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The BiliBlanket Plus High Output (67.5 µW/cm²/nm maximum )Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

The BiliBlankel Plus High Output Phototherapy System has two modes of operation: phototherapy, used for the treatment of hyperbilirubinemia; and transillumination, used for a variety of medical procedures such as locating venipuncture sites and detecting pneumothoraces or hydrocephalus. In the phototherapy mode, a fiberoptic cable and blanket are attached to the illuminator box. Phototherapeutic light, which is light in the blue region (42.5 - 475 nm), is transmitted from the illuminator to the blanket via the fiberoptic cable. The blanket is applied to the patient so as to maximize the patient contact with the blanket. The second mode is transillumination. A fiberoptic cable is attached to the illuminator, and the visible light spectrum (white light) appears at the tip of this fiberoptic cable is used for facilitating vascular stick or injections; it is also used for finding pneumothoraces.

Here's a breakdown of the acceptance criteria and study information for the Ohmeda Medical BiliBlanket Plus High Output Phototherapy System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The 510(k) summary primarily focuses on the modification from the predicate device (increased light output) rather than explicit "acceptance criteria" in the traditional sense of a performance study with pass/fail metrics. The "reported device performance" here is essentially the new specification that the modified device achieves. The regulatory submission implies that meeting this increased light output, while adhering to general safety and design controls, is the basis for substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. No clinical or animal testing was performed.
• Data Provenance: Not applicable, as detailed above.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical or animal testing was performed that would require expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. No clinical or animal testing was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC comparative effectiveness study was not performed. The submission explicitly states: "Since treatment of neonatal hyperbilirubinemia with phototherapy is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary."

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

• Not applicable. This device is a medical device, not an AI/algorithm.

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

• Not applicable. No ground truth in the context of clinical accuracy or diagnostic performance was established for this submission. The validation was based on engineering bench testing to confirm the modified light output specifications.

8. The sample size for the training set:

• Not applicable. This device is not an AI/algorithm and does not involve a training set.

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

• Not applicable. This device is not an AI/algorithm and does not involve a training set or its associated ground truth establishment.

Summary of the Study and Device Proof:

The submission for the BiliBlanket Plus High Output Phototherapy System is a 510(k) for a modified version of an existing predicate device (Ohmeda - BiliBlanket Plus High Output, K993712).

The "study" that proves the device meets its (new) acceptance criteria is extensive bench testing. The manufacturer, Ohmeda, states that "the product was subject to extensive bench testing, and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied."

The primary modification being documented is an increase in the maximum light output level from the predicate's 18-45 ± 25% µW/cm²/nm to the modified device's 21-50 +35% -25% µW/cm²/nm. The rationale for not conducting clinical or animal testing is that "treatment of neonatal hyperbilirulinemia with phototherapy is a well-established clinical practice." This means the general safety and effectiveness of phototherapy for this indication are already understood, and the modification is primarily an engineering change to the device's performance characteristics, validated through engineering testing.

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The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

The BiliBlanket Plus High Output Phototherapy System has two modes of operation: phototherapy, used for the treatment of hyperbilirubinemia; and transillumination, used for a variety of medical procedures such as locating venipuncture sites and detecting pneumothoraces or hydrocephalus. In the phototherapy mode, a fiberoptic cable and blanket are attached to the illuminator box. Phototherapeutic light, which is light in the blue region (400 - 550 nm), is transmitted from the blanket via the fiberoptic cable. The blanket is applied to the patient so as to maximize the patient contact with the blanket. The second mode is transillumination. A fiberoptic cable is attached to the illuminator, and the visible light spectrum (white light) appears at the of this fiberoptic cable is used for facilitating vascular stick or injections; it is also used for finding pneumothoraces.

The provided text describes the 510(k) summary for the Ohmeda Medical BiliBlanket Plus High Output Phototherapy System. However, it explicitly states that no clinical or animal testing was necessary to demonstrate safety and effectiveness due to the well-established clinical practice of treating neonatal hyperbilirubinemia with phototherapy. Instead, the device underwent "extensive bench testing."

Therefore, the requested information regarding acceptance criteria based on clinical studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.

Here’s a summary based on the provided text, highlighting the absence of the requested data:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable. No clinical test set details are provided as no clinical studies were performed. The document mentions "extensive bench testing," but details on sample size or data provenance for this testing are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical test set means no expert ground truth establishment for a clinical study.

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

• Not applicable. No clinical test set was used requiring an adjudication method.

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. An MRMC study was not done, as this device does not involve "human readers" or "AI assistance" in the context of interpretation that would necessitate such a study. It is a medical device for phototherapy and transillumination, not an imaging or diagnostic AI tool.

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

• Not applicable. This is a hardware medical device, not an algorithm, so "standalone performance" in the context of AI algorithms is not relevant. The device operates independently for therapy delivery.

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

• Not applicable for clinical efficacy. For the "extensive bench testing," the ground truth would have been based on engineering specifications and physical measurements (e.g., light intensity, spectrum, electrical safety), not clinical outcomes or expert consensus.

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 that requires a training set.

In summary, the 510(k) summary for the Ohmeda Medical BiliBlanket Plus High Output Phototherapy System focuses on demonstrating substantial equivalence to predicate devices and adherence to design control regulations, rather than presenting clinical trial data. This is explicitly stated due to the established nature of phototherapy for hyperbilirubinemia.

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