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The InstruSafe® Sterilization Container is a reusable sterilization container system 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 for 180 days. The InstruSafe® Sterilization Container includes accessories such as trays, baskets, filters, data cards and tamper proof locks.
The InstruSafe® Sterilization Container consists of various models within the validated product line. All models are available with perforated lids and either perforated or non-perforated bottoms. All models are intended to be used with single use paper filter.
The container is a reusable device designed to be used with the following sterilization cycle parameters:
Pre-Vacuum Steam Sterilization Cycle:
4 minutes
132°C (270 °F)
Drying Time Minimum: 30 minutes

The InstruSafe® Sterilization Container is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. They consist of various sizes of bottoms and lids that provide an effective packaging method for sterilization, storage and transportation of surgical instruments by healthcare providers. These containers are suitable for use in pre-vacuum Steam Sterilizers with a tray or basket accessory. Metal (Stainless Steel) surgical instruments like forceps, scissors, clamps, etc. including lumened/cannulated instruments are placed in the trays or baskets for sterilization.
Note: The maximum number of Lumens/Lumen Configuration is as follow:
2 lumens with ≥ 1mm I.D. x ≤ 200mm and a second lumen ≥ 5mm I.D. x ≤ 400mm
The containers are available in different models such as full size (1/1), three-quarter size (3/4), half size (1/2) and XL.
InstruSafe® Sterilization Container is manufactured using aluminum alloy, stainless steel, silicone and the surfaces are protected by a layer of anodized aluminum oxide to prevent corrosion.
The containers must only be used with single use paper filters.

This document describes the regulatory submission for the InstruSafe® Sterilization Container (K180528) and demonstrates its substantial equivalence to predicate devices. The information provided heavily relies on non-clinical performance data rather than a study with human readers or AI algorithms. As such, many of the requested data points related to MRMC studies, training sets, and expert consensus for ground truth are not applicable to this type of device and submission.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through various non-clinical performance tests, ensuring its ability to sterilize enclosed medical devices and maintain sterility.

Study Proving Device Meets Acceptance Criteria

The studies detailed for the InstruSafe® Sterilization Container are non-clinical, bench-validation studies, rather than clinical trials or AI performance evaluations.

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify numerical sample sizes for the non-clinical tests (e.g., number of containers tested, number of sterilization cycles performed, or number of microbial challenges). It states "The sterilization containers were tested..." which implies a sufficient number for validation, but no precise count is given.
   • Data Provenance: The studies were non-clinical bench testing. The country of origin for the data is not explicitly stated but can be inferred to be in the USA, given the FDA submission. The studies were designed to be prospective validation tests according to established medical device testing standards.

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

   • This is not applicable as the studies are non-clinical, bench-level performance validations for a sterilization container. Ground truth is established by objective measurements against predefined industry standards (e.g., AAMI, ISO) rather than subjective expert interpretation of medical images or data.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like "2+1" or "3+1" are typical for clinical studies involving human readers and subjective assessments (e.g., radiology reads). For non-clinical, objective performance testing, results are determined by adherence to pre-defined scientific and engineering standards and pass/fail criteria.

4. 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 device is a reusable sterilization container and does not involve AI or human "readers" in the context of medical image interpretation or diagnosis. Therefore, an MRMC comparative effectiveness study was not performed.

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

   • Not applicable. This device is a physical medical device (sterilization container), not an AI algorithm.

6. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device is based on objective, verifiable measurements against established medical device sterilization, biocompatibility, and mechanical performance standards, such as those published by AAMI (Association for the Advancement of Medical Instrumentation) and ISO (International Organization for Standardization). For example:
     • Sterilization Efficacy: Measured by indicator organisms (bioburden reduction) after a sterilization cycle.
     • Dry Time: Measured objectively following a sterilization cycle.
     • Sterility Maintenance/Microbial Aerosol Challenge: Measured by preventing microbial ingress over time.
     • Biocompatibility: In vitro and in vivo tests against ISO 10993 standards.
     • Mechanical Integrity: Measured by stress tests, weight limits, and functional checks.

7. The Sample Size for the Training Set:

   • Not applicable. This device is hardware, not a machine learning model, so there is no "training set."

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As there is no training set for a machine learning model, this question is irrelevant to the described device.

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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 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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