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The AUTO SUTURE* ILM** Procedure Kit has application in the surgical mapping of the lymphatic system.

The AUTO SUTURE* ILM** Procedure Kit is indicated for use in lymphatic mapping.

The Kit consists of 5 devices and a drug (see predicate device list) which are packaged together in accordance with their existing labeling and indications for use in lymphatic mapping procedures.

This looks like a 510(k) premarket notification for a medical device kit, specifically a "Lymphatic Mapping Kit." Based on the provided text, the submission focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria in the typical sense of a novel AI/software medical device.

Therefore, many of the requested points regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document, as this type of submission generally relies on demonstrating that the new device's components and intended use are similar to already legally marketed devices.

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

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

• Not Applicable/Not Provided: This document does not present specific quantitative acceptance criteria or a performance study with reported device performance metrics (e.g., sensitivity, specificity, accuracy) for the kit as a whole. The substantial equivalence is based on the components and their existing labeling.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable/Not Provided: No performance study data is presented for a test set. This submission is for a kit composed of existing devices.

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/Not Provided: No ground truth establishment is described, as no specific performance study on a test set is documented.

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

• Not Applicable/Not Provided: No test set or adjudication method is described.

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/Not Provided: This document describes a kit of existing medical devices, not an AI or software-based device that would typically undergo an MRMC study.

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

• Not Applicable/Not Provided: This is not an algorithm or AI device.

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

• Not Applicable/Not Provided: No performance study that would require ground truth is described.

8. The sample size for the training set

• Not Applicable/Not Provided: No training set is relevant as this is not an algorithm/AI device.

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

• Not Applicable/Not Provided: No training set or ground truth establishment relevant to training is described.

Summary from the document:

This 510(k) submission (K971201) is for a Procedure Kit named "AUTO SUTURE* ILM** Procedure Kit" intended for "surgical mapping of the lymphatic system." It is a kit composed of several already marketed devices (predicate devices), including:

• AUTO SUTURE* Premium SURGICLIP*
• Standard Hyperdermic Needle
• Standard Syringe with LuerLock
• Standard Sterile Marking Pen
• Standard Surgical Ruler
• DRUG-Lymphazurin Blue

The submission argues for substantial equivalence based on the fact that the components are "currently marketed instruments which are composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile" and that they are "packaged together in accordance with their existing labeling and indications for use in lymphatic mapping procedures."

The FDA's response confirms substantial equivalence for the device components of the kit, but notes that "Lymphazurin which is subject to --regulation as a drug" and the "substantially equivalent determination does not apply to the drug component of your device." The submitter is advised to contact the Center for Drug Evaluation and Research regarding the drug component.

Key takeaway: This document is a regulatory submission for a physical medical device kit seeking substantial equivalence to existing devices. It is not a performance study for a novel device, especially not an AI/software device, and therefore does not contain the information requested in your prompt regarding acceptance criteria and study results.

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