(11 days)
The iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.
The iScience Surgical Fiberoptic Illuminator (FI) is a portable light source intended to provide illumination during anterior and posterior segment ophthalmic surger. It is designed to be used only with the iScience Surgical iTrack Ophthalmic Microcannula to illum nate tissues during advancement into intraocular structures of the anterior and posterior segment.
The FI consists of a splash proof sheet metal enclosure with panel mounted rocker switches for operational control, and a custom light output connector. The FI houses a laster dionel illumination source, and is specific for the iScience Surgical iTrack Ophthalmic Microcannula. The FI is not intended to be sterilized or placed in a sterile enclosure.
The FI has a custom designed light output connector that contains two redundant safety interlock switches. These switches, in conjunction with electronic circuitry in the Fly ensure that laser light can only emanate from the laser aperture when an iScience Surgical iTrack Ophthalmic Microcannula is installed in the connector. The interlock switches independently detect the proper insertion of the iScience Surgical iTrack Ophthalmic Microoannulaipe into thre connector, ensuring that the microcannula is fully engaged and retained in the connector before laser output is enabled.
The provided 510(k) summary for the iScience Surgical Fiberoptic Illuminator (K062259) does not contain the level of detail typically found in a clinical study for medical device clearance. This submission primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and a limited in-vitro test rather than a full clinical study with acceptance criteria and statistical analysis of performance.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not explicitly provided in the text. I will extract the information that is available and note when details are missing.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" as applied to a quantitative performance metric is not explicitly stated in the document. The study's conclusion is qualitative, focused on the sufficiency of illumination.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Sufficient illumination for advancing microcannula into intraocular structures in enucleated cadaver eyes. | "Both illumination sources provided sufficient illumination at the tip of the iScience Surgical iTrack Ophthalmic Microcannula to advance it into intraocular structures." |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The study states "enucleated cadaver eyes," implying more than one, but no specific number is given.
- Data Provenance: Retrospective (cadaveric eyes), country of origin not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The statement "demonstrated equivalent results" implies an assessment was made, but the number or qualifications of individuals performing this assessment are not provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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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 comparative effectiveness study was not done. This study is an in-vitro comparison of two illumination devices, not an AI-assisted diagnostic device study. The concept of "human readers improve with AI" is not applicable here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI algorithm. The study was an in-vitro comparison of two illumination devices, one of which (the subject device) uses a different light source technology than its predicate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was the qualitative assessment of "sufficient illumination" for the task of advancing the microcannula into intraocular structures. This would likely be assessed by an expert (e.g., an ophthalmic surgeon), but this is not explicitly stated.
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The sample size for the training set:
- Not applicable. This is an in-vitro operational test, not a machine learning model.
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How the ground truth for the training set was established:
- Not applicable. This is an in-vitro operational test, not a machine learning model.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.