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Cuptimize is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component. It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.

The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

Cuptimize is a software as a medical device (SaMD) system that provides acetabular component position data for hip replacement surgery. The software guides the user through a workflow that olves positioning a series of digital annotations on preoperative and intraoperative radiographic images. This enables the system to calculate inclination and anteversion data that describes the acetabular component position.

Here's an analysis of the provided text to extract the acceptance criteria and details of the study for the Cuptimize device:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, JointPoint (K160284), rather than defining explicit acceptance criteria in a quantitative table. However, we can infer the primary acceptance criterion and the study used to demonstrate it.

Inferred Acceptance Criterion and Reported Device Performance

Study Details:

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

   • Sample Size: Not explicitly stated, however, the text mentions "a cadaveric laboratory was performed to gather data." This implies a limited number of cadavers, likely a single cadaver given the singular phrasing ("a cadaver").
   • Data Provenance: Prospective, as it was conducted in a "cadaveric laboratory." The country of origin is not specified.

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

   • This information is not provided in the document. The comparison is made against the output of the predicate device, JointPoint, not against an expert-established ground truth.

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

   • None. The comparison relies on the output of the predicate device, JointPoint, as the reference for "substantial equivalence." There is no mention of independent human adjudication or consensus.

4. 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 study described is a comparison of the Cuptimize device's output against a predicate device's output, not a study involving human readers with and without AI assistance. The device is a "software as a medical device (SaMD) system that provides acetabular component position data," implying it directly outputs measurements, and its function is to "assist in the precise positioning" rather than directly improving human reader performance in interpretation.

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

   • Yes, a standalone performance evaluation was done. The "Cadaver Data - Cup Check" compared the outputs of the Cuptimize system directly against the outputs of the JointPoint predicate device. The device is described as "image-processing software indicated to assist in the positioning," implying it processes images and provides measurements without requiring real-time human intervention in the measurement process, although clinical judgment is still required for its use.

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

   • The "ground truth" for the test set was the output data from the predicate device, JointPoint. This is a comparative ground truth against another device's measurements, rather than an independent expert consensus, pathology, or outcomes data ground truth.

7. The sample size for the training set:

   • This information is not provided in the document. The summary focuses on verification and validation testing, not on the development or training of the software.

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

   • This information is not provided as the training set details are omitted.

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