(26 days)
The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- · Severe arthropathy with a grossly deficient rotator cuff;
- · Previously failed joint replacement with a grossly deficient rotator cuff;
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
- · Bone defect in proximal humerus;
- · Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/or glenoid:
- · Inflammatory arthritis including rheumatoid arthritis;
- · Correction of functional deformity
The humeral stems are intended for cemented or uncemented applications.
The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.
The Catalyst OrthoScience R1 Reverse Shoulder System is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this reverse design is inverted compared to a traditional anatomic total shoulder prosthesis, where the articulating sphere is on the glenoid side of the joint, and the mating insert is fixed into the humeral stem implant. This submission is to add polyethylene inserts with a modified locking ring to the R1 Reverse Shoulder System. These polyethylene inserts are a design modification of the polyethylene inserts cleared in K202611 and K211991. There are no changes to the articulating interface or overall dimensions of the construct in vivo, the only change is to the locking mechanism. These polyethylene inserts do not replace the standard polyethylene inserts cleared in K202611 and K211991 but are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
Based on the provided FDA 510(k) summary for the Catalyst R1 Reverse Shoulder System, the device is a modification to an existing, previously cleared device. The focus of this specific submission (K232583) is to add polyethylene inserts with a modified locking ring to the existing system. The FDA document focuses on demonstrating substantial equivalence to a predicate device rather than outright performance against specific clinical acceptance criteria in the way a novel diagnostic AI might.
Therefore, the information you've requested regarding acceptance criteria and studies (especially in the context of an AI-powered diagnostic device) is largely not present in this document because this is a medical device clearance, not an AI/diagnostic software clearance. The device is a physical implant, and the testing performed relates to the physical and mechanical properties of the implant, not diagnostic performance.
However, I can extract the relevant information that is available and explain why other requested information is not applicable.
1. A table of acceptance criteria and the reported device performance
For this type of physical implant modification, the "acceptance criteria" are typically related to mechanical performance and demonstrating that the modification does not negatively impact the existing cleared device's safety and effectiveness.
| Acceptance Criteria (Inferred from "Performance Data / Non-Clinical Testing") | Reported Device Performance |
|---|---|
| Adequacy for intended use based on fatigue, axial, and torsional disassembly tests. | The results of these tests indicate that the performance of the Catalyst R1 Reverse Shoulder is adequate for its intended use. |
| Substantial equivalence to predicate device regarding intended use, indications, size ranges, design intent, materials, and design features. | The device is substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For physical device testing like fatigue and disassembly, sample sizes are typically determined by engineering standards (e.g., ISO, ASTM) and are usually small (e.g., n=3, n=5, n=10 per test condition) prototypes or manufactured samples, not patient data. Data provenance like country of origin or retrospective/prospective is not relevant for this type of non-clinical mechanical testing.
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 information is not applicable and therefore not provided. "Ground truth" in the clinical sense (e.g., expert consensus on diagnoses) is not relevant for the mechanical testing of a shoulder implant. The "ground truth" for mechanical testing would be defined by engineering specifications and physical test measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies or expert consensus processes for diagnostic interpretation, not for mechanical testing of physical implants.
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 information is not applicable and therefore not provided. An MRMC study is relevant for evaluating diagnostic software's impact on human readers, not for a physical shoulder implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided. Standalone algorithm performance is relevant for AI or diagnostic software. This device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, clinical "ground truth" is not applicable here. For the non-clinical mechanical performance tests, the "ground truth" is defined by engineering specifications and measurements (e.g., force applied, displacement, cycles to failure, component integrity after testing).
8. The sample size for the training set
This information is not applicable and therefore not provided. "Training set" refers to data used to train AI/machine learning models. This device is a physical implant, not an AI model.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. As above, "training set" and its "ground truth" are concepts for AI/machine learning, not for physical medical device clearance based on substantial equivalence.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states:
- Study Type: Non-clinical (benchtop) performance testing.
- Tests Performed: Construct fatigue tests, followed by axial and torsional disassembly tests on the components (specifically the polyethylene inserts with modified locking rings).
- Objective: To demonstrate that the modified locking mechanism does not compromise the mechanical integrity and function of the shoulder system and that the device maintains substantial equivalence to its predicate.
- Conclusion: "The results of these tests indicate that the performance of the Catalyst R1 Reverse Shoulder is adequate for its intended use." And, "The subject device has the same design features, uses the same materials, has the same intended use and indications, has the same size ranges, and the same design intent as the predicate devices. Any noted differences do not raise different questions of safety and effectiveness."
In essence, for this specific 510(k), the "study" was a series of mechanical tests designed to confirm that the design change (modified locking ring) did not negatively impact the device's robust performance, allowing the FDA to determine substantial equivalence. Clinical testing was explicitly stated as "not necessary."
§ 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.”