(120 days)
The Match Point System™ is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty procedures which utilize anatomic landmarks that are identifiable on preoperative CT or MRI medical images.
The Match Point System™ can be used with the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873).
The Match Point System™ Guides are intended for single use only.
The Match Point System™ consists of a software component, SurgiCase Connect and a hardware component, Match Point System™ guide, and is designed to assist the surgeon in the placement of glenoid components.
The Match Point System is for use within the intended use of the compatible components.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Design, intended use, functionality, technology, material, and performance characteristics comparable to predicate devices. | Device comparison analysis showed that the proposed device is substantially equivalent to the predicate devices in: |
- design, intended use, functionality, technology, material and performance characteristics for the Signature Personalized Patient Care System - Acetabular Guide System;
- intended use and functionality for the conventional instrumentation for shoulder arthroplasty (central drill guide). |
| Accuracy and performance adequate for intended use. | "Accuracy performance testing was performed in a cadaveric setting to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended." |
| Guide use, positioning, and accuracy at borders. | "Accuracy performance testing was performed on rapid prototyped models to verify guide use, positioning, and accuracy of the shoulder system at its borders for use." |
| Safety and effectiveness. | "Non-clinical testing was sufficient to demonstrate safety and effectiveness of the device as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "cadaveric setting" or "rapid prototyped models" used in the non-clinical tests.
- Data Provenance: The tests were non-clinical, involving a "cadaveric setting" and "rapid prototyped models." The country of origin for this data is not specified. The tests were presumably prospective as they were specifically conducted for this submission.
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 or their qualifications used to establish ground truth for the non-clinical tests. The tests focused on objective measurements of accuracy and performance in a controlled environment, likely using established anatomical references or engineering specifications rather than expert consensus on subjective interpretations.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method. Given the nature of the non-clinical accuracy and performance testing, it's likely that measurements were taken and compared against predefined engineering tolerances or anatomical landmarks, rather than requiring expert adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The provided text indicates that "Non-clinical testing was sufficient to demonstrate safety and effectiveness of the device as intended," and it explicitly states "No Clinical Data" was required. Therefore, no studies comparing human readers with and without AI assistance (which is what the software component does) were performed or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- A standalone performance assessment of the software component (SurgiCase Connect), in terms of its ability to generate the preoperative plan with a certain level of accuracy prior to surgeon modification, is not explicitly detailed as a standalone study. The description implies the software component (SurgiCase Connect) generates an initial plan which is then "fine-tune[d] and approve[d]" by a qualified surgeon. The accuracy testing seems to be for the entire system (software + guide) in transferring the approved plan.
7. The Type of Ground Truth Used
- In the context of the non-clinical accuracy performance testing:
- For the cadaveric setting, the ground truth would likely be established anatomical landmarks and precise measurements taken relative to these landmarks.
- For the rapid prototyped models, the ground truth would likely be the precise engineering specifications and measurements of the model, which represent the ideal planned scenario.
- Neither "expert consensus," "pathology," nor "outcomes data" are mentioned as the ground truth for these tests. The ground truth for these tests would be based on objective, quantifiable physical measurements against known standards.
8. The Sample Size for the Training Set
- The document does not specify a training set sample size. This device appears to be a medical device software that assists in planning and manufacturing a physical guide, rather than a machine learning model that typically requires a large training set. The "software component" (SurgiCase Connect) seems to be based on algorithms and anatomical modeling principles rather than statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Since there's no mention of a traditional machine learning "training set," there's no information on how its "ground truth" was established. The software's functionality is described as generating a plan based on "medical imaging data" and "surgical technique of the respective implant system," implying a rule-based or model-driven approach rather than data-driven machine learning.
§ 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.”