(385 days)
Indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient 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 stem is intended for cemented use only.
The RSP Modular Glenoid Baseplate is a multiple piece construct as opposed to a single piece construct as the predicate Reverse Shoulder Prosthesis Baseplate (K041066). The RSP Modular Glenoid Baseplate is fabricated from wrought/forged Ti-6A 1-4V that conforms to ASTM F136. The bottom surface of the baseplate is porous coated with commercially pure titanium (ASTM F67 grade 2) beads. This is the same coating previously cleared under K974294. The baseplate is Hydroxyapatite coated that conforms to ASTM F1185. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5mm cancellous screw and is intended to be used with four peripheral screws (3.5mm non-locking and/or 5mm locking and non-locking) for additional fixation. The RSP Modular Glenoid Baseplate female taper of the adapter have geometry identical to those used in the predicate Turon Shoulder (K080402).
Here's an analysis of the provided text regarding the acceptance criteria and study for the RSP Modular Glenoid Baseplate, organized to address your specific points:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from "as safe, as effective, and performs as well as the predicate device") | Reported Device Performance |
|---|---|---|
| Mechanical Fatigue | Comparable fatigue life to predicate devices (K041066 and K080402) | "Results of non-clinical testing demonstrate that the device is as safe, as effective, and performs as well as the predicate device." |
| Dynamic Performance | Comparable dynamic performance to predicate devices (K041066 and K080402) | "Results of non-clinical testing demonstrate that the device is as safe, as effective, and performs as well as the predicate device." |
| Biocompatibility | Materials conform to established ASTM standards (Ti-6A1-4V to ASTM F136; pure titanium to ASTM F67 grade 2; Hydroxyapatite to ASTM F1185). | Explicitly stated: "fabricated from wrought/forged Ti-6A 1-4V that conforms to ASTM F136. ... porous coated with commercially pure titanium (ASTM F67 grade 2) beads. ... Hydroxyapatite coated that conforms to ASTM F1185." |
| Fixation Strength | Adequate fixation comparable to predicate devices. | The design includes "an incorporated 6.5mm cancellous screw and is intended to be used with four peripheral screws (3.5mm non-locking and/or 5mm locking and non-locking) for additional fixation," implying a design to meet fixation needs. |
| Sterilization | Sterilization method is equivalent to predicate devices. | "Features comparable to predicate devices include the same indications, sterilization, packaging and intended use." |
| Packaging | Packaging is equivalent to predicate devices. | "Features comparable to predicate devices include the same indications, sterilization, packaging and intended use." |
Study Information:
Based on the provided text, the device clearance was based on non-clinical testing only. There were no clinical studies performed. The "study" mentioned below refers to the non-clinical testing described.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text only mentions "Mechanical fatigue testing, Dynamic testing." The specific number of devices tested for fatigue and dynamic performance is not provided.
- Data Provenance: Not applicable as this was non-clinical (laboratory) testing, not human data.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. As this was non-clinical mechanical testing, "experts" in the sense of clinical reviewers establishing ground truth for patient data are not relevant. The ground truth would be established by engineering standards and measurements.
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Adjudication Method for the Test Set:
- Not applicable. This was non-clinical mechanical testing, not a clinical study requiring adjudication of expert opinions.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Testing: None provided." This type of study is for comparing human reader performance with and without AI assistance, which is not relevant for a mechanical device clearance based on non-clinical testing.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an AI algorithm.
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The Type of Ground Truth Used:
- For the non-clinical testing, the "ground truth" would be established by engineering standards and measurements. This includes material specifications (ASTM F136, F67 grade 2, F1185), as well as the measured fatigue life and dynamic performance data compared against the performance of predicate devices.
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The Sample Size for the Training Set:
- Not applicable. There was no "training set" in the context of an AI/machine learning model, as this device uses non-clinical mechanical testing for clearance.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. There was 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.”