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510(k) Data Aggregation
(314 days)
OSF
The HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures.
The Hiplnsight system with the HoloLens2 is indicated for visualization of the HipXpert surgical plan and alignment of acetabular implants and instrumentation during hip arthroplasty when pin-based fixation of the HipXpert tools is utilized.
The Hiplnsight System was cleared in K200384 and utilizes the Microsoft HoloLens2 mixed reality headset to display 3D images from the HipXpert planning application. The 3D images are superimposed on the actual patient using known anchoring landmarks relative to the anterior pelvic plane.
The HipXpert software planning application uses CT patient image data to create a detailed 3D model of the pelvis as well as the instrument settings necessary for proper acetabular cup orientation. The HipXpert planning application has the ability to show implant and instrument templates that are either generic or manufacturer specific. The templates can be positioned in relation to the patient's pelvis and femur bones in the surgical plan.
The surgical plan, including all tool settings and usage instructions, is posted to the surgeon's secure folder on the HipXpert website.
The operating surgeon can then download the plan to a desktop or laptop computer and use the HipXpert viewer application to view and adjust the plan according to his/her best surgical judgment.
The purpose of this submission is to introduce additional options for the Hiplnsight system.
Additional surgeon needs include being able to:
- Use mixed-reality guidance with additional 3D objects
- Use mixed-reality quidance without using the HipXpert mechanical docking tools
- Use mixed-reality guidance that provides position accuracy in addition to orientation accuracy
- Use mixed-reality guidance for limb length measurements
The provided text describes the HipXpert and HipInsight Systems, focusing on updates to the HipInsight system. While it mentions performance evaluation, it lacks specific numerical acceptance criteria and detailed study results. The information provided heavily emphasizes comparison to a previously cleared predicate device (K200384) and states that no clinical testing was conducted for this submission.
Therefore, the following response is based on the limited information available in the provided text. Many sections will indicate "Not specified" or "Not applicable" due to the nature of the submission (a 510(k) for device modifications rather than de novo clearance, relying heavily on prior clearance).
Acceptance Criteria and Device Performance Study
The information provided is for a 510(k) submission (K233315) for modifications to the HipXpert and HipInsight Systems, with a strong emphasis on demonstrating substantial equivalence to a previously cleared predicate device (K200384). The performance testing described is primarily comparison testing against the predicate's performance.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., "accuracy must be within X mm or Y degrees"). Instead, the performance evaluation aims to show "equivalence" to the predicate device.
| Performance Metric | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Orientation Accuracy | Equivalent to the predicate device (HipXpert System cleared under K200384). | "All results in terms of orientation accuracy of the subject device were equivalent to those of the predicate." |
| Positional Accuracy | Equivalent to the predicate device (HipXpert System cleared under K200384). | "All results in terms of position accuracy of the subject device were equivalent to those of the predicate." |
| Functionality (3D object display) | Ability to display additional 3D objects, including instruments, aligned with the HoloLens2. | Device allows for "additional 3D objects to be aligned using the HoloLens2, including instruments." |
| Functionality (without mechanical tools) | Ability to provide mixed-reality guidance without requiring HipXpert mechanical docking tools. | Allows for "orientation alignment and positional placement of additional 3D objects... without the requirement to use the physical HipXpert mechanical tool." |
| Functionality (limb length measurements) | Ability to use mixed-reality guidance for limb length measurements. | Not explicitly stated as "met" but listed as an added capability in "Additional surgeon needs." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Simulated cadaveric specimens were used." The exact number of specimens is not specified.
- Data Provenance: The study was likely conducted in the United States, given the applicant and correspondent addresses. The study uses "simulated cadaveric specimens," indicating a pre-clinical, prospective evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not specified. The document does not describe the involvement of human experts for establishing ground truth in this particular performance study, as it focused on direct comparative measurements with the predicate using simulated scenarios rather than expert interpretations of clinical images.
4. Adjudication Method for the Test Set
Not applicable. This type of adjudication (e.g., 2+1, 3+1) is typically used in studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need to be resolved. The described testing involved physical and technical measurements on simulated cadaveric specimens.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical testing was conducted to support the determination of substantial equivalence." Therefore, an MRMC study to compare human readers with and without AI assistance was not done for this submission.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
While the HipInsight system involves human interaction via the HoloLens2, the performance evaluation described ("orientation and position accuracy") is for the system's ability to accurately place 3D objects. This is essentially a standalone (system performance) evaluation, as it quantifies the accuracy of the device's output independently of a surgeon's final clinical outcome. The study aimed to demonstrate the technical accuracy of the augmented features.
