(105 days)
The Anatomical Shoulder™ Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:
- Complex 3 and 4 part fractures of the proximal humerus with subluxation of the head fragment;
- Complex 3 and 4 part fractures of the proximal humerus with loosening of the spongiosa in the head fragment;
- Complex 3 and 4 part fractures of the proximal humerus with additional cross split of the head fragment;
- Fracture instability after osteosynthesis of 3 and 4 fragments of the proximal humerus;
- Posttraumatic necrosis of the humeral head;
- Posttraumatic arthrosis after humeral head fracture.
The Anatomical Shoulder Fracture stem is intended for cemented or cementless use.
The Anatomical Shoulder Fracture System is designed specifically to treat complex 3 or 4 part proximal humerus fractures requiring hemi- or total shoulder arthroplasty. The Anatomical Shoulder Fracture System may be used with or without bone cement. The Anatomical Shoulder Fracture System consists of four components, a stem, baseplate, screw and head. The Anatomical Shoulder Fracture System baseplate offers right and left side-specific versions in order to appropriately match the original shoulder anatomy with respect to right and left humeral anatomy. The Anatomical Shoulder Fracture System head is also designed to articulate with the glenoid components of the Anatomical Shoulder System (K030259). The Anatomical Shoulder Fracture System stem is also designed to accept the Anatomical Shoulder Inverse/Reverse humeral cup (K053274) for conversion from hemi- or total shoulder arthroplasty to an inverse/reverse shoulder arthroplasty in situations when the rotator cuff is irreparable and the patient is experiencing severe instability of the shoulder joint. The Anatomical Shoulder Fracture System stem is comparable in shape and size to stems traditionally used for hemi- and total shoulder arthroplasty. The Anatomical Shoulder Fracture System stem, however, has two features which distinguish it as a stem designed for treatment of proximal humeral fractures. The proximal surface of the humeral stem and much of the surface of the baseplate offer spikes which assist in the stable anchoring of the humeral tuberosities to the stem and allow for primary stability of the tuberosities. The Anatomical Shoulder Fracture System stem and baseplate also offer several suture holes to allow initial stable fixation of the humeral tuberosities with sutures.
The provided text is a 510(k) summary for the Zimmer Anatomical Shoulder™ Fracture System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Key takeaways regarding acceptance criteria and studies:
The document states: "Performance testing indicates that all components meet or exceed predetermined performance criteria for their intended use." However, it does not provide specific numerical acceptance criteria for the device's performance, nor does it detail the specific study designs, methodologies, or results that prove these criteria were met.
Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices, an approach common for 510(k) submissions. This means that the device is considered safe and effective because it is similar in intended use, design, materials, and manufacturing methods to devices already on the market.
Therefore, many of the requested details about specific acceptance criteria and detailed study information are not available in the provided text because it's a summary focused on substantial equivalence rather than a full study report with performance metrics.
Here's a breakdown of what can be inferred or stated as "not applicable/provided" based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific numerical acceptance criteria for performance | Not provided in this summary. The document broadly states: "Performance testing indicates that all components meet or exceed predetermined performance criteria for their intended use." This is an assertion of compliance rather than a report of specific metrics or a table of results. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not provided.
- Data provenance: Not provided. The document mentions "Performance testing" but does not specify if this involved patient data, laboratory tests, or simulation, nor does it give origin or nature (retrospective/prospective). Given it's a 510(k) for an implant, the "performance testing" likely refers to non-clinical bench testing rather than clinical patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable/Not provided. As no clinical "test set" in the context of expert review (e.g., for image interpretation) is described, expert ground truth establishment for such a test set is not relevant here.
- Qualifications of experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not provided. No clinical test set requiring adjudication by experts is described.
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
- MRMC comparative effectiveness study: No. This device is an orthopedic implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.
- Effect size of human readers with/without AI: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance: Not applicable. This device is a physical shoulder implant, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Performance testing for an orthopedic device typically involves biomechanical testing or material testing against engineering standards or established performance benchmarks for similar devices. The "ground truth" would be the measurable physical properties and performance under specific simulated conditions (e.g., fatigue life, strength, range of motion, wear characteristics). The document simply states "Performance testing indicates that all components meet or exceed predetermined performance criteria," implying such testing was conducted but not detailing the 'ground truth' benchmarks.
8. The sample size for the training set
- Sample size for the training set: Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. If "training set" refers to design and testing iterations, these details are not in the summary.
9. How the ground truth for the training set was established
- How ground truth for the training set was established: Not applicable/Not provided. As this is not an AI/ML device, the concept of a training set with established ground truth is not relevant here.
§ 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.”