(68 days)
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.
| Acceptance Criteria (based on Predicate Device: Merit Industries, Inc. K942321 Characteristics) | Reported Device Performance (Curbell Patient Cables) |
|---|---|
| Intended Use: Used to connect electrodes, catheters, 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. | Substantially Equivalent: Used to connect electrodes, catheters, 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. |
| Usage: Reusable | Substantially Equivalent: Reusable |
| Anatomical site: Attached to sensors placed at specified locations as required by the patient monitor. Examples include Left arm, Right arm, Chest, Left leg & Right leg. | Substantially Equivalent: Attached to sensors placed at specified locations as required by the patient monitor. Examples include Left arm, Right arm, Chest, Left leg & Right leg. |
| Design: Shielded and unshielded patient leadwire and shielded patient trunk cables with electrode connectors including snap, pinch, & Sure Lock. | Substantially Equivalent: Shielded and unshielded patient leadwires and shielded patient trunk cables with electrode connectors including snap, pinch, & Sure Lock. |
| Connectors: Electrode connectors - snap & pinch | Substantially Equivalent (with additional options): Electrode connectors - snap, pinch, & Sure Lock. (Note: Curbell offers "Sure Lock" in addition to the predicate's options, implying broader compatibility or an equivalent function). |
| Cable and lead wire length: Trunk Cable lengths include - 7 to 20 ft., Leadwire lengths from 18" to 120" | Within acceptable range/Substantially Equivalent: Trunk Cable lengths include - 10 ft; Leadwire lengths from 18" to 51" (Curbell's lengths fall within the predicate's reported range or are deemed equivalent for intended use). |
| Wire material: Shielded & Unshielded Copper with PVC or Polyurethane Jacket | Substantially Equivalent: Shielded & Unshielded Copper with Polyurethane Jacket (Polyurethane is a comparable material). |
| Sterility: Non Sterile | Substantially Equivalent: Non Sterile |
| Electrical performance testing: Per AAMI - EC 53 | Substantially Equivalent: Per AAMI - EC 53 |
| Electrical safety testing: • Dielectric withstand per AAMI - EC 53 • Insulation resistance per AAMI - EC 53 • Termination resistance per AAMI - EC 53 | Substantially Equivalent: • Dielectric withstand per AAMI - EC 53 • Insulation resistance per AAMI - EC 53 • Termination resistance per AAMI - EC 53 |
| Connector retention force: Per AAMI - EC 53 | Substantially Equivalent: Per AAMI - EC 53 |
| Environmental safety: Cables are RoHS compliant | Substantially Equivalent: Cables are RoHS complainant (compliant). |
| Meets ANSI/AAMI standard: ANSI/AAMI EC53:1995 (revised 2001) | Substantially Equivalent: ANSI/AAMI EC53:1995 (revised 2001) |
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.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).