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510(k) Data Aggregation
(134 days)
The Aequalis Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.
The software
The BLUEPRINT 3D planning software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT 3D planning software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems.
The software supports DICOM standard to import the CT-Scan (Computed Tomography) images of the patient. Only CT-Scan modality can be loaded with BLUEPRINT3D planning software.
BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan.
This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan.
The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide.
BLUEPRINT 3D planning software does not include any system to manufacture the guide.
BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose.
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software).
BLUEPRINT™ Patient Specific Instrumentation is the responsibility of Tornier including the Aequalis Glenoid Guides and BLUEPRINT 3D planning software. Tornier is the legal manufacturer for the hardware and the software.
The hardware
The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and are exclusively reserved for this use.
The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.
The software
BluePrint 3D Planning software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (= total anatomic shoulder replacement).
It is intended to help to plan an operation by allowing surgeons to:
- position and to select the glenoid implant, ●
- design a patient specific pin guide.
The provided text describes BLUEPRINT™ Patient Specific Instrumentation, which consists of Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software. The hardware comprises patient-specific drill guides, and the software is a pre-surgical planner for shoulder orthopedic surgery.
The validation of this device was performed through non-clinical studies using cadaveric specimens or patient data. The summary outlines several validation tests and lists their acceptance criteria as "compliant" or "acceptable," but does not provide specific numerical thresholds for these criteria.
Here's the information requested based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Validation and/or Verification Method | Acceptance Criteria Description | Reported Device Performance |
|---|---|---|
| Seating validation Test | The seating offset between reference method and the software calculation should be compliant | Acceptable |
| Reaming validation Test | The Reaming offset between reference method and the software calculation should be compliant | Acceptable |
| Orientation and Direction angles Validation Test | The orientation angle offset and the Humeral Head Subluxation direction offset between reference method and the software calculation should be compliant | Acceptable |
| Glenoid Version and Inclination angle validation test | The version angle offset between reference method and the software calculation should be compliant. A concordance correlation coefficient ρ between the reference method and the software calculation of the inclination should be compliant. | Acceptable |
| Humeral Head subluxation and direction measure | The Humeral Head Subluxation offset and the Humeral Head Subluxation direction offset between reference method and the software calculation should be compliant | Acceptable |
| Patient Specific Guiding Wire test | Version angle error, inclination angle error and entry point error should be compliant | Acceptable |
| Segmentation Accuracy Test | Mean Distance Error in the surgical zone between 3D reconstruction and the reference reconstruction should be compliant | Acceptable |
| Clinical Case Series | Pre-operative Plan compared to post-operative implant position | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "non-clinical studies performed on cadaveric specimen or performed by using patients' data" for validation. However, it does not specify the sample size for the cadaveric specimens or the patient data, nor does it explicitly state the country of origin or whether the patient data was retrospective or prospective. The "Clinical Case Series" also lacks specific sample size details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It refers to "reference method" and "reference reconstruction" for ground truth but doesn't detail how these were established by experts.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with AI vs. without AI assistance. The testing described is primarily focused on the software's accuracy against a "reference method."
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study of the algorithm's performance appears to have been done. The "Validation and/or Verification Method" in the table explicitly refers to comparing "software calculation" or "3D reconstruction" to a "reference method/reconstruction," indicating that the algorithm's output was directly assessed without human intervention in the loop for those specific tests. The "Clinical Case Series" test involved comparing a "Pre-operative Plan" (generated by the software) to the "post-operative implant position," which also implies an assessment of the software's planning accuracy.
7. The Type of Ground Truth Used:
The ground truth used appears to be a "reference method" or "reference reconstruction" for the various validation tests. For the clinical case series, the ground truth was the "post-operative implant position." While the document implies these are established standards or measurements, it does not explicitly state whether this was expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
The document does not specify the sample size for the training set used for the BLUEPRINT 3D planning software. It only mentions that the studies used "cadaveric specimen or performed by using patients' data."
9. How the Ground Truth for the Training Set was Established:
The document does not provide information on how the ground truth for the training set was established. It describes validation testing but not the process of training the algorithm.
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(135 days)
Cemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Uncemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
The Aegualis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.
Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to relieve pain. The reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.
The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
The present device modification consists in the addition of glenoid base plates with central threaded post and a new coating.
