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Lantern® Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic surgical procedures. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The surgeon in controlling leg length and offset discrepancies.

The Lantern® Hip is indicated for Total Hip Arthroplasty with an anterior hip approach (Direct Anterior Approach) and the patient in the supine position.

The Lantern® Hip (modified device) utilizes a palm- sized computer module and reference sensor to generate positional information in orthopedic procedures, providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

The Lantern® Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies

The Lantern® Hip consists of the sterile, single-use Lantern® Hip navigation unit (packaging includes reference sensor, CR2 battery and femur sensor battery), the non-sterile reusable reference sensor, the non-sterile reusable femur sensor, and associated non-sterile reusable instrumentation. The Lantern® Hip unit is sterile unless the sterile packaging is opened or damaged.

Here's a breakdown of the acceptance criteria and study information for the Lantern® Hip device, based on the provided FDA 510(k) summary:

The provided document is a 510(k) clearance letter and summary for a device modification, not a primary submission for a novel device. Therefore, the depth of performance study details typically found in an original PMA or De Novo submission is not present. The focus here is on demonstrating substantial equivalence to a predicate device rather than exhaustive standalone performance evaluation against a set of independent acceptance criteria for a new clinical use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a Special 510(k) for a device modification, the "acceptance criteria" primarily revolve around demonstrating that the modified device is as safe, as effective, and performs as well as the existing predicate device. The document doesn't explicitly list quantitative clinical acceptance criteria like sensitivity, specificity, or accuracy targets. Instead, the acceptance criteria are met by comprehensive verification and validation testing, confirming that the changes do not adversely affect performance or safety.

2. Sample Size Used for the Test Set and Data Provenance

The document describes "performance testing" and "verification and validation" but does not specify a sample size for a test set in the traditional sense of a clinical study with patient data. The testing appears to be primarily bench testing and software validation, focused on the technical performance of the device itself rather than its performance on a dataset of patient images or clinical cases.

There is no mention of patient data (e.g., retrospective or prospective, country of origin) being used for this particular submission, as the changes are related to software operating system and hardware materials, not a change in the underlying algorithms that process patient-specific data or interact with patient anatomy directly (beyond what was already established for the predicate).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable for this submission as it's a software and material modification. This type of information would be relevant for devices that interpret medical images or physiological signals where expert review is needed for ground truth. The testing described focuses on the device's functional integrity rather than diagnostic accuracy against a ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. Since there's no mention of expert review of cases or patient data for ground truth establishment, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study would be relevant if the AI (or computer-assisted) component was new or significantly changed in a way that might impact a human reader's performance. The Lantern® Hip is a computer-controlled system to assist surgery, not a diagnostic AI that assists in image interpretation for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The "Performance Data" section states: "Device performance testing confirms that the Lantern® Hip can be used according to its intended use. The Lantern® Hip has been verified and validated according to OrthAlign's procedures for product design and development." This type of testing of a computer-controlled system for surgical assistance would primarily involve standalone algorithm performance (accuracy of measurements, positional data, calculations) within simulated or laboratory environments, independent of a human surgeon's interaction, to ensure correctness of the system's outputs.

While not explicitly called a "standalone study," the software verification and validation, and general performance testing, would assess the device's technical capabilities without a human in the loop for the core computations.

7. The Type of Ground Truth Used

The ground truth for the device's performance validation would likely be based on engineering specifications, known physical principles, and established measurement standards. For example:

• For software calculations of mechanical axes, the ground truth would be the mathematically correct axes based on defined anatomical landmarks.
• For positional accuracy, the ground truth would be established by high-precision measurement systems (e.g., optical trackers, coordinate measuring machines) to verify the device's reported positions against known physical positions.
• For material biocompatibility, the ground truth would be established by industry standards like ISO 10993.

It is not based on expert consensus, pathology, or outcomes data in this context, as those relate more to clinical diagnosis or patient treatment effectiveness, which is beyond the scope of a modification focusing on software and material changes for a surgical guidance system.

8. The Sample Size for the Training Set

Not applicable. The Lantern® Hip is a computer-controlled stereotaxic instrument that provides positional information and assists with alignment. While it uses algorithms, the document describes it as "determining reference alignment axes" and "facilitates accurate positioning." This suggests algorithms based on geometric calculations and sensor data processing rather than machine learning algorithms that require large training sets of labeled data (like for image recognition or predictive models). Therefore, a "training set" in the context of machine learning is not mentioned or implied.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no machine learning training set is mentioned, this question is not relevant to the information provided.

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