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The Fixed Patient Leads ECG Cable is used to transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders/monitors for both diagnostic and monitoring purposes.

ECG cables are supplied non-sterilizable; they are reusable devices and are intended for use by trained operators in a medical environment. Usage is limited to the indications for use of the connected monitoring or dagnostic equipment.

The BSC Model 3153 ECG Cable is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body to an external BSC programming system display monitor. One end of each leadwire clip is attached to an ECG patient electrode; the other end is affixed / molded into one end of the trunk cable. The trunk cable then plugs into the BSC programming system.

The provided text describes the regulatory clearance for the Fixed Patient Leads ECG Cable (Model 3153) and its comparison to a predicate device, rather than a clinical study evaluating its diagnostic or AI-assisted performance. Therefore, many of the requested categories in the prompt are not applicable.

Here's the information that can be extracted from the provided text, with "N/A" for sections not covered:

1. Table of Acceptance Criteria and Reported Device Performance

• Electrical Safety standards: IEC 60601-1:2005
• General functional testing
• System electrical design specifications (for Model 3300 Programmer and associated cables). | All requirements were met (including EMI/EMC, Electrical Safety, and general functional testing). Verified that the Model 3300 Programmer and associated cables meet system electrical design specifications. |
  | Design Validation Testing | User needs and intended use of the ECG Cable. | Demonstrated that the cable meets user needs and its intended use. |
  | Biocompatibility Assessment | Standards: EN ISO 10993-5:2009 (in vitro cytotoxicity), EN ISO 10993-10:2013 (irritation and skin sensitization). | Demonstrated that the ECG Cable is biocompatible for its intended use, based on the specified standards. |
  | Design Analysis and Evaluation Testing | Device robustness and correct implementation of the design intent. | Evaluated device robustness and correct implementation of the design intent. Results provided here are a general statement of positive outcome. |
  | Packaging Assessment | Adhesion, legibility, and indelibility requirements for Affinity-manufactured ECG Cable box labels. | Demonstrated that Affinity-manufactured ECG Cable box labels meet adhesion, legibility, and indelibility requirements. |
  | General Performance (Overall Conclusion) | - Meets performance requirements
• Performs as intended
• Appropriate for its Indications for Use
• Substantially equivalent to predicate device. | - Provides reasonable assurance that the proposed device design meets performance requirements and performs as intended.
• Considered substantially equivalent to the predicate BSC Removable Patient Leads ECG Cable (K132253) based on Indications for Use, technological characteristics, and safety and performance testing. |
  | Physical/Structural Characteristics (Comparison) | - Trunk Cable Length: Proposed: $80\pm2"$ vs. Predicate: $120\pm6"$
• Leadwire Length: Proposed: $30\pm2"$ vs. Predicate: $40\pm1.5"$
• Leadwire/Trunk Cable Joint: Proposed: Fixed vs. Predicate: Removable | The table explicitly states these differences but implies they are acceptable variations for substantial equivalence, as the overall conclusion states substantial equivalence. The document does not describe a performance impact due to these differences. |

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 describes engineering and bench testing, not a clinical study with a "test set" of patient data. Therefore, this information is N/A.

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 is N/A as the testing was not clinical or involving expert ground truth for diagnostic accuracy.

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

This is N/A.

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 is N/A. The device is an ECG cable, not an AI-powered diagnostic tool.

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

This is N/A. The device is a physical cable, not an algorithm.

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

The "ground truth" for this device's performance is established by adherence to engineering specifications, electrical safety standards, biocompatibility standards, and functional requirements for a medical device rather than medical "ground truth" like pathology or expert consensus. For example, "ground truth" for electrical safety would be defined by the limits set in IEC 60601-1.

8. The sample size for the training set

This is N/A as there is no "training set" for an ECG cable.

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

This is N/A.

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