(154 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 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 optional sizes of the glenospheres and baseplates to the R1 Reverse Shoulder System. The additional sizes of the glenospheres and baseplates are a design modification of the glenospheres and baseplates cleared in K202611. The glenospheres and baseplates in this submission are not replacing the glenospheres and baseplates cleared in K202611 but are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.
This document, K223655, is a 510(k) premarket notification for a medical device called the "Catalyst R1 Reverse Shoulder System." The submission seeks to add optional sizes of glenospheres and baseplates to an already cleared system.
Based on the provided text, the device in question is a mechanical implant, not an AI/software-based device that would typically involve a "study that proves the device meets the acceptance criteria" in the sense of accuracy, sensitivity, specificity, and human reader performance. Therefore, a table of acceptance criteria and the study that proves the device meets the acceptance criteria as typically understood for AI-driven diagnostic devices is not applicable here.
Instead, the "acceptance criteria" for this mechanical device relate to demonstrating substantial equivalence to a predicate device through non-clinical performance testing and ensuring no new questions of safety and effectiveness are raised by the design modification.
Here's a breakdown of the relevant information provided, structured to address your points where applicable:
A summary of the acceptance criteria and performance for this type of device, as gleaned from the document, is as follows:
Acceptance Criteria and Reported Device Performance (Non-Clinical/Mechanical Testing Focused):
| Acceptance Criteria Type | Specific Criterion (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (Overall) | The device (modified glenospheres and baseplates) must be substantially equivalent to the predicate device(s) regarding intended use, indications, material, and design intent, without raising new questions of safety and effectiveness. | "The optional glenospheres and baseplates are substantially equivalent to the predicate device regarding intended use and indications, material, and design intent. Any noted differences do not raise different questions of safety and effectiveness, nor are there new technological issues." |
| Mechanical Performance (Fatigue/Loosening) | The device must pass specified mechanical tests to ensure integrity and prevent loosening/disassociation under dynamic conditions. Specifically, meeting standards like ASTM F2028 and ASTM F1378. | "Mechanical tests per ASTM F2028 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation, complete construct fatigue testing per ASTM F1378. and post-fatigue disassembly testing were completed. The results of these tests indicate that the performance of the Catalyst R1 Reverse Shoulder is substantially equivalent to the legally marketed predicate device." |
| Material Equivalence | Materials used for the new components should be equivalent to, or not qualitatively different from, those in the predicate. | Implicitly covered under "material" equivalence in the substantial equivalence statement. The document does not specify the materials but implies they are consistent with the predicate. |
| Design Intent Equivalence | The design of the new components should serve the same functional purpose consistent with the predicate. | Implicitly covered under "design intent" equivalence in the substantial equivalence statement. The submission is for "optional sizes," indicating the fundamental design remains the same. |
Addressing your specific points based on the provided text, and highlighting what is not applicable for this type of device submission:
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A table of acceptance criteria and the reported device performance:
- See the table above. These are derived from the "Performance Data / Non-Clinical Testing" section and the comparison of technologies.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This section describes mechanical testing, not patient data or a clinical study. Therefore, "sample size" would refer to the number of test articles (e.g., glenospheres or baseplates) that underwent mechanical testing. The document states "Mechanical tests... were completed" but does not specify the number of test articles (i.e., "sample size") used for these mechanical tests.
- "Data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a clinical study on human subjects but rather laboratory mechanical testing.
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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. "Ground truth" in the context of mechanical device testing typically refers to adherence to engineering standards (e.g., ASTM standards) and meeting predetermined biomechanical performance benchmarks. It does not involve human expert interpretation of data in the way a diagnostic AI would.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication is for resolving discrepancies in human expert interpretation or labeling, which is not part of mechanical device testing.
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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 a mechanical implant device, not an AI-driven diagnostic tool. MRMC studies are used to assess the impact of AI on human reader performance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. "Standalone" performance would describe the device's mechanical integrity and function as an implant in a mechanical test environment (e.g., fatigue machine). The document confirms these mechanical tests were done.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device type is adherence to established engineering and material standards (e.g., ASTM F2028, ASTM F1378) and demonstrating that the mechanical properties of the new components are within acceptable limits and equivalent to the predicate. There is no biological "ground truth" (like pathology or outcomes data) required for this specific filing, as it's a modification to an existing cleared device primarily based on mechanical equivalence.
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The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
In summary, the K223655 submission for the Catalyst R1 Reverse Shoulder System is a 510(k) for a physical medical device. The "study" that proves it meets acceptance criteria is non-clinical, mechanical performance testing (e.g., fatigue, loosening, disassembly per ASTM standards), aimed at demonstrating substantial equivalence to a previously cleared predicate device. This process differs significantly from the AI/software-validation paradigm your questions are designed for.
§ 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.”