(267 days)
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy failed joint replacement with a grossly rotator cuff deficient shoulder joint.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation.
The Lateralized Glenosphere are line extensions to the Medacta Shoulder Reverse System (K170452) and are compatible with the other Medacta cleared products Threaded Glenoid Baseplate (K171058), Glenoid Polyaxial Non-Locking Screws (K181826) and the Short Humeral Stem (K180089).
The Lateralized Glenosphere implants subject of this submission are comprised of the following products (9 sizes):
- Size Ø 32: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5mm
- Size Ø 36: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5 or Ø27mm
- Size Ø 39: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm
- Size Ø 42: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm
The Lateralized Glenosphere implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components:
- Humeral Diaphysis Cemented;
- Humeral Diaphysis - Cementless;
- Humeral Reverse Metaphysis;
- Humeral Reverse HC Liner (also referred to as PE Liner);
- Glenoid Baseplate - Pegged;
- Glenoid Baseplate Threaded;
- Glenosphere;
- Glenoid Polyaxial Locking Screw;
- Glenoid Polyaxial Non-Locking Screw;
- Reverse Metaphysis Screw; and
- Glenosphere Screw.
The glenosphere is attached to the glenoid baseplate and secured by means of a taper connection and a fastening screw.
The purpose of the current submission is to gain clearance for the Lateralized Glenospheres, whose center is more lateralized respect to Medacta predicate device Glenosphere (Medacta Shoulder Reverse System - K170452).
The new option of lateralization allows the surgeon to intraoperatively select the desired level of ROM and resulting joint tension based on the patient's anatomy.
The Lateralized Glenosphere is made of CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery - Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy [Including: Technical Corrigendum 1 (2008)], while the Glenosphere screw packed with the implant is made of Ti alloy (Ti-6A1-4V), enhanced with Type-II anodization, according to ISO 5832-3:2016 Implants For Surgery -Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.
The provided text describes a 510(k) premarket notification for a medical device called the "Lateralized Glenosphere." This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific performance criteria through a study with acceptance criteria in the typical sense of a diagnostic or predictive AI device.
Therefore, the requested information cannot be fully extracted as there is no study that proves the device meets specific acceptance criteria in the context of a diagnostic AI product, because this is a physical implant. The performance data section refers to mechanical tests on the implant itself, not a study of a diagnostic algorithm.
Here's an analysis of what information can be provided based on the input:
1. A table of acceptance criteria and the reported device performance:
Based on the document, there isn't a table of acceptance criteria and reported device performance in the way one would describe for a diagnostic AI device (e.g., sensitivity, specificity, accuracy). Instead, there are mechanical tests performed with acceptance criteria based on established standards for shoulder prostheses.
| Acceptance Criteria (Based on Standards) | Reported Device Performance (Summary) |
|---|---|
| ASTM F2028-17: Standards Test Methods For Dynamic Evaluation of Glenoid Loosening or Disassociation | Assessment conducted in reverse configuration with a lateralized glenosphere. (Implied: Met the standard's requirements for glenoid loosening or disassociation) |
| ASTM F1378-17: Standard Specifications for Shoulder Prosthesis (Fatigue Test) | Fatigue test conducted on threaded glenoid reverse construct with a lateralized glenosphere. (Implied: Met the standard's specifications for fatigue) |
| European Pharmacopoeia §2.6.14 (equivalent to USP chapter ) for Bacterial Endotoxin Test (LAL test) | Bacterial Endotoxin Test conducted. (Implied: Met the standard's requirements for endotoxin levels) |
| **USP chapter ** for Pyrogen Test | Pyrogen test conducted. (Implied: Met the standard's requirements for pyrogenicity) |
| Rationale, Lateralized Glenosphere Wear Assessment | Wear assessment conducted. (Implied: Acceptable wear characteristics based on established rationale) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of a clinical test set for diagnostic accuracy. The "test set" here refers to the physical samples of the medical device (Lateralized Glenosphere and associated components) that underwent mechanical testing. The exact number of physical devices or components tested for each mechanical study is not specified in this summary.
- Data Provenance: The mechanical tests were conducted in a laboratory setting according to written protocols. There's no information about the country of origin or whether it was retrospective/prospective as it relates to patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical implant, not a diagnostic AI device requiring expert-established ground truth for a test set. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM, ISO, European Pharmacopoeia, USP) and the physical properties observed during testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used for establishing ground truth in diagnostic studies, not for mechanical testing of physical implants. The "adjudication" for mechanical tests is agreement with the predefined acceptance criteria of the standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI diagnostic device. No human reader studies (MRMC) were conducted as the device is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance data refers to the mechanical integrity and biological safety of the physical medical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance data is based on recognized engineering standards (ASTM F2028-17, ASTM F1378-17), pharmacopoeia guidelines (European Pharmacopoeia §2.6.14, USP , USP ), and design validation reports for the mechanical and biocompatibility aspects of the implant.
8. The sample size for the training set:
- Not applicable. This device is a physical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI model or training set, this question is not relevant.
In summary: The provided document is a 510(k) summary for a physical medical implant. The "acceptance criteria" and "performance data" refer to mechanical and biocompatibility testing against established engineering and medical device standards, not to the performance of a diagnostic or AI-driven system. Therefore, most of the requested information, which is typically relevant for AI/diagnostic device evaluation, is not applicable or provided in this context.
§ 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.”