7. Type of Ground Truth Used
The ground truth was established through technical measurement and comparison on simulated cadaveric specimens. The "ground truth" for evaluating improvements to the HipInsight system would be the known or measured accurate orientation and position of implants/instruments in the simulated environment, against which the device's output (superimposed 3D objects) was compared. The primary benchmark for the "ground truth" in this 510(k) was the performance of the previously cleared predicate device.
8. Sample Size for the Training Set
Not applicable/Not specified. The document describes a 510(k) submission for modifications to an existing device, and the performance testing mentioned is for verification/validation of these changes (test set), not for training an underlying AI model. The HipXpert planning application uses CT patient image data to create 3D models, which implies some form of data processing, but the document does not discuss a "training set" for a machine learning model. It's possible the original HipXpert development involved training data, but that information is not part of this specific submission summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified. See point 8. No training set is explicitly discussed in the context of this 510(k) summary.
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(345 days)
OSF
The HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures.
The HipXpert 3D Display and Anchoring application with the HoloLens2 is indicated for visual alignment of an acetabular cup impactor during hip arthroplasty when pin-based fixation of the HipXpert tool is utilized.
The HipXpert system provides a patient-specific hip arthroplasty surgical plan allowing for accurate acetabular positioning using CT mapping of a patient's pelvis using a software application and a reusable, manual, mechanical navigation instrument.
The HipXpert software planning application uses patient image data to create a detailed 3D model of the pelvis as well as the instrument settings necessary for proper acetabular cup orientation.
The HipXpert mechanical instrument has three legs which are secured to the pelvis. The legs form three points which define the sextant plane. The HipXpert mechanical instrument has two protractors that are adjusted to orientate an indicator pin in the direction of the desired orientation of the acetabular component.
The subject HipXpert 3D Display and Anchoring Application utilizes the previously cleared (K093491) HipXpert planning application and HipXpert tools in addition to a mixed reality headset (Microsoft HoloLens2) and QR target. The HoloLens2 is an off-the-shelf component developed and manufactured by Microsoft which is used to view superimposed 3D images from the HipXpert planning application on the real HipXpert tool. In order to properly orient the 3D images displayed by the HoloLens2, a QR target is used to anchor these 3D images in space as they are overlaid on the real HipXpert tool.
The HipXpert System, specifically the 3D Display and Anchoring application with the HoloLens2, was evaluated to ensure accurate alignment of an acetabular cup impactor during hip arthroplasty when pin-based fixation of the HipXpert tool is utilized.
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details various validation and verification activities rather than specific quantitative acceptance criteria in a table format. However, the performance reported for the HipXpert System focused on aspects like software validation, system orientation and position accuracy, image registration and tracking accuracy, and headset display performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functionality for file identification, QR recognition, and anchoring. | Successfully validated. |
| Overall system orientation and position accuracy. | Verified in a cadaveric model using screws placed into the acetabulum. |
| System accuracy, image registration accuracy, and tracking accuracy under varying conditions (light, motion, distance, angle). | Verified using methods analogous to ASTM F2554-10. (Specific quantitative results not provided in the summary, but the methods were established for accuracy evaluation). |
| Headset display performance (Field of View, resolution, luminance, distortion, contrast ratio, contrast of physical object, location of virtual image, stability of virtual objects due to motion). | Demonstrated by verifying all listed elements. (Specific quantitative results not provided in the summary, but verification confirms performance met internal standards). |
2. Sample Size Used for the Test Set and Data Provenance
The non-clinical testing included a cadaveric model for verifying overall system orientation and position accuracy. The specific number of cadaveric models used is not specified.
Regarding data provenance for the accuracy testing, it was conducted internally as part of the device's verification and validation. The text does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's a device validation, it would be considered prospective for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for establishing ground truth for the test set. The validation methods mentioned (cadaveric model using screws placed into the acetabulum and methods analogous to ASTM F2554-10) imply objective measurement rather than expert consensus on subjective evaluations.
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 comparative effectiveness study was mentioned. The HipXpert system is a surgical planning and alignment tool, and the focus of this submission is on the accuracy of the augmented reality display for guiding tool placement, not on interpreting images or improving human reader performance in a diagnostic context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The HipXpert system, including the 3D Display and Anchoring application, is inherently a human-in-the-loop system. It provides visual guidance to a human surgeon. Therefore, a standalone (algorithm only) performance evaluation without human interaction would not be applicable or relevant to its intended use and was not described. The validation focused on the system's accuracy while being used by a human, even if a cadaver was the "patient."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the accuracy evaluations appears to be based on objective physical measurements and established engineering standards. For instance, in the cadaveric model, the ground truth for "overall system orientation and position accuracy" would likely be the known, precise placement of screws in the acetabulum, validated by direct measurement or pre-defined landmarks. For system accuracy, image registration accuracy, and tracking accuracy, the ground truth would be precise measurements and positional data defined by the test setup, as per methods analogous to ASTM F2554-10, which are standards for evaluating the accuracy of medical image processing software and surgical navigation systems using precise physical fiducials and defined spatial relationships.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set of any machine learning algorithms within the HipXpert System. The text primarily focuses on the validation of the system's functionality and accuracy, specifically the 3D display and anchoring application, rather than the development of the underlying planning algorithms (which existed in the predicate device K093491).
