(86 days)
The Promos Modular Shoulder System is indicated for:
- Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or . inflammatory arthritis '
- Avascular necrosis of the humeral head o
- Complex fractures of the proximal humerus
- Complex freetarse of the precially in the case of post-traumatic loss of the joint configuration .
The humeral component is intended for cemented or cementless use. The glenoid component is for use with bone cement only
The Promos Modular Shoulder System, as cleared via premarket notification K063578, consists of two primary components: the glenoid component and the modular humeral component. The modular humeral component consists of a distal stem, body, inclination set, and humeral head. Subject of this premarket notification is a review of changes to the Promos inclination set. No changes will be made to the glenoid, humeral head, body, or distal stem as a result of this premarket notification. Modifications to the inclination set components are intended to increase the overall strength and stability of the construct. The design concept remains the same, and the inclination set continues to mate with the humeral head and proximal body in the same way.
The modified devices consist of three components: internal cone, sleeve, and set screw. The subject inclination sets are manufactured from Ti-6Al-4V material conforming to ISO 5832-3 and are available in four sizes.
The provided document describes a 510(k) premarket notification for the Promos Modular Shoulder System. This notification focuses on modifications to the inclination set components of an already cleared device, intended to increase overall strength and stability. The submission highlights mechanical testing as the basis for demonstrating safety and effectiveness, and no clinical data or studies comparing AI to human performance were conducted as this is a device modification submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must achieve) | Reported Device Performance (How the device performed) |
|---|---|
| Mechanical Strength and Stability: Capable of withstanding expected in vivo loading without failure. | Demonstrated that the Promos Modular Shoulder System, with the modified inclination sets, is capable of withstanding expected in vivo loading without failure. |
| Static Testing of Set Screw: Specific criteria for set screw static strength (details not provided in the document). | Testing performed and results indicated no new issues related to safety and effectiveness. |
| Pre-fatigue Taper Strength: Specific criteria for taper strength before fatigue (details not provided). | Testing performed and results indicated no new issues related to safety and effectiveness. |
| Construct Fatigue, including Post-fatigue Taper Evaluations: Specific criteria for fatigue of the overall construct and taper integrity after fatigue (details not provided). | Testing performed and results indicated no new issues related to safety and effectiveness. |
Note: The document states that "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." Specific quantitative acceptance criteria or threshold values for the mechanical tests are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of units tested) for each mechanical test. It generally refers to "mechanical data" and "mechanical testing."
- Data Provenance: The data is generated from retrospective mechanical testing performed on the modified Promos Modular Shoulder System components. The country of origin for the testing data is not explicitly stated but is implicitly within the scope of Smith & Nephew's internal development and testing processes, likely in the US or where their manufacturing/R&D facilities are located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. This submission is for a medical device modification based on mechanical performance, not a diagnostic or AI-driven system requiring expert assessment of a test set for ground truth. The "ground truth" here is the physical performance of the device against engineering standards.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, there is no expert-adjudicated test set in the context of this 510(k) submission. Mechanical test results are interpreted against established engineering principles and standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. A MRMC comparative effectiveness study was not conducted. This is a submission for a mechanical device modification, not a diagnostic or AI-assisted system. No human readers or AI assistance are involved in the performance evaluation described.
6. Standalone (Algorithm Only) Performance Study
- No. A standalone performance study of an algorithm was not conducted. This submission pertains to a physical medical device.
7. Type of Ground Truth Used
- Engineering Standards and Mechanical Properties. The ground truth for evaluating the device's performance is based on established engineering principles, material properties, and mechanical test standards (e.g., ISO 5832-3 for Ti-6Al-4V material). The "review of mechanical data" against expected in vivo loading conditions serves as the basis for determining safety and effectiveness.
8. Sample Size for the Training Set
- Not Applicable. This is a mechanical device submission. There is no "training set" in the context of algorithm development. The design and manufacturing processes are iterative but do not involve machine learning training sets.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As per point 8, there is no training set for which ground truth would need to be established.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”