(7 days)
The Unimed patient cables and lead wires are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The patient cables and lead wires are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.
Unimed's most common cable lead wire configuration ECG cables with specific various length are the replacements for similar cables manufactured by Original Equipment Manufacturers(OEM) and other third party after market manufacturers for their respective monitors.
These cables consist of connectors on each cable end and a shielded bulk cable. The cables are used to transfer the signals from the electrodes to the patient monitor.
The Unimed cables use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC cable jacket with medical grade PVC overmolded connectors with integral relief.
The provided document is a 510(k) submission for patient monitoring cables and lead wires. It details the device's characteristics, intended use, and comparison to a predicate device, as well as the FDA's clearance letter. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert involvement, or AI involvement.
The document states that "Bench Testing demonstrates that Unimed devices perform as intended" and declares conformity to consensus standard ANSI/AAMI EC53-1995(R)2001. This implies that the acceptance criteria are likely based on the performance requirements outlined in this standard.
Based solely on the provided text, here's what can be extracted:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from conformity to standard) | Reported Device Performance |
|---|---|
| Connector Retention Force: Conforms to ANSI/AAMI EC53A-1998(R)2001 EC53A-1998(Amendment) | "Bench Testing demonstrates that Unimed devices perform as intended" and "The company has declares conformity to consensus standard ANSI/AAMI EC53-1995(R)2001 and its attachment EC53A-1998(R) 2001 relating to Electrical/Safety/Mechanical" (specifically lists Connector Retention Force as a comparison point with predicate, implying it meets this standard). |
| Electrical Performance & Safety: Conforms to ANSI/AAMI EC53A-1998(R)2001 | "Bench Testing demonstrates that Unimed devices perform as intended" and "The company has declares conformity to consensus standard ANSI/AAMI EC53-1995(R)2001 and its attachment EC53A-1998(R) 2001 relating to Electrical/Safety/Mechanical" (specifically lists Electrical Performance and Safety as a comparison point with predicate, implying it meets this standard). |
| Mechanical Performance: Conforms to ANSI/AAMI EC53-1995(R)2001 and EC53A-1998(R)2001 | "Bench Testing demonstrates that Unimed devices perform as intended" and "The company has declares conformity to consensus standard ANSI/AAMI EC53-1995(R)2001 and its attachment EC53A-1998(R) 2001 relating to Electrical/Safety/Mechanical" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: The document states that "Bench Testing" was performed. Given Unimed Medical Supplies Inc is based in Shenzhen, China, it's highly probable the testing was conducted there. It is a prospective test, as it's specifically for this device prior to market release.
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)
- Not applicable/Not specified. This device is a cable, and its performance is assessed against engineering standards, not through expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Performance is determined by measurements against engineering standards, not through adjudication of expert opinions.
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
- No. This is a medical device (patient cables) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by engineering and safety standards (specifically ANSI/AAMI EC53-1995(R)2001 and its amendment EC53A-1998(R)2001) for connector retention force, electrical performance, safety, and mechanical aspects.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm.
§ 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).