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Found 33 results
510(k) Data Aggregation
(263 days)
Mab 411028 INDIA
Re: K233043
Trade/Device Name: Smart Scope® (CX) Regulation Number: 21 CFR 884.1630
|
| Classification Number: | 21 CFR 884.1630
|
| Regulation
Number | 21 CFR 884.1630
| 21 CFR 884.1630
Smart Scope® CX is intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting areas for biopsy. The Net4Medix® application is intended to provide documentation of the field of view of the scope. The Smart Scope® CX camera probe is intended to be inserted into the a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.
Smart Scope® CX is a handheld, reusable transvaginal digital examination camera designed for use in a hospital or clinical setting. It is intended for close examination and magnified visualization of the external genitalia, vagina, and cervix. The Smart Scope® CX camera probe is equipped with an integrated green and white LED light, which serves to illuminate the object under observation. Additionally, it features a 10X magnification camera, facilitating the capture of color images. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances by pressing respective buttons in the smart scope probe. By establishing a USB connection between the Smart Scope and a tablet, users can access live images and capture necessary stills using the Net4Medix® application, installed on the tablet. These captured images are then stored directly on the tablet. The Net4Medix® software further enables the creation and management of patient records, visit histories, and seamless integration with the Smart Scope® CX for functions such as image streaming, capture, storage, and assignment to the respective patient records. The Smart Scope® CX is designed and intended to be used only with speculum and it is not intended to come into direct contact with the body. Smart Scope® CX is not a substitute for histopathology and is not a diagnostic test.
The provided text is a 510(k) summary for the Periwinkle Technologies Pvt. Ltd.'s Smart Scope® CX, a digital colposcope. It focuses on demonstrating substantial equivalence to a predicate device (Pocket Colposcope System K181034) by comparing technical specifications and performance data.
However, the document does not contain the detailed study information typically requested for evaluating "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-driven device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance (in the sense of clinical performance metrics like sensitivity, specificity, or reader agreement). The tables provided compare technical specifications of the device itself (e.g., illumination, magnification) rather than clinical performance outcomes or AI model performance metrics.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details. The document outlines the physical and software components of the device and its intended use for visual examination, but there is no mention of an AI algorithm making diagnostic interpretations or classifications that would require such rigorous validation studies.
Based on the provided text, the Smart Scope® CX is a digital colposcope that provides magnified visualization and image documentation. It is NOT an AI/ML-driven device that provides diagnostic interpretations or classifications. Therefore, the specific types of acceptance criteria and study designs typically used for AI/ML medical devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by expert consensus) are not present or applicable in this 510(k) submission.
The performance data mentioned in the document refers to:
- Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2.
- Software: Compliance with FDA guidance and IEC 62304.
- Cybersecurity: Compliance with FDA guidance and IEC 81001-5-1.
- Risk Management: Compliance with ISO 14971.
- Reprocessing: Compliance with FDA guidance.
- Labels & IFU: Compliance with ISO 15223-1 and ISO 20417.
- Performance (Optical): Compliance with ISO 8600-3, ISO 8600-5, IEC 62471, and general optical performance evaluations. These relate to the physical device's imaging capabilities (e.g., field of view, resolution, photobiological safety), not an AI's diagnostic performance.
Therefore, I cannot fulfill the request as it relies on information typically found in submissions for AI/ML devices, which is not present in this document for the Smart Scope® CX. The "acceptance criteria" here are met through demonstrating technical comparability and compliance with relevant safety, software, and optical performance standards for a medical imaging device, rather than through a clinical performance study of an AI algorithm.
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(165 days)
Re: K220969
Trade/Device Name: GelPOINT® V-Path Vaginal Access System Regulation Number: 21 CFR§ 884.1630
|
| Classification: | Regulation: 884.1630
The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.
The GelPOINT V-Path Vaginal Access System consists of an Intravaginal Alexis retractor and two access channels that are placed vaginally to create a pathway to gynecological organs. A GelSeal cap attaches to the retractor at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.
