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The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days.

Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270°F (132°C) for 4 minutes with a drying time of 30 minutes.

Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container.

Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is single use only.

The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days.

The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used as described in the instructions for use.

Reusable trays and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container.

The Jewel Precision Reusable Rigid Sterilization Container System comprises a sealed sterilization container consisting of a base, cover, filter retainers, single use replaceable paper filters, and accessories consisting of inner trays, and support brackets. Support brackets are configured to securely support container contents, and are secured to inner trays with stainless steel screws and cap nuts. The container is designed to allow efficient exposure of the tray's contents to sterilant gas during the sterilization process, and to contain and protect reusable surgical instruments during sterilization, transport, and storage. The cover incorporates a sealing gasket, and is secured to the base with latches which lock in place. The latching mechanism places a load on the gasket, which is held in compression against the top surface of the container base, maintaining sterile integrity and preventing unwanted separation. The cover also incorporates an alignment flange along its perimeter, which ensures correct alignment of the cover with the container bottom. Provisions are made on the external container surfaces for the use of user provided Sterilizer Load Data Cards and user provided Tamper Evident Locks, through the incorporation of stainless steel Load Data Card Holders and stainless steel hasp and pin studs are designed to fit standard autoclaves, and are manufactured of materials capable of withstanding repeated steam sterilization cycles. The containers and accessories are manufactured from materials which are suitable for use with Pulsed Pre-Vacuum Steam Sterilization methods.

Filter media is Ahlstrom Reliance 335 WL11359D paper, FDA cleared under K800123, which allows ingress and egress of sterilant gas while providing a microbial barrier. The Filter media is single use only.

The Jewel Precision Reusable Rigid Sterilization Container System is used to organize, protect, and transport surgical instruments during steam sterilization and subsequent storage. The Jewel Precision Reusable Rigid Sterilization Container System maintains sterility of enclosed instruments, having been validated for a period of 30 days post sterilization, using containers previously subjected to more than 100 sterilization usage cycles. The Jewel Precision Reusable Rigid Sterilization Container System is intended for sterilization of non-porous and porous items, e.g. scissors, hooks, probes, extractors, suction instruments, drivers, rasps, obturators, etc. The container does not come into direct patient contact while in use.

The provided document describes the Jewel Precision Reusable Rigid Sterilization Container System and its performance validation for sterilization efficacy, dry time, and biocompatibility, rather than an AI/ML medical device. Therefore, the information needed to answer many of the specific questions about AI/ML acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment for AI/ML) is not present in this document.

However, I can extract the relevant acceptance criteria and reported performance for the described medical device.

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

Based on the "Performance Data" and "Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence" sections, the following acceptance criteria and device performance are reported:

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 provide a specific sample size for "test sets" in the context of an AI/ML model. The testing performed is for a physical medical device (sterilization container). It mentions "containers previously subjected to more than 100 sterilization usage cycles" for the sterility maintenance claim, suggesting these cycles were part of the testing. No information on data provenance (country of origin, retrospective/prospective) is applicable or provided as it's not a data-driven AI/ML study.

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 section is not applicable as the device is a physical sterilization container, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.

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

This section is not applicable as the device is a physical sterilization container, not an AI/ML algorithm requiring expert adjudication. The "ground truth" for this device's performance is established through standardized laboratory and engineering tests (e.g., sterility testing, drying tests, biocompatibility).

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. No MRMC study was done, as this is a physical medical device and not an AI/ML diagnostic aid intended to improve human reader performance.

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

This section is not applicable. This is a physical medical device, not an AI/ML algorithm.

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

The "ground truth" for this medical device's performance relies on objective, quantitative measurements and laboratory tests based on recognized standards for sterilization (e.g., 12 log reduction for sterility assurance level), drying (absence of visible moisture), and biocompatibility (cytotoxicity testing). It is not based on expert consensus, pathology, or outcomes data in the sense of a diagnostic AI/ML system.

8. The sample size for the training set

This section is not applicable as there is no AI/ML model for which a training set would be used.

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

This section is not applicable as there is no AI/ML model or training set.

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The Stat-Mat® Minor multipurpose surgical instrument tray is used for loading an entire kit of surgical instruments for a specific case in order to conveniently organize, sterilize, transport and store the instruments between uses.

The Stat-Mat® Minor is designed using plastic and metal materials that can be reused with prevacuum or gravity displacement steam sterilization methods. The Stat-Mat® Minor should be used only with FDA-cleared and legally marketed sterilization wraps that have been cleared for the sterilization cycles listed below. The Stat-Mat® Minor has been validated with the Dextex II Sterilization Wrap [K800123]. The base containing organized surgical instrumentation can be placed directly on the back table or onto a Mayo Tray. Instruments with lumens were not tested in the Stat-Mat® Minor validation process and are therefore not recommended for use with the Stat-Mat® Minor.

