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Found 6 results
510(k) Data Aggregation
(126 days)
Medimaging Integrated Solution, Inc. (MiiS)
MiiS Horus Bronchoscope:
The MilS Horus Bronchoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiS Horus Endoscope Display System -Video Box (EVS 700). The device provides endoscopic visualization of airways and tracheobronchial tree, in conjunction with displaying system to perform various endoscopic procedures.
The MilS Horus Bronchoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.
MiiS Horus Endoscope Display System -Tablet:
The MiS Horus Endoscope Display System -Tablet (EDS 500) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.
MiiS Horus Endoscope Display System -Video Box:
The MilS Horus Endoscope Display System -Video Box (EVS 700) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.
MiiS Horus Bronchoscope (ECB 100 S/R/L) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronchial tree.
MiiS Horus Bronchoscope (ECB 100 S/R/L) have an LED light source and a camera at the distal end of the applied part. The Bronchoscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System - Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.
MiiS Horus Endoscope Display System -Tablet (EDS 500) is a tablet which showing live image or snapshot from ECB 100.
MiiS Horus Endoscope Display System -Video Box (EVS 700) is a standalone imaging transfer system; it can be connected to computer to project live imaging. If needed, the pictures or videos can be storage to Tablet (EDS 500 Tablet) or computer.
There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The working channel provide access for accessories to conduct surgical procedures.
MiiS Horus Bronchoscope has been designed to be compatible with the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA).
This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) premarket notification summary for the MiiS Horus Bronchoscope and its compatible display systems, aiming to demonstrate substantial equivalence to a predicate device.
The document states that no clinical studies were performed (page 9, "Clinical Tests"). Therefore, there is no information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the document focuses on demonstrating substantial equivalence through nonclinical tests and comparison of technological characteristics with the predicate device.
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(280 days)
Medimaging Integrated Solution Inc. (MiiS)
The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue™ Tablet OR VersaVue™ Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract.
The Cystoscope is intended to provide visualization via displaying unit.
The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.
VersaVue™ Single-Use Flexible Cystoscope is a single-use, flexible, sterile cystoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected display system (VersaVue™ Tablet OR VersaVue™ Video Box). The working channel provide access for accessories to conduct surgical process.
VersaVue™ Tablet is a tablet. The live imaging or snapshot will present directly on the tablet.
VersaVue™ Video Box is a standalone imaging transfer system, it can be connected to computer to project live imaging. The function of VersaVueTM Single-Use Flexible Cystoscope is to provide live imaging of the lower urinary tract, including tissue appearance recording, snapshot, vertical flip and horizontal flip.
The provided text does not contain information about acceptance criteria for a device's performance that would require a study with a test set, expert adjudication, or MRMC studies. The document describes a 510(k) premarket notification for a cystoscope, focusing on substantial equivalence to a predicate device based on technical characteristics and nonclinical tests.
Therefore, I cannot provide the requested information. The document states:
"Clinical Tests
No clinical studies were performed."
This indicates that the submission did not include studies that would typically define acceptance criteria based on performance with a test set and ground truth. The listed nonclinical tests focus on safety, electrical compatibility, sterilization, and basic optical performance specifications, not on clinical performance metrics with a patient dataset.
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(186 days)
Medimaging Integrated Solution Inc. (MiiS)
The ENT Nasopharyngoscope EES 100 is a sterile, single-use, and flexible device intended to be operated with its compatible display (EVS 100) for endoscopic procedures within nasal lumens and upper airway anatomy. The Video Box EVS 100 is intended to provide visualization via the connected tablet. The Nasopharyngoscope is intended for use in a hospital environment. It is designed for adult use.
ENT Nasopharyngoscope and Accessories contain nasopharyngoscope (model name: EES 100) and image transfer system (Video Box, model name: EVS 100A). EES 100 is a single-use, flexible, sterile nasopharyngoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected Video Box (EVS 100A). EVS 100A is attached on a tablet. The live imaging or snapshot will present directly on the tablet. The function of Nasopharyngoscope is to provide live imaging of the nasal tissue, including tissue appearance recording, snapshot, vertical flip and horizontal flip. The device does not provide any instruction for diagnosis nor treatment.
This document does not describe the acceptance criteria and a study that proves the device meets those criteria in the way typically seen for AI/ML devices. Instead, it is a 510(k) premarket notification for a medical device called the "ENT Nasopharyngoscope and Accessories" which outlines its substantial equivalence to a predicate device.