This document is a 510(k) summary for the GelPOINT® V-Path Vaginal Access System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request:
1. Table of acceptance criteria and the reported device performance:
The document describes functional testing but doesn't explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics in a table format. Instead, it describes general successful outcomes.
| Acceptance Criteria (Inferred from study goals) | Reported Device Performance (Summary of results) |
|---|---|
| Ability to maintain transvaginal access. | The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to establish and maintain a path of entry for minimally invasive instruments. |
| Ability to facilitate instrument access to the surgical site. | The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to establish and maintain a path of entry for minimally invasive instruments. |
| Ability to allow for device removal. | The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to allow for device removal. (Inferred from "Device removal" being an assessed function). |
| Ability to maintain device retention/anchoring. | The studies confirm that the GelPOINT V-Path Vaginal Access System can remain anchored in the patient while withstanding conditions under normal clinical use. |
| Ability to maintain insufflation. | The studies confirm that the integrity and sealing capability of the device system are adequate to maintain insufflation as a means to provide visualization of the surgical space. |
| Biocompatibility (non-cytotoxic, non-sensitizer, non-irritant, non-systemically toxic, non-pyrogenic). | The biocompatibility test results demonstrate the GelPOINT V-Path Vaginal Access System is biocompatible and has met the criteria to be classified as non-cytotoxic, non-sensitizer, non-irritant, non-systemically toxic, and non-pyrogenic. |
| Shelf-life of 3 years. | Results from testing demonstrated that the devices could maintain their specifications over the stated shelf-life duration of 3 years. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "bench testing" and "Functional bench testing" but does not provide specific sample sizes (e.g., number of devices tested, number of trials).
- Data Provenance: The studies were internal company studies ("A protocol was developed by Applied Medical"). There is no mention of country of origin of data, and these are laboratory bench tests, not patient data, so the retrospective/prospective distinction is not applicable in the usual sense for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies are described as functional bench tests, suggesting engineering or quality assurance personnel would evaluate the performance rather than clinical experts establishing a ground truth in the context of diagnostic accuracy.
4. Adjudication method for the test set:
This information is not provided. Given the nature of bench testing, it's unlikely an adjudication method like 2+1 or 3+1 (typically used for clinical imaging assessments) would be applied.
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:
- MRMC Study: No.
- AI Assistance: The document describes a medical device for surgical access, not an AI-powered diagnostic or assistive tool. Therefore, a study on human readers improving with AI assistance is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not applicable.
7. The type of ground truth used:
For the functional tests, the "ground truth" would be the successful demonstration of the device's intended functions (e.g., maintaining an open pathway, retaining its position, maintaining insufflation). For biocompatibility, the ground truth is established by meeting the pass/fail criteria outlined in the referenced ISO standards and USP . For shelf-life, the ground truth is the device maintaining specifications after accelerated aging.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, this is not an AI/machine learning device.
In summary:
This 510(k) summary focuses on demonstrating the substantial equivalence of a physical surgical access device through functional bench testing, biocompatibility testing, and shelf-life studies. It does not involve clinical studies with patient data, expert review of images, or artificial intelligence algorithms. Therefore, many of your requested points related to AI performance, reader studies, and large-scale data sets are not relevant to this type of device submission.
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(206 days)
Colposcope, Exempt |
| Regulation Number: | 21 CFR 884.4120 | 21 CFR 884.1630
electrocautery and
accessories (21 CFR 884.4120)
Product Code: HGI
Colposcope, Exempt (21 CFR
884.1630
)
Product Code: PTZ
Class II | Colposcope (21 CFR 884.1630)
Product Code: HEX
Class II |
The IRIS Thermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing as needed for a colposcopy exam.
The Liger Medical IRIS Thermocoagulator and Digital Colposcope is a portable thermal coagulator with integral colposcope that provides assistance for clinician examination of the cervix as well as utilizes a heated probe to ablate human tissue. It is specifically designed for use in resource-limited settings. The colposcope and thermal ablation modes can be used separately from each other. The device is a handheld, portable, battery-operated, ablator with an LCD display and optical camera to assist diagnosis and treatment, in a safe, effective, easy to use package with sufficient battery life to sustain work for 4 hours. Thermal coagulation can be used in hospital and non-hospital professional healthcare locations.
The IRIS colposcope/thermal ablation device is not intended on into the vaginal canal during colposcopic examination. The camera remains outside the vaginal cavity and functions comparably to a standard non-invasive colposcope in terms of providing magnified visual assistance to the clinician. There is no patient contact during the colposcopic examination. Contact between the clinician and the device is mitigated through good clinical practice of wearing protective gloves, limiting contact to intact skin protected by operating gloves.
The thermal ablation probe, which is reusable and provided non-sterile, is designed to perform low-power destruction of human tissue with high temperatures by tissue contact with an electrically heated probe tip. The biocompatibility of the probe materials conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for limited duration mucosal membrane contact.
