Search Results

Software: The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit presurgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.

Hardware: The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection. The Precision AI Guides and Biomodels are indicated for single use only. The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only. The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components: Enovis and Lima.

The Precision AI Surgical Planning System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific guides and models to transfer the plan to surgery. The subject device is a system composed of the following: The Precision AI Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operatively then create a physical Patient Specific Instrument (or Guide), using 3D printing by selective laser sintering. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position to correct the measured deformity for that specific patient. The Precision AI Guides, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery.

The provided text is an FDA 510(k) summary for the Precision AI Surgical Planning System (PAI-SPS). It describes the device and its intended use, but it does NOT contain specific acceptance criteria, detailed study designs, or performance results in terms of metrics like sensitivity, specificity, accuracy, or effect sizes for human reader improvement.

The document states that "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements and validation against user needs." It also mentions that "Design verification and validation testing demonstrated that the PAI-SPS meets all design requirements and is as safe and effective as its predicate device (K233992)."

However, it does not explicitly lay out the acceptance criteria (e.g., "model must achieve 90% accuracy") or the results against those criteria. It focuses more on demonstrating substantial equivalence to a predicate device (PAI-SPS K233992) by showing that the technology and intended use are similar, with the main differences being the addition of compatibility with more implant systems.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will provide information based on what is available and indicate where information is missing.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

Based on the provided FDA 510(k) summary, the PAI-SPS device is being cleared primarily through demonstrating substantial equivalence to an already cleared predicate device (PAI-SPS, K233992). The key claim for equivalence rests on similar intended use, fundamental scientific technology, design, functionality, operating principles, and materials, with the primary difference being expanded compatibility with additional implant systems.

The document implicitly suggests that the "acceptance criteria" are tied to demonstrating that these technological differences "do not raise any different questions of safety and effectiveness." The studies cited are primarily focused on software verification and validation, ensuring the new compatible implant systems do not negatively impact the established safety and effectiveness.

Here is a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy percentages, specific error bounds) or detailed performance metrics. The performance is largely framed as demonstrating that the device "meets all design requirements and is as safe and effective as its predicate device."

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

• The document does not specify the sample size for any test set (e.g., for software validation or hardware accuracy).
• Data Provenance: Not explicitly stated for specific test sets. Given the company is "Precision AI Pty Ltd" in Australia, and the document discusses "previous cadaver testing and composite bone model testing," it's likely a mix of lab-based/simulated data and potentially some retrospective clinical imaging data for initial AI development/testing, but this is not detailed. The document implies that new testing was not extensively conducted for this submission, relying heavily on the predicate device's prior validation and the minor changes to compatibility.

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

• The document does not specify the number of experts or their qualifications used to establish ground truth for any test set.
• It mentions that the software allows a "qualified surgeon" to approve pre-surgical plan data, implying that expert surgical review is part of the workflow.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The focus of this 510(k) is substantial equivalence based on technological similarity and expanded compatibility, not a comparative study against human readers or performance improvement with AI assistance.

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

• The document states that the AI algorithm performs "auto segmentation via a locked, or static, artificial intelligence algorithm." While this indicates a standalone AI component, the document does not provide standalone performance metrics for this AI segmentation. The overall system is described as a "pre-surgical planner" where the surgeon can "visualize, measure, reconstruct, annotate and edit pre-surgical plan data," suggesting a human-in-the-loop workflow.

7. The Type of Ground Truth Used

• For software, the implicit ground truth appears to be expert consensus or approved surgical plans for judging the accuracy of the software's representations and planning capabilities. The document states "The software allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data."
• For hardware, "previous cadaver testing and composite bone model testing" were used, implying physical measurements against a known standard or "true" position established in these models.

8. The Sample Size for the Training Set

• The document does not specify the sample size used for the training set for the AI segmentation algorithm.

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

• The document does not specify how the ground truth for the AI training set was established. It only mentions that the AI algorithm for auto-segmentation is "locked, or static," implying it was trained previously.

