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510(k) Data Aggregation
(260 days)
The MINNE TIES™ MMF Suture System is an adjustable flexible plastic band that wraps between and around a tooth to create an anchorage point for maxilla-mandibular fixation and immobilization. MINNE TIES™ MMF Suture System is suitable for:
- Pre-operative fixation
- Per-operative fixation
- Short-term (up to 3 weeks) fixation for minimally displaced fractures
- Splintage post jaw dislocation
The MINNE TIES™ MMF Suture System contains:
- Four (4) 1.0mm sized sutures
- Seven (7) 0.7mm sized sutures
- One (1) 0.5mm Sized suture
and are used to establish maxilla-mandibular fixation (MMF) and immobilization by applying independently balanced series of sutures bilaterally between and/or around the teeth in the interdental space (i.e. triangular apical embrasure). The sutures provide a stabilizing occlusive force allowing for short term (up to 3 weeks) fixation for minimally displaced fractures for pre-operative and per-operative fixation and splintage post jaw dislocation. An Introducer is used to advance sutures between and/or around the teeth. A cheek retractor is included with the system to organize the ties during the procedure.
The MINNE TIES™ MMF Sutures are made of polypropylene, polyester and stainless steel. The cheek retractor is made of polypropylene.
The provided text describes a 510(k) premarket notification for the "MINNE TIES™ MMF Suture System". This document indicates the device's substantial equivalence to a legally marketed predicate device rather than a ground-up study proving its performance against acceptance criteria for a novel AI/ML device.
Therefore, the information required to answer the prompt for an AI/ML device (e.g., acceptance criteria for AI performance, sample sizes for AI training/test sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided document.
The document focuses on:
- Device Description: The components and general use of the MINNE TIES™ MMF Suture System.
- Intended Use/Indications for Use: What the device is intended for (maxilla-mandibular fixation).
- Predicate Device Comparison: A detailed comparison to a previously cleared device (Rapid IMF™ - K030605) to demonstrate substantial equivalence.
- Non-Clinical Testing: Physical and material tests (tensile strength, fatigue, biocompatibility, sterilization, packaging, shelf life, corrosion resistance, system handling/cadaver test) to show that the new device performs similarly and safely to the predicate.
- Clinical Testing: Explicitly states that clinical data was not required for this device, which further indicates the absence of human-in-the-loop performance studies or deep learning-based performance evaluations.
In summary, this document is for a medical device that does not involve artificial intelligence or machine learning, and thus the specific metrics and study methodologies requested in the prompt related to AI/ML device acceptance criteria are not applicable or provided.
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(111 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 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.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Sterilant Penetration in Amsco V-PRO Low Temperature Sterilization Systems (Standard, Lumen, Non Lumen Cycles) | Sterilization validation testing was performed to demonstrate Instru-Safe Instrument Protection System compatibility when used in an Amsco V-PRO Low Temperature Sterilization Systems with a legally marketed wrap or Aesculap rigid container. |
| Material Compatibility | No changes from predicate device (K133015). |
| Toxicological Properties (Biocompatibility/Cytotoxicity) | MEM Elution Cytotoxicity (ISO 10993-5): Test samples met USP and ISO 10993-5 requirements; considered non-cytotoxic under test conditions. |
| Shelf Life | No Change (Reusable, 5-year accelerated shelf life study for predicate device). |
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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(246 days)
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
| Acceptance Criteria (Implied from Performance Data Section) | Reported Device Performance (from "Performance Data" and "Performance" sections) |
|---|---|
| Sterilization compatibility (allowing sterilization of enclosed medical devices during a Sterrad 100NX Flex Sterilization Cycle with legally marketed wrap or Aesculap rigid container) | Sterilization validation testing was performed to demonstrate Instru-Safe Instrument Protection System compatibility when used in a Sterrad 100NX Flex Sterilization Cycle with a legally marketed wrap or Aesculap rigid container. This new sterilization cycle does not affect safety and effectiveness of the Instru-Safe Instrument Protection System. The device's "Performance" section explicitly states "Sterrad 100NX Flex Sterilization Cycle" under "Sterilant Penetration." |
| Material Biocompatibility (cytotoxicity) | MEM Elution Cytotoxicity (ISO 10993-5) test samples met USP and ISO 10993-5 requirements, passed, and are considered non-toxic. |
| Shelf Life (reusability) | Reusable (5-year accelerated shelf life study). "No Change" (from predicate device's shelf life). |
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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(189 days)
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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(142 days)
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:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- 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).
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done. (Not applicable for a physical device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set. (Not applicable for a physical device, as there is no "training set" in the AI/ML sense).
- 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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(169 days)
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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