The provided text is a 510(k) Summary for the Liger Medical IRIS Thermocoagulator and Digital Colposcope. It details the device's intended use, comparison to predicate devices, and non-clinical performance testing. However, it explicitly states "Not Applicable" under "9. Clinical Performance Data."
Therefore, based solely on the provided text, a detailed response to points 1-7, 8, and 9 for a study proving the device meets acceptance criteria cannot be fully constructed, as the document states no clinical performance data was used for this submission. The device's substantial equivalence was demonstrated through non-clinical performance testing and comparison to predicate devices.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document describes various non-clinical tests performed, implying these tests have acceptance criteria, but the specific numerical acceptance criteria and the precise quantified performance results are not detailed in a comparative table format. We only get a list of tests performed.
Table of Acceptance Criteria (Implied) and Reported Device Performance (General):
| Acceptance Criteria (Implied from tests) | Reported Device Performance (General Statement) |
|---|---|
| Electrical/Thermal Safety | Met ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 |
| Electromagnetic Compatibility (EMC) | Met IEC 60601-1-2:2014 (4th Ed) |
| Probe Fault Detection | Tested; Implied to have met design input requirements |
| Battery Fault Detection | Tested; Implied to have met design input requirements |
| Probe Heat-up time and Temperature Stability at Set-Point | Tested; Implied to have met design input requirements |
| Heater Circuit Hardware Checks | Tested; Implied to have met design input requirements |
| Heater Performance on Tissue | Tested; Implied to have met design input requirements |
| Software Application Testing | Tested; Implied to have met design input requirements |
| Use-Life Testing | Tested; Implied to have met design input requirements |
| Interoperability and Connectivity Testing | Tested; Implied to have met design input requirements |
| Endoscope General Requirements | Met ISO 8600-1:2015 |
| Field of View and Direction of View | Met ISO 8600-3:2019 |
| Limiting Spatial Resolution | Tested; Implied to have met design input requirements |
| Biocompatibility | Conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1" for limited duration mucosal membrane contact. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified as no clinical performance data was provided. The non-clinical tests would have involved specific test units, but the "sample size" in terms of patient data is not applicable here.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical performance data/test set with human expert ground truth was mentioned.
4. Adjudication method for the test set:
- Not applicable as no clinical performance data/test set requiring adjudication was mentioned.
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, a MRMC comparative effectiveness study was not done according to this document. The device includes a digital colposcope for magnified visualization to aid in selecting areas for biopsy and diagnosis, but the submission explicitly states "Not Applicable" for clinical performance data, meaning no study assessing human reader improvement with or without AI assistance was presented here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical instrument (thermocoagulator and digital colposcope), not an AI algorithm in isolation. While it has a "Digital Colposcope" component capable of camera-assisted visualization, the document does not describe any standalone algorithm performance.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" would be the established engineering and safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 8600-1, ISO 8600-3, ISO 10993-1) against which the device's technical performance was measured. No clinical ground truth (e.g., pathology, outcomes data) was used or presented in this 510(k) summary.
8. The sample size for the training set:
- Not applicable. This document is for a physical medical device, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable.
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(96 days)
Kfar Saba, 4442520 Israel
K190187 Re: Trade/Device Name: Gynescope™ System Regulation Number: 21 CFR§ 884.1630
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| Regulation Number: | 21 CFR 884.1630
The Gynescope™ System is intended for the examination of the vagina, cervix, and external genitalia, to investigate, by means of magnification, abnormalities such as lesions or cancer. The Gynescope™ System is intended to select areas for biopsy, when indicated.
The Gynescope™ Single Use Vaginal Speculum component of the Gynescope™ System is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The Gynescope™ Single Use Vaginal Speculum can be used only with the Gynescope™ System.
The Gynescope™ System is intended for use in hospitals, clinics, and doctors' offices.
The Gynescope™ System is a colposcope platform for physicians to perform examinations of the vagina, cervix and external genitalia. The Gynescope™ System consists of the following components:
- Gynescope™ Image Acquisition System (IAS)
- Gynescope™ System Console
- Gynescope™ Single Use Vaginal Speculum
The IAS is a handheld colposcope that includes imaging optics and provides white and green illumination using both centered and side illumination techniques. The IAS also includes color and monochrome sensors. The color sensor is used for standard examinations under white or green illumination, while the monochrome sensor is only used for imaging target tissues under green illumination. Key functions of the device (e.g., magnification, illumination, light source, image capture, etc.) can be operated using a built-in keypad on the IAS. A cable connects the IAS to the Gynescope™ System Console.