Therefore, many of the requested fields related to AI/ML device studies (like sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this document, as this device does not appear to be an AI/ML product.
Here's a breakdown of what can be extracted from the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a table format with corresponding device performance for specific claims, as would be common for AI/ML device studies. Instead, it focuses on demonstrating substantial equivalence to a predicate device through conformity to various engineering and safety standards, and through similar technical specifications.
The "acceptance criteria" are implied by adherence to these standards and the similarity to the predicate. The "reported device performance" is essentially the statement that the device meets these standards and has comparable specifications.
| Category | Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformity to IEC 60601-1 | Device meets requirements of IEC 60601-1. |
| Electromagnetic Compatibility | Conformity to IEC 60601-1-2 | Device meets requirements of IEC 60601-1-2. |
| Sterilization Validation | Conformity to ISO 11135 | Sterilization validated per ISO 11135. |
| Package Integrity | Conformity to ISO 11607-1 | Package integrity tested per ISO 11607-1. |
| EO/ECH Residue | Conformity to ISO 10993-7 | EO/ECH residue tested per ISO 10993-7. |
| Transportation Test | Conformity to ASTM D4169-16 | Transportation tested per ASTM D4169-16. |
| Aging Test | Conformity to ASTM F1980-16 | Aging tested per ASTM F1980-16. |
| Sterility Test | Conformity to ISO 11737-1 | Sterility tested per ISO 11737-1. |
| Risk Management | Conformity to ISO 14971, EN ISO 14971, MDR 2017/745 | Risk management performed per specified standards. |
| Light Hazards | Conformity to IEC 62471 | Device meets requirements of IEC 62471. |
| Biocompatibility | Conformity to ISO10993-5 and ISO10993-10 | Biocompatibility tested per specified standards. |
| Optical Specification | Comparable to predicate (FOV 85°, DOV 0°, DOF 6-50 mm) | FOV: 90°, DOV: 0°, DOF: 7-50 mm (differences deemed not significant). |
| Mechanical Specification | Comparable to predicate (Bending angle 130°, Length 300mm, OD 3.5mm) | Bending angle: 130°, Length: 300mm, OD: 3.6mm (differences deemed not significant). |
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 device is hardware-focused, and the testing described consists of non-clinical, bench tests against recognized standards rather than a clinical "test set" in the context of an AI/ML algorithm. No data provenance for software performance is discussed.
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. This is not an AI/ML device that requires expert-established ground truth for its performance assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no diagnostic test set requiring adjudication.
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. This is not an AI/ML device, so no MRMC study, AI assistance, or effect size is discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an endoscopic instrument and not an algorithm. Its function is to provide live imaging which is interpreted by a human user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of AI/ML. The "ground truth" for this device's performance is its adherence to established engineering and safety standards (e.g., IEC, ISO, ASTM) and its ability to provide clear visualization, confirmed through bench testing and usability testing, as opposed to diagnostic accuracy evaluated against pathology or expert consensus.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, therefore, there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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(57 days)
Medimaging Integrated Solution Inc. (MiiS)
MiiS Horus Eye Anterior Camera is a digital hand-held slit lamp system indicated for non- invasive illumination, magnification, visualization and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area.
MiiS Horus Eye Anterior Camera is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualize and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. It is a Li-ion battery-powered optical device. It brings more complete medical records about the static photos as well as the dynamic videos. MiiS Horus Eye Anterior Camera has an LED light source with visible white light. The device is designed with high-resolution lens and 5M pixels CMOS Sensor, faithful rendering color of the anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. The device can store pictures or videos in memory card, or via the USB, Wi-Fi and Bluetooth transfer pictures or videos to a computer. In addition to rendering images in the 3.5-inch full color TFT-LCD, through the HDMI output, you can connect the device to the big screen (TV, LCD screen) showing the pictures or videos.
MiiS Horus Eye Anterior Camera includes two models. The first model consists of control unit DSC 300 and lens unit DEA 200. The second model consists of control unit DSC 300P and lens unit DEA 200P. Either auto or manual focus can be used in first model while only manual focus is used in the second model.
The control unit DSC 300 includes a cover glass while DSC 300P does not. The contact rim in lens unit DEA 200 is different from that in DEA 200P.
This document does not include information about AI/ML features, acceptance criteria, or ground truth establishment. The device described, MiiS Horus Eye Anterior Camera, is a digital hand-held slit lamp system. It is a traditional medical device for visualization and recording of the anterior segment of the eye, not an AI/ML-powered diagnostic tool.
