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The Midfield Light Pipe is a disposable microsurgical instrument used to conduct a field of light to the posterior seqment of the eye in order to visualize the internal structures of the eyes during ophthalmic surgery.

The Midfield Light Pipe will be offered in a 23 gauge (GA), 25GA and 27GA size. Each device consists of an ABS handpiece, 304 stainless steel illumination connector, LDPE EVA jacket material, PMMA illumination fiber, 304 stainless steel needle and a PMMA scleral depressor. The Midfield Light Pipe is an external communicating device, in contact with tissue/bone/dentin for a limited duration (<24 hours). The device will be identical to the existing Peregrine 23GA and 25GA Chandelier Illuminator (K151604), except the illumination fiber used in the Midfield will have a higher numerical aperture (NA). The higher NA of the fiber will allow for a wider light field for improved visibility for the surgeon, without compromising illumination intensity ("brightness").

Peregrine will also provide a scleral depressor for use with the Midfield Light Pipe. Transcleral illumination makes use of the scleral depressor for examination of the vitreous base by manipulating and indenting the sclera while illuminating through the sclera. The scleral depressor is only intended to contact the outer surface of the eye (sclera) for a limited duration (<24 hours).

The Midfield Light Pipes are comprised of common materials used in ophthalmic devices. The light pipe is mechanical and contains no electrical components. The Midfield Light Pipes only transmit light energy, they do not control the intensity of the light output - this is controlled by the operating system to which it is attached.

I am sorry, but based on the provided text, there is no information about acceptance criteria and a study that proves a device meets these criteria in the context of AI/ML performance, human reader studies, or associated metrics like AUC, sensitivity, specificity, etc.

The document discusses a 510(k) premarket notification for a medical device called "Midfield Light Pipe." The performance testing described is related to the physical characteristics and safety of the device, such as light output, needle strength, phototoxicity, sterilization, shelf-life, packaging, and biocompatibility.

Therefore, I cannot provide the requested information.

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The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures. The IR Viewer is indicated for use in procedures for inserting a needle or catheter in superficial, peripheral vessels.

The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures.

The provided document does not contain acceptance criteria or a study that proves the device meets acceptance criteria.

The document is a 510(k) premarket notification summary for the IR Viewer, a device for visualizing patient vasculature. It outlines the device description, intended use, predicate devices, and the FDA's substantial equivalence determination.

Here's a breakdown of what is and isn't in the document regarding your request:

What is present:

• Device Description: The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing for procedures involving needle or catheter insertion in superficial, peripheral vessels.
• Intended Use Statement: Clearly defined.
• Predicate Devices: ESP7 (Ironmaster) and Venoscope (Trinity Partners) are mentioned.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.

What is explicitly stated but lacks detail:

• "Performance Data: Performance data were submitted to characterize the device." This line is present, indicating that performance data exists and was submitted to the FDA, but the document does not elaborate on what that data entails, what the acceptance criteria were, or the results of any specific study.

Therefore, I cannot provide the requested information because it is not contained within the provided text. To answer your questions, details from the actual performance data submission would be required.

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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 Pick Manipulator is a manual tool for aiding the procedural needs of the surgeon during ophthalmic surgery, such as tissue manipulation and membrane delamination.

Hand-held illuminated pick and membrane delamination instrument for ophthalmic surgery.

The Infinitech Bullet® Endo Illuminated Pick Manipulator is a manual tool intended for ophthalmic surgery, specifically for tissue manipulation and membrane delamination. The provided 510(k) summary does not include a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or any quantitative measure of effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on device type, intended use, patient contact materials, and manufacturing/sterilization processes. The concept of "effectiveness" mentioned in the summary is broad and stated as: "The instrument is constructed of commonly used materials for ophthalmic surgical instruments and is configured in a common tool geometry." This implies that its effectiveness is assumed based on its similarity to existing, legally marketed devices.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be found in the provided document because the 510(k) pathway for this device did not require such a study to demonstrate performance against explicit acceptance criteria.

Below is the information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Based on the provided document, there are no explicit quantitative acceptance criteria or detailed performance metrics reported for the Infinitech Bullet® Endo Illuminated Pick Manipulator. The "effectiveness" is stated qualitatively by comparing it to predicate devices. The acceptance was based on "substantial equivalence" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical or performance study involving a test set with human or patient data is described in the provided document for the purpose of demonstrating device performance against specific metrics. The device's substantial equivalence was based on a comparison of its design and intended use to existing predicate devices.

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)

Not applicable. No ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No adjudication method is mentioned as there was no test set in the context of device performance evaluation.

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

Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

Not applicable. This is a manual surgical instrument and does not involve an algorithm.

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

Not applicable. No ground truth in the context of performance evaluation was used or described.

8. The sample size for the training set

Not applicable. This is a manual surgical instrument; there is no training set involved in the context of machine learning or algorithm development.

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

Not applicable. As there is no training set mentioned, the establishment of ground truth for it is not relevant.

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