(76 days)
Not Found
The Select Shoulder Humeral Stem is a metallic humeral component manufactured from cobalt chrome alloy (CoCrMo) and is intended for use either with or without bone cement in hemiarthroplasty. The humeral stem is available in a variety of sizes and lengths and features a proximally grit blasted surface (except for the head stem taper) for biologic or cement fixation. The proximal trapezoidal shape tapers in the A-P plane, thus providing for a stable cement mantle. The proximal body also features an antirotation fin on the lateral aspect. Suture holes are provided in the medial proximal body and lateral fin to allow for soft tissue/bony fragment attachment and tensioning, thus resulting in a more biomechanically stable construct for repair of proximal humeral fractures. A male IOI morse type taper permits attachment of one of the metallic humeral heads offered by Intermedics Orthopedics. This taper is identical to the taper of the previously cleared Select Shoulder System. Distally, the stem is rounded and fluted to provide enhanced fixation and rotational stability. The distal stem tip is designed to accept a cement centralizer. The humeral stem is designed for use with Intermedics Orthopedics humeral heads in a variety of sizes and heights for increased stability of the glenohumeral joint.
Here's an analysis of the provided text regarding acceptance criteria and a device study:
Based on the provided 510(k) summary for the Intermedics Orthopedics, Inc. Select® Shoulder System CoCr Humeral Stem, the document does not describe acceptance criteria in the typical sense of a pre-defined performance metric that the device must achieve. Instead, it focuses on demonstrating substantial equivalence to predicate devices and inherent material/design properties.
Furthermore, the document does not detail a formal study with a defined test set, ground truth, or expert involvement as would be expected for a diagnostic or AI-driven device.
Here's a breakdown of the requested information based only on the provided text, indicating where information is present versus absent:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as such in the provided text. The overarching "acceptance criteria" for a 510(k) submission is typically demonstrating substantial equivalence to a predicate device and ensuring safety and effectiveness. | "Fatigue analysis and taper testing of the Select Shoulder Humeral Stem indicated that the device would survive physiologic loading." |
Explanation: The document mentions "fatigue analysis and taper testing" as indicating the device's ability to survive physiologic loading. This is the closest the summary comes to a performance claim, but it's presented as an outcome of engineering analysis rather than a pre-defined acceptance criterion for a study.
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Absent. The document refers to "fatigue analysis and taper testing" but does not specify a "test set" in terms of patient data or a sample size of devices tested for clinical performance. This is an orthopedic implant, and the testing would likely involve mechanical testing rather than patient data in this context.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Absent. No ground truth establishment by experts is described, as the testing mentioned appears to be mechanical/engineering-based.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Absent. Not applicable to the type of testing mentioned.
-
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:
- Absent. This is an orthopedic implant, not an AI-driven diagnostic device. MRMC studies are not relevant here.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Absent. This is an orthopedic implant, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implicitly mechanical/engineering standards. For fatigue and taper testing, the "ground truth" would be established mechanical failure points, adherence to design specifications, material properties, and relevant industry standards (e.g., ISO, ASTM for implant testing). It's not clinical ground truth.
-
The sample size for the training set:
- Absent. This is not an AI/machine learning device requiring a training set. The "training" for an implant design would be engineering principles, material science, and prior art.
-
How the ground truth for the training set was established:
- Absent. Not applicable given this is not an AI/machine learning device.
Summary of what can be gleaned from the document regarding "study":
The document mentions "Fatigue analysis and taper testing of the Select Shoulder Humeral Stem indicated that the device would survive physiologic loading." This is a statement of engineering validation, not a clinical study in the typical sense of evaluating diagnostic or treatment efficacy on patients. The primary evidence for this 510(k) submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices, coupled with mechanical testing to confirm the new device's material and structural integrity under simulated physiological conditions.
§ 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.