9. How the Ground Truth for the Training Set Was Established
Since no specific information about a training set for machine learning was provided, the method for establishing its ground truth is also not mentioned. The HipXpert software planning application itself, which creates the 3D model and instrument settings, was part of a previously cleared device (K093491). The current submission focuses on the augmented reality display portion.
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(394 days)
OSF
The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures.
The HipSextant Instrument is a manual mechanical acetabular positioning device. The devices is used in conjunction with CT mapping of the individual patients pelvis. The instrument has three legs which land on the pelvis. The legs form three points which define the sextant plane. The sextant has two protractors that are adjusted to orientate a direction pin in the direction of the desired orientation of the acetabular component. During surgery a small pin is placed into the ischium and a cannulated leg and the sextant are seated onto the ischium. The second leg is seated onto the lateral side of the anterior spine by placing an arthroscopic style trocar through a cannula. Finally, a third leg is also seated using a trocar. With the sextant firmly docked onto the pelvis, the cup impactor is then aligned with the sextant direction pin. The device is used with an Excel spreadsheet which is used to assist the surgeon in performing calculations regarding alignment.
The provided text describes a 510(k) submission for the Hip Sextant Instrument System, a manual surgical instrument used to align acetabular components during hip arthroplasty procedures. However, the document does not contain the specific information required to complete all parts of your request regarding acceptance criteria and a study proving those criteria are met.
Here's what can be extracted and what information is missing:
Missing Key Information:
- Specific Acceptance Criteria: The document mentions "successfully passed clinical and nonclinical testing" but does not define any specific quantitative acceptance criteria for device performance (e.g., accuracy of alignment in degrees, precision, error margins).
- Detailed Study Design and Results: While "clinical experience" and "validation of software" are listed as tests, there are no details about study design, participants, comparative effectiveness, or specific numeric results that would allow for a table of acceptance criteria vs. reported performance.
- Sample sizes (test set and training set): Not mentioned.
- Data provenance: Not mentioned.
- Number of experts/qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC study information: Not mentioned.
- Effect size of AI assistance: Not applicable as this is a mechanical device, not an AI system.
- Standalone performance: Not applicable in the context of AI. The device is a "manual mechanical acetabular positioning device" implying it's used by a surgeon.
- Type of ground truth: Not mentioned.
- How ground truth for training set was established: Not mentioned.
Based on the provided text, here is what can be inferred or directly stated:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (General) |
|---|---|
| Biocompatibility | "The subject device is composed of medical grade biocompatible materials." |
| Sterilization Efficacy | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Sterilization Validation" |
| Cleaning Efficacy | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Cleaning Validation (including protein residual)" |
| Durability/Repeated Use | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Repeated autoclave studies to evaluate performance and wear" |
| Software Functionality (for calculations) | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Validation of software used in conjunction with the device to perform calculations." (The device is used with an Excel spreadsheet for calculations). |
| Clinical Use (Safety & Effectiveness) | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Clinical experience." The submission concludes: "We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate devices." (No specific quantitative performance metrics like alignment accuracy are provided.) |
| Substantial Equivalence to Predicate Devices | "Surgical Planning Associates, Inc. believes that the subject device is substantially equivalent to the cited predicate devices. ...the conclusion of substantial equivalency is based on the identical indications for use, design concept, level of surgical invasiveness, and that all cited instruments are metal and reusable. Equivalence is further substantiated by clinical and nonclinical data." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the validations or clinical experience.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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 specified. The document mentions "clinical experience" but does not detail how ground truth was established or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- MRMC Study: Not applicable/not performed as this is a mechanical surgical instrument, not an AI or imaging diagnostic device.
- Effect Size of AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a manual mechanical device, not an algorithm/AI. The device is explicitly stated to be a "manual mechanical acetabular positioning device" used "in conjunction with CT mapping" but actively manipulated by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. The general statement "clinical experience" does not elaborate on the type of ground truth used to assess performance.
8. The sample size for the training set
- Not applicable/not specified. This is a mechanical device, not an AI system that requires a "training set" in the machine learning sense. The "validation of software" implies software testing, but a "training set" for the device itself is not relevant here.
9. How the ground truth for the training set was established
- Not applicable/not specified, as there is no "training set" in the context of this mechanical device.
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