposure
• 15-minute dry time

ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm.

DO NOT STACK ONE TRAY® CONTAINERS DURING STERILIZATION

Examples of validated materials that can be processed within the ONE TRAY®- Metals: Stainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic

The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

The ONE TRAY® Sealed Sterilization Container is a sealed rigid container with a lid and base containing a rectangular patterned group of perforations to permit steam penetration of sterilant. Single use SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filter cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle.

ONE TRAY® Sealed Sterilization Containers are a reusable device whose base and lid are composed of anodized aluminum to prevent corrosion.

The gaskets used in the ONE TRAY® Sealed Sterilization Containers are made from medical grade silicone material identical to that used by predicate containers. The lid is firmly secured to the base with a cam-locking latch at each end.

The provided FDA 510(k) clearance letter and summary describe a physical medical device (sterilization container) and its performance, not an AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically involve a "test set," "ground truth," expert adjudication, or MRMC studies.

Therefore, many of the requested details about acceptance criteria and study design (especially those related to AI/SW performance) are not applicable to this type of device and the information presented in this document.

However, I can extract the relevant acceptance criteria and study information provided for the physical sterilization container.

Analysis of Acceptance Criteria and Study for ONE TRAY® Sealed Sterilization Container System

The device under review is the ONE TRAY® Sealed Sterilization Container System, a reusable rigid sterilization container. The studies described are nonclinical tests to demonstrate the safety and effectiveness of the container in maintaining sterility of enclosed medical devices during steam sterilization, storage, and transport. The criteria and studies are designed for a physical device, not an AI/SW product.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable/Not Provided (due to the nature of the device)

The following points are typically relevant for AI/SW performance studies, but the provided document describes a physical medical device (sterilization container). Therefore, the information for these points is not applicable (N/A) in this context, or the details are not explicitly provided as they would be for an AI/SW submission.

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

  • Sample size: Not specified in terms of "test set" for data-driven models. The studies involve multiple sterilization cycles, microbial challenges, and material compatibility tests, but the exact number of cycles/samples for each test is not detailed in this summary.
  • Data provenance: N/A for a physical device. These are laboratory performance tests.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth is established by objective scientific measurements (e.g., biological indicator growth, weight difference, visual inspection, cytotoxicity assays), not expert readers.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Adjudication is not relevant for these types of objective performance 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: N/A. This is not an AI/SW device.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical device, and its function is standalone in terms of sterilizing/maintaining sterility.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance studies is based on established sterilization efficacy standards (e.g., biological indicator sterility/growth, physical measurements like weight change, absence of moisture, and material biocompatibility testing). It is objective performance data, not subjective human assessment or pathology.

• 8. The sample size for the training set: N/A. This is a physical device, not an AI/ML model that requires a training set.

• 9. How the ground truth for the training set was established: N/A. See point 8.

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The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The recommended sterilization cycles are as follows:

• Steam Sterilization: 4 minutes at 132°C (270°F); 10 minutes dry time for gauze and plastic loads, and 20 minutes dry time for metal loads.
• Ethylene Oxide (ETO) Sterilization: 8 hours at 50°C (122°F); relative humidity between 30%-90%; ethylene oxide concentration is 700mg/L, 7 days aeration time at 23°C(73.5°F).

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch maintains the sterility of the enclosed devices for up to 6 months post Steam or ETO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark green after sterilization.

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process.

I'm sorry, but the provided FDA 510(k) Clearance Letter for "Self Sealing Sterilization Pouches" does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or software-based medical device.

The document is a clearance letter for a physical medical device (sterilization pouches) and details its intended use, sterilization methods, material properties, and maximum load capacity. It also outlines regulatory requirements for such devices.

There is no mention of AI, algorithms, software, ground truth, expert readers, retrospective/prospective studies, or any of the other specific questions related to AI/software device performance evaluation.

Therefore, I cannot provide the requested information based on this document.

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The Turbett Surgical Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with Turbett Surgical Filters.

The unit is intended to be used in a pre-vacuum steam sterilizers with a pre-vacuum cycle of 270°F (132°C) and exposure time of 4 minutes.

