(88 days)
The DePuy Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.
Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.
The DePuy Total Elbow System is intended for cemented use only.
The DePuy Total Elbow System is designed to be implanted as either an unlinked (semiconstrained) or linked (constrained) elbow. When the DePuy Total Elbow System is implanted as an unlinked elbow it relies on existing soft tissues, such as the medial collateral ligament and triceps tendon for support and stability. While the linked system is held together with the linked ulnar component and pin assembly, and is used when there is poor bone stock.
The DePuy Total Elbow System humeral stems are available in 100, 150, and 200mm lengths. The ulnar stems available in two lengths 60 and 80mm lengths, right and left, to accommodate different patient anatomy. Both the humeral and ulnar stems are intended for use with bone cement.
The provided text, K992656, is a 510(k) summary for the DePuy Total Elbow System, submitted to the FDA in 1999. This document is a premarket notification for a medical device and, as such, does not contain information about a study that proves the device meets specific acceptance criteria related to its performance in patients or comparative effectiveness with AI assistance.
The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its clinical effectiveness through detailed studies and acceptance criteria as one might find in an AI medical device submission nowadays.
Therefore, I cannot provide the information requested for acceptance criteria and a study that proves the device meets those criteria, a multi-reader, multi-case study, or standalone algorithm performance. The document focuses on establishing equivalence based on design, materials, indications for use, and manufacturing processes.
However, I can extract information related to the device description and the basis for its substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
Based on the provided document, there are no specific performance acceptance criteria or reported performance data in the context of clinical outcomes or diagnostic accuracy from a study included. The "performance" described relates to the design of the device:
| Acceptance Criteria (Implied Design Features/Performance) | Reported Device Performance (Description) |
|---|---|
| Ability to be implanted as unlinked (semi-constrained) | Relies on existing soft tissues (medial collateral ligament and triceps tendon) for support and stability. |
| Ability to be implanted as linked (constrained) | Held together with the linked ulnar component and pin assembly, used when there is poor bone stock. |
| Availability of various humeral stem lengths | Humeral stems available in 100, 150, and 200mm lengths. |
| Availability of various ulnar stem lengths | Ulnar stems available in 60 and 80mm lengths, right and left, to accommodate different patient anatomy. |
| Intended for use with bone cement | Both humeral and ulnar stems are intended for use with bone cement. The system as a whole is intended for cemented use only. |
| Reduce pain and improve function/mobility | Indicated to reduce pain and improve the function and mobility of the affected joint in patients with painful arthritic joint (osteoarthritis, rheumatoid arthritis, post traumatic arthritis) and pathological fractures of the distal humerus, where bone stock is adequate for fixation. |
No specific quantitative or qualitative acceptance criteria beyond the product description and intended use are explicitly stated or supported by a study within this 510(k) summary.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study data are presented in this 510(k) summary for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is described.
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, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is described in the context of a performance study. The 510(k) relies on the "ground truth" of existing similar devices demonstrating safe and effective performance over time.
8. The sample size for the training set: Not applicable. No training set is described.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment is described.
Summary of 510(k) Basis for Equivalence:
The document states that the substantial equivalence of the DePuy Total Elbow System is substantiated by its similarity in:
- Indications for use
- Design
- Materials
- Sterilization
- Packaging
to the following predicate devices:
The determination of substantial equivalence was based on a detailed device description and conformance with voluntary performance standards (though the specific standards are not listed in the provided text). This indicates that the "study" demonstrating performance is primarily regulatory compliance and comparison to previously approved devices, rather than a prospective clinical trial.
§ 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.”