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RPI replacement phototherapy bulbs are designed to be used as replacement light bulbs for use wi various phototherapy units and infant radiant warmers.

The RPI Replacement phototherapy lights are intended to be used as replacement parts for various Hill-Rom Air Shields phototherapy units and infant radiant warmers. The replacement phototherapy lights are available in different wattage and other specifications. The lights are provided nonsterile.

This document describes an application for a 510(k) premarket notification for "RPI Replacement phototherapy lights/bulbs". The application asserts substantial equivalence to existing predicate devices.

Summary of Acceptance Criteria and Device Performance:

Study Information:

The provided document does not describe a clinical study or performance study in the traditional sense, as would be conducted for a novel medical device or software. Instead, it is a 510(k) Premarket Notification applying for substantial equivalence for replacement parts.

Here's why a typical "study" as requested isn't present:

• Nature of the Device: The device is a "replacement phototherapy bulb" – essentially a consumable part for existing approved medical devices (phototherapy units and infant radiant warmers).
• Basis for Approval: The manufacturer is claiming substantial equivalence to already legally marketed predicate devices. This means they are asserting their replacement bulbs are as safe and effective as the original bulbs they are designed to replace, without introducing new performance or safety characteristics.
• Lack of Novelty: The document explicitly states: "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Replacement phototherapy bulbs. The design, form, and materials of the lights are identical to their predicate devices."

Therefore, based on the provided text, the following information cannot be extracted:

1. Sample size used for the test set and the data provenance: Not applicable, as no dedicated "test set" and corresponding performance data are provided for this type of substantial equivalence claim.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no independent ground truth evaluation was conducted for a novel device.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable in the context of a performance study for a novel device feature. The "ground truth" here is the established safety and efficacy of the predicate devices.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In essence, the "study" for this 510(k) application is the demonstration and assertion of identical design, materials, and intended use as the legally marketed predicate devices, rather than a clinical or performance trial for a new medical technology. The FDA's issuance of a "substantial equivalence determination" (K021531) indicates they agreed with this assessment based on the documentation provided by RPI.

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