• The TS1500 Container may be loaded to a maximum weight of 375 lbs., not to exceed 25 lbs. in any tray. Minimum drying time for loads up to 140lbs. is 10 minutes, for loads up to 375 lbs. is 30 minutes.
• The TS1200 Container may be loaded to a maximum weight of 300 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes for loads up to120 lbs. and 30 minutes for loads up to 300 lbs.
• The TS1000 Container may be loaded to a maximum weight of 100 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.
• The system was validated with 0.7 mm x 500 mm and 1.0 mm x 850 mm rigid and flexible lumens.

Use only uncovered, perforated, or wire mesh general delivery trays within the Turbett Surgical Instrument Pod.

The Turbett Surgical Instrument Pod is a multi-tray rigid sterilization container with a fenestrated door holding a single use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Unwrapped, uncovered, perforated sterilization trays are stacked into the container, separated by anodized aluminum dividers, which allow steam to evenly penetrate and allow condensation to drain.

The container is manufactured from 304 stainless steel sheet metal and bar stock. The container is sealed on all sides except one which is the door / filter panel.

The single fenestrated door consists of two perforated anodized aluminum panels which cover the exposed container side wall. A custom-made disposable filter consisting of 2 layers of filter paper separated by a layer of compressible single-use gasket material is placed between the two perforated metal panels of the door. Spring loaded latches compress the anodized aluminum door frame with filter assembly to the container for a secure seal.

The Turbett Surgical Instrument Pod is loaded into the auto clave with a dedicated transfer mechanism and cart.

The provided FDA 510(k) clearance letter and summary for the Turbett Surgical Instrument Pod does not describe an AI/ML device or a study involving human readers or ground truth derived from expert consensus, pathology, or outcomes data. Instead, it describes a rigid sterilization container used for medical instruments.

Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) are not applicable to this medical device submission.

The "study" in this context refers to non-clinical performance testing of the physical sterilization container.

Here's the information that can be extracted and presented based on the provided document, framed within the context of hardware device performance testing:

Device Description

The Turbett Surgical Instrument Pod is a multi-tray rigid sterilization container designed to enclose other medical devices for sterilization by a healthcare provider. It allows sterilization of enclosed materials and maintains sterility for up to 30 days. It is intended for use in pre-vacuum steam sterilizers with specific temperature and exposure times. The container is made of stainless steel and aluminum, includes a single-use filter, and accommodates various sizes of instrument loads and lumens.

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through a series of non-clinical tests to demonstrate its safety and effectiveness as a sterilization container. The acceptance criteria were based on medical device sterilization standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Performance Testing)

1. Sample size used for the test set and data provenance:

   • The document does not specify exact sample sizes (e.g., number of containers tested) for each non-clinical test.
   • It mentions three specific container models (TS1500, TS1200, TS1000) and indicates that the system was validated with specific rigid and flexible lumens (0.7 mm x 500 mm and 1.0 mm x 850 mm for the subject device).
   • Data provenance: Not explicitly stated, but typically for 510(k) submissions, non-clinical tests are conducted by the manufacturer or accredited testing laboratories in a controlled environment as part of the design validation process. This is a prospective testing design to meet regulatory standards.

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

   • Not applicable in the context of AI/ML. For this physical device, "ground truth" is established by adherence to recognized consensus standards for sterilization and medical device testing (e.g., ANSI/AAMI ST77:2013, ANSI/AAMI ST79:2007, TIR 30:2011, ANSI/AAMI HE75:2013). The "experts" are the qualified personnel within the testing laboratories who perform the tests according to these validated methods.

3. Adjudication method:

   • Not applicable. This is not a human-in-the-loop or interpretation-based task that would require adjudication. Results are quantitative measurements against defined criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size of improvements:

   • No. This is not a study assessing human reader interpretation of images or data.

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

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is defined by established consensus standards and validated chemical/physical/biological testing methods (e.g., sterility assurance levels, gravimetric measurements for dryness, chemical residue analysis, microbial growth/no-growth observations).

7. The sample size for the training set:

   • Not applicable. No AI/ML training set is mentioned or implied.

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

   • Not applicable. No AI/ML training set is mentioned or implied.

Summary regarding AI/ML criteria: The provided document pertains to a physical medical device (sterilization container) and its non-clinical performance testing. It does not involve AI/ML, human readers, image analysis, or expert consensus-based ground truth typical of AI/ML device clearances.

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