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The Tecomet Global Unite Short Stem Instrumentation (GUSS) are intended to be used to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder, in accordance with its cleared indications for use and contraindications.

The Tecomet Global Unite Short Stem Instrumentation (GUSS) is intended only for use as surgical instrumentation for the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder. Tecomet manufactures this instrumentation exclusively for DePuy. The instrumentation is intended to be used with the GLOBAL UNITE Short Stem Shoulder System which was cleared separately under premarket notification K202098 (K202098 did not include instruments). The Tecomet GUSS instruments are a combination of Class I General Use Instruments, Class II Short Stem Shoulder-specific instruments and a Class II Sterilization Tray. The instruments include Humeral Stem Brosteotomes in 8mm-16mm sizes, a Stem Wrench, 155° Proximal Reaming Guides, 145° Proximal Reaming Guides, Bullet Tip Reamers and a sterilization tray. Although the tray is included in the system, it is not the subject of this premarket notification. The tray is already cleared by the Tecomet (Symmetry Medical) 510(k) K012105 (Polyvac Surgical Instrument Delivery System).

The Tecomet Global Unite Short Stem Instrumentation (GUSS) is all manufactured from 17-4 PH SST Stainless Steel. The instruments are exclusively for, and must be used in accordance with the DePuy GLOBAL UNITE Platform Anatomic and Reverse Shoulder Surgical Technique. The devices are reusable and must be sterilized by the user prior to use.

Here's a breakdown of the acceptance criteria and study information for the Tecomet Global Unite Short Stem Instrumentation, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the sterilization efficacy, dry time, or design validation testing. Specifically:

• Sterilization and Dry Time: No sample size is mentioned for these tests.
• Design Validation: "N/A design validation cadaver testing" is mentioned, implying cadavers were used, but the quantity is not specified.
• Data Provenance: The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any of the tests.

4. Adjudication Method

• The document does not specify any adjudication method for the test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This device is surgical instrumentation, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance

• This question is not applicable. The device is surgical instrumentation, not an algorithm or software.

7. Type of Ground Truth Used

• Sterilization Efficacy: The ground truth is the demonstration of a 10⁻⁶ SAL, which is a microbiological standard.
• Pre-vacuum Dry Time: The ground truth is the established minimum dry time achieved necessary for effective sterilization.
• Design Validation: The ground truth is "acceptable performance" during cadaver testing, likely assessed by surgeons or qualified personnel evaluating the functionality and usability of the instruments in a simulated surgical environment.

8. Sample Size for the Training Set

• This question is not applicable as the device is surgical instrumentation and does not involve a training set as would be found in machine learning models.

9. How Ground Truth for the Training Set Was Established

• This question is not applicable as there is no training set for this type of device.

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Klockner Surgical Box is a set of sterilization cassettes (thirteen different models between injection molding and machining sterilization cassettes). They all are designed to hold various dental surgical drills, instruments and/or tools in order to organize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians and dental professionals in health care or equivalent facilities. The sterilization cassettes have to be enclosed in an FDAcleared steam sterilizable wrap and sterilized in an FDA-cleared sterilizer according to the following cycle:

• o Pre-vacuum Steam at 134℃ for 4 minutes with 15 minutes drying time.
  The trays are intended for sterilization of metal and thermoplastic loads.

Klockner Surgical Box is a reusable rigid sterilization cassette or organizing tray intended for the purpose of containing reusable (and in some cases, non-reusable) devices for sterliization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization.
Under the device trade name "Klockner Surgical Box", two different sets of sterliization surgical boxes are presented: (Both sets differ in the way the plastic is molded).

• Injection molding sterilization cassettes ●
• Machined sterilization cassettes ●

The provided text describes the Klockner Surgical Box, a set of sterilization cassettes, and its regulatory clearance (K173642). It focuses on non-clinical data to demonstrate substantial equivalence to predicate devices, rather than clinical data or AI algorithm performance.

