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To provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures.

The Harmony Port System includes the Harmony Port, which provides surgical exposure during minimally invasive procedures, along with accessory instruments designed to facilitate the use of the Port and rigidly fix the system during use.

The provided 510(k) notification summary for the Harmony™ Port System does not contain specific acceptance criteria or a study that proves the device meets such criteria. Instead, it indicates that the device's substantial equivalence to a predicate device was established through non-clinical testing.

Here's a breakdown of the information that is present and what is missing based on your requested categories:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: "The results of non-clinical testing and evaluation demonstrate that the device is safe and effective." No specific performance metrics (e.g., accuracy, precision, duration of use) are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided. The summary only mentions "non-clinical testing," which typically refers to bench testing, mechanical testing, or simulations, rather than human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable and not provided, as the testing was non-clinical and did not involve human-derived data that would require expert ground truthing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable and not provided, as the testing was non-clinical.

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

• This information is not applicable. The device is a surgical retractor, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted or referenced.

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

• This information is not applicable. The device is a physical surgical tool, not an algorithm.

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

• This information is not applicable. For non-clinical device testing, ground truth typically refers to engineering specifications, physical measurements, or established mechanical properties, rather than clinical outcomes or pathology. The document does not detail the specific "ground truth" or reference standards used for the non-clinical tests.

8. The sample size for the training set

• This information is not applicable. The device is a physical product, not a machine learning model.

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

• This information is not applicable. The device is a physical product, not a machine learning model.

Summary of Device and Evidence:

The Harmony™ Port System is a surgical retractor intended "to provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures."

The basis for its 510(k) clearance (K050706) is its substantial equivalence to a predicate device, The Bright Medical Dilation Retractor System (K992898). The submission states that the Harmony Port System "has the same intended use, is manufactured from similar materials using similar processes, and is similar in design when compared to the predicate device."

The only performance data mentioned is: "The results of non-clinical testing and evaluation demonstrate that the device is safe and effective." This statement indicates that bench or mechanical tests were performed to confirm the device's functionality and safety, consistent with its classification as a Class II surgical retractor. However, no specific details about these tests, the acceptance criteria, or the reported performance metrics are provided in the excerpt.

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