Ask a specific question about this device

In an anatomic shoulder configuration, the FX V135™ Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

• a severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
• other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
  In a reverse shoulder configuration, the FX V135™ Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with massive and non-repairable rotator cuff tear.
  The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
  The humeral stem of the FX V135™ Cementless Shoulder is intended for cementless use only, with optional cortical bone screws for the longer stems. The glenoid components of the FX V135™ Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

The FX V135™ Shoulder Prosthesis is a shoulder replacement system that may be used as a total or hemi shoulder replacement in either an anatomic or a reversed shoulder construct. The new components of the system included in this submission are the FX V135™ Additional Humeral Stems that are added to the system as a line extension of the cementless humeral stems.
The FX V135™ Shoulder Prosthesis is manufactured from Ti-6l-4V ELI alloy conforming to ISO 5832-3 and are available in diameters of 8-16mm in the diaphysis dependent upon the epiphyseal size 32, 36, and 40mm. The longer stems added to the system are available in lengths 120mm, 180mm and 200mm. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP-Ti) and Hydroxyapatite (HA) coating. The distal end of the humeral stem is cylindrical and bead blasted with unthreaded screw holes oriented in the medial / lateral direction for optional fixation using cortical bone screws.
The FX V135™ Shoulder Prosthesis incorporates a female taper for attachment of compatible components.
The FX V135™ Shoulder Prosthesis can be used with previously cleared components including a taper adapter, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomic shoulder configuration.
For reverse configuration, the FX V135™ Shoulder Prosthesis can be used with a humeral cup and optional spacer, a centered or eccentric glenosphere with or without a central screw, a qlenoid baseplate (with or without a central screw), optional post extensions and standard (compression) and locking bone screws around the periphery of the baseplate. The previously cleared Humeral Cups mate with the FX V135™ Additional Humeral Stems to complete the reverse configuration.

The provided text is a 510(k) summary for the FX V135™ Shoulder Prosthesis, which is a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing independent performance against a specific set of acceptance criteria through a clinical study.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies is not available in this document because the device's clearance relied on non-clinical testing and comparison to existing devices, not a new clinical study with performance benchmarks.

Here's an breakdown of why the requested information cannot be fully provided based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable: The document does not define specific "acceptance criteria" for clinical performance. Instead, it states that "Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed. The results of these tests indicate that the performance of the FX V135™ Shoulder Prosthesis is adequate for its intended use and substantially equivalent to the predicate device." This refers to non-clinical mechanical testing, not clinical outcomes.

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

• Not Applicable (for clinical data): The document explicitly states: "Clinical testing is not necessary to determine substantial equivalence of the FX V135™ Shoulder Prosthesis to the predicate device." Therefore, there is no clinical "test set" with associated sample size or data provenance in this submission. For the non-clinical fatigue testing, specific sample sizes are not provided in this summary.

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

• Not Applicable: No clinical ground truth was established for a test set, as no clinical study was deemed necessary.

4. Adjudication method for the test set:

• Not Applicable: No clinical test set and thus no adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No: The document states that clinical testing was not necessary. Therefore, an MRMC study was not conducted.

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

• Not Applicable: This device is a physical medical implant (shoulder prosthesis), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The type of ground truth used:

• Not Applicable (for clinical ground truth): As no clinical study was conducted, there's no clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the non-clinical testing would be the engineering specifications and performance standards met by the predicate device and reproduced by the subject device.

8. The sample size for the training set:

• Not Applicable: This is a physical medical device, not an AI model, so there is no "training set."

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

• Not Applicable: As above, no training set.

Summary based on the provided text:

The device, FX V135™ Shoulder Prosthesis, obtained 510(k) clearance by demonstrating "substantial equivalence" to existing predicate devices (FX V135™ Shoulder Prosthesis (K213117), Humelock Reversed® Shoulder (K162455), and Encore Humeral Shoulder Stem (K141990)).

The primary evidence provided in this summary to support this claim comes from non-clinical testing:

• "Range of motion analysis demonstrated comparability to the predicate device."
• "Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed."

The conclusion is that these non-clinical tests indicate the performance is "adequate for its intended use and substantially equivalent to the predicate device." The document explicitly states, "Clinical testing is not necessary to determine substantial equivalence of the FX V135™ Shoulder Prosthesis to the predicate device."

Therefore, the device meets its "acceptance criteria" (which are performance benchmarks derived from the predicate device and established through non-clinical testing) by demonstrating comparable range of motion and successful completion of fatigue testing without failures or loosening. This approach leverages the pre-existing FDA clearance of the predicate devices.

Ask a specific question about this device