Therefore, the requested information regarding AI algorithm performance metrics (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, effect size of human readers with AI assistance) is not applicable to this document. This document pertains to the physical and functional performance of a medical device (sterilization cassettes) and not an AI-powered diagnostic or assistive tool.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, based on the provided non-clinical performance testing.

1. Table of acceptance criteria and the reported device performance:

The document describes performance tests in "Table 5.1 Brief description of non-clinical performance testing" on page 11. The "Results" column essentially serves as the reported device performance, and the context of the "Standard(s) used" implies the acceptance criteria defined by those standards.

2. Sample sized used for the test set and the data provenance:

The document states that "Surgical Box Kit Klockner and Bone Space Maintainers Box Kit are the containers that represent worst cases" for the validation tests. This implies that these specific models were used as representatives for the entire Klockner Surgical Box line. The exact number of units of these "worst-case" models used for testing is not explicitly stated, but it refers to "the kits" for the limits of reuse test.

• Test Set Sample Size: Represented by "Surgical Box Kit Klockner" and "Bone Space Maintainers Box Kit" as worst-case containers. The precise number of these kits tested is not provided, other than "the kits" for reuse.
• Data Provenance: The tests were carried out to demonstrate compliance for the device manufactured by Soadco, S.L. in Andorra, implying the tests were conducted for this device and potentially at their facility or a contracted lab. The document does not specify if the data is retrospective or prospective, but given it's for premarket notification, it would be data collected specifically for this submission.

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

This information is not applicable. The study is a non-clinical performance evaluation of a physical sterilization device, not an AI model that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be defined by the rigorous standardized methods of the cited regulatory standards (e.g., absence of microbial growth, visual cleanliness, material integrity after cycles).

4. Adjudication method for the test set:

Not applicable, as it pertains to expert consensus for AI model evaluation, which is not relevant here. The evaluation methods for the device performance tests would follow the protocols of the cited standards.

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 a non-clinical study for a physical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a non-clinical study for a physical device, not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests is based on objective, quantifiable measures and methodologies prescribed by recognized international and national standards:

• Cleaning validation: Visual inspection and quantifiable cleaning measures (e.g., residual soil detection).
• Steam sterilization validation: Absence of microbial growth in biological indicators after sterilization.
• Limits of reuse: Meeting inspection and performance criteria (e.g., material integrity, functionality) after a specified number of reprocessing cycles.
• Drying time: Visual and quantifiable dryness.

8. The sample size for the training set:

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

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The iDrive™ Ultra sterilization tray (IDRVTRAY) is intended to provide storage for the iDrive™ Utra powered stapling system during sterilization, storage and transportation within the hospital environment. The iDrive™ Ultra Sterilization Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2) iDrive™ battery insertion guides and one (1) iDrive™ Ultra manual adapter tool. The tray is intended to be sterilized by the following cycles:

Prevacuum Steam Cycles 132°C for 4 minutes 134°C for 3 minutes

Vacuum Dry: 20 minutes

The iDrive™ Ultra sterilization tray is an optional, over-the counter, accessory to aid in storage and sterilization of the iDrive™ Ultra powered handle, Endo GIA™ adapter, iDrive™ battery insertion guide and iDrive™ Ultra manual adapter tool. It can simultaneously accommodate the following components:

One (1) iDrive™ Ultra powered handle

Two (2) Endo GIA™ adapters

Two (2) iDrive™ battery insertion guides

One (1) iDrive™ Ultra manual adapter tool

The iDrive™ Ultra sterilization tray is an aluminum tray which is perforated to allow penetration of steam during steam sterilization. The tray can be processed through a minimum autoclave cycle of either 134°C for 3 minutes or 132°C for 4 minutes while being wrapped with a CSR wrap or within a sterilization container system.

Here's an analysis of the provided text regarding the iDrive™ Ultra sterilization tray, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed report of a new clinical study. As such, information regarding AI performance metrics (like sensitivity, specificity, F1 score), sample sizes for AI training/testing, expert qualifications, and MRMC studies will not be present as this device is a physical sterilization tray, not an AI diagnostic or assistive tool.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Due to the nature of the device (a physical sterilization tray) and the document (510(k) Summary), this information is not applicable in the context of an AI/algorithm test set. The "test set" here refers to the actual physical trays and associated sterilization equipment used for physical, performance-based testing.

