(177 days)
The Comprehensive® Segmental Revision System is intended for use in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive® Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive® Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
The Comprehensive® Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.
The Comprehensive® Segmental Revision System is intended for use with bone cement in distal humeral and total humeral applications.
Tissue Attachment Augments provide the option for tissue stabilization and attachment.
The Comprehensive® SRS address the needs of the upper extremity, especially in cases where there is marked bone loss. Applications of the system include proximal humeral (shoulder) replacements distal humeral (elbow) replacements and total humeral replacements. Components of the system include humeral heads, proximal humeral bodies, intercalary segments, humeral stems, total humeral couplers, distal bodies with a modular flange, and modular tissue attachment augments.
The provided text describes a 510(k) submission for the "Comprehensive® Segmental Revision System (SRS)," a shoulder, elbow, and total humeral replacement prosthesis. The submission details the device's characteristics and its substantial equivalence to predicate devices based on non-clinical testing. Crucially, the document explicitly states, "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence."
Therefore, many of the requested elements regarding acceptance criteria and studies (especially clinical ones) cannot be extracted from this document, as they were not conducted or submitted for this device.
Here's a breakdown of the information that can be provided based on the input:
1. A table of acceptance criteria and the reported device performance
The document lists "Performance Data" which are summaries of non-clinical tests. It does not explicitly state numerical acceptance criteria for these tests, but implies that the device "performed within the intended use" and was comparable to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Structural integrity at weakest point of construct | Engineering analysis to determine weakest point of the construct (presumably met acceptable design specifications) |
| Range of motion | Engineering analysis to determine range of motion (presumably within physiological limits for the intended use) |
| Strength of smaller diameter long stems | Engineering analysis to justify smaller diameter long stems (presumably demonstrating adequate strength) |
| Stem strength compared to predicate | Cantilever fatigue testing to compare stem strength to predicate (results indicated comparable strength, leading to substantial equivalence) |
| Augment stability post-cyclic loading | Cyclic loading followed by screw torque out to confirm augment stability (results indicated stability) |
| Flange loading determination | Engineering analysis for flange loading determination (presumably met design specifications) |
| Humeral flange fatigue | Cyclic fatigue testing of humeral flange (results indicated acceptable fatigue life) |
| Static axial separation of SRS taper junction | Static Axial Separation of SRS taper junction (results indicated acceptable separation force) |
| Static axial separation of Comprehensive® taper junction | Static Axial Separation of Comprehensive® taper junction (results indicated acceptable separation force) |
| Elbow condyle strength | Shear testing to determine elbow condyle strength (results indicated acceptable strength) |
| MR compatibility | MR Compatibility to ASTM F2182-09 (results indicated compliance with the standard) |
| Overall safety and effectiveness (compared to predicate devices) | The results of analysis and mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices. (This is the overarching conclusion, implying all acceptance criteria were met by showing equivalence to legally marketed devices.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified for any of the non-clinical tests. Non-clinical mechanical testing typically involves a small number of samples depending on the test type (e.g., typically N=3 to N=6 or more for fatigue testing per ISO standards).
- Data provenance: The tests are non-clinical, so country of origin of patient data is not applicable. The tests were performed as part of a 510(k) submission in the US. The design of these tests suggests they are prospective in nature within a laboratory setting.
- Retrospective or prospective: The non-clinical tests are, by nature, prospective in that they were designed and executed to evaluate specific performance aspects of the newly designed device.
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 data submitted" there was no ground truth established by experts for a test set in the clinical sense. The "ground truth" for non-clinical tests would be the established engineering and materials science principles and standards against which the device performance was measured. These would typically be evaluated by engineers and materials scientists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set with expert adjudication was involved.
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. No MRMC study was conducted. This device is a physical implant, 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 a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" was based on established engineering principles, material properties standards (e.g., relevant ASTM standards like F2182-09 for MR Compatibility), and performance characteristics of predicate devices. The goal was to demonstrate that the new device performed equivalently or acceptably according to these engineering benchmarks, not against clinical outcomes or expert diagnoses.
8. The sample size for the training set
- Not applicable. As no clinical data was submitted and the device is a physical implant, there was no "training set" in the context of machine learning or AI models. The design and testing of the device would have involved an iterative process where engineering data might inform design changes, but this is not analogous to a machine learning training set.
9. How the ground truth for the training set was established
- Not applicable, as there was no training set in the context of machine learning or AI models.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”