During use, the IAS is attached to the Gynescope™ Single Use Vaginal Speculum to form a single body. When combined, the Gynescope™ Single Use Vaginal Speculum provides access to the vaginal cavity and prevents direct contact of the IAS with the patient. This component also includes a separate opening for instruments if needed during an examination. The Gynescope™ Single Use Vaginal Speculum is non-sterile, made of polycarbonate, and is provided in four sizes.
The Gynescope™ System Console is responsible for data processing, storage and display of information to the user. In addition, the Gynescope™ System Console can be used to control functions of the IAS (e.g., magnification, illumination, light source, image capture, etc.). User's interact with the Gynescope™ System Console via a 12.2-inch touchscreen interface. This component also includes a video output connection that allows connection to a peripheral video device (e.g., monitor). A cradle is also mounted on the Gynescope™ System Console that is used to hold and protect the IAS between uses.
The provided text describes a 510(k) summary for the Gynescope™ System, a colposcope. However, it does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm's performance. The "Summary of Performance Testing" section details various engineering and safety tests (electrical safety, EMC, software, cybersecurity, imaging evaluation, biocompatibility, mechanical testing of the speculum) but does not present a clinical study with specific acceptance criteria related to a device's diagnostic performance against a ground truth, especially not involving AI.
Therefore, **I cannot extract the requested information based on the provided text, as it does not contain details about:
- A table of acceptance criteria and reported device performance for a diagnostic task.
- Sample sizes for a test set or its provenance for such a diagnostic study.
- Number of experts or their qualifications for establishing ground truth for a diagnostic test set.
- Adjudication methods for a diagnostic test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance without human-in-the-loop.
- Type of ground truth (expert consensus, pathology, outcomes data) for a diagnostic task.
- Sample size for a training set (indicating the absence of an AI component being evaluated here).
- How ground truth for a training set was established.**
The document primarily focuses on the device's technical specifications, safety, and functional equivalence to a predicate colposcope, not on the performance of a diagnostic algorithm or AI system.
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(60 days)
Philadelphia, PA 19103
Re: K182764 Trade/Device Name: Biop Digital Colposcope Regulation Number: 21 CFR§ 884.1630
of Device: Biop Digital Colposcope Common or Usual Name: Digital Colposcope Classification: 21 CFR 884.1630
The Biop Digital Colposcope is intended for magnified viewing of the vagina, cervix and external genitalia, in order to assist doctors in diagnosing abnormalities such as lesions or cancer and selecting areas for biopsy. The images from the Digital Colposcope are to be viewed on a color display. The Biop Digital Colposcope is intended for use in hospitals, clinics, and doctor's offices.
The Biop Digital Colposcope comprises 3 components:
. Biop Digital Colposcope Control unit;
. Biop Digital Colposcope unit;
Dedicated PC (touch screen) containing software and vertical stand.
The Biop Digital Colposcope is designed to be utilized at a working distance (WD) of 8" (200mm) -12" (300mm) from the cervix and acquires magnified images according to the doctor's requirements. The colposcope includes LED illumination and digital green filter capabilities as well.
The user can operate the Biop Digital Colposcope unit using the keypad on the Biop Digital Colposcope Control unit and/or via the touch screen of the PC. Via the operation screen on the monitor, the user can visualize the cervix, take snapshots, take video, and use the green filter and additional illumination functionalities. Each of these functions can be controlled and adjusted by designated menus.
The touch-screen graphical user interface (GUI) consists of three menu options: Menu 1, 2, or 3, which allow control over the Biop Digital Colposcope, including the illumination system, zoom functions and Pan options. Each Operation Screen can be used during the colposcopy exam and shows the video taken by the Biop Digital Colposcope camera in real time. Images acquired during colposcopy are shown on the right of the screen. The user can toggle through all images obtained via the Biop Digital Colposcope unit and, if indicated, can acquire the biopsies in a standard manner. In addition, the system also enables full screen presentation of the images.
This document describes the Biop Digital Colposcope and its equivalence to a predicate device. However, it does not contain specific acceptance criteria for a device's performance in diagnosing abnormalities or selecting areas for biopsy using AI or advanced algorithms, nor does it provide a study proving such criteria are met. The document focuses on the physical and optical specifications of the colposcope itself, and its compliance with general medical device standards.
