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Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterlized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.

Sterilization methods and configurations - Sterrad NX Standard Sterilization Cycle

Lumen claims for Sterrad NX Standard Sterilization Cycle

The worst case validated load by vent-to-volume calculation is the IN-2681 tray.

Summit Medical Inc. InstruSafe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes / trays do not have direct patient contact. The cassettes / trays by themselves do not maintain sterility.

The cassettes / trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes / trays have perforations to allow sterilant penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassette / tray during the sterilization process and subsequent storage and transportation.

InstruSafe Instrument Protection System cassettes include

• perforated base
• perforated cover
• silicone inserts (hold-it / hold down)
• Handles
• Latches
• Feet
• Posts (optional)
• Divider (optional)
• Shelf (optional)

The cassette contains components made of anodized aluminum, stainless steel, blue silicone, black silicone, polyester, ultem™ 1000

The provided document is a 510(k) premarket notification for the InstruSafe® Instrument Protection System. It describes the device, its intended use, and a comparison to a predicate device, focusing on sterilization methods.

However, the document does not contain information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. This document is for a non-AI medical device and primarily focuses on demonstrating substantial equivalence to a predicate device, particularly regarding a new sterilization cycle. Therefore, I cannot extract the requested information as it is not present.

Specifically, the document does NOT contain information on:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set sample size related to an AI/ML device.

The information provided pertains to the physical and functional characteristics of instrument protection cassettes and their compatibility with a specific sterilization cycle. The "performance data" mentioned refers to sterilization validation testing, not AI algorithm performance.

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Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during Amsco V-PRO Low Temperature Sterilization Cycles. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.

Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes / trays by themselves do not maintain sterility. The cassettes / trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes / trays have perforations to allow sterilant penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassette / tray.

The provided document is a 510(k) premarket notification for a medical device (Instru-Safe® Instrument Protection System), which focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. The document primarily details the device's intended use and compares its characteristics and performance to a previously cleared predicate device.

Therefore, many of the requested elements for describing an acceptance criteria study, such as sample size for test sets, ground truth establishment for test and training sets, the number and qualifications of experts, adjudication methods, or MRMC studies, are not explicitly mentioned or applicable in this type of regulatory submission.

However, based on the information provided, here's an attempt to address the request as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the intended use and the predicate device's performance. The "Performance Data" section in the summary directly addresses this.

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

The document does not specify a separate "test set" in the context of an AI/algorithm study. For the sterilization validation, the specific number of units tested (cassettes/trays, instruments, sterilization cycles) is not provided. The data provenance would be from internal testing conducted by Summit Medical Inc. as part of their regulatory submission. The study is prospective in nature for a new device attempting to be cleared for the specified sterilization cycles.

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

Not applicable. This document does not describe the establishment of ground truth by experts for a test set in the context of an AI/algorithm. The "ground truth" for sterilization effectiveness would be determined by standard microbiological and physical indicator tests, which do not typically involve human expert interpretation in the same way as, for example, image analysis.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication for a test set as this is not an AI/algorithm performance study.

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-assisted device, and no MRMC study was performed or described.

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

Not applicable. This device is a physical instrument protection system, not a software algorithm.

7. The type of ground truth used

For the sterilization validation, the ground truth would be established through sterilization effectiveness testing using biological and chemical indicators, which are standard methods to confirm the complete inactivation of microorganisms. For the biocompatibility claim, the ground truth was established by laboratory testing against ISO 10993-5 requirements.

8. The sample size for the training set

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

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

Not applicable. As there is no training set mentioned.

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Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100NX Flex Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.

Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes / trays by themselves do not maintain sterility. The cassettes / trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes / trays have perforations to allow sterilant penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassette / tray.

The provided document is a 510(k) premarket notification for a medical device (Instru-Safe® Instrument Protection System) and describes the device's intended use and performance testing related to sterilization. It is not an AI/ML device, and therefore, many of the requested categories for AI/ML studies are not applicable.

Here's a breakdown based on the provided text, while noting the irrelevance of AI-specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the sterilization validation testing. It mentions "Sterilization validation testing was performed" for compatibility with the Sterrad 100NX Flex Sterilization Cycle. The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given the nature of validation for a physical medical device, it would most likely be prospective testing conducted in a laboratory or clinical setting.

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

Not applicable. The "ground truth" for this device involves demonstrating the physical property of sterilization compatibility and material biocompatibility, which are typically assessed through standardized laboratory tests, not expert interpretation of diagnostic data.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation of data 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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The ground truth used would be based on the validated efficacy of the Sterrad 100NX Flex Sterilization Cycle to sterilize medical devices and the results of ISO 10993-5 cytotoxicity testing. This is objective, measurable data from physical and biological tests, not expert consensus, pathology, or outcomes data in a diagnostic sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed Genesis rigid containers. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility.

Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes / trays by themselves do not maintain sterility. The cassettes / trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes / trays have perforations to allow sterilant penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassette / tray.

The provided document is a 510(k) summary for the Instru-Safe® Instrument Protection System, which is a sterilization tray. This document focuses on demonstrating substantial equivalence to a predicate device (K133015) rather than on presenting a clinical study or performance data of a new AI device. Therefore, many of the requested elements for describing an AI device's acceptance criteria and study proving its performance (such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or type of ground truth) are not applicable or cannot be extracted from this document.

The document discusses the performance data in terms of sterilization validation testing for the device's ability to allow sterilization of enclosed medical devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Indications for Use" and the "Sterilization methods and configurations" which specify the conditions under which the device is intended to function effectively for sterilization. The reported performance is that the device has passed "Sterilization validation testing" under these conditions.

Since the provided text is for a traditional medical device (sterilization tray) and not an AI/ML powered device, the following points are largely not applicable. However, I will answer them based on what can be inferred or explicitly stated, noting the limitations.

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 a distinct "test set" sample size in terms of cases or patients, as this is a device validation, not a clinical trial evaluating diagnostic or predictive accuracy. The "test" in this context refers to the sterilization validation testing of the physical device models and lumen configurations. For lumen claims, specific models like IN-2681, IN-0000, and IN-6105 with various lumen dimensions were tested. The "worst case validated load" (IN-2681 tray) suggests testing was performed to cover the most challenging scenarios.
   • Data Provenance: Not applicable in the context of clinical data. The performance data is derived from laboratory-based sterilization validation testing of the physical devices.

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. The "ground truth" for a sterilization device is whether it effectively sterilizes, which is determined by microbiological and physical testing methods, not expert human interpretation of medical images or pathologies.

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

   • Not applicable. Adjudication methods are relevant for subjective interpretations, whereas sterilization effectiveness is assessed objectively through validated protocols (e.g., biological indicators, chemical indicators, physical parameters).

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. MRMC studies are used for evaluating diagnostic performance of imaging modalities or AI systems that assist human readers. This device is a physical sterilization tray.

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

   • Not applicable. This is not an algorithm or AI system. Its performance is inherent in its design and its ability to withstand and facilitate sterilization processes.

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

   • The "ground truth" for this device's performance is the successful completion of sterilization validation testing, typically involving:
     • Biological Indicators: Confirmation of microbial kill (e.g., Geobacillus stearothermophilus spores).
     • Chemical Indicators: Verification of exposure to sterilant.
     • Physical Monitoring: Verification of temperature, pressure, and exposure time within the sterilizer.
     • Dryness Assessment: Ensuring instruments are dry after the cycle.
   • The document states "Sterilization validation testing was performed to demonstrate Instru-Safe Instrument Protection System compatibility when used in a Four (4) minute pre-vacuum steam sterilization cycle within a Genesis rigid container." This implies the use of standard sterilization validation protocols to confirm efficacy.

8. The sample size for the training set

   • Not applicable, as this is not an AI/ML device that requires a training set.

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

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

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Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad® 100NX Express Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. The Instru-Safe Instrument Protection System has no lumen claims for the Sterrad 100NX Express Cycle.

Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider.

The provided text is a 510(k) premarket notification for a medical device called the "Instru-Safe® Instrument Protection System." This document is a regulatory filing with the FDA and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The device described, an "Instrument Protection System," is a sterilization tray used to organize and protect other medical devices during sterilization. It is a traditional medical device, not an AI/ML diagnostic or therapeutic system. Therefore, the questions related to AI/ML device performance metrics (such as effect size of human readers with AI assistance, standalone algorithm performance, training set details, or ground truth establishment for AI models) are not applicable to this document.

The document lists "Indications for Use" which specify how the device is intended to be used, but these are not "acceptance criteria" in the sense of performance metrics for an AI/ML algorithm. The table on page 4/6 provides technical specifications for different parts of the "Instru-Safe® Instrument Protection System" (e.g., maximum number of instruments, estimated weight), which are characteristics of the physical device rather than performance metrics of a diagnostic algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device from the provided document.

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Instru-Safe ® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. The Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.

Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider.

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Instru-Safe Instrument Protection System." This document describes the device, its intended use, and lists various models. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Based on the provided text, I can only provide the following information:

Device Description:

• Trade/Device Name: Instru-Safe Instrument Protection System
• Regulation Number: 21 CFR 880.6850
• Regulation Name: Sterilization Tray
• Regulatory Class: II
• Product Code: KCT
• Manufacturer: Summit Medical Incorporated

Intended Use/Indications for Use:

"Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. The Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instrument Protection System cassettes are not intended on their own to maintain sterility."

