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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.

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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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The C3A, C6A video colposcope is intended for gynecological examination. It provides magnified visualization of the vagina, cervix and external genitalia, which can help diagnose 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 or to touch the patient.

The Edan video colposcope, including models C3A and C6A, consists of the camera module (CCD color camera), stand (vertical or swing arm stand), video capture box, foot switch, and video colposcope software. The Edan video colposcope is a non-patient contacting medical device. The C3A, C6A video colposcope is a digital imaging equipment that works as follows: The loop group LED light illumines the target, and the CCD camera takes images of the target. The images are converted into video signals, which are then captured and transmitted to a commercially available computer or monitor. The video colposcope software implements the functions of displaying images, capturing images or taking videos, storing and managing images and providing reports.

The provided text is a 510(k) summary for the Edan Instruments, Inc. Video Colposcope, models C3A and C6A. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.

Here's an attempt to extract and infer information based on the request, acknowledging that a direct "study proving acceptance criteria" as might be found in a clinical trial report is not present in this regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format for direct comparison with performance results for clinical outcomes. Instead, it lists technical specifications and compares them to a predicate device. The performance data section refers to bench testing and compliance with standards.

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The LT-300 Digital 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.

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This document, primarily a 510(k) clearance letter and an "Indications for Use" statement, does not contain the detailed study information or acceptance criteria for the LT-300 Video Colposcope.

The provided text only states that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence determination typically relies on demonstrating that the new device has the same intended use as a predicate device and has similar technological characteristics (or, if different, that the differences do not raise new questions of safety and effectiveness).

Therefore, I cannot provide the requested information from the given text. A 510(k) summary or the full 510(k) submission would be required to find details about performance testing, acceptance criteria, study methodologies, and ground truth establishment.

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MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues 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 Video Colposcope are to be viewed on a color monitor. The Digital Video Colposcope is intended for use in hospitals, clinics, and doctors' offices.

The MedGyn Digital Video Colposcope, models AL-106, AL-106SA and AL-106B (collectively, the "MedGyn Colposcope"), has the same application as traditional colposcopes. However, while traditional optical colposcopes use binocular eyepieces for magnification, the MedGyn Colposcope uses electronic imaging technology to assist doctors in reviewing, checking, analyzing, and diagnosing abnormalities or lesions of the vulva, vagina, cervix and external genitalia. It is designed to be used in hospitals, doctors' offices and clinics by qualified or trained personnel.

The MedGyn Colposcope is an active, non-contact examination device. It uses a HAD CCD color digital video camera with a digital magnification of up to 40x (or only 32x for model AL-106B), a field of view of 52° at 1x and 2° at 32X, and a green filtered light source. The camera is attached to a floor stand; model AL-106SA has a swing-arm floor stand. A cable coming from the bottom of the floor stand connects to the signal conversion box. The customer then uses the composite video cable or the s-video cable to connect a commercially available monitor to the conversion signal box.

Tissue is magnified and viewed on the doctor's own computer monitor (not included with device). Both the doctor and the patient can observe the monitor's screen, thus helping the doctor explain the abnormalities and the suggested treatments to the patient, and allowing patient to see the abnormalities for herself and better understand her medical situation.

The provided document is a 510(k) summary for the MedGyn Digital Video Colposcope, which outlines its substantial equivalence to a predicate device. This type of submission relies on non-clinical performance testing rather than clinical studies to demonstrate safety and effectiveness. Therefore, the device does not have "acceptance criteria" in the sense of a clinical trial's endpoint metrics, nor does it present a study that proves the device meets such criteria for diagnostic accuracy or clinical outcomes.

Instead, the document focuses on demonstrating that the MedGyn Colposcope meets relevant performance standards and technical specifications that are comparable to a legally marketed predicate device.

Here's an analysis based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-clinical submission, "acceptance criteria" are tied to engineering specifications and compliance with voluntary performance standards. There are no diagnostic "performance" metrics (like sensitivity, specificity) derived from a clinical application in this document.

• IEC60601-1-1:2000 (Medical Electrical Equipment Safety - Collateral Standard: Medical Electrical Systems)
• IEC60601-1-2:2007 (Medical Electrical Equipment EMC)
• ISO 8600-3:1997 (Endoscopes - Field of View and Direction of View)
• ISO 8600-5:2005 (Endoscopes - Optical Resolution) |
  | On-Axis Resolution | (Implied: Sufficient for intended use, comparable to predicate, or within established industry benchmarks for colposcopes) | 11.31 line-pairs/mm |
  | On-Axis Angular Resolution | (Implied: Sufficient for intended use, comparable to predicate, or within established industry benchmarks for colposcopes) | 0.02534 degrees |
  | Geometrical Distortion | ≤ 3% (explicitly stated as acceptable) | - AL-106B = +1%
• AL-106 & AL-106SA = +2.49% |
  | Thermal Safety | (Implied: Minimal temperature rise, meeting safety standards) | From 200mm, temperature rise of only 0.20 Celsius after 30 minutes continuous working. |
  | Magnification | Up to 40x digital (AL-106, AL-106SA), up to 32x digital (AL-106B) and 1-36x optical (AL-106, AL-106SA), 1-18x optical (AL-106B) | AL-106, AL-106SA: Digital 1-40x, Optical 1-36x
  AL-106B: Digital 1-32x, Optical 1-18x |
  | Field of View (200mm WD) | (Implied: Sufficient for intended use, comparable to predicate) | At 1x >= 195mm (52°), At 32x >= 6.978mm (2°) |
  | Depth of View | (Implied: Sufficient for intended use, comparable to predicate) | 5mm~120mm |

