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DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is a reusable sterilization tray intended for pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices. DetachaTip® III Plus Multi-Use Instrument Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.

DetachaTip® III Plus Multi-Use Instrument Tray is intended for use with DetachaTip® III instruments and ConMed reusable medical devices meeting challenge conditions defined in Table 1. The MAXIMUM recommended load is: 25 lb [11.3 kg].

The ConMed DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is used to retain reusable instruments during steam sterilization. The tray consists of a perforated tray base and lid made from polypheny sulfone (Radel®). Latches securely hold the tray base, and handles are provided for transportation. A perforated silicone mat protects instruments placed in the bottom of the tray. A Radel® instrument rack separates and secures the DetachaTip® III instruments throughout sterilization processing and/or storage. The tray is not intended to maintain sterility. The instrument tray is to be used with an FDA cleared sterilization wrap.

DetachaTip® III Plus Multi-Use Instrument Tray is designed to fit a standard autoclave, comprised of materials resistant to corrosion, and able to withstand repeat steam sterilization cycles. The tray is designed to withstand repeated use. It is not designed to be serviced or repaired. The materials comprising the tray are biocompatible and will not contaminate reusable medical devices.

The provided document describes a 510(k) summary for the ConMed DetachaTip® III Plus Multi-Use Instrument Tray. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel medical device like an AI algorithm.

Therefore, many of the requested categories for describing an AI study's acceptance criteria and performance cannot be directly extracted from this document, as it pertains to a physical sterilization tray.

Here's an attempt to answer the questions based on the available information, with clear indications where information is not available or not applicable to this type of device submission.

Acceptance Criteria and Device Performance (as much as applicable)

Study Details (Information not present in the document for an AI study)

1. Sample size used for the test set and the data provenance: Not applicable. This is not an AI algorithm. The performance testing refers to physical tests on the sterilization tray. The details of these tests (e.g., number of cycles tested, specific load configurations) are not provided in this summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., expert consensus, pathology) is not relevant for a sterilization tray. Compliance with ANSI/AAMI ST77 and functional performance (e.g., ability to hold instruments, withstand sterilization) is the focus.
3. Adjudication method for the test set: Not applicable. (See #2)
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 is a physical device, not an AI or diagnostic algorithm requiring human interpretation.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (See #4)
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For this device, the "ground truth" equates to demonstrated performance against established industry standards and defined parameters for sterilization effectiveness and device durability. The predicate device serves as a benchmark for substantial equivalence.
7. The sample size for the training set: Not applicable. There is no training set for a physical device like this.
8. How the ground truth for the training set was established: Not applicable. (See #7)

Summary of what the document does provide regarding performance and equivalence:

The document states that the DetachaTip® III Plus Multi-Use Instrument Tray meets requirements of ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization. It further asserts that "Based on the nonclinical performance testing, the subject device is as safe and effective as the legally marketed predicate device."

The comparison table (page 2) highlights that the performance testing for both the subject and predicate devices refers to ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization. This standard outlines the specific tests and criteria that such devices must meet. While the specific numerical results of these tests are not included in this summary, the statement "meets requirements" implies successful completion of these tests.

In essence, the study (performance testing) mentioned for this device is the demonstration that it complies with the ANSI/AAMI ST77 standard and is substantially equivalent to a previously cleared device (K092414) in terms of its materials, design, and ability to perform its intended function of holding instruments during steam sterilization.

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The DetachaTip® III Multi Use Instruments are intended for use in a variety of laparoscopic procedures to transect, dissect, grasp, and coagulate tissue.

The DetachaTip® III Multi Use Laparoscopic Instrument family comprises a series of sterile, multi-use laparoscopic scissors, graspers and dissectors designed to be used in conjunction with an appropriately sized cannula. All the instruments provide monopolar electrosurgical capability via a standard 4mm monopolar post. A single handle design accommodates 33cm and 43cm instrument shafts. Instrument shafts are available in a variety of blade or jaw configurations.

For graspers and dissectors, a lever on the handle allows the user to activate the ratcheting feature in a fixed ON/OFF position or an intermittent position. The ratcheting mode changes from intermittent to "OFF" once the user releases the lever. The ratcheting feature is intended for use with the grasper and dissector shafts only. The design of the scissors instrument shaft does not allow for ratcheting of those instruments.

A rotator knob on the instrument shaft allows for 360°axial rotation of the shaft and tip. The devices are designed with a Luer port located on the rotator knob that allows for flushing of the central shaft prior to steam sterilization.

The provided text describes a 510(k) summary for the ConMed® DetachaTip® III Multi-Use Laparoscopic Instrument, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a study that establishes acceptance criteria for novel performance claims. Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

However, I can extract the available information and state what is missing:

1. A table of acceptance criteria and the reported device performance

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: Not specified for any specific test set. The document refers to "non-clinical bench and simulated use testing" without detailing the number of units tested.
• Data Provenance: Not specified. The testing described is non-clinical/bench-level and simulated use, not involving patient data or clinical trials.

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

• Number of Experts: Not applicable/not specified. The "ground truth" for the tests mentioned (safety standards compliance, substantial equivalence to predicate devices) is based on technical specifications and comparison, not expert consensus on diagnostic or clinical outcomes.
• Qualifications of Experts: Not applicable/not specified.

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

• Adjudication Method: Not applicable/not specified. The type of testing described (bench and simulated use for substantial equivalence) does not typically involve adjudication in the sense of resolving discrepancies between expert opinions on a test set.

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

• MRMC Study: No. This device is a laparoscopic surgical instrument, not an AI or imaging diagnostic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.
• Effect Size: Not applicable.

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

• Standalone Performance Study: Not applicable. This device is a surgical instrument that requires human operation; it is not an algorithm or a standalone automated system.

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

• Type of Ground Truth: For the "substantial equivalence" claim, the ground truth is primarily based on technical specifications, material properties, and functional performance characteristics of the predicate devices. For parts of the testing, compliance to recognized consensus standards (AAMI/ANSI ES60601-1, IEC 60601-2-2, ISO 10993-1) serves as the "ground truth" for safety and material compatibility.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a physical surgical instrument, not an AI model or software algorithm that requires a "training set."

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

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