Therefore, I cannot provide details on acceptance criteria for AI/ML performance, study designs involving AI assistance, or related ground truth methodologies, as these are not relevant to the information provided in the input text.
The closest relevant sections in the provided text are regarding nonclinical tests and optical radiation safety assessment. These sections outline tests performed to ensure the device's safety and functionality in a traditional sense, not related to AI/ML performance metrics.
Specifically, the document states:
- Nonclinical Tests: "The following tests have been performed in support of the substantial equivalence determination: IEC 62304 for Software verification and validation testing. - IEC/EN 60601-1:2005/2006+A1:2012/2013 for electrical safety. - IEC/EN 60601-1-2:2014/2015 for electromagnetic compatibility. - Bluetooth testing for compatibility and functionality. - HDMI compliance test was conducted in compliance with HDMI 1.4b sink and source devices. - ISO 14971:2007 and EN ISO 14971:2012 for risk management. - -ISO 15004-2:2007 for light hazards. ISO10993-5:2009 and ISO10993-10:2010 standards for biocompatibility. The patient contacting parts are the holder of chin rest CR100 and the forehead stopper."
- Clinical Tests: "No clinical studies were performed."
- Optical Radiation Safety Assessment: "The MiiS Horus Eye Anterior Camera was tested according to 15004-2:2007 to determine acceptable light safety limits for both the illumination and background lights. The test results demonstrate the MiiS Horus Eye Anterior Camera is in compliance with the of Group 2 instrument requirements provided by the standard."
These tests confirm the device's compliance with safety and performance standards for a medical imaging device, but not for an AI/ML algorithm's diagnostic accuracy or performance.
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(406 days)
Medimaging Integrated Solution Inc. (MiiS)
MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of eyeball.
MiiS Horus Scope DPT 100 is a Li-ion battery-powered device. The Li-ion battery is rechargeable. It is a digital portable tonometer used to measure intraocular pressure of eyeball.
The device uses a white LED for illumination and capture image. The device has been tested according to the ISO 15004-2 (first edition, 2/15/2007) and been classified as Group I device.
The device has a CMOS sensor. The sensor accomplishes a task of capturing light and converting it into electrical signals.
The device store images to a SD card and have connectivity towards PC. The device uses an USB 2.0 interface to transfer data or picture to PC when connected.
The operation method of the device is described step by step in the attachment A1 "User manual". There is a graphical user interface color TFT display and keypad that is used for making adjustments before and during measure intraocular pressure of eyeball. Its' measure rang is 7-55 mmHg.
The MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of the eyeball. The following information details its acceptance criteria and the study proving its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from ISO 8612:2009 and ANSI Z80.10-2014) | Reported Device Performance (MiiS DPT 100) |
|---|---|---|
| Operating Range | Not explicitly stated in the provided text as a numerical range, but implied to be sufficient for clinical use. Predicates have 0-60 mmHg. | 7-55 mmHg |
| Accuracy | Not explicitly quantified in the provided text, but implied to meet standards. | Met the acceptance criteria for accuracy with a manometer-controlled model. |
| Repeatability | Not explicitly quantified in the provided text, but implied to meet standards. | Met the acceptance criteria for repeatability with a manometer-controlled model. |
| Reproducibility | Not explicitly quantified in the provided text, but implied to meet standards. | Met the acceptance criteria for reproducibility with a manometer-controlled model. |
| Compliance with Ophthalmic Standards | Meets requirements of ISO 15004-2:2007 (for optical hazards, Group 1 classification). | Met all requirements of ISO 15004-2:2007, classified as Group 1 for optical hazards. |
| Biocompatibility | Meets ISO 10993-5:2009 and ISO 10993-10:2010 standards for contact materials. | Met ISO 10993-5:2009 and ISO 10993-10:2010 standards for the chin rest holder material. |
Note: The document primarily focuses on overall compliance with standards rather than specific numerical targets for all performance metrics. For "Accuracy," "Repeatability," and "Reproducibility," the text states "The units under test met the acceptance criteria," indicating successful conformance without providing the specific numerical criteria or results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Human Eye Clinical Performance Test: The document does not specify the exact number of human subjects or measurements used in the clinical performance test. It only states that "Data was collected" in comparison to the predicate device.
