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illumination of the operating field during ophthalmic surgery

The trade name of the device for which the determination of substantial equivalence is being sought is "MBI Fiberoptic Endo-Illuminator". The classification name of the device is Illuminator, Fiberoptic, Surgical Field. It is classified as Illuminator, Fiberoptic, Surgical Field - HBI Reg 878.4580. There are no standards applying to it.

The device is identical to the Storz, MVS Disposable Fiberoptic Lightpipe marketed as a class II postamendment device by Storz Ophthalmics, Inc. under 510(k) marketing clearance issued by FDA as document control number K854587. The MBI device has the same intended use (illumination of the operating field during ophthalmic surgery) and the same technological characteristics (materials used and methods of manufacture). The applicant has been functioning as a capive manufacturing site producing. the predicate device for Storz and now intends to produce and sell to other customers the same device it has been manufacturing for Storz.

Performance is identical to that of the predicate device. When in use during ophthalmic surgery, part of the device will come into contact with the eye of the patient. The distal end that will contact the patient is a 20 ga. stainless steel tube enclosing a plastic fiber-optic filament whose flat end surface will give off the light needed by the surgeon. All materials are identical to those used in the predicate device. Just as in the predicate device, except for three plastic constituents white color added, all components are natural with no colorants added. Those constituents having white color added are the proximal end plug. that is insected into the light source device which is away from the patient, the sheathing for the fiber-optic filament, and the surgeon's grasping point that holds the distal tube that is inserted into the patient's eye during surgery. The colorant is in the plastic material of which the components are made. No constituent to which colorant is added will come into contact with the patient. There are no changes from the color additives used in the predicate device.

The device will be marketed as a single-use, sterile device. As with the prodicate device, sterility will be obtained by packaging the device in a clean, sealed envelope having a clear plastic window as one side and gas-permeable non-woven plastic (Tyvek) as the other side. In a process identical to that used for the predicate device, sealed envelopes containing the device will be sterilized by ethylene oxide gas which will penetrate the gas-permeable non-woven plastic fabric killing all pathogens on the device. Maximum residual levels of ethylene oxide, ethylene chlorohydrin, and ethylene glycol on the device are 250 PPM, 250 PPM, and 5000 PPM respectively. Successful sterilization will be confirmed by culturing spoor strips embedded in the lot to be sterilized. The device will meet sterility assurance level 10°. The constituents of the envelope are impenetrable by pathogens ensuring that sterility is maintained as long as package integrity is not compromised. The device is not considered non-pyrogenic.

The provided document is a 510(k) summary for the "MBI Fiberoptic Endo-Illuminator." It is a submission to the FDA seeking clearance for a medical device. As such, it describes the device as being substantially equivalent to a predicate device, rather than providing a detailed study proving its performance against acceptance criteria in the way a clinical trial might.

Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for a study) are not applicable to this type of regulatory submission. The document focuses on demonstrating equivalence to an already-cleared device.

However, I can extract the relevant information regarding acceptance criteria and reported performance as presented within the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This document is a 510(k) submission based on substantial equivalence to a predicate device, not a performance study in the typical sense with a "test set" of patient data. The "test" here is demonstrating identical characteristics and processes to the predicate device.
• Data Provenance: The "data" primarily comes from the manufacturing specifications and processes established for the predicate device, which MBI Inc. was already producing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. No expert ground truth establishment for a diagnostic test set is described. The "ground truth" for this submission is the performance and safety profile of the predicate device, which has already been cleared by the FDA.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication is described in this regulatory submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not an MRMC study. It's a submission for substantial equivalence based on manufacturing an identical product to a previously cleared device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is a physical medical device (an illuminator), not an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness profile of the predicate device (Storz, MVS Disposable Fiberoptic Lightpipe, K854587) as determined by its prior FDA clearance. The entire submission hinges on demonstrating that the MBI device is identical in all material aspects.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device or a diagnostic performance study. The "experience" or "basis" comes from MBI's historical manufacturing of the predicate device.

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

• Not applicable. See point 8. The manufacturing history and established specifications for the predicate device serve as the foundational "knowledge" for the submission. The sterility assurance is confirmed by "culturing spoor strips embedded in the lot to be sterilized," which is a quality control measure rather than establishing a "ground truth" for a training set.

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