Therefore, for the specific questions requested, much of the information cannot be found in the provided text.
Here is what can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
The document lists various specifications and states that the device "met its predefined optical specifications" or "met predefined specifications" for those criteria. It does not provide specific acceptance values or thresholds for all listed specifications, nor does it present "device performance" in terms of diagnostic accuracy, sensitivity, or specificity, as the device itself is a viewing tool, not an AI diagnostic system.
| Acceptance Criteria (from specifications/standards) | Reported Device Performance |
|---|---|
| Illumination (2200 Lux at 300mm WD, Diameter > 60mm at 200mm WD) | Met predefined specifications |
| On-axis spatial resolution (57 line-pairs/mm) | Met predefined specifications |
| On-axis angular resolution (0.005°) | Met predefined specifications |
| Geometric Distortion ( |
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(156 days)
City, Utah 84112
Re: K181034
Trade/Device Name: Pocket Colposcope System Regulation Number: 21 CFR 884.1630
|
| Classification: | Colposcope, 21 CFR §884.1630
use or to
touch the patient. | | |
| Class | 21 CFR §884.1630
The Pocket Colposcope is a digital video colposcope intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The Pocket Colposcope System is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.
The Pocket Colposcope is a reusable, high-definition video colposcope intended to be used in a hospital / clinical environment for examination of the tissues of the vagina, cervix and external female genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The Pocket Colposcope can be used outside of the body to capture images of the vagina and external genitalia or can be inserted through a vaginal speculum to capture images of the cervix and surrounding tissue. The Pocket Colposcope it is not intended to come into direct contact with the body.
The Pocket Colposcope utilizes a ring or single loop of LED lights to illuminate the target tissue. The digital color image generated by the Pocket Colposcope is intended to be used to aid in diagnosing abnormalities and selecting areas for biopsy. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances.
The Pocket Colposcope has a 5 MP CMOS camera with a 0° angled lens. The Pocket Colposcope uses a computer-based software program to display the camera output on a computer screen and to capture images. Together, the Pocket Colposcope and the software comprise the Pocket Colposcope System.
The provided text does not contain detailed acceptance criteria or a study directly comparing the device's performance against specific clinical efficacy metrics. Instead, it focuses on demonstrating safety, essential performance, and technological equivalence to a predicate device.
However, based on the Summary of Performance Testing section, we can infer some general "acceptance criteria" through the standards the device was tested against and the statement "All test results met pre-determined acceptance criteria."
Here's an attempt to answer your request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since specific numerical acceptance criteria (e.g., minimum sensitivity/specificity for a diagnostic claim) are not provided, the table below reflects what can be inferred from the regulatory submission document. The "Reported Device Performance" here refers to the outcome of the testing mentioned, which is that the device complied or met the standards.
| Acceptance Criteria (Inferred from standards tested) | Reported Device Performance |
|---|---|
| Electrical Safety (Compliance with IEC 60601-1:2005, + A1:2012) | Meets requirements |
| Essential Performance (Compliance with IEC 60601-1:2005, + A1:2012) | Meets requirements |
| Electromagnetic Compatibility (EMC) (Compliance with IEC 60601-1-2 and related standards) | Meets requirements |
| Software Verification and Validation (Compliance with FDA guidance for software in medical devices) | Met documentation requirements; level of concern considered minor. |
| Imaging Performance - Field of View (Compliance with ISO 8600-3:2003) | Met acceptance criteria. |
| Imaging Performance - Optical Resolution (Compliance with ISO 8600-5:2005) | Met acceptance criteria. |
| Imaging Performance - Distortion (Compliance with ISO 9039:2008) | Met acceptance criteria. |
| Illumination Performance (Compliance with ANSI/NEMA FL-1:2009) | Met acceptance criteria. |
| Photobiological Safety (Compliance with IEC/EN 62471:2008) | Met acceptance criteria. |
| User Needs/Requirements (Validation through evaluation by trained medical professionals) | Performed as intended and met user needs and requirements. |
2. Sample Size for Test Set and Data Provenance
The document does not specify a "test set" in terms of cases (e.g., patient images for diagnostic performance). The performance testing described is primarily engineering and usability-focused.
- Sample Size for Test Set: Not applicable in the context of clinical diagnostic performance. For the "Design Validation" where medical professionals evaluated the device, the sample size is referred to as "several trained medical professionals," which is not a specific number.
