(59 days)
The Univers Revers Shoulder Prosthesis System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. 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 Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to rotator cuff deficiency.
(Humeral) Stems are intended for cementless applications for use with Arthrex Humeral SutureCups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex Univers Revers Monoblock Stem Size 4/33 as a line extension to the Arthrex Univers Revers Humeral Stems cleared under K130129 for use in the Arthrex Univers Revers Shoulder Prosthesis System.
The Arthrex Univers Revers Monoblock Stem Size 4/33 is a humeral stem that is manufactured from Titanium (Ti-AL-4V), coated with either Calcium Phosphate (CaP) or Hydroxyapatite (HA), and offered sterile.
The provided text describes a 510(k) premarket notification for a medical device, the Arthrex Univers Revers Monoblock Stem Size 4/33. This notification aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or AI performance evaluation.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/ML-based medical devices or studies proving clinical efficacy against defined endpoints, are not applicable to this 510(k) submission.
This submission focuses on demonstrating that the new device, a line extension, is technologically equivalent to its predicate. The "Performance Data" section describes engineering tests to assess the device's physical properties and safety, not a study evaluating performance against acceptance criteria in the context of diagnostic accuracy or clinical outcomes.
Here's a breakdown of why the requested information is not present:
- Acceptance Criteria and Reported Device Performance (Table): Not applicable. The submission is for substantial equivalence, not for demonstrating performance against specific clinical or diagnostic accuracy criteria. The performance data mentioned (fatigue testing, SAR patterns) are engineering-based assessments, not performance against clinical acceptance criteria.
- Sample size for the test set and data provenance: Not applicable. There is no "test set" in the context of clinical accuracy or AI performance evaluation. The "testing" refers to mechanical and computational engineering simulations of the device itself.
- Number of experts and their qualifications: Not applicable. No experts were used to establish ground truth for a test set, as this is not an AI/ML or clinical efficacy study.
- Adjudication method: Not applicable for the same reasons above.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant to this device's submission.
- Standalone (algorithm only) performance: Not applicable. This device is a physical implant, not an algorithm.
- Type of ground truth used: Not applicable. Ground truth, in the context of clinical or diagnostic studies, is not established here. The "results" are from engineering tests.
- Sample size for the training set: Not applicable. There is no AI model being trained for this device.
- How the ground truth for the training set was established: Not applicable.
Summary of "Performance Data" from the document:
The "Performance Data" section in the 510(k) summary describes engineering evaluations, not clinical performance or AI algorithm performance.
- Dynamic fatigue testing: Performed to evaluate the fatigue resilience of the proposed stem.
- Range of motion (ROM): Dictated by the ROM of mating liners and previously cleared components.
- Computational electromagnetic method: Used to evaluate surface SAR (Specific Absorption Rate) patterns of the stem under MRI radio frequency coil emissions (64-MHz for 1.5Tesla and 128-MHz for 3Tesla MRI).
- Results indicated that for device-induced heating, the maximum 1g averaged SAR values (corresponding maximum temperature rises) are located near the end of the device.
- In-vivo modeling: Indicated a maximum temperature rise after 60 minutes exposure of less than 6 degrees Celsius under specified WB SAR conditions (2W/kg inside tissue and 1W/kg inside bone).
Conclusion from the document:
The submission concludes that the proposed device, the Arthrex Univers Revers Monoblock Stem Size 4/33, is substantially equivalent to the predicate device (K130129) because the only difference is size. It states that the proposed line extension has the same indications for use, is manufactured from the same materials, undergoes the same manufacturing and sterilization processes, has the same packaging, and shelf-life as the predicate. The differences are considered minor and do not raise questions concerning safety or effectiveness.
§ 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.”