(234 days)
The Humelock II Cementless Shoulder System is indicated for use in hemi shoulder replacement for fractures of the proximal humerus. The Humelock II Cementless Humeral Stem is intended for use with two cortical screws and is intended for cementless use only.
The Humelock II Cementless Shoulder System is a hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, cortical bone screws and an optional protector and hex screw to prevent bone ingrowth into the threaded hole in the proximal stem.
The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The distal end of the humeral component is cylindrical with a grit blasted surface and two unthreaded screw holes oriented in the anterior / posterior direction for fixation using bone screws.
The proximal portion of the humeral component has a plasma sprayed commercially pure Titanium (CP Ti) coating and a hydroxyapatite (HA) coating. A hole in the proximal portion of the humeral component allows attachment to instrumentation designed to provide correct positioning (height and retroversion) of the implant. The humeral stem is available in sizes 8 - 15.
The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral·head.
The double taper connector is manufactured from Ti-6A1-4V allor conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads. The double taper connector has a male taper on each end and is used to connect the humeral head to the humeral stem. An impactor / extractor hole is incorporated into the proximal end of the connector.
The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 54mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem.
The cortical bone screws are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and are available with a diameter of 4.5mm in lengths of 18 - 40mm in 2mm increments.
The screw hole protector and hex screw are manufactured from Ti-6Al-4V alloy conforming to Ti-6Al-4V alloy conforming to ISO 5832-3.
The provided text describes the Humelock II Cementless Shoulder System, a hemi-shoulder replacement system. The document is a 510(k) summary submitted by Fx Solutions to the FDA, demonstrating substantial equivalence to predicate devices. It focuses on the mechanical testing performed to support this claim in lieu of clinical testing.
Here's the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for the mechanical tests or reported device performance in a quantitative manner. It describes the types of tests conducted and their purpose.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Demonstrate fatigue strength of the humeral stem. | Mechanical testing was conducted to demonstrate the fatigue strength of the humeral stem. (Implied that the device met acceptable fatigue limits, though no specific values are given.) |
| Demonstrate stability of the modular connection between the double taper connector and the humeral stem. | Mechanical testing was conducted to demonstrate the stability of the modular connection between the double taper connector and the humeral stem. (Implied that the modular connection was stable.) |
| Evaluate pull-off strength of the humeral head from the taper. | Pull-off testing of the humeral head from the taper was conducted previously. (Implied results were acceptable, no specific values given.) |
| Characterize CP Titanium plasma spray coating. | Characterization data was provided for the CP Titanium plasma spray coating. (Implied coating met specifications, no specific data provided.) |
| Characterize hydroxyapatite coating. | Characterization data was provided for the hydroxyapatite coating. (Implied coating met specifications, no specific data provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Mechanical testing" was conducted. This refers to non-clinical, in-vitro laboratory testing of device components, not clinical studies involving human patients. Therefore, terms like "test set," "data provenance," "retrospective or prospective," "country of origin," and "sample size" in relation to human data are not applicable here. The "sample size" for the mechanical tests would refer to the number of physical device units or components tested, which is not specified.
3. 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)
Not applicable. As described above, this submission relies on non-clinical mechanical testing, not clinical data requiring expert evaluation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This submission relies on non-clinical mechanical testing, not clinical data requiring adjudication.
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
Not applicable. This submission relies on non-clinical mechanical testing. There is no mention of AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission relies on non-clinical mechanical testing. There is no mention of an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical mechanical testing would be the physical properties and performance observed during the tests (e.g., maximum load before failure, fatigue life, adhesion strength of coatings) as measured by calibrated equipment according to predefined test protocols and engineering standards (e.g., ISO standards mentioned for materials). There is no "expert consensus" or "pathology" in this context.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is a traditional medical device submission based on mechanical testing and substantial equivalence, not an AI/ML device requiring training data.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or corresponding ground truth as this is not an AI/ML device.
§ 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.