(247 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 and 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 purpose of this submission is to gain clearance for the new Medacta Shoulder System: Threaded Glenoid Baseplate (also referred to as Threaded Glenoid Baseplate) which is part of the Medacta Shoulder System: Reverse; a modular system intended to be used for Reverse Shoulder Arthroplasties (RSA). The Medacta Shoulder System: Threaded Glenoid Baseplate is an alternative option to the pegged glenoid baseplate that is part of reference device Medacta Shoulder System (K170452). The Medacta Shoulder System: Threaded Glenoid Baseplate is made of titanium alloy.
The Threaded Glenoid Baseplate is intended to replace only the glenoid side of the glenohumeral joint. The Threaded Glenoid Baseplate is intended to be used in the reverse configuration only. The Threaded Glenoid Baseplate is designed to be fixed on the glenoid bone by means of a central threaded post and the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with a Glenoid Baseplate by means of a taper Morse connection and secured by a central securing screw. The Threaded Glenoid Baseplate directly couples with the Glenoid Polyaxial Locking Screws and Glenoidsphere as part of the Medacta Shoulder System (K170452).
The provided text describes a 510(k) premarket notification for a medical device (Medacta Shoulder System: Threaded Glenoid Baseplate), not an AI/ML powered device. Therefore, the information requested in the prompt, such as acceptance criteria for AI performance metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical performance testing for a physical implant. The relevant "acceptance criteria" in this context refer to the successful completion and passing of these mechanical and material tests based on established standards.
Here's the information that can be extracted or inferred from the provided text, framed within the spirit of the request as much as possible for a non-AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Based on Standards) | Reported Device Performance |
|---|---|
| Fatigue Testing: To meet requirements of ASTM F1378-12: Standard Specification For Shoulder Prostheses. | "Testing was conducted to written protocols with acceptance criteria that were based on standards." (Implies successful passing of tests based on the standard) |
| Micromotions Assessment: To meet requirements of ASTM F2028-14: Standards Test Methods For Dynamic Evaluation of Glenoid Loosening Or Disassociation Prostheses. | "Testing was conducted to written protocols with acceptance criteria that were based on standards." (Implies successful passing of tests based on the standard) |
| Coating Tests: Characterize Titanium Y367 Coating on Threaded Glenoid Baseplate Medacta. | "Glenoid Baseplate: Characterization Report Titanium Y367 Coating on Threaded Glenoid Baseplate Medacta" (Implies successful characterization and meeting of internal specifications for the coating). |
| Pyrogenicity: To meet requirements of European Pharmacopoeia §2.6.14 (equivalent to USP chapter ) and USP chapter for pyrogenicity determination. | "Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14... and the Pyrogen Test according to USP chapter for pyrogenicity determination." (Implies successful testing and compliance for pyrogenicity). |
| Biocompatibility: Materials are same or similar to predicate devices and follow standards. | "Additional biocompatibility testing was deemed unnecessary because the materials are the same or similar to the predicate devices and follow standards for manufacturing." (Implies historical acceptance and compliance with biocompatibility standards). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified as individual units. For mechanical testing, samples are typically tested until the standard's criteria are met or failure modes are understood. The text states "testing was conducted."
- Data provenance: The tests were non-clinical (laboratory/mechanical testing). The device manufacturer is Medacta International SA, located in Switzerland. The testing was conducted in support of an FDA 510(k) submission in the USA.
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)
- Not applicable. This device is a physical implant, not an AI model that requires expert-established ground truth from medical images or data. The "ground truth" here is the physical and mechanical performance of the device against engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML clinical study. Adjudication methods are relevant for resolving discrepancies in human expert evaluations, which is not pertinent to mechanical 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
- No. The document explicitly states: "No clinical studies were conducted." This relates to a physical implant, not an AI device, so MRMC studies examining reader performance with or without AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is defined by established engineering and material science standards (e.g., ASTM F1378-12, ASTM F2028-14, European Pharmacopoeia, USP chapters). Compliance with these standards demonstrates the physical and mechanical integrity and biocompatibility of the implant.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
§ 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.”