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Curbell patient cables are used to connect electrodes and/or sensors placed at the appro priate sites on the patient to a monitoring device for general monitoring and/or diagno stic evaluation by a healthcare professional.

Curbell Patient Monitoring Cables and Lead Wires. Curbell patient cables are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional.

The provide document is a 510(k) summary for Curbell Patient Monitoring Cables. It asserts substantial equivalence to a predicate device (Merit Cables, Inc. K942321) rather than establishing novel performance criteria through a study. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance, is not directly applicable to this document.

However, based on the provided text, I can extract information related to how this device demonstrates equivalence for its intended use. The "acceptance criteria" here are effectively the performance characteristics and standards met by the predicate device, and the study is the nonclinical performance data demonstrating the Curbell device also meets these.

Here's an interpretation based on the provided document:

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

For this 510(k), the "acceptance criteria" are implied by the characteristics of the predicate device, and the "reported device performance" is the claim that the Curbell device possesses substantially equivalent characteristics.

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 does not detail a "test set" in the context of data for an AI/ML device. Instead, the testing pertains to nonclinical performance data of the physical device. The provenance of the data is that it was generated through testing of Curbell Patient Monitoring Cables against established standards. No specific sample sizes for these tests are mentioned beyond the implication that sufficient samples were tested to demonstrate compliance with the referenced standards. The data is likely prospective, generated specifically for this submission.

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 document is for a medical device (patient monitoring cables), not an AI/ML algorithm that requires expert ground truth labeling. Therefore, this information is not applicable. The "ground truth" for compliance testing is defined by the technical specifications and requirements of the referenced standards (e.g., AAMI EC 53).

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

Not applicable for this type of medical device submission. Adjudication methods are typically relevant for human interpretation of data where consensus among experts is needed for ground truth.

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 is not an AI/ML device, nor does it involve human readers interpreting data enhanced by AI.

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

Not applicable. This is a physical medical device (cables and lead wires), not an algorithm.

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

The "ground truth" for the device's performance is based on the requirements and methodologies outlined in recognized national and international standards:

• 21 CFR 898
• IEC 60601-1, Subclause 56.3(c)
• ANSI/AAMI EC53:1995(R)2001

Compliance with these standards, as demonstrated through electrical, mechanical, and material testing, serves as the basis for asserting safety and effectiveness.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this device.

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The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm.

The 12-Lead Glove has been designed to obtain an electrocardiogram (ECG) with pre-positioned electrodes affixed to the underside of a glove-like sheath. The pre-printed conductive circuity is contained within the sheath (or shell) on a flexible substrate. To obtain the tracing, the operator need only connect the glove via a single (multi-conductor) cable connected to the ECC monitor, slip on the glove, position their hand on the patient's chest, and attach three extendable electrodes which will provide a full 12-Lead recording. The 12-Lead Glove saves valuable time required for set-up compared to the standard approach with multiple electrode placements. It eliminates the confusion of working with the standard cables and eliminates erroneous ECG readings.

Unfortunately, the provided document, the "IneedMD - ILC Dover 12-Lead Glove 510(k) Summary," primarily focuses on the device's description, component materials, and regulatory clearance (510(k)) based on substantial equivalence to predicate devices. It does not contain details about acceptance criteria or a study proving the device meets specific performance criteria, which would typically include performance metrics like sensitivity, specificity, accuracy, or details about clinical trials.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered proc to May 20, 1978, 11:15 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA)." This indicates the device received clearance based on demonstrating equivalence to existing devices, rather than through a study specifically designed to establish and meet novel acceptance criteria for its performance.

Therefore, I cannot extract the requested information (points 1-9) from the provided text, as it is not present. The summary focuses on material biocompatibility and comparison to predicate device materials, not clinical performance metrics.

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