(30 days)
The Constrained Elbow is indicated for use in the following conditions:
- Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Revisions where other treatments or devices have failed
- Correction of severe functional deformity
- Treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods
This device is intended for cemented use.
The Constrained Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. The humeral components are available with or without an anterior flange. All ulnar and humeral components are manufactured with or without Bond coat.
The device design allows the load to be carried at the primary articulation. The primary articulation is the spherical interface between the humeral condyles and the ulnar bearing. The secondary articulation is the axle attached to one condyle, which fits into the hole of the opposite condyle. The geometry of the components is designed to minimize bone loss and eliminate sharp resection cuts.
The humeral stem has been designed to incorporate a five degree carrying angle with a five degree internal rotation to closely match the anatomical morphology. The ulnar component incorporates a bowed stem and neck angle also designed to closely match the anatomical morphology.
The provided document is a 510(k) premarket notification for a medical device called the "Discovery Elbow." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing new performance criteria through clinical trials. Therefore, the document does not contain the information required to populate a table of acceptance criteria and reported device performance based on a study of the device itself.
Here's why and what information is available:
- No Acceptance Criteria and Reported Performance Table: The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence." This means there was no study conducted on the Discovery Elbow to measure its performance against predefined acceptance criteria. Instead, substantial equivalence was established through non-clinical testing (Finite Element Analysis) and by comparing its technological characteristics (materials, design, sizing, and indications) to a predicate device.
Therefore, I cannot provide the requested table or answer most of the detailed questions about a study on the Discovery Elbow.
However, I can extract information relevant to how substantial equivalence was determined:
1. A table of acceptance criteria and the reported device performance:
- Not applicable. No clinical study was performed on the Discovery Elbow to generate performance data against acceptance criteria. Substantial equivalence was based on comparison to a predicate device.
2. Sample size used for the test set and the data provenance:
- Not applicable. No clinical "test set" was used for the Discovery Elbow itself. The evaluation relied on non-clinical data (Finite Element Analysis) and comparison to a predicate device for which clinical data presumably existed but is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical "test set" was established for the Discovery Elbow.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This device is an elbow prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an elbow prosthesis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For substantial equivalence, the "ground truth" was the performance and characteristics of the legally marketed predicate device (Constrained Elbow, K003253). The Discovery Elbow was deemed equivalent based on its design, materials, and intended use aligning with that predicate, supported by Finite Element Analysis.
8. The sample size for the training set:
- Not applicable. No training set was used as this is not a machine learning device, and no clinical study was conducted.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device and Equivalence Information from the document:
- Device Name: Discovery Elbow
- Predicate Device: Constrained Elbow, K003253
- Intended Use (for both Discovery Elbow and implied for predicate):
- Non-Inflammatory Degenerative Joint Disease (osteoarthritis, avascular necrosis)
- Rheumatoid arthritis
- Revisions where other treatments or devices have failed
- Correction of severe functional deformity
- Treatment of acute or chronic fractures with humeral epicondyle involvement unmanageable by other methods
- Method of Substantial Equivalence Demonstration:
- Non-Clinical Testing: Finite Element Analysis was performed.
- Clinical Testing: Explicitly stated: "Clinical testing was not used to establish substantial equivalence."
- Technological Characteristics Comparison: The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate device.
This document serves as an FDA clearance letter based on substantial equivalence, not a report of a performance study with acceptance criteria.
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,”
(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,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”