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The intended use of the Nomad™ ND1000M system is to display video data or images while worn on the user's head.

The Nomad™ ND1000M Augmented Vision System is a monochromatic head-worn monocular display. The intended use of the Nomad™ ND1000M system is to display video data or images while worn on the user's head. It can be connected to any SVGA video source. The display combines the ambient environment with the displayed image (the image is superimposed over the normal field of vision). The display may be adjusted over either eve. Optionally, the display may be used in a non see-through fashion (occluded) with addition of the provided ocular cover.

The system consists of a display module, attached to headgear, that is connected via a .non-detachable interconnecting cable to a video control electronics module. The video input is connected to the video control electronics module. The device accepts power from a battery or an optional medical grade AC to DC power supply, both supplied with the device. A beit to hold the video control module and battery is provided. A rechargeable Li-Ion battery is also supplied along with a battery charger.

This document is a 510(k) submission for the Microvision Nomad™ ND1000M Augmented Vision System, seeking clearance from the FDA. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance as a medical video monitor.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or multi-reader studies, as this document does not describe such a study or performance metrics. It's an administrative document for regulatory approval based on equivalence, not a clinical or performance validation study.

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The scleral plugs are intended to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures.

Scleral plugs, 19 and 20 gauge, for use in ophthalmic surgical procedures. Both 19 and 20 gauge plugs are stainless steel. The 19 gauge plugs are gold plated.

This is a 510(k) premarket notification for a medical device (Scleral Plugs) and not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device based on material, construction, function, and biocompatibility testing. It states:

• Basis for Substantial Equivalence (Section 6):
  • No change in materials, basic components, or manufacturing methods compared to the predicate device.
  • No change in basic configuration or construction.
  • Biocompatibility testing by an independent lab was performed.
  • The function and use are no different from the predicate device.

The document asserts that the Micro Vision Scleral Plugs are substantially equivalent to the predicate device (Storz MVS 19 & 20 Gauge Scleral Plug, K854507) and that "any differences are minor and do not raise new issues of safety and effectiveness."

Without further documentation detailing specific performance studies and acceptance criteria for this non-AI device, it is not possible to provide the requested table or additional information.

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The MicroVision Scleral Buckling Components are solid silicone and silicone sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachments.

The MicroVision Scleral Buckling Components are molded solid silicone and silicone sponge devices available in a variety of shapes and sizes. The components are provided as sterile for single use only. Biocompatibility testing conducted according to ISO 10993 confirmed that the components are biocompatible and nontoxic.

The provided text is a 510(k) summary for the MicroVision Scleral Buckling Components. This document outlines the device's characteristics, intended use, and its substantial equivalence to previously cleared predicate devices. However, it does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way one might find for more complex diagnostic or therapeutic algorithms.

Here's a breakdown of why the requested information cannot be fully provided from this document:

1. Nature of the Device: Scleral buckling components are physical implants used in surgery. Their regulatory clearance relies heavily on material biocompatibility, physical properties, and equivalence to existing, established predicate devices, rather than clinical performance metrics in the same way a diagnostic AI would. There are no "performance metrics" in terms of sensitivity, specificity, accuracy, or reader improvement for this type of device.

2. Type of Regulatory Submission: A 510(k) submission generally focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves bench testing (physical and chemical properties), material characterization, and a comparison of intended use, rather than extensive clinical efficacy studies with ground truth established by experts.

Based on the provided text, here's what can be extracted and why other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation for Missing Information: For devices like these, "acceptance criteria" are typically met by demonstrating that the new device is "substantially equivalent" to predicate devices across several key attributes (materials, intended use, performance, safety). The "reported device performance" here describes how it meets those equivalence criteria rather than numerical performance metrics like those for an AI algorithm.

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

• Not applicable/Not provided. This device is a physical implant, not a diagnostic algorithm that uses a "test set" of data. The "testing" involved bench testing for physical and material properties, and biocompatibility testing. The document does not specify sample sizes for these types of tests, or where their data originated from (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not provided. "Ground truth" established by experts is relevant for diagnostic or AI-driven devices where human assessment is the reference standard. For a medical device implant, ground truth regarding its material properties or biocompatibility is established through standardized laboratory tests (e.g., ISO 10993), not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. As there's no "test set" of clinical cases requiring expert interpretation, no adjudication method (like 2+1 or 3+1) was used.

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

• No. An MRMC study is designed to compare human reader performance, often with and without AI assistance, on a set of clinical cases. This is not relevant for a physical implant device designed for surgical treatment. Therefore, no effect size of human reader improvement with AI assistance is applicable or reported.

6. Standalone (Algorithm Only) Performance:

• Not applicable/Not provided. This is not an algorithm or AI device; it's a physical medical implant. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

• Regulatory/Bench Testing Standards: The "ground truth" for this device's acceptance is based on adherence to recognized standards for biocompatibility (ISO 10993) and demonstration of equivalent physical and dimensional properties through bench testing, compared to legally marketed predicate devices. It's not based on expert consensus on clinical cases, pathology, or outcomes data in the traditional sense for diagnostic tools.

8. Sample Size for the Training Set:

• Not applicable/Not provided. This device is not an AI algorithm, so there is no concept of a "training set" for machine learning.

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

• Not applicable/Not provided. Since there's no training set, this question is not relevant.

In summary, the 510(k) summary for MicroVision Scleral Buckling Components demonstrates substantial equivalence primarily through bench testing and material characterization to established predicate devices, which aligns with the regulatory pathway for this type of device. The extensive clinical study details, expert consensus, and AI-specific metrics requested are not applicable or provided in this document given the nature of the device and the regulatory submission.

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The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

The Fiber Optic Endoillumination Probe is provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.

The provided text is a 510(k) summary for the MicroVision, Inc. Fiber Optic Endoillumination Probe. It does not describe an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the typical sense of a clinical or performance study with defined metrics. Instead, this document focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested elements for a study that "proves the device meets acceptance criteria" are not applicable or cannot be extracted from this document, as it's not a report of such a study.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document doesn't define quantitative acceptance criteria for performance; instead, it establishes equivalence based on descriptive characteristics.

Study Details (Not Applicable/Cannot be Extracted from a 510(k) Summary for Substantial Equivalence):

The 510(k) summary is a premarket notification to demonstrate substantial equivalence, not a detailed report of a performance study with specific acceptance criteria in the sense of clinical trial outcomes or detailed engineering specifications. It relies on comparing descriptive and technological characteristics to a legally marketed predicate device.

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. This document describes the device itself and its comparison to a predicate, not a performance study on a test set. There is no mention of a "test set" of patients or data.

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. Ground truth establishment for a test set is not relevant to a 510(k) substantial equivalence submission for this type of device. The "ground truth" here is essentially the characteristics of the predicate device.

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

• Not applicable. No test set or adjudication process is described.

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 fiber optic endoillumination probe, a physical medical device for illumination during surgery, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

• Not applicable. This device is a physical surgical tool, not an algorithm.

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

• For the purpose of substantial equivalence: The "ground truth" is the established characteristics and performance of the predicate device (Infinitech, Inc. Fiber Optic Probe, K870942). The claim is that the new device is functionally identical or very similar.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

• Not applicable. No training set is involved.

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