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THE DEDICE IS DESIGNED TO DE INSELTED INTO THE PERIORERAL DENDES SYSTEM FOR THE INFOSION OF SOUTHOUS INTO THE CENTRAL varies system.

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Midclavicular Catheter.

The provided text is a 510(k) summary for a medical device called the "Midclavicular Catheter" or "Cavafix." It outlines the device's description, materials, and substantial equivalence to previously cleared devices. However, this document does not contain the type of information requested about acceptance criteria, detailed study design, or performance evaluation from a clinical or technical perspective.

Specifically, the document focuses on:

• Device identification: Product name, trade name, classification.
• Substantial equivalence: Comparing the device to existing predicate devices (K861479 Cavafix and SoloPICC).
• Material compatibility: Stating materials were tested according to ISO Standard 10993.
• Safety and effectiveness (general statement): Mentioning that finished products are tested to meet release specifications, including physical testing and visual examination, as per Quality Control Test Procedure documents and GMPs.

This information is typical for a 510(k) submission seeking clearance based on substantial equivalence, rather than a de novo approval or clinical trial report that would detail specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document only broadly states "All finished products are tested and must meet all required release specifications."
2. Sample size used for the test set and the data provenance: Not mentioned. The "testing" referred to appears to be internal manufacturing quality control, not a clinical or performance study of a defined "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such study is described.
4. Adjudication method: Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as no external "ground truth" performance study is detailed. The ground truth for internal quality control would be the device specification itself.
8. The sample size for the training set: Not applicable, as this is not an algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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The indication for use is when the patient's condition requires the peripheral intusio

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Peripherally Inserted Central Catheter.

This 510(k) submission (K964929) describes a Peripherally Inserted Central Catheter (PICC) and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about the performance of an AI/ML powered device, nor does it detail a study that establishes acceptance criteria for such a device. Instead, it describes general safety and effectiveness testing for a medical device.

Therefore, many of the requested sections regarding acceptance criteria for an AI device, specific study designs, data provenance, expert ground truth, and comparative effectiveness studies cannot be answered from the provided text.

Here's an attempt to answer the applicable sections based only on the provided text, while making it clear where the information is not present or not relevant to AI/ML device performance.

Acceptance Criteria and Study for K964929 (Peripherally Inserted Central Catheter)

This 510(k) submission is for a conventional medical device (Peripherally Inserted Central Catheter) and not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance, ground truth, and specific study designs for AI systems is not present in the provided text. The "acceptance criteria" and "device performance" described relate to the physical and functional characteristics of the catheter, not an algorithm's output.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with quantitative performance metrics for an AI/ML component. Instead, it states that "All finished products are tested and must meet all required release specifications before distribution." and lists general categories of testing:

2. Sample size used for the test set and the data provenance

Not applicable to an AI/ML powered device. For this physical device, testing is conducted on "all finished products" before distribution, indicating a 100% inspection or testing rate for release. The data provenance is intrinsic to the manufacturing process of the medical device itself.

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

Not applicable to an AI/ML powered device. The "ground truth" for this device relates to its physical properties and functionality, verified through standardized tests and design specifications rather than expert interpretation of data.

4. Adjudication method for the test set

Not applicable to an AI/ML powered device. The "adjudication method" for this device involves established testing procedures and parameters defined by Quality Control Test Procedure documents, with approval, release, and revision in accordance with GMP's.

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

No, an MRMC comparative effectiveness study was not done, as this is not an AI/ML powered device.

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

Not applicable, as this is not an AI/ML powered device.

7. The type of ground truth used

For this medical device, the "ground truth" is based on:

• Compliance with ISO Standard 10993 for material biocompatibility.
• Adherence to product design specifications.
• Fulfillment of Quality Control Test Procedure documents.
• Results from physical testing and visual examinations.

8. The sample size for the training set

Not applicable, as this is not an AI/ML powered device. There is no concept of a "training set" for a physical medical device.

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

Not applicable, as this is not an AI/ML powered device.

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