- Data Provenance: Not explicitly stated. The manufacturer is based in Taiwan (R.O.C.), but the country of origin for the clinical test data is not provided. The study appears to be prospective as it's a "Clinical Performance Test" conducted to evaluate the device against a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. Instead, it relies on a predicate device (Goldmann applanation tonometry (GAT) Keeler Digital Applanation Tonometer (D-KAT) (K133234)) as the comparative standard for the human eye clinical performance test.
4. Adjudication Method
Not applicable. The study compares the device's measurements directly to a predicate device, not against an adjudicated expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focused on the device's technical performance and its direct comparison to a predicate tonometer. There is no mention of human readers or AI assistance.
6. Standalone Performance
Yes, a standalone performance evaluation of the algorithm (or device in general, as it's a tonometer, not specifically an AI algorithm for image interpretation) was conducted. The "bench test" evaluated the operating range, accuracy, repeatability, and reproducibility with a manometer-controlled model. The "Clinical Performance Test" also assessed the device's standalone performance by comparing its measurements to a predicate device on human eyes.
7. Type of Ground Truth Used
- For bench testing: A manometer-controlled model was used as the ground truth for evaluating operating range, accuracy, repeatability, and reproducibility.
- For clinical performance testing: Measurements from a Goldmann applanation tonometry (GAT) Keeler Digital Applanation Tonometer (D-KAT) (K133234) served as the comparative standard (ground truth) for human eye measurements. Goldmann Applanation Tonometry (GAT) is widely considered the gold standard for intraocular pressure measurement.
8. Sample Size for the Training Set
Not applicable. The MiiS Horus Scope DPT 100 is presented as a tonometer device for direct measurement of intraocular pressure, not an AI-based system that requires a "training set" in the context of machine learning. The document does not mention any AI components or machine learning models that would necessitate a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI-based system.
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(232 days)
Medimaging Integrated Solution Inc. (MiiS)
MiiS Horus+ Scope DEA 200 is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualization and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area.
MiiS Horus* Scope DEA 200 is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualize and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. It is a Li-ion battery-powered optical device. It brings more complete medical records about the static photos as well as the dynamic videos. MiiS Horus* Scope DEA 200 has an LED light source with visible white light. The device is designed with high-resolution lens and 5M pixels CMOS Sensor, faithful rendering color of the anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. The device can store pictures or videos in SD memory card, or via the USB transfer pictures or videos to a computer. In addition to rendering images in the 3.5-inch full color TFT-LCD, through the AV output, you can connect the device to the big screen (TV, LCD screen) showing the pictures or videos. Below includes a summary of the technical information used in the substantial equivalence comparison. It is more efficient and suitable for many different applications, such as electronic filing.
The provided document is a 510(k) Pre-market Notification from the FDA for a device named "MiiS Horus+ Scope DEA 200". This document focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, device performance, or human-in-the-loop studies as typically found in clinical validation reports for AI/CAD devices.
Therefore, the following information CANNOT be extracted from the document:
- A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria (e.g., sensitivity, specificity, AUC targets) for detecting conditions, nor does it provide performance metrics against such criteria.
- Sample size used for the test set and the data provenance: No information on a test set, its size, or origin is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document does not describe any expert-established ground truth or the qualifications of such experts.
- Adjudication method for the test set: No test set means no adjudication method.
- 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: The document explicitly states, "No clinical studies were performed." This implies no MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device described in the document is a digital hand-held slit lamp system, a hardware device for imaging and recording. It is not an AI algorithm, so a standalone algorithm performance study is not applicable.
- The type of ground truth used: Not applicable as there's no mention of a test set or performance evaluation against any ground truth.
- The sample size for the training set: The device is a hardware imaging system, not an AI model, so there is no concept of a "training set" in the context of this document.
- How the ground truth for the training set was established: Not applicable.
What the document does describe is a technical comparison of the "MiiS Horus+ Scope DEA 200" with two predicate devices (KOWA SL-15 and MiiS Horus Scope DEC 100) to demonstrate "substantial equivalence" based on similar intended use, technological characteristics, and safety evaluations (e.g., EMC, electrical safety, and optical radiation hazard assessment according to ISO 15004-2:2007). The document concludes that "bench performance tests support the conclusion of substantial equivalence."
In summary, this document is a regulatory submission for a medical imaging device (a digital hand-held slit lamp) and not an AI/CAD algorithm. Therefore, it does not contain the information requested about acceptance criteria, device performance, or clinical validation studies typically associated with AI systems.
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