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The Celerity System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-Driven Rhythm
• Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of an additional method is necessary to confirm catheter tip location.

The Celerity™ ECG Cable Accessory Pack consists of a sterile remote cover and a specialized alligator PICC clip. The Celerity™ ECG Cable Accessory Pack is designed to be used in conjunction with the Celerity™ System to provide a continuous display of electrocardiograph waveforms to guide placement of peripherally-inserted central catheters in the patient's right atrium of the heart.

This document describes the Celerity™ ECG Cable Accessory Pack, an accessory product used with the Celerity™ System for positioning Peripherally Inserted Central Catheters (PICC). The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K142889).

Here's an analysis of the provided information, focusing on the requested criteria:

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

Based on the provided regulatory document, the acceptance criteria are primarily focused on demonstrating substantial equivalence to the predicate device K142889 for an accessory pack consisting of an ECG cable and remote cover. The performance reported is that the accessory pack does not raise new or different questions of safety and effectiveness and performs identically to the predicate device's components.

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

The document primarily describes bench/performance/non-clinical testing for an accessory pack, not a clinical study involving patients. Therefore, traditional "test set" and "data provenance" as applied to clinical data are not fully applicable here.

• Sample size for non-clinical testing: The document does not specify exact sample sizes for each test listed (e.g., how many alligator clips were subjected to accelerated aging). It lists the types of tests performed.
• Data Provenance: The data provenance is from internal non-clinical testing conducted by the manufacturer, Medical Components, Inc. (dba Medcomp®). No country of origin is explicitly stated for the testing, but the manufacturer is based in Harleysville, Pennsylvania, USA, implying the testing likely occurred in the USA or through US-based labs. The tests are non-clinical (bench testing).

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 section is not applicable as the submission is for an accessory pack and relies on non-clinical, bench testing to demonstrate substantial equivalence. There is no clinical "test set" requiring expert ground truth establishment in the context of diagnostic accuracy. The ground truth for the non-clinical tests would be defined by engineering specifications and standards for electrical conductivity, material integrity, and aging performance.

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

This section is not applicable. Since there is no clinical test set requiring human interpretation or diagnosis, there is no need for an adjudication method.

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 section is not applicable. The device is an ECG cable accessory pack, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.

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

This section is not applicable. The device is a physical accessory pack that facilitates the existing Celerity System's ECG-based tip confirmation technology. It does not involve a standalone algorithm.

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

For the non-clinical testing conducted, the "ground truth" would be objective engineering and performance specifications. For example:

• Functional performance: The ability of the alligator clips and remote cover to conduct an ECG signal accurately and reliably.
• Durability/Aging: Ability to withstand accelerated aging simulation for 1 and 3 years without compromising function or integrity.
• Shipping Integrity: Ability of the packaged accessory pack to withstand shipping stresses (ISTA 2A).
• Material Composition: Conformance to specified material compositions.

These "ground truths" are established by engineering standards and internal quality control, not by expert clinical consensus, pathology, or outcomes data, as this is a non-clinical submission for an accessory.

8. The sample size for the training set

This section is not applicable. This submission is for a physical accessory product and describes non-clinical testing to demonstrate substantial equivalence to a predicate. There is no machine learning or AI component requiring a "training set."

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

This section is not applicable for the same reasons as point 8.

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