- Data Provenance: Not applicable for engineering and usability testing as described. If "Design Validation" involved patient interaction, the provenance is not specified.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: "several trained medical professionals"
- Qualifications of Experts: "trained medical professionals (intended users)" - no specific experience level (e.g., "10 years of experience") or specialization (e.g., "radiologist") is given. They are described as "intended users."
4. Adjudication Method for Test Set
Not applicable. The performance testing described does not involve a multi-reader, multi-case adjudication process for establishing ground truth for diagnostic accuracy, as it's not a diagnostic AI device requiring such. The "Design Validation" focused on user satisfaction and device function, not diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The Pocket Colposcope System is a physical imaging device, not an AI diagnostic aid for human readers in the described context.
- Effect size of improvement: Not applicable.
6. Standalone (Algorithm Only) Performance
- Was a standalone performance study done? No. The device itself is an imaging tool. The "Software Verification and Validation Testing" focused on the software within the device meeting regulatory requirements, not on a standalone diagnostic algorithm's performance on a dataset.
7. Type of Ground Truth Used
- For the engineering and usability tests, the "ground truth" was compliance with established industry standards (e.g., IEC, ISO, ANSI/NEMA, CISPR) and, for design validation, user feedback on device function and meeting needs.
- The document does not describe a ground truth derived from expert consensus, pathology, or outcomes data in the context of clinical diagnostic accuracy testing for the device.
8. Sample Size for Training Set
Not applicable. This device is an imaging system, not a machine learning algorithm that requires a training set for diagnostic classification.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no mention of a training set or machine learning components that would require such ground truth.
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(96 days)
CA 91108
K170446 Trade/Device Name: LT-300 SD Digital Video Colposcope Regulation Number: 21 CFR§ 884.1630
The LT-300 SD Digital Video Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.
Not Found
The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the LT-300 SD Digital Video Colposcope. The document is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory compliance requirements but does not detail performance metrics, study designs, or ground truth establishment.
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(165 days)
Re: K161871
Trade/Device Name: EVA (Enhanced Visual Assessment) System Regulation Number: 21 CFR 884.1630
Common Name: | Colposcope |
| FDA Classification Name: | 21 CFR 884.1630
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The device is intended for use in hospitals, doctor's offices, and remote and rural clinics.
The EVA (Enhanced Visual Assessment) System is a handheld device in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, CervDx app for image capture, and online portal for image transfer and remote viewing. The device also includes the strap, carrier case, and instruction manual. During colposcopy, the operator may mount the EVA System on a tripod for hands free imaging, turn on the LED light for improved viewing, see a magnified view of the vagina and cervix on a smartphone screen resting at the back of the device, annotate and save images on the CervDx app, and upload images to the portal. The EVA System is compatible with Motorola G2 and Motorola G3 smartphones.
The EVA System is capable of working for ten hours before recharging. The EVA System weighs about 0.5 kg and is light enough that the device can be operated for 10 minutes at a time without any fatiguing.
The device operates at a working distance of 22.5 - 42.5 cm with an optical magnification up to 4.0x and ultimately up to 16x, with digital zoom.
The provided text describes the EVA (Enhanced Visual Assessment) System, a colposcope, and its substantial equivalence to a predicate device. However, it does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or accuracy for diagnosing abnormalities.
The document focuses on non-clinical performance testing to verify design specifications and compliance with standards, and a comparison with a predicate device based on technical characteristics.
Here's a breakdown of the information that is and is not available based on your request:
1. A table of acceptance criteria and the reported device performance
The document lists several technical specifications for the EVA System and compares them to the predicate device. It also states that "Non-clinical tests were conducted to verify that the EVA System met all design specifications." However, it does not explicitly define "acceptance criteria" as target performance for clinical endpoints (e.g., a specific sensitivity or specificity for abnormality detection). Instead, the "performance" discussed relates to technical aspects.
