(94 days)
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
- non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods:
- revision of a failed primary implant;
- cuff tear arthropathy (CTA Heads only).
The Large Resection Stems (not available in the US) are indicated for oncology applications.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.
The SMR 40mm Glenosphere is a Co-Cr-Mo glenosphere intended to be used with the 40mm standard UHMWPE reverse liner (standard or retentive) as part of the SMR Reverse Shoulder System (K110598). The SMR Reverse Shoulder System consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenoid, a glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems are provided for both cemented and cementless (K100858, K101263, K111212, K113523) fixation as well as reverse humeral bodies (K110598). The SMR Reverse Shoulder System metal back glenoids (K110598. K113254 and K133349) and glenospheres (K110598) are intended for uncemented pressfit use only with the addition of screws for fixation.
SMR 40mm Glenosphere is made of CoCrMo alloy that conforms to ASTM F1537 - ISO 5832-12 in two (2) different designs: a standard glenosphere that can be centered with respect to the glenoid component or eccentrical glenosphere that provides offset. Both designs have a spherical shape of 40mm diameter and articulate with the standard 40mm ultra-high molecular weight polyethylene (ASTM F648 - ISO 5834-2) liners that are coupled to the humeral body. Two designs for the 40mm liners are available: standard and retentive.
The 40mm glenospheres are coupled to a SMR metal-back glenoid (K113254, K133349) through a double male taper, one side of which is connected to the glenosphere while the other is coupled with the glenoid component. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. The screw is inserted through a hole on the surface of the glenosphere, passing through the internal cavity of the connector and then screwed to the metal-back.
The SMR 40mm Liners are made from standard ultra-high molecular weight polyethylene conforming to ASTM F648 – ISO 5834-2. They are coupled to the SMR Reverse Humeral Bodies (K110598) via a taper. The liners are designed with a bevel cut in their inferior aspect to reduce the possibility of accidental contact between the polyethylene liner and the scapular bone during adduction - abduction movements. The 40mm liners are available in standard and retentive designs in three (3) thicknesses (STD, +3mm and +6mm) with the retentive liners characterized by a deeper spherical concavity than is present in the standard liners.
The provided text is a 510(k) summary for the SMR 40mm Glenosphere. It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical testing, rather than novel performance claims from a study. Therefore, most of the requested information regarding acceptance criteria and detailed study specifics (like sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies) is not present.
Here's what can be extracted and what is not provided based on the input:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of software or diagnostic device evaluations. Instead, it relies on demonstrating that the device meets the fatigue resistance requirements of the modular connection, and performs under expected clinical conditions, as evidenced by mechanical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fatigue resistance of the modular connection to the metal-back glenoid component under worst-case conditions | Testing results demonstrated the device's ability to perform under expected clinical conditions. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The text mentions "worst case components or constructs" were mechanically tested, but the number of units tested is not provided.
- Data Provenance: The testing was "Non-Clinical Testing" and involved "Mechanical testing." This implies laboratory-based physical testing of the device, not data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was mechanical testing of a medical implant, not a study requiring expert readers to establish ground truth on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is for studies involving human interpretation of data, which is not the case here.
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
No. A MRMC study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR 40mm Glenosphere to the predicate devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device is a physical implant, not an algorithm. The non-clinical testing performed can be considered a "standalone" evaluation of the device's mechanical properties, without a human-in-the-loop directly influencing its physical function during the test.
7. The type of ground truth used
The "ground truth" for the non-clinical testing would be the engineering specifications and failure criteria for fatigue resistance. The device either passed or failed the mechanical tests according to predefined engineering standards, implicitly demonstrating performance "under expected clinical conditions."
8. The sample size for the training set
Not applicable. The device is a physical implant, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.”