(128 days)
Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signature™ Personalized Patient Care System can be used with the following Biomet knee systems and their respective components: Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system.
The Signature™ guides are intended for single use only.
Signature тм Personalized Patient Care System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the placement of total knee replacement components.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it refers to validation against intended use and substantial equivalence to predicate devices. The performance is broadly stated as "adequate."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy performance adequate for intended use (e.g., precise pin placement for total knee replacement components). | "Testing verified that the accuracy and performance of the system is adequate to perform as intended." |
| Guide deformation verification after sterilization adequate for intended use. | "guide deformation verification after sterilization was performed to determine substantial equivalence." |
| Substantial equivalence to predicate devices (SurgiCase K073449 and Zimmer Patient Specific Instruments System 2.0 K093533). | "Device comparison showed that the proposed device is substantially equivalent to the predicate devices... Testing verified that the accuracy and performance of the system is adequate to perform as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The text states "cadaveric trials" were performed. However, it does not provide a specific number or range of cadavers used for these trials.
- Data Provenance: The cadaveric trials imply a prospective data collection for the performance testing. The country of origin for the cadavers is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the CADAVERIC test set. The evaluation appears to be based on direct measurement of device output (e.g., pin placement accuracy). If human judgment was involved, it is not detailed.
4. Adjudication Method for the Test Set
As the document does not detail the use of experts or a subjective assessment for the test set's ground truth, an adjudication method is not described. The assessment seems to be based on objective measurement during the cadaveric trials.
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, an MRMC comparative effectiveness study was not mentioned in this 510(k) summary. The device, Signature™ Planner, is a software for pre-surgical planning and the Signature™ guides are patient-specific templates. The focus is on the accuracy of these tools directly, not on improving human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in spirit. The "Signature™ Planner software... has been validated for its intended use" and "Accuracy performance testing by means of cadaveric trials" was performed. While a surgeon uses the software to "inspect, fine-tune and approve the pre-surgical plan," the performance testing described seems to primarily evaluate the system's (software + guides) ability to accurately transfer the plan to the physical space (cadaver) without explicitly measuring the impact of human fine-tuning on the accuracy results reported in the cadaveric trials. The accuracy reported ("adequate") is the outcome of the system's ability to produce precise pin locations.
7. The Type of Ground Truth Used
The ground truth for the cadaveric trials would likely be established through direct, precise measurement of the actual pin placements on the cadaveric bones relative to the intended pre-surgical plan. This would involve highly accurate measurement techniques (e.g., CMM, optical tracking, or high-resolution CT scans of the cadaver after pin insertion) to determine the deviation from the planned positions. This falls under objective physical measurement rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set size. This is typical for medical device submissions focusing on predicate pathway and substantial equivalence, especially for technologies predating the widespread use of deep learning models that require large training datasets. The "Signature™ Planner" likely relies on established geometric algorithms and imaging processing techniques rather than a machine learning model that requires a distinct training phase with labeled data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), no information is provided on how its ground truth would have been established.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.