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The RPI heating elements are used to emit infrared radiant heat in an infant radiant warmer to maintain an infant's body temperature. The heating elements are identical to those supplied as original equipment as part of the infant radiant warmer.

The RPI Replacement Heating Elements are intended to be used as replacement parts for the Hill-Rom Air Shields infant radiant warmers. The RPI heating elements are used to emit infrared radiant heat in an infant radiant warmer to maintain an infant's body temperature. The Replacement Heating Elements are available in different outputs (wattage) and terminations. The heating elements are provided nonsterile.

This 510(k) summary (K020966) describes RPI Replacement Heating Elements, which are replacement parts for infant radiant warmers. The submission states that "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Replacement Heating Elements. The design, form, and materials of the probes are identical to their predicate devices." Therefore, the document leverages substantial equivalence to predicate devices rather than presenting a study where the device itself meets specific performance criteria.

As such, acceptance criteria and device performance as typically understood for new medical devices or software algorithms are not applicable or provided in this 510(k) submission.

Here's an breakdown based on the information provided and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission asserts substantial equivalence based on identical design, form, and materials to existing predicate devices. There are no performance metrics or acceptance criteria reported for the RPI Replacement Heating Elements themselves.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable, as no specific performance testing on a "test set" for the RPI Replacement Heating Elements is described. The basis for clearance is manufacturing the replacement parts to be identical to existing, already cleared components.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no mention of expert involvement in establishing ground truth, as the device is a replacement part asserting identicality to existing parts.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. This device is a heating element, not an interpretive system that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical heating element, not a software algorithm.

7. Type of Ground Truth Used

Not applicable. No ground truth is established or used for performance evaluation of the RPI Replacement Heating Elements in this submission. The "ground truth" for regulatory clearance is the established performance and safety of the predicate devices to which these parts are identical.

8. Sample Size for the Training Set

Not applicable. This device is a physical replacement part, not an AI or machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set or ground truth for algorithmic development is mentioned.

Summary of the K020966 Submission for RPI Replacement Heating Elements:

This 510(k) submission for RPI Replacement Heating Elements is a premarket notification asserting substantial equivalence to several predicate infant radiant warmer heating elements. The key argument for approval is that the RPI heating elements are identical in design, form, materials, and intended use to existing, legally marketed predicate devices.

The submission explicitly states:

• "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Replacement Heating Elements."
• "The design, form, and materials of the probes are identical to their predicate devices."
• "The heating elements are identical to those supplied as original equipment as part of the infant radiant warmer."

Because the device is a replacement part claimed to be identical to already approved components, a detailed performance study with specific acceptance criteria, test sets, expert ground truth, or algorithm-specific metrics (like those relevant to AI/ML devices) is not presented or required for this type of submission. The 'proof' of meeting acceptance criteria is the demonstration of identicality to already approved predicate devices.

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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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RPI Skin or Air Temperature Probes are designed to be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain preselected temperature settings.

The RPI Temperature Probes are intended to be used as replacement parts for Air Shields infant radiant warmers and infant incubators. The RPI Temperature Probes are used to monitor the patient's skin temperature or the unit's air temperature when used in conjunction with the infant radiant warmer or infant incubator. The probes are connected to a unit controller to automatically adjust the heater output of the unit to maintain a pre-selected skin or air temperature. Two of the probes are used in "baby-controlled mode" to monitor the skin temperature of the baby and one of the probes is designed to be used in "air controlled mode", to monitor the air temperature of the incubator or radiant warmer. One probe is a disposable skin temperature probe. The RPI Skin Temperature Probes have a thermistor tip which is attached to the infant's skin. A cable attaches the probe to the unit controller. The electrical flow resistance changes in response to changes in the skin temperature. This resistance change is converted into a temperature reading. The Skin Temperature Probe is available in three models, including a disposable probe and a reusable probe. The Air Temperature Probe has the same thermistor tip, which is attached to a cable connecting the probe to the controller. The Temperature Probes are provided nonsterile.

The provided text is a 510(k) summary for RPI Replacement Temperature Probes. It does not contain information about acceptance criteria or a study proving device performance in the context of detailed performance metrics, test set characteristics, expert involvement, or statistical analysis.

A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, which in this case, involves showing similar design, materials, indications for use, and technological characteristics. Performance data, if present, would likely be limited to confirming that the device functions as expected and is comparable to the predicate.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This detailed performance data is not included.
• Sample size used for the test set and data provenance: No test set or related detailed evaluation is mentioned.
• Number of experts used to establish ground truth and their qualifications: Not applicable, as detailed performance validation regarding ground truth is not described.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable (not an AI/ML device requiring a training set).
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device Name: RPI Skin and Air Temperature Probes
• Intended Use: To be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide temperature feedback to maintain pre-selected temperature settings.
• Predicate Devices:
  • Accutemp-Probe, Kentec Medical, Inc. (K970686)
  • Hill-Rom ISOLETTE Infant Incubator; Hill-Rom Air-Shields (K001242)
  • First Touch Disposables Temperature Probes, First Touch Disposables, Inc. (K950422)
• Technological Characteristics: States that "No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Temperature Probes. The design, form, and materials of the probes are equivalent to their predicate devices." This is the core argument for substantial equivalence, implying that since the predicate devices are already cleared, this device, being equivalent, meets the necessary "acceptance criteria" by extension.

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