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Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for precise bone cuts and implant positioning during intraoperative hip reconstructive procedures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, relative to a CT or MR based model of the anatomy.

Example orthopaedic procedures for these instruments include, but are not limited to:

• Total Joint Replacement (TJR)
• Revision Surgery of TJR
• Tumor resection and Bone/Joint Reconstruction

DePuy CAS Hip Instruments are computer recognized by application specific VectorVision Hip software on Ci hardware platform, owned by BrainLAB. Together, instruments and hardware/software enable operational planning and navigation during orthopaedic hip surgery. The VectorVision Hip software is designed to read DePuy instrument and implant data and offers planning and navigating intraoperatively during surgery. BrainLAB designed the Ci hardware platform exclusively for DePuy. Instrument/implant data is tracked by flexible passive markers imposed on a virtual computer 3D image of the patient's bone. Landmarks on the bone surface are acquired to intraoperatively navigate the femoral and acetabular instrumentation and implants for the most accurate position.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

It is important to note that the provided documents (K052178 Summary of Safety and Effectiveness, and subsequent FDA correspondence) do not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them, in the typical sense of a performance study with metrics like sensitivity, specificity, accuracy, etc.

The document primarily focuses on establishing substantial equivalence to predicate devices for the purpose of 510(k) clearance. This means the device is deemed safe and effective because it is similar enough to devices already on the market. The "study" here is more of a demonstration of similarity and shared characteristics rather than a rigorous performance evaluation against predefined metrics.

However, I will extract what information is present related to equivalency and performance.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a Computer Assisted Surgery (CAS) Hip Instrumentation device emphasizing substantial equivalence, "acceptance criteria" are generally tied to demonstrating that the device performs as intended and is as safe and effective as its predicates, rather than achieving specific numerical performance thresholds (e.g., 95% accuracy).

From the provided text, the core "performance" of the device is its ability to track instruments and allow for accurate navigation. The "acceptance criteria" would thus implicitly revolve around the successful demonstration of this functionality, as evidenced by its similarity to predicate devices.

Study Details (Based on Substantial Equivalence Justification)

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

   • Test Set Sample Size: Not explicitly mentioned. In a 510(k) for substantial equivalence, a "test set" in the sense of a clinical trial or performance study with quantified metrics against ground truth is often not required or present in the summary. The demonstration is typically based on technical characteristics, engineering testing, and comparison with predicate devices.
   • Data Provenance: Not explicitly mentioned for any specific test data. The submission relies on the established safety and effectiveness of the listed predicate devices (K040368, K033223, K033341, K021798), which are already marketed in the US. The "study" isn't a new clinical trial; it's a comparison.

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

   • Not applicable/Not mentioned. There is no indication of an external "test set" requiring expert consensus for ground truth as part of this 510(k) submission. Substantial equivalence relies on the regulatory body's assessment of similarity.

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

   • Not applicable/Not mentioned. This type of adjudication is typically for clinical studies involving reader evaluations, which isn't described here.

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 mentioned or described. This device is not an AI/CAD system for image interpretation, but rather a navigation system used during surgery. The concept of "human readers improving with AI" does not apply to this device's function.

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

   • No. The device is explicitly described as "instrumentation," "hardware," and "software" that "enable operational planning and navigation during orthopaedic hip surgery." It is inherently a "human-in-the-loop" system, assisting the surgeon. There is no concept of its performance in a standalone (algorithm-only) capacity.

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

   • Not explicitly defined for a "study" of the DePuy CAS Hip Instrumentation device itself. For substantial equivalence, the "ground truth" is that the predicate devices have been proven safe and effective through prior regulatory processes (which might have involved clinical data, engineering tests, etc., but those details are not in this document). The ground truth for this device is its similarity to those predicates.

7. The sample size for the training set:

   • Not applicable/Not mentioned. The document does not describe a machine learning algorithm that requires a "training set" in the conventional sense. The "software" reads instrument and implant data, likely following predefined algorithms and anatomical models, not adaptive learning from a training set.

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

   • Not applicable/Not mentioned, as there is no described training set.

Summary of "Study" in the Context of a 510(k) for this Device:

The "study" for this 510(k) is essentially a comparison to predicate devices to demonstrate substantial equivalence. The document states:

• "Computer Assisted Surgical Hip Instruments are substantially equivalent to other legally marketed Class II stereotaxic instruments by means of tracking patient anatomy through infrared passive markers imposed onto computer images."

This statement is the core of the "study" and its conclusion. It establishes that because the new device uses the same fundamental technology (infrared passive markers, 3D imaging), has the same intended use (navigating hip surgery), and similar technological characteristics as already-cleared devices, it is considered equally safe and effective, and thus "meets acceptance criteria" for market clearance. No independent, quantitative performance study with specific metrics is detailed in this summary.

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