FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The hardware: 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 BLUEPRINT 3D 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.

Device Description

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is the responsibility of Tornier. 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 select the glenoid implant, design a patient specific pin guide.

This submission seeks clearance for: Hardware: a guide made of Titanium with an orientation hole which allows for controlling rotation of the commercially available implant, AequalisTM PerFORM. Software modified to: Integrate a guide made of titanium, Add a glenoid sphere radius measurement.

AI/ML Overview

The BLUEPRINT Patient Specific Instrumentation device's acceptance criteria and the study proving it are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

Validation and/or Verification Method	Acceptance Criteria Description	Reported Device Performance
Patient Specific Guiding Wire test	Version angle error, inclination angle error, main (central) entry point error, and rotation entry point error must be compliant with device specifications	Acceptable
Dimensional test of the titanium guide	The titanium guide meets dimensional specifications	Acceptable

2. Sample Size and Data Provenance:

Sample Size: The document states that studies using cadaver specimens were used for non-clinical testing. However, the exact sample size (number of cadavers) is not specified.
Data Provenance: The cadaver studies were used for testing, implying prospective data collection for this specific validation. The country of origin of the data is not specified.

3. Number and Qualifications of Experts for Ground Truth:

The document primarily focuses on validating the device's accuracy in guiding surgical procedures and meeting dimensional specifications. It does not explicitly mention the use of experts to establish a "ground truth" for a test set in the traditional sense of diagnostic AI performance. The ground truth for the "Patient Specific Guiding Wire test" would likely be derived from precise measurements taken during the cadaver studies, ensuring compliance with the device's design specifications. No information about expert qualifications or numbers is provided for this.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned. The "Acceptable" results for the non-clinical tests suggest that the measurements taken during the studies met predetermined specifications without requiring an adjudication process by multiple reviewers.

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

No information about a multi-reader multi-case (MRMC) comparative effectiveness study is provided. This device is primarily a surgical planning software and patient-specific instrumentation, not a diagnostic AI intended to assist human readers in image interpretation for improved diagnostic accuracy.

6. Standalone Performance Study:

Yes, a standalone performance was done. The document outlines "Non-clinical testing" for BLUEPRINT™ Patient Specific Instrumentation to "assess that no new safety or effectiveness questions were raised." This testing includes a "Patient Specific Guiding Wire test" and a "Dimensional test of The titanium guide," both of which evaluate the device's performance based on predefined acceptance criteria without human-in-the-loop performance described. The software's ability to measure in preoperative planning and generate a guide matching patient anatomy was validated using cadaver specimens.

7. Type of Ground Truth Used:

The ground truth for the "Patient Specific Guiding Wire test" and "Dimensional test of The titanium guide" appears to be based on device specifications and direct physical measurements taken during cadaver specimen studies. For example, for the guiding wire test, the ground truth would be the ideal or intended version angle, inclination angle, and entry point, against which the device's actual performance is measured. Similarly, for the dimensional test, the ground truth is the specified dimensions of the titanium guide.

8. Sample Size for the Training Set:

No information about a separate training set or its sample size is provided. The document outlines validation studies to assess the device's performance, but it does not detail the development or training of any machine learning components that would typically require a training set. The software mentioned is for pre-operative planning, visualization, measurement, and annotation, and the generation of a 3D file, which might not rely on machine learning in the same way a diagnostic AI would.

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

Since there is no mention of a training set, there is no information provided on how its ground truth was established.

Summary

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”