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

• Sample Size: Not applicable in the context of clinical "test sets" for diagnostic accuracy. The testing mentioned in Section 7 ("Discussion of Non-Clinical Tests Performed") refers to engineering and bench testing of the device itself (e.g., resolution targets, distortion grids, temperature sensors) rather than patient data.
• Data Provenance: Not applicable. The "data" are measurements and compliance certificates from device testing, not patient data from a specific country or collected retrospectively/prospectively.

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

• Number of Experts: Not applicable. This submission does not involve a clinical test set requiring expert-established ground truth for diagnostic accuracy since it's a non-clinical performance evaluation focused on engineering specifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for the same reason as point 3.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with or without AI assistance, which is beyond the scope of a 510(k) summary relying on non-clinical testing to demonstrate substantial equivalence for a colposcope that is essentially an imaging tool, not a diagnostic AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No. This device is a colposcope, an imaging instrument used by a human clinician. It does not incorporate an independent algorithm for diagnosis that would typically warrant a standalone performance evaluation.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the clinical sense. The "ground truth" for the non-clinical tests involved objective physical measurements and compliance verification against established engineering standards (e.g., resolution charts, distortion grids, temperature probes).

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set" of data.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

In summary: The K122973 submission for the MedGyn Digital Video Colposcope is a demonstration of substantial equivalence based on non-clinical performance testing and compliance with voluntary international standards. It explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This means no clinical studies were conducted, and therefore, no "acceptance criteria" related to diagnostic accuracy or clinical outcomes were evaluated using patient data or expert ground truth. The acceptance criteria are engineering specifications and safety standards defined by regulatory bodies and consensus organizations.

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The Goldway Digital Video Colposcope Imaging System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color screen, printed on a color printer or archived for storage and subsequent retrieval. The device is intended for use in Hospitals and clinics.

The Goldway Digital Video Colposcope Imaging Systems, SLC-2000A and SLC-2000B are intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy.

The SLC-2000A consists of a ¼' Super HAD CCD color camera and image management workstation. Tissue is magnified and viewed directly either via a 5.6" LCD screen attached to the capture device or on the 14'' color monitor attached to the image workstation. The SLC-2000B contains the same capture device but does not include the image workstation. Images can only be viewed via the 5.6'' LCD screen with this model. The images provide recorded documentation for the physician or nurse practitioner to review for diagnostic purposes. The Goldway Colposcopes have a non-patient contact of up to 350mm. Both colposcopes have the option of being equipped with a Dermatology and Venereal Disease application kit and Dynamic White Polarization kit.

The Goldway Colposcopes, SLC-2000A and SLC-2000B are a non-patient contacting CCD color camera with a magnification of x1 ~ x28, working distances supporting 150-350mm, and a green filtered light source mounted on a floor stand. The SLC-2000B also comes with an image workstation which consists of a CCD camera, computer, LCD monitor, a mouse, a keyboard and color printer. The functions of the image management workstation include:

• Storing digital images for viewing during the colposcopy exam, and for printing and/or later review
• Storing textual information about a patient's medical history related to colposcopy
• Storing textual information about observations seen during a colposcopy examination
• Printing a colposcopy report that integrates images and textual information

The provided 510(k) summary for the Goldway SLC-2000 Digital Video Colposcope Imaging System states that no clinical tests were performed for the determination of substantial equivalence.

Therefore, the following information cannot be extracted from the document:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone performance results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states under section "8. Discussion of Clinical Tests Performed:" that it is "Not Applicable." The submission relies on non-clinical tests (meeting standards like IEC60601-1, ISO9001, EN46001) and comparison to predicate devices to demonstrate substantial equivalence, arguing that "any differences in their technological characteristics do not raise any new questions of safety or effectiveness."

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The Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.

The Galileo Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.

The Leisegang Video Colposcope consists of a CCD camera with a halogen light source, green filter and is mounted on a mobile base.

This 510(k) summary (K981958) is for the Leisegang Video Colposcope. It describes the device's intended use and compares it to predicate devices. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence rather than performance data. The device is a direct viewing instrument, not an AI/algorithm-driven device, which means the requested parameters (e.g., sample size for training set, MRMC studies, ground truth) are not applicable to the information provided in this 510(k) summary.

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