Here's an analysis of the provided text regarding the Aequalis Reversed Shoulder Prosthesis, focusing on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) Premarket Notification summary for a modification to an already cleared device ("Aequalis Reversed II glenoid base plate"). Therefore, the studies are primarily aimed at demonstrating substantial equivalence of the new components to the previously cleared ones, rather than establishing de novo safety and effectiveness for a completely new device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission for a modification, the "acceptance criteria" are framed around demonstrating equivalence to previously cleared predicate devices, particularly concerns about the new glenoid base plate's anchorage.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Equivalence of Pull-out Resistance (Glenoid Anchorage): The new glenoid base plate must demonstrate equivalent resistance to pull-out forces compared to the cleared glenoid base plate, independently of post design. | Demonstrated Equivalence: Pull-out testing (E1586) was conducted and results showed that the new Aequalis Reversed base plates (with the modified post design and dimensions) were equivalent to the cleared models in terms of resistance in pull-out. The document explicitly states: "To demonstrate the equivalence between the new glenoid base plate and the cleared glenoid base plate the resistance in Pull-out has to be equivalent." and "The result shows that primary fixation has been achieved without scapular fracture or other major peri-operative complications." |
| Proper Use of Instruments and Implants (Surgical Feasibility): The new components and associated instruments must be able to be used effectively without major peri-operative complications. | Demonstrated Feasibility: Cadaver testing was performed to "ensure proper use of instruments and implants." The results indicated "primary fixation has been achieved without scapular fracture or other major peri-operative complications." |
| Risk of Glenoid Fracture: The new post dimensions and drilled hole diameter should not increase the risk of glenoid fracture compared to the predicate. | Equivalent Risk: The submission states, "In comparison of the recommended drilled hole diameter of the pending Aequalis Reversed base plate and the predicate, we can see that the pending Reversed base plate is equivalent with the predicates concerning the risk of glenoid's fracture." |
| Equivalent Intended Use | Met: The new glenoid base plate "have the same intended use as the cleared glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis." |
| Equivalent Technological Characteristics (General features, fixation, materials) | Met: Overall, it's stated that "Major technological characteristics are equivalent between the new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis and the predicate devices: Equivalence of general features - Equivalent means of fixation - Equivalent materials." |
2. Sample Size Used for the Test Set and Data Provenance
- Pull-out Testing (E1586):
- Sample Size: Not explicitly stated as a number. The text mentions "Posts of glenoid base plate (pending and cleared) are impacted in the same foam bloc in several configurations." This implies a comparative test with multiple specimens/configurations for both the new and cleared devices.
- Data Provenance: The study was "conducted on the new Aequalis Reversed II glenoid base plate and the cleared Aequalis Reversed II glenoid base plate." This indicates controlled laboratory testing, not human patient data.
- Cadaver Testing:
- Sample Size: Not explicitly stated (e.g., number of cadavers).
- Data Provenance: "Cadaver testing was performed." This is prospective testing on biological tissue from cadavers, likely conducted in a laboratory or simulated surgical environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the engineering tests (pull-out) and cadaver testing described, "ground truth" is typically established by objective physical measurements (e.g., force required for pull-out, visual inspection for fractures/complications) rather than expert consensus on interpretive data.
- No information is provided about the number or qualifications of experts for establishing ground truth in these non-clinical tests. This type of testing relies on engineering and biomechanical principles, not clinical interpretation.
4. Adjudication Method for the Test Set
Given the non-clinical, objective nature of the tests (pull-out force, observational findings during cadaver surgery), formal adjudication methods like 2+1 or 3+1 (common in diagnostic imaging studies) are not applicable or described. The results would be based on direct measurement and observation by the testing personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- This submission pertains to a medical implant (shoulder prosthesis modification), not a diagnostic device or a system involving human interpretation of data. Therefore, the concept of human readers or AI assistance in the context of an MRMC study does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm-only performance study was not done.
- This is an implantable medical device, not a software algorithm.
7. The Type of Ground Truth Used
- Pull-out Testing: The ground truth used was objective physical measurement of the force required to pull out the glenoid base plate from a foam block. The "truth" was the measured load/resistance.
- Cadaver Testing: The ground truth was based on direct observation and qualitative assessment of surgical outcomes, specifically whether "primary fixation has been achieved without scapular fracture or other major peri-operative complications." This involved visual inspection, palpation, and potentially other assessments during and after the simulated surgical procedure.
8. The Sample Size for the Training Set
- Not applicable. This is a medical implant, not a machine learning algorithm. There is no concept of a "training set" in this context. The device's design is based on engineering principles and previous device iterations, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
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