(180 days)
The Indications for Use of the Sidus Stem-Free Shoulder are:
- Osteoarthritis;
- Posttraumatic arthrosis;
- Focal avascular necrosis of the humeral head;
- Previous surgeries of the shoulder that do not compromise the fixation.
The Sidus Stem-Free Shoulder components (Anchors and Humeral Heads) are intended for cementless use.
The Sidus Stem-Free Shoulder is a modular humeral component (consisting of a humeral anchor and a head) designed to be used as a total- shoulder arthroplasty long- term implant. Both humeral anchor and humeral head components are available in multiple sizes. The Sidus Stem-Free Shoulder replaces the proximal humeral bone, including the articulating surface, using an anatomical reconstruction surgical technique philosophy. The Sidus Stem-Free humeral anchor fixes within the proximal humeral bone via an uncemented interference press-fit. The Sidus Stem-Free humeral head mates to the Sidus Stem-Free humeral anchor via a Morse taper with the male taper on the humeral anchor and female taper on the humeral head.
Here's a breakdown of the acceptance criteria and study information for the Sidus Stem-Free Shoulder, extracted from the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Composite Clinical Success at 2 years) | Reported Device Performance (Sidus IDE Trial) |
|---|---|
| ASES overall score improvement of at least 30 points from baseline. | 98.5% of Sidus IDE patients had over a 30-point improvement on the ASES score from preoperative. |
| Radiographic success defined as: | 98.5% of patients completing two-year visits successfully passed the radiographic success criteria. |
| - No progressive radiolucencies of the humeral component > 2 mm | Met (included in overall radiographic success). |
| - No progressive migration or subsidence of the humeral component ≥ 5 mm | Met (included in overall radiographic success). |
| No device-related serious adverse events (SAE). | 27 adverse events were determined to be definitely, possibly, or uncertain in their relation to the investigational device. (This doesn't directly state "no SAEs", but rather categorizes reported SAEs.) |
| No reoperation or revision of the study implants. | 3 revisions were reported. |
| Overall Clinical Success Rate (Composite): | 93.0% |
Clinical Performance Goal for Comparison (Bigliani/Flatow historical control): 85.42% success rate. The Sidus IDE trial achieved 93.0% success, exceeding this goal.
Study Details
2. Sample Sizes and Data Provenance
- Test Set (Sidus IDE Trial):
- Sample Size: 71 subjects
- Data Provenance: United States and Canada (Multicenter Investigational Device Exemption (IDE) Trial) - Prospective
- Test Set (Sidus PMCF Study):
- Sample Size: 43 subjects
- Data Provenance: Europe (Multicenter, Prospective, Non-Controlled Post-Market Clinical Follow-up Study (PMCF)) - Prospective
- Historical Control (Bigliani/Flatow):
- Sample Size: 48 subjects (for the specific success criteria comparison)
- Data Provenance: Implied retrospective (referred to as "historical control")
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. The clinical success criteria (ASES score, radiographic evaluation, SAEs, revisions) inherently involve clinical assessments and potentially radiographic interpretations by healthcare professionals, but the formal process for establishing a "ground truth" by a panel of independent experts is not detailed.
4. Adjudication Method
The document does not specify an adjudication method (such as 2+1 or 3+1) for the test set evaluations. The success criteria are based on objective measures (ASES score improvement, specific radiographic criteria, occurrence of SAEs/revisions), which would typically be assessed by the treating physicians and study coordinators according to the study protocol.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The clinical studies compare the device's performance against a historical control (Bigliani/Flatow shoulder) based on patient outcomes, not on readers' interpretations with or without AI assistance. The device in question is a medical implant, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance
No, a standalone (algorithm only) performance study was not done. The device is a physical shoulder implant, not an algorithm. The performance evaluation focuses on the in-vivo clinical outcomes of the implant.
7. Type of Ground Truth Used
The ground truth for the clinical studies (Sidus IDE and PMCF) was based on a composite of:
- Clinical Outcomes/Patient Reported Outcomes: ASES overall score improvement.
- Radiographic Assessment: Evaluation of progressive radiolucencies and migration/subsidence of the humeral component.
- Safety Data: Occurrence of device-related serious adverse events.
- Intervention Data: Reoperation or revision of the study implants.
This combines objective measurements, physician assessments, and patient-reported data.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of the clinical studies. This is expected as the device is a physical implant, not a machine learning algorithm that requires a separate training set. The non-clinical tests (FEA, mechanical testing) would have used internal design data and models, but these are not referred to as "training sets" in the typical ML sense.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" (in the machine learning context) for this physical implant device, the document does not describe how ground truth for a training set was 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.”