Sterilization cycle parameters:

| Cycle Type | Temperature | Sterilization
Time | Pre-Vac Pulses | Dry Time |
|------------|---------------|-----------------------|----------------|------------|
| Gravity | 250°F (121°C) | 30 minutes | none | 30 minutes |
| Pre-vacuum | 270°F (132°C) | 4 minutes | 4 | 30 minutes |

The Stat-Mat® Minor is a multipurpose surgical instrument tray that consists of three primary components: a base, cover, and instrument roll. The base and cover are composed of Radel plastic. which meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with standard steam sterilization methods. The instrument roll is composed of aluminum and is used to keep ringed instruments open during sterilization. The Stat-Mat® does not contact the patient.

The provided text describes a medical device called the Stat-Mat® Minor, a sterilization tray, and details the nonclinical testing performed to validate its sterilization effectiveness. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, I cannot provide information on the aspects related to AI, ground truth establishment for AI, MRMC comparative effectiveness studies, or standalone algorithm performance.

Here's the information related to the device and its validation as per the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Stat-Mat® Minor are defined by its ability to achieve sterility assurance under specific steam sterilization cycles, as demonstrated by the inactivation of Geobacillus stearothermophilus spores. The reported performance confirms that these criteria were met.

Detailed Study Information:

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

   • Test Set Sample Size: The text states, "10 Geobacillus stearothermophilus spore strips and thermocouples were placed in the test articles." It also mentions "The test articles were double-wrapped." The number of "test articles" (Stat-Mat® Minor units) used is not explicitly stated, but it implies a sufficient number were tested to accommodate 10 spore strips and thermocouples.
   • Data Provenance: The study was conducted by MacPherson Medical Inc., presumably in the USA. The study design appears to be prospective in nature, as it involves active testing of the device for sterilization efficacy.

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

   • This question is not applicable as the study involves a physical device and sterilization efficacy, which is determined by microbiological and physical measurements, not interpretation by human experts. The "ground truth" is objective (sterility or lack thereof).

3. Adjudication method for the test set:

   • Not applicable as the determination of sterility is based on scientific methods (presence/absence of microbial growth, temperature readings), not subjective expert judgment requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiology images) to assess the impact of AI on reader performance.

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

   • No, a standalone algorithm performance study was not done. This device is a physical medical instrument tray, not an AI algorithm.

6. The type of ground truth used:

   • The ground truth used was microbiological efficacy and physical parameter measurement:
     • Microbiological: The inactivation of Geobacillus stearothermophilus spore strips to demonstrate a sterility assurance level (SAL) of 10⁻⁶. This is assessed by culturing the spore strips after sterilization to determine if any viable spores remain.
     • Physical: Thermocouples were used to verify that the required temperatures were reached and maintained within the test articles during the sterilization cycles. This ensures the physical conditions for sterilization were met.

7. The sample size for the training set:

   • Not applicable. This is a nonclinical validation study for a physical device, not an AI algorithm that requires a training set.

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

   • Not applicable, as there is no training set for this type of device validation.

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The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep™ Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep™ Antegrade catheter is intended for use in adult patients.

The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is a 15 Fr, 2 lumen, one piece Carbothane catheter with a preloaded stylet and step tip designed for antegrade placement. The catheter is available in multiple lengths. The procedure kit includes the necessary accessories to correctly insert the catheter.

The provided 510(k) summary for the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238) does not describe a study that uses AI/algorithm performance. Instead, it focuses on demonstrating the substantial equivalence of a medical device (a catheter) to a predicate device through traditional engineering and biological performance testing.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context.

Here's a breakdown of the information that is available based on your request, adapted for a medical device rather than an AI/algorithm:

Acceptance Criteria and Device Performance for Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238)

This submission describes a medical device, a chronic hemodialysis catheter, and its performance is assessed through laboratory testing to demonstrate substantial equivalence to a predicate device, not through an AI/algorithm performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion from Submission: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. Based on the indications for use, design, safety and performance testing, the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheters met the requirements that are considered adequate for its intended use and is substantially equivalent to the predicate devices."

The following points are not applicable (N/A) as the submission describes a physical medical device and not an AI/algorithm:

2. Sample size used for the test set and the data provenance: N/A (This was a physical device performance study, not a data-driven test set.)
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 not relevant for physical device testing this context; performance is measured against physical standards/benchmarks.)
4. Adjudication method for the test set: N/A (Not applicable for physical device testing.)
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-assisted device.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is not an algorithm.)
7. The type of ground truth used: N/A (For physical devices, performance is measured against engineering specifications, industry standards, and predicate device performance, not "ground truth" derived from expert consensus or pathology in the sense of an AI model.)
8. The sample size for the training set: N/A (This is not an AI/algorithm that requires a training set.)
9. How the ground truth for the training set was established: N/A (Not applicable.)

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