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The UNICO Colpo-Master Colposcope is indicated for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy

The Colposcope consists of three main assemblies: Microscope head and lens; Stand; and Illuminator. . The microssope 200m head magnifies the arca of the human body to be observed by a physician. It works like a "tclcscope" and the closest point is more than 300mm away from the body part. The microscope head and lens are made of optical glass, brass, stecl, and aluminum.

Here's an analysis of the provided text regarding the UNICO Colpo-Master Colposcope's acceptance criteria and studies:

Based on the provided document, the UNICO Colpo-Master Colposcope's submission states: "Clinical tests are not necessary, since the Colpo-Master uses the same technology as the predicate devices." This explicitly indicates that no dedicated clinical study was performed for this device to prove its performance against acceptance criteria in the typical sense of a novel device. Instead, the justification for market clearance relied on substantial equivalence to existing legally marketed predicate devices.

Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not available or applicable from this document as no such study was conducted for the Colpo-Master itself.

However, we can infer some information based on the overall context of a 510(k) submission for a device deemed substantially equivalent.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

Since direct clinical performance data for the UNICO Colpo-Master is explicitly stated as "not necessary," the acceptance criteria for this device are implicitly tied to demonstrating that it performs as safely and effectively as its predicate devices. The "reported device performance" would therefore be the assertion that it meets these implied criteria by sharing the same technology and intended use.

Study Information (Based on Substantial Equivalence)

1. Sample size used for the test set and the data provenance:

   • Not Applicable. No dedicated clinical test set was used for the UNICO Colpo-Master. Its performance relies on the established performance of its predicate devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. No clinical test set was created or evaluated by experts for this specific device.

3. Adjudication method for the test set:

   • Not Applicable.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No. No MRMC study was performed as no clinical study was deemed necessary for this device.

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

   • Not Applicable. This is an optical medical device, not an AI or algorithm-based device.

6. The type of ground truth used:

   • Not Applicable for the UNICO Colpo-Master itself. For the predicate devices whose performance is implicitly referenced, the ground truth for diagnosing abnormalities and selecting biopsies would typically involve a combination of expert pathological examination of biopsies (histopathology) and clinical expert consensus or follow-up.

7. The sample size for the training set:

   • Not Applicable. This device did not involve AI or machine learning that would require a training set.

8. How the ground truth for the training set was established:

   • Not Applicable.

Summary of the UNICO Colpo-Master's Justification:

The UNICO Colpo-Master Colposcope received 510(k) clearance based on its substantial equivalence to existing predicate devices (Wallach Zoom K853389, Intermed Zoom K031639, Welch-Allyn K955635). The manufacturer stated that "Clinical tests are not necessary, since the Colpo-Master uses the same technology as the predicate devices." This means the device met its implied acceptance criteria by demonstrating that its design, technology, and intended use were fundamentally the same as devices already cleared for market, and it met relevant non-clinical safety standards (IEC 601-1-2). No new clinical studies were conducted to explicitly measure performance against novel acceptance criteria.

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