Search Results

The Paljet-B patient cable system is a reusable ECG suction electrode system. It is designed for diagnostic purposes and is compatible with all electrocardiographs on the U.S. market.

The Paljet-B patient cable system is a reusable ECG suction electrode system. The entire electrode assembly was redesigned using some different materials (these materials never come in contact with the patient and are made of plastic) these provided for a more reliable electrode. Also a safer electrode because of the elimination of any sharp edges on the contact surfaces that came into contact with human skin. Changed from an AC power source to DC power source reduced the weight and eliminated the hanging arm configuration to enhance the portability aspects of the new device. Many changes were made in the mechanical aspects of the machine, however the basic operational aspect of the Paljet is unchanged from the Wavetracer.

The provided 510(k) summary for the "Venturi suction electrode patient cable system - PALJET-B" does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a modern AI/ML device submission would.

Instead, this 1998 submission focuses on establishing substantial equivalence to a predicate device (the WaveTracer) based on the operational aspects and intended use rather than detailed performance metrics derived from clinical studies. The rationale for equivalence is primarily based on:

1. Redesign for the American market: Changes made to materials (non-patient contacting), elimination of sharp edges, change from AC to DC power, reduced weight, and enhanced portability.
2. Unchanged basic operational aspect: The core function of the device is stated to be unchanged from the predicate WaveTracer.
3. Identical Indications For Use: Both devices are designed as reusable ECG suction electrode systems for diagnostic purposes, compatible with all electrocardiographs on the U.S. market.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to AI/ML or comparative effectiveness studies) are not applicable or present in this document.

Here's an attempt to answer the questions based only on the provided text, supplemented by general knowledge about 510(k) submissions of that era:

510(k) Summary Analysis for PALJET-B

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in the provided document. In 1998, for this type of device, acceptance criteria were typically demonstrated by meeting recognized standards (e.g., electrical safety, biocompatibility if applicable), and demonstrating that the device performed its intended function comparably to a predicate. The document implies that the device performance is equivalent to the predicate, the WaveTracer, for its stated diagnostic purpose.

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is mentioned for a performance study. Equivalence is primarily argued through design comparisons to the predicate.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication 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. This device is an ECG electrode system, not an AI/ML diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This device is not an algorithm.

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

Not applicable. No formal ground truth for performance evaluation is described. The "ground truth" for demonstrating equivalence largely rests on the predicate device's established performance and the fundamental operational similarity.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. This device is not an AI/ML algorithm.

Summary of Approach for this Device (1998):

The 510(k) submission for the PALJET-B relies on demonstrating "substantial equivalence" to a legally marketed predicate device (WaveTracer) as per the regulations of that time. This typically involved:

• Comparison of Indications for Use: Showing they are identical or very similar.
• Comparison of Technological Characteristics: Explaining any differences and demonstrating they do not raise new questions of safety or efficacy. In this case, material changes (non-patient contact), power source changes, and mechanical redesigns were explained as improvements that maintained or enhanced safety and effectiveness without altering the fundamental operational principle.
• Performance Data (if applicable): While not detailed here, for devices like ECG electrodes, performance data would typically focus on aspects like electrical specifications, signal integrity, biocompatibility (if patient-contacting materials changed significantly), and possibly limited clinical testing to show equivalent signal acquisition. The provided summary states the "basic operational aspect...is unchanged," which implicitly covers the primary performance characteristic of an ECG electrode.

This document clearly pre-dates the regulatory considerations and study expectations for AI/ML devices. Therefore, a direct comparison using the requested structure is largely incongruent with the information provided.

Ask a specific question about this device