(29 days)
The Discovery Elbow - X-Small is intended for cemented use in patients with the following conditions:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- Rheumatoid arthritis,
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods
The Discovery™ Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. Placing the humeral articulation through the ulnar articulation links the ulnar and humeral component. The humeral components are available with or without a flange. The numeral and ulnar components are avialalbe with either a smooth or roughened surface. The components contained in this submission are X-Small in size.
The provided text is a 510(k) summary for the Discovery™ Elbow - X-Small, an elbow prosthesis. It is a submission to the FDA for market clearance and discusses the device description, intended use, and comparison to a predicate device.
Based on the information provided, no acceptance criteria or a study that proves the device meets specific acceptance criteria are described in the typical format of a clinical trial or performance study for a medical device with measurable outcomes (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Discovery™ Elbow, K013042 and K051975). This is a regulatory pathway that primarily relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device.
Here's an analysis of the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for performance metrics. The underlying acceptance criterion for this 510(k) submission is that the device is substantially equivalent to the predicate device. This means it must:
- Have the same intended use.
- Have the same technological characteristics, or have different technological characteristics that do not raise different questions of safety and effectiveness.
- If there are different technological characteristics, data must demonstrate that the device is as safe and effective as the predicate device.
- Reported Device Performance:
- Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This is a very general statement and does not provide specific performance metrics, methodology, or results in a table format. It implies mechanical and material testing, but no details are given.
- Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical performance data was used to demonstrate substantial equivalence for this particular submission.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. There is no "test set" in the context of clinical or device performance data described in this 510(k) summary because no clinical testing was performed for this submission. Non-clinical (laboratory) testing was mentioned but no sample sizes or data provenance for that testing are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. As no clinical testing was performed and no "ground truth" for a test set was established in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set or associated adjudication method is mentioned.
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 (a physical implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. As above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical ground truth data was used for this submission. The "ground truth" for substantial equivalence is effectively the performance (safety and effectiveness) of the predicate device, which is assumed to be established.
8. The sample size for the training set
- Not applicable. There is no "training set" mentioned or relevant for this type of 510(k) submission for an elbow prosthesis.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is mentioned.
In summary, the provided 510(k) summary details a regulatory submission based on substantial equivalence to a predicate device, supported by non-clinical laboratory testing. It does not contain information about specific acceptance criteria for performance metrics, clinical studies, or expert-adjudicated ground truth data, as these are typically not required for this type of submission when demonstrating substantial equivalence without clinical data.
§ 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.”