(316 days)
In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat- Cut QUANTUM® talar implants.
PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the positioning of the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.
TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.
The previously cleared single use QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of:
• QUANTUM® patient specific instrumentation (PSI) and reusable instruments:
- QUANTUM® patient specific tibial and talar guides;
- QUANTUM® reusable instruments;
- QUANTUM® patient specific tibial and talar bone models
• ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software (specific modification implemented in this submission).
The QUANTUM® PSI Guides are patient-specific devices adapted to the patient bones anatomy and the preoperative surgical plan validated by the surgeon. QUANTUM® PSI guides and bone models are designed using the dedicated ORTHO-PLANIFY TAR planning software.
The QUANTUM® system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The ORTHO-PLANIFY TAR planning software involved in this submission was previously cleared under K221432.
The scope of this submission is an addition of a manufacturer for the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883.
This FDA document, K231699, describes the QUANTUM® Patient Specific Instrumentation (PSI) System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The document primarily focuses on:
- The FDA's determination of substantial equivalence for the device.
- The indications for use of the device and its associated planning software.
- A 510(k) summary, which outlines contacts, device description, predicates, and a high-level statement about performance data.
Key points from the document regarding performance:
- Performance Data: "Non-clinical performance data were included in the 510(k) submission. Functional cadaver testing and software validations (previously provided under K221432) were conducted to demonstrate that the QUANTUM® PSI system is substantial equivalence to the predicate device."
Based on the provided text, I can answer some of your questions, but not all, as the detailed study information is not present.
Here's an analysis of what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "non-clinical performance data were included in the 510(k) submission," and mentions "functional cadaver testing and software validations." However, the actual acceptance criteria (e.g., specific thresholds for accuracy, precision) and the reported performance values from these tests are not detailed in this publicly available summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Partially available. The document mentions "functional cadaver testing." This implies the test set involved cadavers. The sample size (number of cadavers or cases) is not specified. The provenance (e.g., country of origin, retrospective/prospective) of the cadaver data or the software validation data is not provided.
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)
- Cannot be determined. The document does not mention the use of experts to establish ground truth for a test set, nor their number or qualifications. The "pre-operative planning validated by the surgeon" for the PSI guides suggests surgeon involvement in the clinical application, but not necessarily in an independent ground truth assessment for a test study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be determined. The document does not describe any adjudication methods used for a test set.
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/Cannot be determined. The device is a "Patient Specific Instrumentation (PSI) System" and "TAR Planning Software" which assists in orthopedic surgery. It doesn't appear to be an AI-driven diagnostic or interpretative tool that would typically involve "human readers" in a traditional MRMC study comparing AI assistance. The software "allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively." This is an assistive tool for surgical planning, not an AI for image interpretation. Therefore, a conventional MRMC study comparing human readers with/without AI assistance using diagnostic images is unlikely to have been performed or would be relevant in the typical sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied, but details are missing. The "software validations" mentioned likely included testing of the software's algorithms in a standalone capacity (e.g., accuracy of measurements, positioning calculations) without direct human interaction as part of the performance evaluation. However, the exact nature of these standalone tests and their results are not provided. The device is explicitly designed for a "surgeon... to use advanced display and positioning tools," indicating a human-in-the-loop system for its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied to be anatomical/measurement-based. For surgical planning software and patient-specific instrumentation, ground truth would typically relate to anatomical accuracy (e.g., how closely the PSI guide matches the actual anatomy, or how accurately the software calculates bone cuts/implant positions relative to predefined anatomical landmarks). Given "functional cadaver testing," direct anatomical measurements on cadavers would form the basis of ground truth. Exact details are not specified.
8. The sample size for the training set
- Not applicable/Not provided. This document describes a medical device submission, not specifically a machine learning model's training set. While the software algorithms might have been developed using data, this document does not specify a "training set" in the context of an AI model.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As with point 8, this information is not relevant to the content of this FDA document.
In summary, while the document confirms that performance data (functional cadaver testing and software validations) were submitted, it does not provide the specific details regarding acceptance criteria, reported performance values, sample sizes for test sets, expert involvement, or ground truth methodologies in a detailed manner.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.