| Acceptance Criteria (Implied for Device Characteristics) | Reported Device Performance (EVA System) |
|---|---|
| Working Distance | 225-425mm |
| Focusing Mechanism | Manual |
| Magnification | 225:16x (digital) |
| 425: 15x (digital) | |
| 225: 4.0x (optical) | |
| 425: 3.8x (optical) | |
| Digital Magnification | 1x-4x |
| Depth of Field | 17mm (at 225mm) - 34mm (at 425mm) |
| Field of View | 45mm (at 225mm) – 100mm (at 425mm) |
| On-axis Spatial Resolution | 11.78 line-pairs/mm |
| On-axis Angular Resolution | 0.022° |
| Distortion | ≤2.5% |
| Light Source | 3W 6500k star LED |
| Illuminance | ≥1000lux at working distance 425mm |
Note: The document only states that "Non-clinical tests were conducted to verify that the EVA System met all design specifications." It doesn't explicitly list the acceptance criteria thresholds for each of these technical specifications, only the reported performance. The underlying assumption is that the reported performance meets the internal design specifications.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable (N/A). The document explicitly states "Clinical Performance Data: Not Applicable." The non-clinical tests mentioned do not involve a "test set" of patient data in the sense of clinical performance evaluation. The "Cervical Model Image Quality" test likely used a physical model, not patient 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 (N/A). As no clinical performance study involving a test set of patient data was conducted, there was no need for experts to establish ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable (N/A). No clinical test set requiring adjudication was used.
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 (N/A). The document does not describe any MRMC study, nor does it mention AI assistance. The EVA system, as described, is a colposcope for magnified viewing, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A). The EVA System is described as a device that "aids in diagnosing abnormalities and selecting areas for biopsy" and provides "magnified viewing." It is a tool for human use, not a standalone algorithm performing diagnoses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable (N/A). Since no clinical performance study for diagnosing abnormalities was conducted, no clinical ground truth (like pathology or outcomes data) was established or used for the purpose of proving diagnostic performance. The ground truth for non-clinical tests would be the known properties of the physical testing apparatus (e.g., known resolutions of test charts for optical resolution tests).
8. The sample size for the training set
Not Applicable (N/A). The device as described does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not Applicable (N/A). As there is no training set for an AI/ML algorithm involved, this question is not relevant.
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(219 days)
System Models: KN-2200/ KN-2200A/ KN-2200I/ KN-2200I(H)/ KN-2200B/ KN-2200BI Regulation Number: 21 CFR& 884.1630
Classification: Class II Product Code: HEX, colposcope (and colpomicroscope) Regulation Number: 21CFR 884.1630
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| Regulation Number | CFR 884.1630
| CFR 884.1630
| CFR 884.1630
The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.
The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Colposcope System has two kinds of colposcopes, a video colposcope and a binocular colposcope.
The video colposcope system is a non-patient contacting image capture device (CCD color camera) with a digital magnification of up to x16, working distance supporting 200mm, and a green filtered light source mounted on a vertical stand, swing arm stand or trolley. Tissue is magnified and viewed directly via the LCD screen attached to the capture device or on the commercially available color monitor. The video colposcope system has four models, including KN-2200A, KN-22001 and KN-2200I(H).
The binocular colposcope system is designed based on an optical colposcope. Its imaging system consists of optical imaging and CCD imaging. It permits viewing of the vagina, cervix and external genitalia by a telescopic system and the CCD camera captures digital images. The binocular colposcope system has two models, including KN-2200B and KN-2200BI. The two models have the same binoculars, CCD camera, cables except for the light source size and the stand type.
Both video colposcope system and binocular colposcope come with image management software, which is provided on a CD-ROM. The image management software allows the viewer to view, compare, record and print the image by series peripheral units, such as computer, monitor and printer.
The provided document is a 510(k) Summary for the Xuzhou Kernel Medical Equipment Co., Ltd. Colposcope System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner an AI device might.
Therefore, the information required to fully answer the request, particularly regarding specific performance metrics (like sensitivity, specificity, accuracy), sample sizes for test and training sets, expert qualifications, ground truth establishment for a diagnostic AI, or MRMC studies, is not present in this document.
However, I can extract the available information related to non-clinical tests and performance specifications that are analogous to acceptance criteria in this context.
