(90 days)
The components of Bio-Modular® Shoulder System included in this submission are intended for total shoulder joint arthroplasty. Indications for use include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate
Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.
The Bio-Modular® Shoulder System consists of a humeral stem that is used in conjunction with a modular head and a metal backed or all polyethylene glenoid component. The Humeral Component is available in various lengths and porous coating levels. The Bio-Modular® Humeral stern features a biplaner taper to promote stress transfer down the length of the stem. Each stem has a lateral fin to provide rotational stability. Holes in the fin provide the surgeon with the option of suture attachment during fracture reconstruction. A collar minimizes subsidence. The stems are circumferentially porous coated proximally to provide fixation by tissue ingrowth. The proximal portions of the humeral stems feature a reverse Morse taper for attachment of the modular humeral head. Offset and Bi-Polar humeral heads are also available. Modular, metal backed glenoid components are available for total shoulder replacement. These devices feature a central peg and the option of using screws for immediate fixation and porous coating to provide biological fixation when used without bone cement. All polyethylene glenoid components are available for cemented application.
The provided text is a 510(k) Premarket Notification for the Bio-Modular® Shoulder System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria through clinical studies as would be required for a novel device or one with a higher risk classification.
Therefore, the document does not contain the detailed information typically associated with establishing acceptance criteria and proving a device meets them through clinical or standalone studies for AI/software devices. Instead, it focuses on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.
Here's an analysis based on the information provided, highlighting the absence of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify performance-based acceptance criteria for an AI/software device, nor does it report specific performance metrics for the Bio-Modular® Shoulder System in terms of diagnostic accuracy, sensitivity, specificity, etc. The "performance" demonstrated here is primarily through mechanical testing and similarity to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable: This 510(k) submission is for a medical implant (shoulder system), not an AI/software device that would have performance metrics like sensitivity/specificity. The primary 'acceptance criterion' for a 510(k) is substantial equivalence to legally marketed predicate devices. | Mechanical Testing: "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions." (No specific quantitative results are provided in this summary.) |
| Characterization of Porous Surface: "A full characterization of the porous surface has been provided." (Details of this characterization are not included in this summary.) | |
| Materials, Surface Finishes, and Processing: "The materials, surface finishes and processing of the Bio-Modular® Shoulder System are similar to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. No clinical test set data is provided in this submission; the primary evidence is based on mechanical testing and comparison to predicate devices, not a test set of patient cases.
- Data Provenance: Not applicable. No patient data (retrospective or prospective) is mentioned for a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. There is no mention of a test set requiring expert ground truth establishment for this device.
4. Adjudication Method for the Test Set:
- Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is typically for evaluating the diagnostic performance of a reading system, often involving AI, with human readers. This device is a shoulder implant and the submission explicitly states: "Clinical Testing: None provided."
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is not an algorithm for which standalone performance would be typically evaluated in this manner. The "standalone" performance tested here relates to the mechanical properties of the implant itself, not an AI algorithm.
7. Type of Ground Truth Used:
- Not applicable in the context of diagnostic performance. The "ground truth" for the device's functionality is its physical and mechanical integrity, demonstrated through mechanical testing and comparison to predicate devices. For a surgical implant, the ultimate "ground truth" of its effectiveness would come from clinical outcomes data, but this submission explicitly states "Clinical Testing: None provided."
8. Sample Size for the Training Set:
- Not applicable. This application is for a medical implant and does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
Based on the provided document, the "study" that proves the Bio-Modular® Shoulder System meets its (implicit) acceptance criteria for substantial equivalence to predicate devices consists of:
- Mechanical Testing: Demonstrating the device's ability to perform under expected clinical conditions. While the details are not provided, this would involve standardized tests to evaluate strength, durability, fatigue resistance, and other biomechanical properties relevant to orthopedic implants.
- Porous Surface Characterization: To verify the properties of the porous coating for biological fixation.
- Comparison to Predicate Devices: Demonstrating that the materials, surface finishes, and processing methods are similar to previously cleared devices (K872454, K915596, K992119, K992899, K002998 for Bio-Modular®; K914695, K943300, K974044, K981487, K011047 for Gobal® Advantage). This similarity, combined with non-clinical testing, forms the basis for the FDA's determination of substantial equivalence, implying the new device is as safe and effective as the predicates.
Key takeaway: This 510(k) relies on non-clinical (mechanical) testing and comparison to predicate devices, rather than clinical studies or the types of performance evaluations (e.g., sensitivity, specificity, human-in-the-loop studies) typically associated with AI/software medical devices. The explicit statement "Clinical Testing: None provided." confirms this approach.
§ 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.”