(435 days)
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a combination of software design and additive manufacturing for customized virtual pre-surgical treatment planning in Maxillofacial reconstructive surgeries. The system processes patients' imaging data files obtained from the surgeons for treatment planning and outputs various patient-specific products (both physical and digital), including surgical guides for harvesting bone grafts from the Fibula or Ilium, anatomical models of the Fibula and Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. The physical products (surgical guides, anatomical models) are manufactured with biocompatible polyamide (PA-12) using additive manufacturing (Selective Laser Sintering).
The provided text is a 510(k) Summary for the CenterMed Patient Matched Assisted Surgical Planning (ASP) System. This document focuses on demonstrating substantial equivalence to a predicate device (KLS Martin Individual Patient Solutions (IPS) Planning System).
Crucially, this type of submission (510(k)) does not typically involve clinical performance studies to establish "acceptance criteria" through a traditional clinical trial or MRMC study in the way medical AI/imaging devices often do. Instead, the focus is on a comparison to a legally marketed predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" in terms of clinical performance (like sensitivity, specificity, reader performance, etc.) are not applicable to this 510(k) summary. The "acceptance criteria" here are primarily around demonstrating engineering performance, biocompatibility, sterilization, and software validation to ensure the device performs as intended and is as safe and effective as the predicate.
Here's a breakdown based on the provided document and the nature of a 510(k) submission for this type of device:
1. A table of acceptance criteria and the reported device performance
The provided document details non-clinical performance data and their conclusions. These serve as the "acceptance criteria" for demonstrating the device's functional and safety characteristics.
| Test Category | Acceptance Criteria / Guidelines | Reported Device Performance / Conclusion | Safety and Efficacy Confirmed |
|---|---|---|---|
| Mechanical Testing | ISO 178:2019 (bending strength), ISO 20753:2018 (tensile testing with smaller specimens), ASTM D638 (tensile testing with larger specimens), ISO 527-2:2012 (tensile strength) - Pre-defined criteria: maintain 85% of initial bending/tensile strength. | The results showed that the sterilized and aged test specimens met the pre-defined acceptance criteria: maintain 85% of initial bending strength. The smaller test specimens used for tensile testing were designed according to ISO 20753:2018. The larger test specimens used for tensile testing were designed according to ASTM D638. The results showed that the sterilized and aged test specimens can reach the pre-defined criteria: maintain 85% of initial tensile strength. | Yes |
| Dimensional Testing | Pre-defined dimensional tolerance limits | The results showed that the dimensional changes were within the predefined acceptance criteria. | Yes |
| Wear Debris Testing | Pre-defined average amount of material loss | The results showed that the average material loss was within the predefined acceptance criteria. | Yes |
| Cytotoxicity | ISO 10993-5, GB/T 16886.5-2017 - No evidence of cell lysis or toxicity. | The results showed no evidence of the test specimen causing cell lysis or toxicity. | Yes |
| Sensitization | ISO 10993-10, GB/T 16886.10-2017 - No evidence of delayed dermal contact sensitization. | The test specimen extracts showed no evidence of causing delayed dermal contact sensitization. | Yes |
| Intracutaneous Reactivity | ISO 10993-10, GB/T 16886.10-2017 - No evidence of intra-cutaneous reactivity. | The results showed no evidence of intra-cutaneous reactivity. | Yes |
| Acute Systemic Toxicity | ISO 10993-11, GB/T 16886.11 2011 - No mortality or evidence of systemic toxicity. | The results showed no mortality or evidence of systemic toxicity. | Yes |
| Pyrogenicity | USP , ISO 10993-11 - Meet requirements for absence of pyrogens. | The results met the requirements for the absence of pyrogens. | Yes |
| Sterilization Validation | ANSI/AAMI/ISO 17665-1 - Assurance of sterility of 10-6 SAL. | The results demonstrated the assurance of sterility of 10-6 SAL (sterility assurance level) for surgical guides and anatomical models individually packaged in a single-pouched or wrapped sterilization configuration. | Yes |
| Software Validation | Pre-defined requirement specifications - Conformity with specifications and acceptance criteria. | All the COTS software applications for image segmentation and manipulation are FDA cleared. Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to the system requirements. Testing required as a result of risk analysis (level of concern) and impact assessments showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates all appropriate steps have been taken to ensure mitigation of any potential risks and the system performs as intended based on the user requirements and specifications. | Yes |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- No clinical test set was used for this 510(k) submission. The submission relies on non-clinical (mechanical, biocompatibility, sterilization) and software validation testing.
- The raw material for the device (patient CT scans) would be prospective in real-world use, but for the purpose of this submission, no patient data was used to "test" the device's diagnostic performance. The software processes existing DICOM data.
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. No clinical ground truth was established as no clinical performance study was conducted. The "ground truth" for the device's outputs (models, guides, plans) is established through the surgeon's approval of the digital models and plans, as described in the workflow.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical 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
- No MRMC study was performed. The device is an "Assisted Surgical Planning System" that produces physical and digital outputs for Maxillofacial reconstructive surgeries, not a diagnostic AI that assists human readers in interpreting images. It is used by "well-trained engineers" and "evaluated by physicians" for surgical planning. The submission explicitly states "Clinical testing was not necessary for the determination of substantial equivalence, or safety and effectiveness."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable for a typical AI performance metric. The device is described as an "Assisted Surgical Planning System" where "well-trained engineers" use "COTS software systems" for image transfer, manipulation, and simulation, with outputs "evaluated by physicians." This implies a human-in-the-loop system for the actual planning process, not a standalone diagnostic algorithm. The software validation detailed in the report is for the underlying software's functionality and adherence to specifications, not its stand-alone diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests (mechanical, biocompatibility, sterilization), the "ground truth" is adherence to established international and industry standards (ISO, ASTM, USP) and pre-defined internal acceptance criteria.
- For the software, the "ground truth" is adherence to "pre-defined requirement specifications" and "traceable to the system requirements," validated through "Quality and on-site user acceptance testing."
- There is no clinical ground truth in terms of patient outcomes or expert pathological diagnosis as this was not a clinical performance study for image interpretation.
8. The sample size for the training set
- Not applicable. The document does not describe a machine learning model that requires a "training set" in the context of deep learning. The software uses "Commercially off-the-shelf (COTS) software systems" for image processing and simulation, which would have been developed and validated by their respective vendors, not developed from scratch by CenterMed using a large training dataset for a novel AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.