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The Sientra Portfinder is a battery-operated standalone port detection device that is intended for use with the Sientra AlloX2 Pro and Dermaspan Tissue Expanders.

The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander, enabling fill of the tissue expander or use of the drain system.

The enclosed device is nonsterile and for postoperative use only.

The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander. The Portfinder is intended to locate the fill and drain ports of the Sientra AlloX2 Pro Breast Tissue Expanders (AlloX2 Pro) and fill port of the Sientra OPUS Dermaspan Breast Tissue Expanders (Dermaspan); enabling the user to mark the location of the ports for subsequent fill and drain of the respective tissue expander.

The Portfinder contains an LCD screen that displays the location of the intended port (drain or fill port). A single button of the Portfinder is used to power on/off and change modes.

The Portfinder housing has features to temporarily indent the port location on the surface of the skin or use a skin marker to mark the port location.

The Portfinder is intended to be used by clinicians in medical settings such as hospitals and medical clinics. It can be disinfected between uses for multi-patient reuse.

The provided document does not contain detailed information about the acceptance criteria or a specific study proving the device meets those acceptance criteria. However, it does mention "Design verification tests were performed on the Portfinder as a result of the risk analysis and product requirements" and "Software Verification and Validation testing was performed on Portfinder".

Without the full details of these verification and validation tests, it's not possible to populate all the requested fields comprehensively. The document explicitly states that clinical testing was not necessary to demonstrate substantial equivalence, which means the study described would likely be bench testing.

Based on the available information, here is a summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not specified. The document only mentions "Design verification tests" and "Software Verification and Validation testing."
• Data provenance: Not specified. These would be laboratory-based verification and validation data, likely from internal testing at Sientra, Inc.

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. Since clinical testing was not performed, "experts" in the context of establishing clinical ground truth (e.g., radiologists) would not be applicable here. Ground truth would likely be based on engineering specifications and direct measurement/observation in a lab setting.

4. Adjudication method for the test set

• Not specified. Given the nature of bench and software testing, a formal adjudication process like 2+1 or 3+1 would not typically be used. Testing would likely involve comparing device output against known inputs or expected behaviors.

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, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of Portfinder to the predicate device." The device is a port detector, not an AI-assisted diagnostic tool for human readers.

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

• Yes, a form of standalone performance was assessed. The "Software Verification and Validation testing" and "Design verification tests" would evaluate the device's performance independently, without human interaction in a clinical setting, to ensure it met its operational requirements. The device itself is described as a "standalone port detection device."

7. The type of ground truth used

• Engineering specifications and known physical properties/measurements. For functional testing, ground truth would be established by the known location of the tissue expander ports in test setups. For software testing, the ground truth would be defined by the expected behavior and outputs based on software requirements.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The software mentioned is likely embedded control software, not a learning algorithm.

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

• Not applicable (see point 8).

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