Sterilization Validation:

The device models were validated with specified rigid containers for:

• Sterrad 100S Standard Cycle
• Sterrad 100NX Standard Cycle

Lumen Claims for Sterrad 100S Standard and Sterrad 100NX Standard Cycles:

• 4 Stainless steel lumens with 3mm inner diameter × 400mm length (All appropriate sized models listed in Table 1 with the exception of IN-2681)
• 2 Stainless steel lumens with 3mm inner diameter × 200mm length
• 1 Stainless steel lumens with 3mm inner diameter × 200mm length (IN-2681)
• 1 Stainless steel lumens with 1mm inner diameter × 65mm length

Missing Information:

The document does not contain any of the following information explicitly related to acceptance criteria or a study proving the device meets them:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs. without AI assistance. (This device is a physical sterilization tray, not an AI software, so this section is not applicable).
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done. (Not applicable for a physical device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set. (Not applicable for a physical device, as there is no "training set" in the AI/ML sense).
9. How the ground truth for the training set was established. (Not applicable).

To obtain the missing information, one would need to review the actual submission documents (e.g., test reports, validation studies) that were provided to the FDA by Summit Medical Incorporated for K140289. The letter provided here is merely the FDA's decision letter based on that submission.

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Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility.

Not Found

The provided text is a 510(k) premarket notification from the FDA regarding the "Instru-Safe® Instrument Protection System." This document is primarily concerned with regulatory approval and does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of a "study" related to AI device performance.

The device in question, the "Instru-Safe® Instrument Protection System," is classified as a "Sterilization Wrap" (21 CFR 880.6850). This is a physical medical device used to organize and protect other medical devices during pre-vacuum steam sterilization cycles.

Therefore, the requested information for an AI-related study (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and effect size with AI assistance) is not applicable to this document.

The document states the Intended Use of the device, which acts as the de facto acceptance criteria in terms of functionality. These are:

• To organize and protect other medical devices.
• To allow sterilization of the enclosed medical devices during pre-vacuum steam sterilization cycles.
• To be used in conjunction with a legally marketed wrap or Aesculap rigid container.
• Not intended on their own to maintain sterility.

The document also specifies the validated sterilization parameters:

• Cycle: Pre-vacuum
• Temperature: 270°F (132°C)
• Exposure Time: 4 minutes
• Minimum Dry Time: 30 minutes

And for certain models used with Aesculap containers:

• Sterilization: Steam prevacuum sterilizers ONLY operating at 270°F (132°C) for 4 minutes exposure time.

And specific lumen size validations:

• Minimum Inside Diameter: 1mm, 3mm, 5mm
• Maximum Length: 65mm, 76mm, 177mm, 200mm, 241mm, 400mm
• Number of Lumens: 1, 2, 4, 17

This information pertains to the physical and functional characteristics of the sterilization cassettes, ensuring they are compatible with the specified sterilization processes and can hold certain instruments. It does not involve any AI or software validation.

In summary, none of the requested AI-related study information can be extracted from this document because the device described is a physical medical device (sterilization wrap/cassette), not an AI/software as a medical device.

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Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam or ethylene oxide sterilization cycles. The Instru-Safe System cassettes are intended to be used in conjunction with central legally marketed wrap or with a Genesis rigid container. The Instru-Safe System cassettes are not intended on the own to maintain sterility.

Not Found

The provided text is a 510(k) premarket notification decision letter from the FDA regarding "INSTRU-SAFE Instrument Protection Systems" (K051157). It confirms substantial equivalence to predicate devices for device sterility. However, it does not contain any information about acceptance criteria, device performance, validation study details, or ground truth as requested in the prompt.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

The document primarily focuses on:

• Device identification: INSTRU-SAFE Instrument Protection Systems.
• Regulatory classification: Class II, Product Code KCT, Regulation Number 21 CFR 880.6850 (Sterilization wrap).
• Indications for Use: Used to organize and protect medical devices during pre-vacuum steam or ethylene oxide sterilization cycles, in conjunction with legally marketed wraps or rigid containers.
• Sterilization methods and configurations: Specific times for steam and ethylene oxide sterilization cycles with different wrap/container types (140 count woven wrap, non-woven wrap, Genesis Container).
• FDA's determination: The device is substantially equivalent to legally marketed predicate devices.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or the actual study report submitted with the 510(k) application, which would detail the validation studies conducted to demonstrate the device's performance against established criteria for sterility.

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