(69 days)
The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. The humeral stems are intended for cemented or cementless use.
The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use.
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 deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally 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 humeral stems are intended for cemented or cementless use.
The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient's joint must be anatomically and structurally 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 humeral short stem is intended for cementless use.
The Shoulder System - TiNbN Coating is a line extension to the Shoulder System to provide a larger product offering. The subject devices are marketed as individually packaged humeral head, Glenosphere and lateralized Glenosphere components.
Shoulder System - TiNbN Coating includes the following implants:
- . Humeral Head TiNbN Coating (10 sizes, Ø 40 mm to Ø 58 mm)
- . Lateralized Glenosphere TiNbN Coating implants (9 sizes) and
- Glenosphere implants TiNbN Coating 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 o
- Size Ø 36: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5 or Ø27mm O
- Size Ø 39: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm o
- Size Ø 42: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm O
The Glenosphere and Lateralized Glenosphere - TiNbN Coating implants, are manufactured from CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery – Part 12: Wrought Cobalt- Chromium-Molybdenum Allov [Including: Technical Corrigendum 1 (2008)] with a TiNbN coating, while the Glenosphere screw packed with the implant is made of Ti alloy (Ti-6Al-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 Humeral Head - TiNbN Coating implants, are manufactured from CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery - Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy [Including: Technical Corrigendum 1 (2008)] with a TiNbN coating.
This document is a 510(k) Premarket Notification from the FDA for a medical device (Shoulder System - TiNbN Coating). It focuses on establishing substantial equivalence to existing predicate devices, primarily through non-clinical performance testing and comparison of characteristics, rather than clinical studies proving a specific performance metric against a ground truth.
Therefore, many of the requested elements for describing acceptance criteria and a study proving the device meets them (especially those related to clinical performance, expert ground truth, MRMC studies, and AI algorithms) are not applicable or cannot be extracted from this type of FDA submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of quantitative acceptance criteria with corresponding reported numerical performance that would be typical for an AI/algorithm-based device study. Instead, it lists types of non-clinical tests performed, with the implied acceptance criterion being that the device met the requirements of the specified standards/protocols.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Meet requirements of defined test protocols for: | - Met requirements of Medacta Test Protocol IL 07.09.631 rev 0 and Medacta Test Report B.3 and ENDOLAB report 167 200908 60 238-rev 0 part 1 ASTM F2009-11: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| Humeral Head TiNbN coated: | - Met requirements of Medacta Test Protocol IL07.09.630 rev 0 and Medacta Test Report B.1, and ENDOLAB report: 167 200908 60 238-rev 0 part 2 ISO 7206-4:2010(E) and ASTM F1378-17 |
| - Pull-off testing (ASTM F2009-11) | |
| - Fatigue testing (ISO 7206-4:2010(E), ASTM F1378-17) | |
| Glenosphere TiNbN coated: | - Met requirements of Medacta Test Protocol IL07.09.629 rev 0 and Medacta B.2, and Test Report ENDOLAB report: 167 200908 60 239-rev0 167 201002 60 242-rev0 |
| - Fatigue testing | |
| Coatings (referenced from predicate device GMK Total Knee System): | - Met requirements, previously cleared for GMK Total Knee System (TiNbN) Coating, K202684 |
| - Third body wear test | - Met requirements, previously conducted on predicate devices and reviewed as part of Shoulder System K170452, K193175, K170910 |
| System (referenced from predicate devices): | |
| - Wear test | |
| - Geometrical Analysis | |
| - Micromotion assessments | |
| Biocompatibility: | - Met requirements, conducted according to European Pharmacopoeia §2.6.14 (equivalent to USP ), USP , ISO 10993 series and FDA Biocompatibility Guidance document |
| - Pyrogenicity (Bacterial Endotoxin Test, Pyrogen test) | |
| - Biocompatibility assessment (ISO 10993 series, FDA guidance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical bench testing (mechanical, material, and biocompatibility tests) rather than a clinical study with a "test set" of patient data. Therefore, "sample size" here refers to the number of implants or material samples tested. The specific number of samples for each test (e.g., how many humeral heads for pull-off testing) is not explicitly stated in this summary, only the test protocols.
There is no "data provenance" in terms of patient data (country, retrospective/prospective) because this is not a study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. Ground truth, in the context of this 510(k), relates to validation against established engineering, material science, and biocompatibility standards, not expert medical diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used for clinical review of images or patient outcomes, not for mechanical bench testing.
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
This is not applicable. This submission is for a physical implant (shoulder prosthesis components) and does not involve AI or human readers. The document explicitly states: "No clinical studies were conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this regulatory submission is adherence to established international and national standards (e.g., ISO 7206-4, ASTM F2009-11, European Pharmacopoeia, USP, ISO 10993 series) and the results of bench testing. The success criteria are meeting the performance specifications outlined in these standards and the internal test protocols.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set."
§ 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.”