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510(k) Data Aggregation
(194 days)
AltiVate Anatomic Canal-Sparing (CS) Shoulder
The AltiVate® Anatomic CS Shoulder is indicated for severely painful and/or disabled shoulder joint resulting from osteoarthritis or traumatic arthritis.
The humeral components with a porous coated surface are indicated for uncemented (press-fit) applications. Glenoid components are indicated for cemented use only.
The AltiVate Anatomic Canal-Sparing (CS) Shoulder is a canal-sparing prothesis intended for use in an anatomic Total Shoulder Arthroplasty (aTSA) application. The canal-sparing prosthesis is a modular humeral component consisting of a metaphyseal humeral stem and humeral neck that are compatible with previously cleared DJO humeral heads and DJO keeled and pegged glenoids.
AltiVate Anatomic CS Humeral Stem -
The AltiVate Anatomic CS Humeral Stem component (Ti-6Al-4V per ASTM F1472) is a 3-fin design that extend radially from the central body and are equally spaced at 120°. It has a female Morse taper to accept the humeral neck component. The stem is tapered and has one consistent collar diameter. It has porous coating applied around the outer central body, fins, and bottom of the collar for cementless fixation in the proximal humerus. The stem is offered in three sizes, ranging from 18mm to 24mm in length.
AltiVate Anatomic CS Humeral Neck -
The AltiVate Anatomic CS Humeral Neck component (CoCr per ASTM F1537) is a dual Morse taper and is the modular connection between the humeral stem and the humeral head and is offered in one neutral size.
This document describes a 510(k) premarket notification for the AltiVate® Anatomic Canal-Sparing (CS) Shoulder system. Based on the provided text, there was no clinical study performed or required for this device to prove it meets acceptance criteria. The submission relies solely on non-clinical testing to demonstrate substantial equivalence to predicate devices.
Therefore, many of the requested details regarding acceptance criteria and study methodology cannot be filled from the provided text.
Here is a breakdown of what can and cannot be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
The document states: "Non-clinical testing has demonstrated the device's ability to perform under expected conditions." and "All testing has determined that the device is substantially equivalent to the predicate devices."
However, specific numerical acceptance criteria (e.g., "pull-out strength must be > X N") and the exact reported performance values from these non-clinical tests are not detailed in the provided text. The document lists the types of non-clinical tests performed:
| Test Type | Reported Device Performance (as described in document) |
|---|---|
| Taper Disassociation Testing | Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices. |
| Humeral Construct Fatigue Testing | Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices. |
| Torque-Out Testing | Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices. |
| Axial Pull-Out Testing | Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices. |
| Humeral Micromotion - Cadaveric Experimental Analysis | Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices. |
| Humeral Micromotion - Finite Element Analysis (FEA) | Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices. |
| Humeral Fit Analysis | Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices. |
| Endotoxin Assessment | Pyrogen limit specifications are met via the Kinetic Chromogenic method. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the non-clinical tests (e.g., how many cadaveric humeri were used, how many fatigue cycles were performed).
- Data Provenance: Not specified. This would typically refer to the origin of the test materials (e.g., cadaveric specimens from a specific tissue bank) or the location of the testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a non-clinical evaluation, not a clinical study requiring expert ground truth establishment for patient data.
4. Adjudication method for the test set:
- Not applicable due to the nature of the non-clinical testing.
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 MRMC or any clinical study was done. The device is a physical shoulder implant, not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For physical mechanical tests, the "ground truth" is typically the measured physical properties and performance against predefined engineering specifications or predicate device performance. For the cadaveric analysis, the 'ground truth' would be the direct physical measurement outcomes from those experiments.
8. The sample size for the training set:
- Not applicable. There was no clinical study, and thus no "training set" in the context of machine learning or clinical data analysis.
9. How the ground truth for the training set was established:
- Not applicable.
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