(351 days)
The Signature™ Personalized Patient Care System – Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans.
The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components.
The Signature™ guides are intended for single use only.
The Acetabular Guide System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the orientation of an acetabular cup.
The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with the following Biomet acetabular systems and their respective compatible components: Bio-Clad™ All-Poly Cup (K810120 and K926107), Ranawat/Burstein™ All-Poly Cup (preamendment), RX-90™ Low Profile Shell (K920639 and K042989), Full Hemisphere Shell (K920640), Mallory/Head™ Shells (K861114, K921181, and K030055), Quadrant Sparing Shells (K920640 and K050124), Ranawat/Burstein™ Shells (K911685, K921277, and K050124), Regenerex™ Porous Titanium Shells (K052996), Regenerex™ Ringloc+ Shell System (K070369), Ringloc+ Acetabular System (K070369), Tri-Spike Pegged Shells (K970501 and K030055), Tri-Polar Shell (K991990), Universal Shells (K861433, K921301, and K030055), Vision™ Shells (K954417 and K030055), Freedom™ Constrained All-Poly Cups (K030047), M2a-Magnum™ with E1™ Active Articulation (K101336), and M2a-Magnum™ with ArComXL™ Active Articulation (K110555).
Here's a breakdown of the acceptance criteria and study information for the Signature™ Planner and Signature™ guides, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a quantitative format (e.g., "accuracy > 95%"). Instead, it describes general performance requirements that were met.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Accuracy Performance | "Testing verified that the accuracy and performance of the system is adequate to perform as intended." |
| Dimensional Stability | "Testing verified that the accuracy and performance of the system is adequate to perform as intended." |
| Intended Use | "Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices." |
| Materials | "Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Accuracy performance testing and guide dimensional stability testing was performed to determine substantial equivalence."
- Sample Size: The sample size for the test set is not specified in the provided text.
- Data Provenance: The provenance of the data (e.g., country of origin, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the text. The document refers to "Accuracy performance testing" but does not detail the methodology for establishing ground truth for this testing.
4. Adjudication Method for the Test Set
The adjudication method (e.g., 2+1, 3+1, none) for the test set is not specified in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done or reported. The document states, "Clinical data: Not applicable." This indicates that no human reader studies (MRMC or otherwise) were performed and submitted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, a standalone study was done. The "Accuracy performance testing" and "guide dimensional stability testing" described are typical of standalone, algorithm-only performance evaluations for devices like this. The device is a "software component, Signature™ Planner and a hardware component, Signature™ guides," which implies the software's performance (planner) and the physical guide's performance (accuracy of transfer) were tested.
7. The Type of Ground Truth Used
The type of ground truth used is not explicitly stated beyond "Accuracy performance testing." For a device assisting in surgical orientation, typical ground truth for such testing would involve:
- Manufacturing tolerances/specifications: for the guides.
- Precision measurement tools: to verify the accuracy of the planned orientation transferred by the guides to a physical model or cadaver.
- High-resolution imaging or coordinate measuring: to establish true anatomical landmarks and compare against the device's output.
However, the specific methodology is not detailed.
8. The Sample Size for the Training Set
The document does not mention a training set or any details about it. Given that this is a 510(k) submission for a device that generates patient-specific guides based on MRI data, the "training" aspect is more likely to be related to the development and validation of the algorithms and manufacturing processes, rather than a separate "training set" of patient data in the context of machine learning. The focus here is on the accuracy of the planning and guide manufacturing.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is also not provided.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular 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.