(97 days)
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.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Organize and protect other medical devices sterilized by a healthcare provider. Allow sterilization of enclosed medical devices during a pre-vacuum steam sterilization cycle. Used in conjunction with legally marketed Genesis rigid containers. Not intended on their own to maintain sterility. | The device's indications for use align with this, and its performance is validated through sterilization testing. |
| Sterilization Parameters | Cycle: Pre-Vacuum | Sterilization validation testing was performed to demonstrate compatibility with a pre-vacuum steam sterilization cycle. |
| Temperature: 270°F (132°C) | Sterilization validation testing was performed at 270°F (132°C). | |
| Minimum Exposure Time: 4 minutes | Sterilization validation testing was performed with a 4-minute exposure time. | |
| Minimum Dry Time: 30 minutes | Sterilization validation testing was performed with a 30-minute dry time. | |
| Lumen Claims | Specific dimensions for minimum inside diameter, maximum length, and number of lumens for various Summit Cassette Models (e.g., IN-2681: 3mm ID, 200mm length, 1 lumen; IN-0000: 1mm ID, 400mm length, 5 lumens). | The device's performance is demonstrated for the specified lumen claims in the table. |
| Worst Case Load | IN-2681 tray identified as the worst case validated load by vent-to-volume calculation. | The system is validated for the worst-case load. |
| Total Weight Limit | Total weight of the container system (container, tray, instrument load) must not exceed 25 lbs. | Not explicitly stated as "met," but implied by the successful sterilization validation. The table for "Estimated Weight - Tray w/ instruments" for various part numbers shows individual tray weights well below 25 lbs, so the cumulative system weight would need to adhere to this. |
| Material Composition | No changes from predicate device; components made of anodized aluminum, stainless steel, blue silicone, black silicone, polyester, ultem™ 1000. | Confirmed as "No changes from predicate device." |
| Physical Properties | Includes perforated base, perforated cover, silicone inserts, handles, latches, feet, and optional posts, dividers, and shelves. | Confirmed as identical to the predicate device. |
| Toxicological Properties | No change from predicate device; biocompatibility, including sterilant residue limits. | Confirmed as "No change." |
| Shelf Life | Reusable (5-year accelerated shelf life study). | Confirmed as "No change." |
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.
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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.
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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.
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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).
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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.
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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.
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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.
- The "ground truth" for this device's performance is the successful completion of sterilization validation testing, typically involving:
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The sample size for the training set
- Not applicable, as this is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device 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.(b)
Classification. Class II (performance standards).