(359 days)
Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate.
The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older).
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 humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side.
The Duocentric® Reversed shoulder prosthesis is a prosthesis that uses the biomechanical concepts of reverse shoulder arthroplasty as originally described by Paul Grammont.
The Duocentric® Reversed shoulder prosthesis is composed of a humeral stem, a humeral baseplate, a humeral insert, a gleonosphere (Duoglene), and a glenoid baseplate. The humeral insert is made of ultra-high-molecular-weight polyethylene (UHMWPE), while all other components are made of wrought high nitrogen stainless steel M30NW. The humeral stem is intended for cemented use unless coated with hydroxyapatite (HA). The glenoid baseplate is coated with a double coating of pure titanium and hydroxyapatite (Ti/HA), is intended for cementless use, and is fixated with wrought high nitrogen stainless steel screws. The device is provided sterile.
The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580 and are performed by Medical Coating (Vault-en-Velin, FR) according to their Master File MAF-1633.
This document is a 510(k) premarket notification for the Duocentric® Reversed Shoulder Prosthesis. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML-based medical devices, as it is a traditional medical device (implant). Therefore, I will extract relevant information from the document that is analogous to the requested criteria for traditional medical devices.
Here's the breakdown based on the provided text, interpreting the request for a traditional medical device:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit Standard): The device (Duocentric® Reversed shoulder prosthesis) must meet predetermined specifications and be adequate for its intended use. This is common for traditional medical devices, where "specifications" often relate to mechanical properties, material integrity, and design functionality.
- Reported Device Performance: "Pre-clinical performance testing concluded that the Duocentric® Reversed shoulder finished product and its components met all pre-determined specifications and are adequate for their intended use."
Acceptance Criteria (Implicit) Reported Device Performance Device meets all pre-determined specifications. Pre-clinical performance testing concluded the device and its components met all pre-determined specifications. Device is adequate for its intended use. Pre-clinical performance testing concluded the device and its components are adequate for their intended use. Materials conform to ASTM standards. HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580. Does not raise new issues of safety and effectiveness. The subject device does not raise any new issues of safety and effectiveness (as compared to predicate devices). Comparable to predicate devices in specific aspects. Substantially equivalent to predicate devices based on similarities in indications for use, materials, dimensions, design, packaging and sterilization. -
Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of a "test set" for performance evaluation in the context of clinical data. The performance mentioned refers to "pre-clinical performance testing," which typically involves bench testing of components and assemblies. The number of physical units tested is not provided.
- Data Provenance: The pre-clinical testing data would be generated in a lab setting, likely in France (where Aston Medical is located). The document also mentions "post-market data" from Europe starting in 2003, indicating real-world usage data, but this is not the primary basis for the pre-market submission's performance claim.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to this type of device submission. The "ground truth" for a mechanical implant is established through engineering and material science standards and testing, not expert clinical interpretation of data in the same way an AI diagnostic tool would.
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Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic studies, which is not relevant here. Determining if mechanical specifications are met is typically done through measurement and comparison to predefined tolerances.
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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, not an AI-assisted diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical implant, not an algorithm.
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The type of ground truth used
- For the pre-clinical performance testing, the "ground truth" is defined by engineering specifications, material standards (e.g., ASTM F1185, ASTM F1609, ASTM F1580), and functional requirements for the device and its components. These are objective, measurable criteria.
- The submission also references post-market data from Europe (since 2003) which "has shown to be safe and effective," indicating real-world clinical outcomes as a type of ground truth, but this wasn't the main pre-market evidence.
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The sample size for the training set
- Not applicable. This is a traditional medical device, not an AI/ML model that requires a training set.
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How the ground truth for the training set was established
- Not applicable. As above, this device does not use a 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.”