Search Results

The Acetabular Cup Orientation (ACO) System is intended to be used as a surgical instrument to place a visual reference k-wire alignment pin to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty procedures. The system utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative CT imaging scans.

The ACO System can be used with any 510(k) cleared, legally marketed, hemispherical acetabular cup implant system for primary Total Hip Arthroplasty (THA) and its respective compatible components, with the additions listed below:

• · Spherically shaped, symmetrical acetabular cups.
• · Without protrusions for fixation such as spikes, threads, pegs, flanges or similar protruding elements.
• · Cups with smooth outer surface or uniform coating.

· The central axis of the cup matches the direction of impaction; the inner and outer spherical surface of the cup have the same central axis.

• · Cups have an apex hole to connect an impactor.
• · Allowed deviations from a hemispherical cup shape (as long as the conditions stated above are fulfilled): o Cups with a very slightly flattened dome.
  • o Cups with one or more holes for fixation with screws.

The ACO guides can only be used with hip systems that include reamers and impactors with straight handles.

The ACO guides can be used for posterior approach (Moore, also referred to as the 'Southern approach'), postero-lateral approach (Marcy-Fletcher), lateral approach (Hardinge) and antero-lateral approach (Watson-Jones).

The ACO guides are intended for single use only.

The Acetabular Cup Orientation System consists of a software component, the Acetabular Cup Orientation Planner and a hardware component, the Acetabular Cup Orientation guides and is designed to assist the surgeon in the pre-op visualization and planning of the acetabular cup orientation and to assist intra-operatively in the orientation of the acetabular cup implant by placement of a visual reference pin.

The Acetabular Cup Orientation System is designed for cup orientation guidance within total hip arthroplasty surgery (THA).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated in a table format within the provided document. However, the text mentions that the "deviations between planned versus achieved orientation of the acetabular cup component were within the preset acceptance criteria." This implies that the primary acceptance criteria relate to the accuracy of the device in facilitating the planned orientation of the acetabular cup.

Since the specific numerical acceptance criteria (e.g., maximum allowable deviation in degrees) are not given, the table below will reflect this, along with the reported general performance.

Study Details:

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

   • Sample Size: "a series of cadaveric specimens" (the exact number is not specified).
   • Data Provenance: Cadaveric specimens. The original country of origin for these cadavers is not mentioned in the document. This was a non-clinical study.

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 ground truth (planned orientation) was established by a pre-operative plan, presumably created by a qualified surgeon using the device's software, but the number and qualifications of experts involved in comparing this plan to the achieved orientation are not detailed.

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

   • This information is not provided in the document.

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 MRMC comparative effectiveness study was done. The study described is a non-clinical validation using cadavers, focusing on device accuracy rather than human reader performance. This device is described as assisting a surgeon, but the study doesn't quantify human improvement with its use.

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

   • The study described is a non-clinical test of the combination of the software (planning) and hardware (guides) on cadavers. While the software creates the plan, the "achieved orientation" depends on the physical application of the guides, which involves human interaction. Therefore, a purely "algorithm-only" performance for the entire system as intended for use was not performed; rather, the integrated system's performance was evaluated.

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

   • The ground truth for the validation study was the pre-operative plan (the planned acetabular cup orientation). The "achieved orientation" on the cadaver was then compared against this plan.

7. The sample size for the training set:

   • The document does not provide information on a separate 'training set' for the device's software component. It describes a non-clinical validation study of the device.

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

   • As no information on a training set is provided, this question cannot be answered from the given text.

Ask a specific question about this device