(704 days)
Immersive View Surgical Plan (IVSP®) is intended for use as a software system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the ImmersiveView Surgical Plan (IVSP®) system and the result is an output data file that 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, surgical splints, and surgical guides for use in maxillofacial surgery. The Immersive View Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
The ImmersiveView Surgical Plan (IVSP®) system is a software based pre-surgical planning system. It is intended for use as a software system for the transfer of imaging information from a medical scanner such as CT based system. Physical outputs include surgical splints, and surgical guides that will be used in maxillofacial surgery. Surgical marking guides and surgical splints are not intended to come in contact with surgical cutting or drilling tools and therefore should not interface with surgical cutting or drilling tools.
ImmersiveTouch receives patient specific medical imaging information which is further utilized by ImmersiveTouch trained employees within the ImmersiveView Surgical Plan (IVSP®) system. This includes software to extract anatomical areas of interest from 3D medical scan images and create patient-specific physical and digital outputs. Throughout the process, a physician reviews and approves the plan prior to delivery of the final outputs.
Physical model outputs include surgical splints, and surgical guides for use in maxillofacial surgery. Surgical splints and surgical guides are designed and manufactured by ImmersiveTouch trained employees. Trained employees utilize the ImmersiveTouch additive manufacturing workflow to design and manufacture surgical guides, and, surgical splints using polymer resin. Surgical splints and surgical guides are provided in a NON-sterile condition and instructions for use provide the steps for cleaning and sterilization prior to use in surgery. Surgical splints and surgical guides are manufactured based on recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."
Prior to use in surgery, the physician confirms the accuracy and level of precision by attaching surgical splints and surgical guides to the anatomical models are designed and manufactured using similar workflow and materials as the subject devices.
Reports are generated for each patient specific case illustrating the plan and accompany the physical outputs that are delivered once verified and approved by the physician.
The provided document is a 510(k) summary for the ImmersiveView Surgical Plan (IVSP®) system. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific clinical study with acceptance criteria and device performance metrics in the way a clinical trial report would.
Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this 510(k) summary.
Here's what can be extracted and what is explicitly not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided as a quantifiable table with specific performance metrics (e.g., accuracy, sensitivity, specificity) against defined acceptance criteria.
- The document states: "The performance data indicates that the verification and validation testing performed on the ImmersiveView Surgical Plan (IVSP®) system successfully demonstrates that design outputs meet design inputs." This is a high-level statement but doesn't offer specific numerical acceptance criteria or performance results.
- Mechanical Strength Testing: "The result of the testing concluded that subject device was in accordance with the pre-defined acceptance criteria." This implies criteria existed, but they are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document refers to "patient specific medical imaging information" but does not give any details on the number of cases or their origin.
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 provided. The document mentions "a physician reviews and approves the plan prior to delivery of the final outputs" and that "ImmersiveTouch trained employees" utilize the system. It also notes that "the physician confirms the accuracy and level of precision by attaching surgical splints and surgical guides to the anatomical models." However, this does not detail ground truth establishment in a study context, expert numbers, or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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 provided. The document focuses on the system as a pre-surgical planning tool and highlights "Human Intervention for Interpretation of images: Yes" for both the subject and predicate devices, indicating a human-in-the-loop approach. However, a comparative effectiveness study measuring improvement with AI assistance is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not directly addressed in terms of formal performance metrics. The device description indicates human involvement in the planning process: "ImmersiveTouch receives patient specific medical imaging information which is further utilized by ImmersiveTouch trained employees within the ImmersiveView Surgical Plan (IVSP®) system." And "Throughout the process, a physician reviews and approves the plan prior to delivery of the final outputs." This implies it's not a standalone, algorithm-only device in its clinical workflow.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in a study context. The closest mention to "ground truth" or verification is a physician confirming the accuracy of physical outputs against anatomical models.
8. The sample size for the training set
- Not applicable/Not provided. This document describes a surgical planning system that utilizes medical images as input to create patient-specific outputs and does not describe an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "image segmentation system" mentioned is part of the overall workflow but no details on its AI/ML training are given.
9. How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8)
Summary of available "performance data" categories from the document:
The "Performance Data" section primarily addresses verification and validation activities related to manufacturing and quality control, ensuring the physical outputs meet certain standards, rather than clinical performance metrics of the software itself.
- Device Performance Validation: "processes validation methods such as IQ, OQ, and PQ to ensure that the manufacturing process can effectively produce patient matched devices." Also, "Equipment used for production purposes have been qualified to ensure the equipment used for manufacturing of surgical guides, surgical splints and, anatomical models meet production needs."
- Sterilization Validation: Conducted in accordance with ISO 17665 and FDA guidance to a Sterility Assurance Level (SAL) of 1x10^-6.
- Biocompatibility Validation: Conducted in accordance with ISO 10993-1 and FDA guidance.
- Mechanical Strength Testing: "The result of the testing concluded that subject device was in accordance with the pre-defined acceptance criteria." (Specific criteria and results not detailed).
In conclusion, the document provides evidence for the safety and substantial equivalence of the device through manufacturing process validation, sterilization validation, biocompatibility validation, and mechanical strength testing of the physical outputs. However, it does not include the type of detailed performance study you've asked for, which typically involves comparing diagnostic or functional output capabilities against a ground truth using specific metrics and sample sizes. This level of detail is often found in clinical study reports, which are usually separate from the 510(k) summary focused on substantial equivalence.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.