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The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery.

The proposed device and the predicate device(s) are composed of metallic 28- to 32-gauge wire, an extruded insulation coating, a special curved needle to ease the transcutaneous placement of the electrode in the skin, and a snap-off straight needle. The leads are available in various sizes, lengths, and quantities.

This document describes a 510(k) premarket notification for a medical device called the "Disposable Temporary Pacing Wire" by RIVER Medical, Inc. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies with specific acceptance criteria and performance metrics as might be found in a De Novo or PMA submission.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable in this context. The information provided outlines the device's description, intended use, indications for use, and a comparison of technological characteristics to a predicate device, along with the regulations and standards it complies with.

Here's an attempt to address your points based on the provided text, noting where specific information is absent:

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

This information is not explicitly provided in the summary of safety and effectiveness for a 510(k) submission. A 510(k) focuses on demonstrating equivalence to a predicate device, often by showing compliance with recognized standards and design controls, rather than establishing new, specific performance acceptance criteria for the device beyond what the predicate meets. The document lists several standards and regulations that the device and its predicate comply with, which implicitly define acceptable performance within those standards.

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

This information is not provided. A 510(k) submission primarily relies on comparisons to predicate devices and adherence to recognized standards, rather than new extensive clinical or performance studies with defined test sets and data provenance for demonstrating novel performance.

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)

This information is not provided. As no specific test set or ground truth establishment process is described, expert involvement for this purpose is not mentioned.

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

This information is not provided. No test set or associated 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

This information is not applicable and not provided. The device is a "Disposable Temporary Pacing Wire," which is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human reader studies.

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

This information is not applicable and not provided. The device is a physical medical device, not an algorithm.

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

This information is not provided. There is no mention of a specific ground truth used for validating the device's performance in the context of this 510(k) submission. Device performance is generally inferred from compliance with standards and equivalence to the predicate.

8. The sample size for the training set

This information is not provided. As this is a physical medical device, there wouldn't typically be a "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided.

Summary of what is provided related to device validation/substantiation:

The document emphasizes that the device meets safety and effectiveness requirements by:

• Substantial Equivalence: It is substantially equivalent to a legally marketed predicate device.
• Material and Design Comparison: The proposed device comprises "the same or similar material" as the predicate device.
• Compliance with Standards and Regulations: Both the manufacture and QC testing of the device, and implicitly its performance, are in substantial compliance with numerous recognized standards and regulations, including:
  • 21 CFR 898; 62 FR 25497
  • USP Sutures - Needle Attachment
  • USP Tensile Strength - Surgical sutures
  • USP Sterility Tests
  • USP Sutures - Diameter
  • ANSI/AAMI/ISO 10993-7 (Biocompatibility/Biological Evaluation)
  • Various clauses and sub-clauses of IEC 60601-1, IEC 60601-2-27 (Medical electrical equipment - safety and essential performance)
  • ANSI/AAMI EC 53 (Pacing System Leads)
  • UL 2601; 55

These standards and regulations serve as the de-facto "acceptance criteria" for this type of device in a 510(k) submission, confirming that it meets established safety and performance benchmarks for similar devices on the market. The "study" proving the device meets these criteria is the manufacturing and QC testing processes that demonstrate compliance with these listed standards.

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