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The Magellan™ Ratio Dispenser Kit is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue prior to repair.

The Magellan Ratio Dispenser Kit consists of the following components: 12 cc legally marketed disposable piston syringe 1 cc legally marketed disposable piston syringe Dispenser Handle Plunger clip Dual channel tip (spray or cannula) Two medicine cups

The provided text describes a 510(k) premarket notification for the "Magellan Ratio Dispenser Kit." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance data.

Therefore, many of the requested categories for device performance and study design cannot be fully addressed from the provided text. The document explicitly states that the performance data is unchanged from the predicate device (K020147). This indicates that no new, independent study was conducted for this specific 510(k) submission to establish new performance criteria.

Here's a breakdown of what can and cannot be extracted:

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

• Acceptance Criteria: Not explicitly stated in the provided text. In a 510(k) for a device like this, acceptance criteria would typically revolve around demonstrating that the device performs as intended and is as safe and effective as the predicate. This would likely involve testing of material compatibility, sterility, dispensing accuracy (if applicable), and mechanical integrity. However, specific quantitative targets are not given.
• Reported Device Performance: Not reported as new data for this submission. The text states: "Performance data that supports the safety and effectiveness of the use of Magellan Ratio Dispenser Kit is included in the submission. This data is unchanged from the predicate, which is our currently marketed Magellan Ratio Dispenser kit (K020147)." This implies that the performance established for the prior K020147 device is being referenced. Without access to the K020147 submission, specific performance metrics for this device cannot be outlined here.

2. Sample sized 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 this submission. Since the performance data is stated to be "unchanged from the predicate," this information would reside within the K020147 submission.
• Data Provenance: Not specified for this submission. As above, this information would be tied to the predicate device's performance data.

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. This type of information is typically relevant for studies involving subjective interpretation (e.g., medical imaging, pathology slides). The Magellan Ratio Dispenser Kit is a mechanical device for fluid application, not an interpretative diagnostic tool. Its performance would be evaluated through engineering and functional testing rather than expert-established ground truth.

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

• Not applicable. See explanation for #3.

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 device is a mechanical fluid dispenser, not an AI-assisted diagnostic or interpretative tool. MRMC studies are used for evaluating reader performance in diagnostic accuracy tasks.

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

• Not applicable. This is a mechanical device, not an algorithm or AI system.

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

• Not applicable. For a device of this nature, "ground truth" would be objective measurements of its mechanical and functional performance (e.g., fluid volume dispensed, spray pattern consistency, material integrity, sterility).

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI/ML model that requires a "training set."

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

• Not applicable. See explanation for #8.

Summary of what is known from the provided text:

• Device Name: Magellan Ratio Dispenser Kit
• Indications for Use: "The Magellan™ Ratio Dispenser Kit is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue prior to repair."
• Predicate Devices:
  1. Magellan Ratio Dispenser Kit, Medtronic, Inc (K020147 - 04/03/2002)
  2. Harvest Technologies Dual Liquid Applicator, Harvest Technologies (K020252 - 04/05/2002)
• Performance Data: The submission states that performance data supports safety and effectiveness, and this data is "unchanged from the predicate, which is our currently marketed Magellan Ratio Dispenser kit (K020147)." This implies that the current submission relies on the existing performance data of the K020147 device to demonstrate substantial equivalence, rather than providing new performance studies.
• Basis for Substantial Equivalence: Product design, materials, packaging, and sterilization are considered substantially equivalent to the predicate devices.

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The Medtronic Magellan™ Ratio Dispenser Kit including tip is intended to assist the user in simultaneously delivering two non-homogenous liquids to the same treatment area(s).

The Magellan Ratio Dispenser Kit consists of the following components: 12 cc legally marketed disposable piston syringe 1, 1 cc legally marketed disposable piston syringe 1, Dispenser Handle 1, Plunger clip 1, Dual channel tip (spray or cannula) 1, Two medicine cups.

The provided text is a 510(k) summary for the Medtronic Magellan™ Ratio Dispenser Kit. It explicitly states that performance data supporting the safety and effectiveness of the device is included in the submission but does not detail the acceptance criteria or the specific study that proves the device meets those criteria.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: Not explicitly stated in the provided text. The document broadly states "Performance data that supports the safety and Effectiveness of the use of Magellan Ratio Dispenser Kit is included in the submission." without providing any specifics.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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

• Number of Experts: Not applicable, as no ground truth establishment is described for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Not applicable, as no test set evaluation with adjudication is described.

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

• Study Conducted: No MRMC study is mentioned.
• Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only):

• Study Conducted: This device is a physical medical device (syringe dispenser kit), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The performance data would relate to the physical and functional aspects of the dispenser.

7. Type of Ground Truth Used:

• Not applicable, as the document refers to performance data for a physical device, not an AI algorithm requiring ground truth in the typical sense (e.g., expert consensus, pathology for diagnostic tasks). Performance data for such a device would likely involve measurements of dispensing accuracy, consistency, ease of use, material compatibility, etc.

8. Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable.

Summary of Missing Information:

The provided 510(k) summary is a high-level overview. It declares that performance data exists and supports the substantial equivalence claim but does not provide any specifics regarding:

• The actual performance criteria the device was intended to meet.
• The results of any performance testing in quantitative terms.
• Details about the studies conducted (e.g., design, sample sizes, methodology, data sources).

To obtain this detailed information, one would typically need to review the full 510(k) submission document, which is generally not publicly available in its entirety but summarized in documents like this. The 510(k) summary is designed to provide just enough information to support the substantial equivalence claim without revealing proprietary details of the tests.

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