(92 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
- Complex fractures of the proximal humerus
- Functional impairment especially in the case of post-traumatic loss of the joint configuration
The humeral component is intended for cementless use. The glenoid component is for use with bone cement only.
The modified PROMOS® Modular Shoulder System is intended to aid in the restoration of shoulder motion and elimination of pain. This device consists of two primary components, the glenoid component and the modular humeral component. The changes to the PROMOS® Shoulder that resulted in the modified PROMOS® Shoulder and are subject of this 510(k) include:
- Addition of size 3.5 humeral stem, cementless .
- Addition of six humeral ball heads R21 R26, with 4 mm eccentricity .
- Redesign of body and inclination set to add face gear to area between . inclination set and body
- Addition of three Monoblock stems, cementless, size 02/30, 35 and 40 mm .
- Various labeling changes .
The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe) according to ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms. The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
The modular humeral component consists of a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross-sectional shape, previously available in seven cemented and seven cementless sizes, and now available in seven cemented and eight cementless sizes. It is attached to the body via a Morse type taper.
The cementless and cemented stems are fabricated from titanium alloy (Ti6Al4V) according to ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
The body is made of same titanium alloy as the distal stems and is available in three sizes. The body and inclination set have been redesigned to add a face gear to the area between the inclination set and body. As before the modified inclination set consists of three components: an inclination insert, an offset module, and a ball head screw.
The modular humeral heads are manufactured from wrought cobalt-chromiummolybdenum (CoCrMo) alloy according to ISO 5832-12:1996, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy, previously available in eight different sizes/eccentricities, and now available in 14 different sizes/eccentricities.
Since cementless or cemented stems in size 01 may be too large for some patients, the company has developed a humeral stem, size 02. The narrow crosssection of a size 02 stem precluded a modular design, i.e., 02 size stem and a selection of bodies. As a result, the company implemented the size 02 as a Monoblock system with three different heights for body sizes 30mm, 35mm, and 40mm. The design of the cross-section is the same as mentioned above in the description of the distal stem and the stem is made of the same titanium allov. The proximal portion has also been redesigned to add face gear to the area between inclination set and body.
This document describes the 510(k) Premarket Notification for the PROMOS® Modular Shoulder System. The submission focuses on modifications to an existing device, K032126. It is a traditional 510(k) and primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards and design controls rather than extensive clinical studies or acceptance criteria defined in terms of device performance metrics like sensitivity/specificity.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a novel AI/software device, because it is a submission for a physical medical device (shoulder prosthesis). Instead, the acceptance criteria are related to compliance with established standards for materials, sterility, and design controls for mechanical devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Compliance: Ultra High Molecular Weight Polyethylene (UHMWPe) for glenoid component | Conforms to ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms. |
| Material Compliance: Titanium alloy (Ti6Al4V) for cementless/cemented stems | Conforms to ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. |
| Material Compliance: Wrought cobalt-chromium-molybdenum (CoCrMo) alloy for modular humeral heads | Conforms to ISO 5832-12:1996, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy. |
| Sterility: Radiation sterilization | Conforms to AAMI / ANSI / ISO 11137:1994, Sterilization of health care products - Requirements for validation and routine control -radiation sterilization and ANSI/AAMI/ISO 11137:1994 (Amendment 1:2002). |
| Biocompatibility: | Assessed by conformance to material standards (ISO 5834-2, ISO 5832-3, ISO 5832-12). No separate biocompatibility testing mentioned beyond material standards. |
| Performance Testing (Bench Testing): Design verification and validation | Performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30. Specific quantitative results (e.g., fatigue strength, wear rates) are not provided in this summary but would be in the full submission. |
| Substantial Equivalence: To predicate device K032126 (PROMOS® Modular Shoulder System) | Conclusion states that the modified device is substantially equivalent to the predicate device with respect to indications for use/intended use, and technical characteristics based on review of design control documentation and bench testing. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of an AI/software performance study. The data provenance refers to materials (e.g., titanium alloy, UHMWPe) and the design files, not a clinical dataset. The testing performed is bench testing (e.g., mechanical, material characterization), not a study on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth, in the context of an AI/software device, refers to a definitive answer derived from expert review or a gold standard. For this physical device, "ground truth" relates to the specification of material properties and design requirements, which are established by engineering standards and internal design teams, not by medical experts reviewing a test set for diagnostic accuracy.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This is a physical orthopedic implant, not an imaging analysis or diagnostic AI device. An MRMC study is designed to assess the performance of human readers, with and without AI assistance, on a set of clinical cases. This type of study is not relevant to the evaluation of a shoulder prosthesis.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done
No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
For this device, the "ground truth" for demonstrating performance is based on:
- Engineering Standards: Compliance of materials (UHMWPe, Ti6Al4V, CoCrMo) with recognized ISO standards (e.g., ISO 5834-2, ISO 5832-3, ISO 5832-12).
- Sterilization Standards: Compliance with AAMI/ANSI/ISO 11137 for radiation sterilization.
- Design Controls: Verification and validation activities performed as per FDA's Design Control Requirements (21 CFR Part 820.30), which would involve testing against predefined engineering specifications and functional requirements.
- Predicate Device Comparison: Establishing substantial equivalence by comparing technical characteristics and indications for use to the legally marketed predicate device (K032126).
8. The Sample Size for the Training Set
This is not applicable. There is no AI/machine learning algorithm involved that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
In summary:
This 510(k) submission is for modifications to a physical orthopedic implant. The "acceptance criteria" and "studies" are focused on demonstrating manufacturing quality, material compatibility, and engineering performance through adherence to recognized standards and bench testing, rather than clinical performance metrics typically associated with AI or diagnostic devices. The core of the submission relies on establishing substantial equivalence to a previously cleared predicate device based on these engineering and material considerations.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.