Acceptance Criteria and Device Performance (Derived from Non-Clinical Tests and Specifications)
| Acceptance Criteria (Performance Specification) | Reported Device Performance (Proposed Device) | Predicate Device 1 (K021153) Performance | Predicate Device 2 (K070845) Performance | Predicate Device 3 (K140754) Performance |
|---|---|---|---|---|
| Video Colposcope System (KN-2200/2200A/2200I/2200I(H)) | ||||
| Illumination (at 200-400mm working distance) | ≥1200 Lx | 2200 Lx (at 200-400mm) | N/A | N/A |
| Illumination range (at 200mm working distance) | ≥φ60mm | ≥φ60mm (at 200mm) | N/A | N/A |
| Light source lifetime | ≥ 10,000 hours | ≥ 10,000 hours | N/A | N/A |
| MTBF (Mean Time Between Failures) (KN-2200) | 59817 hours | ≤ 50,000 hours | N/A | N/A |
| MTBF (KN-2200A) | 26985 hours | ≤ 50,000 hours | N/A | N/A |
| MTBF (KN-2200I) | 19778 hours | ≤ 50,000 hours | N/A | N/A |
| MTBF (KN-2200I(H)) | 37301 hours | ≤ 50,000 hours | N/A | N/A |
| System resolution (KN-2200/2200A) | ≥ 700 TVL | ≥ 470 TVL | N/A | N/A |
| System resolution (KN-2200I) | ≥ 550 TVL | ≥ 470 TVL | N/A | N/A |
| System resolution (KN-2200I(H)) | ≥ 1000 TVL | ≥ 470 TVL | N/A | N/A |
| Image geometric distortion |
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(93 days)
Ste. 100 San Marino, CA 91108
Re: K160380
| Trade/Device Name: LT-300 HD Regulation Number: 21 CFR 884.1630 |
|---|
| Common Name: |
| CFR Section: |
The LT-300 HD digital video colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.
LT-300 HD digital video colposcope is a digital video colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. LT-300 HD digital video colposcope is used to diagnose abnormalities and select areas for biopsy. LT-300 HD digital video colposcope acquires and displays high-resolution still and sequentially captured images and videos.
LT-300 HD digital video colposcope offers non-patient contact, fully digital and highresolution imaging of the cervix. The field of view is illuminated by circular LED group light source; a high-resolution color CCD camera provides crisp magnified color images. The images can be viewed on a commercially available color monitor.
The provided text is a 510(k) summary for the LT-300 HD digital video colposcope. It describes the device, its intended use, and a comparison to a predicate device (LT-300 Digital Colposcope, K143119). However, it does not contain a detailed study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to performance standards. It explicitly states that "These differences do not raise different questions of safety or effectiveness, and accepted test methods were used to assess the effects of these differences on device performance."
Therefore, I cannot populate most of the requested fields as the information is not present in the provided text. The document refers to "nonclinical tests" on image quality but does not provide specific acceptance criteria or results from studies involving human readers or ground truth for diagnostic accuracy.
Here's what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
The document lists performance standards the device meets, but these are general engineering and optical standards, not specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for disease detection).
| Acceptance Criteria (from standards) | Reported Device Performance (from standards) |
|---|---|
| Optical Performance (Met general standards) | Met general optical standards |
| Field of View (ISO 8600-3:1997) | Conforms to standard |
| Optical Resolution (ISO 8600-5:2005) | Conforms to standard |
| Electrical Safety & EMC (Met general standards) | Met general electrical safety & EMC standards |
| Medical Electrical Equipment Safety (IEC 60601-1:2005) | Conforms to standard |
| Electromagnetic Compatibility (IEC 60601-1-2:2007) | Conforms to standard |
| Other Nonclinical Tests | Met as tested |
| Thermal Safety Test | Met |
| Image Distortion Test | Met |
| Field of View Test | Met |
| Illuminance (≥ 2000Lux at 300mm working distance) | ≥ 2000Lux |
| Field of View (min mag > Φ 60mm & max mag > Φ 10mm) | > Φ 60mm & > Φ 10mm |
| Depth of Field (min mag > 120mm; max mag ≥5mm) | > 120mm & ≥5mm |
Missing information: Acceptance criteria for clinical performance (e.g., diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value) are not provided, as this is a 510(k) summary focusing on substantial equivalence through technical characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing from text: No information provided regarding a test set for clinical performance. The "tests" mentioned are non-clinical engineering and performance standard tests.
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)
- Missing from text: No information provided, as there is no described test set for diagnostic accuracy with a stated ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing from text: No information provided, as there is no described test set for diagnostic accuracy.
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
- Missing from text: No MRMC study or AI assistance is mentioned. This device is a colposcope, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing from text: Not applicable, as this is a medical device (colposcope) that is used by a human operator, not an algorithm, and no standalone algorithm performance is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing from text: No information about ground truth for diagnostic accuracy is provided. The tests described are engineering and compliance tests, not clinical performance evaluations against a diagnostic ground truth.
8. The sample size for the training set
- Missing from text: Not applicable. This is not a machine learning or AI-driven device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
- Missing from text: Not applicable.
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