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The intended use is to cut the umbilical cord clamp off a newborn's umbilical cord.

The subject device is a cutter designed to safely cut the umbilical cord clamp. The device is composed I fier book acrise is a outadiene Styrene) Doc 26720NT Natural resin with a stainless steel blade. The device does not make contact with the patient. The device is provided non-sterile and is labeled for single natient use. The subject device is packaged in a 3"x5" Glassine Bag and will be included in the dispenser box with the Busse Posi-Grip Umbilical Cord Clamps.

The Busse Umbilical Cord Clamp Cutter (K021055) is designed to safely cut the umbilical cord clamp. The device is composed of a natural resin with a stainless steel blade. It does not contact the patient, is non-sterile, and is labeled for single patient use.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Busse Umbilical Cord Clamp Cutter are based on its functional performance when used with specific umbilical cord clamps.

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not specify an exact numerical sample size for the product qualification testing. It broadly states that the device was "tested with Busse Posi-Grip Umbilical Cord Clamps."
• Data Provenance: The data is from "Product qualification testing" conducted by the submitter (Busse Hospital Disposables Inc. or Azary Technologies LLC on their behalf). No information on the country of origin or if it was retrospective or prospective is provided, but it would typically be considered prospective in-house testing.

3. Number of Experts and Qualifications:

Not applicable. The study described is a functional performance test of a medical device, not a diagnostic or interpretive device requiring expert review for ground truth establishment.

4. Adjudication Method:

Not applicable, as no expert review or adjudication of results is mentioned or relevant for this type of functional performance test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This device is a mechanical cutter, not involved in image interpretation or diagnosis.

6. Standalone Performance:

Yes, a standalone performance assessment was conducted. The product qualification testing focused solely on the "umbilical cord clamp cutter to function properly when tested with Busse Posi-Grip Umbilical Cord Clamps." This test assesses the intrinsic functionality of the device without human interaction beyond its intended operation.

7. Type of Ground Truth Used:

The ground truth for the performance test was operational success – whether the device could physically cut the umbilical cord clamps without problems. This is a functional outcome directly observed during testing.

8. Sample Size for Training Set:

Not applicable. This device is a mechanical cutter and does not involve AI or machine learning that requires a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for this mechanical device.

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