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The Sounmed Colposcope COLPO-99 is intended to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy.

The ColposcopeS COLPO-99 / 99 PLUS is a precise optical instrument designed specially for the gynecologic examination. The Sounmed colposcope can be used to view vaginal en cervical tissues using stereoscopic optics. The COLPO-99/ 99 PLUS Colposcope has detailed features that include a wide field of view, long focal length, uniform illumination, adjustable brightness, ease operation, and exceptional optics. It is an essential instrument for any gynecologic examination. The general features of the device are as follows: Eyepiece Magnification: 12.5X with diopter adjustment. Focal Length: 300mm. Green filter light. Easy replacement of halogen light bulb. Ball joint gives you 360 degree easy motion for gross focus.

The provided text is a 510(k) Summary for the Sounmed Colposcopes COLPO-99/99 PLUS. It states that no clinical tests were performed as it was deemed "Not Applicable." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

The document discusses non-clinical tests performed to demonstrate substantial equivalence, which primarily involved compliance with certain standards:

• EN 60601-1-1
• EN 60601-1-2
• ISO 14971:2000

Since no clinical study was performed, the following information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows:

• Fetal-OB/GYN
• Abdominal
• Small Organs (breast, thyroid, testicle)
• Trans-Vaqinal
• Trans-Rectal

Typical examinations performed using the system are:

• General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
• Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
• First, second and third trimester pregnancy studies.
• Prostate, bladder and rectum visualization.

The Sounmed SD-2000 Plus (KX2000G) is a black and white mobile diagnostic ultrasound imaging system. This device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. Operating Modes of SD-2000 Plus (KX2000G) are B, B/B, B/M, and M. The Sounmed SD-2000 Plus (KX2000G) supports a selection of Linear and Convex probes for wide variety of application. It is an ultrasound scanner, which provides high resolution, high penetration, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz.

The provided 510(k) summary for the Sounmed SD-2000 Plus Portable Ultrasound scanner indicates that clinical tests were "Not Required" for this device. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on its performance in clinical use.

The document states that the conclusion drawn from testing is that the device "is as safe, as effective as well as the legally marketed predicate devices." This implies that the acceptance criteria are met through substantial equivalence to a predicate device (SonoAce 600 Diagnostic Ultrasound System, K000030) rather than new clinical performance data.

However, based on the information provided, here's a breakdown of what can be inferred about the acceptance criteria and the "study" that supports the device's clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical studies were not required and no specific performance metrics beyond "safe and effective" equivalence are reported from patient data, a direct table of quantitative acceptance criteria and device performance is not available in the provided text.

The "acceptance criteria" in this context are primarily qualitative and based on demonstrating that the new device shares similar technological characteristics, intended uses, and safety standards with a legally marketed predicate device, thereby inferring similar performance.

Implicit Acceptance Criteria (based on substantial equivalence):

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

• Sample Size: Not applicable. No clinical test set data from human subjects is mentioned for performance evaluation.
• Data Provenance: Not applicable. The "study" relied on technical comparisons and adherence to standards, not patient data in the context of a clinical trial.

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

• Not applicable. Since no clinical test set was required, there was no ground truth establishment by experts for such a set described in this document.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set was utilized.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Tests: Not Required".

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

• Not applicable. This device is an ultrasound system and transducers, which are hardware components for imaging. The concept of "standalone algorithm performance" is not relevant here as there's no mention of an embedded AI algorithm being evaluated separately. The clearance is for the imaging system itself.

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

• Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) submission is effectively the predicate device's established safety and effectiveness, and compliance with international and national standards for medical electrical equipment and diagnostic ultrasound. The FDA's determination of "substantial equivalence" serves as the validation.

8. The sample size for the training set

• Not applicable. This document describes the clearance of an ultrasound imaging system, not an AI/ML algorithm that would require a training set.

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

• Not applicable. As above, no training set for an AI/ML algorithm is mentioned.

In summary, the "study" that proves the device meets the acceptance criteria is a demonstration of substantial equivalence to a legally marketed predicate device (SonoAce 600 Diagnostic Ultrasound System, K000030) and adherence to a list of relevant safety and performance standards. No human clinical trial data or performance metrics from a test set were required or presented in this 510(k) summary.

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