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Silhouette is indicated for wound measurement and documentation and can be used on all external wound types.

Silhouette consists of a camera connected to a PDA, for the measurement and tracking of wounds

The provided text describes the Silhouette Wound Measurement and Documentation System (K070426) and its 510(k) summary, but it does not contain the specific acceptance criteria or the study details to prove the device meets those criteria.

The document primarily focuses on:

• Device identification and classification.
• Comparison to predicate devices.
• Indications for use.
• FDA's substantial equivalence determination.

Therefore, many of the requested details cannot be extracted from this text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be extracted. The document mentions that "Standard wound measurements made with Silhouette are more accurate than those made with the predicate devices," but it does not specify what "more accurate" quantitatively means, nor does it list specific acceptance criteria (e.g., minimum accuracy, precision, or other performance metrics) or precise reported device performance values.

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

• Cannot be extracted. The document does not provide details about any specific test set, its sample size, or the provenance of the data used for performance claims.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Cannot be extracted. The document makes no mention of expert involvement in establishing ground truth for any test or validation.

4. Adjudication Method:

• Cannot be extracted. No information is provided regarding adjudication methods.

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

• Cannot be extracted. There is no mention of an MRMC study or quantitative effect sizes for human readers with/without AI assistance. The device is a "Wound measurement and documentation system" that includes a camera and PDA, implying that it assists human measurement rather than being a standalone AI system in the modern sense.

6. Standalone Performance Study:

• Cannot be extracted. While the system itself could be considered "standalone" in its function of acquiring images and measuring wounds, the document does not describe a formal standalone performance study with specific metrics, particularly in the context of an AI algorithm as implied by the question. Its comparison to predicate devices is noted, but not in the format of a standalone study against defined criteria.

7. Type of Ground Truth Used:

• Cannot be extracted. The document does not specify how "ground truth" for wound measurements was established or what type it was (e.g., manual caliper measurements, pathology, etc.).

8. Sample Size for the Training Set:

• Cannot be extracted. There is no mention of a "training set" as this device predates the widespread use of machine learning that requires such sets, or at least the explicit reporting of them in 510(k) summaries. The device performs measurement and documentation based on image capture, not an AI model trained on a large dataset.

9. How Ground Truth for the Training Set was Established:

• Cannot be extracted. Similar to point 8, no training set is described.

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