• Sample Size: Not explicitly stated as a number of "samples" in the way an AI study would define it. The testing involved multiple sterilization cycles and evaluations on the physical device. Typically, for such devices, a statistically significant number of cycles or tests are performed (e.g., n=3 for replicates, or stress testing until failure for durability), but the exact numbers are not detailed in this summary.
• Data Provenance: Not explicitly stated. The testing would have been conducted by Covidien, LLC, likely in their own laboratories or through contract labs. It's prospective testing for the purpose of this submission.
• Country of Origin: Not specified for the testing itself, but the submitter is Covidien LLC from North Haven, CT, USA.

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

This is not applicable as the device is a physical sterilization tray, not an AI system requiring expert-derived ground truth. The "ground truth" for sterilization effectiveness would be determined by objective measures (e.g., biological indicators, chemical integrators, sterility assays, temperature/pressure monitoring) according to validated protocols, not expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

Not applicable for a physical device. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert ratings are resolved for diagnostic classifications, which is irrelevant for a sterilization tray.

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 a physical medical device, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of a sterilization tray involves objective, verifiable outcomes related to sterilization efficacy and device integrity:

• Sterilization Efficacy: Achieved by passing established sterilization cycle parameters (temperature, pressure, time, vacuum dry time) and demonstrated sterility through biological indicators (killing of spore-forming bacteria), chemical indicators (color change), and physical monitoring of the autoclave cycle.
• Material Compatibility: Demonstrated by conformity to ISO 10993-1.
• Durability/Reusability: Demonstrated by the tray's physical integrity and functional performance after repeated sterilization cycles.
• Containment/Organization: Demonstrated by the physical fit of the specified components within the tray.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/machine learning device.

Summary of the Study Proving Device Meets Acceptance Criteria (from the 510(k) Summary):

The document states: "PERFORMANCE DATA: Testing has been performed and includes testing to the following standards: - ANSI/AAMI ST77:2006 - AAMI TIR30:2003 ."

These standards are critical for sterilization practices and medical device material compatibility, respectively:

• ANSI/AAMI ST77:2006 (or its current version): This standard typically covers "Containment devices for reusable medical device sterilization." It would detail requirements and test methods for instrument trays, wrappers, and containers regarding their ability to facilitate sterilization, prevent recontamination, and withstand reprocessing.
• AAMI TIR30:2003 (or its current version): This Technical Information Report (TIR) from AAMI focuses on "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices." While the tray itself isn't a "reusable medical device" in the same sense as an instrument, this TIR often provides guidance on material compatibility and resistance to reprocessing methods, including sterilization.

Implicit Study Design:

The "study" would involve:

1. Preparation: Loading the iDrive™ Ultra sterilization tray with the specified maximum configuration of instruments/components.
2. Sterilization Cycles: Running the loaded tray through the specified prevacuum steam cycles (132°C for 4 minutes and 134°C for 3 minutes, both with a 20-minute vacuum dry time) in a validated autoclave, likely using an FDA-cleared sterilization wrap.
3. Sterility Assurance: Monitoring the sterilization cycle parameters, and using biological and chemical indicators to confirm that sterility was achieved within the tray.
4. Material Compatibility/Integrity: Visual and functional inspection of the tray and its components after multiple sterilization cycles to ensure no degradation, melting, warping, or other adverse effects that would compromise its function or the sterility of the contents.
5. Biocompatibility: Evidence of compliance with ISO 10993-1, likely through material certificates and prior evaluations of the silicone and aluminum materials.
6. Load Capacity Testing: Demonstrating that the tray can safely support 15 pounds without structural failure.

The "acceptance criteria" are implied by the successful completion of these tests in accordance with the cited standards and the stated operational parameters for the device. The conclusion of the 510(k) is that, based on this testing and comparison to predicate devices, the iDrive™ Ultra sterilization tray is substantially equivalent and safe and effective for its intended use.

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