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Smart SPACE Shoulder 3D Positioner

Smart SPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Smart SPACE Shoulder Cubit Guidance

Smart SPACE Shoulder Cubit Guidance consists of a patient-specific 3D mapper, single use instrumentation, and an intraoperative guidance software. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Smart SPACE Shoulder Planner software

Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.

Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system.

The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software.

Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.

It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan.

The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.

Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.

Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.

The Smart SPACE Shoulder System consists of the Smart SPACE Shoulder Planner software which assists the user in planning reverse and anatomic total shoulder arthroplasty. In addition, a choice of intraoperative execution of the surgical plan using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance. The Smart SPACE Shoulder System (subject device) is compatible with Lima Corporate shoulder replacement implants; Verification testing was conducted utilizing those systems.

The provided text describes the Smart SPACE Shoulder System, which includes software for pre-surgical planning and patient-specific instrumentation (3D positioner or Cubit Guidance) for intraoperative positioning of shoulder components. The device aims to assist in total anatomic or reverse shoulder arthroplasty procedures.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document does not explicitly state quantitative acceptance criteria for device performance. Instead, it states that "Testing has successfully demonstrated that the subject device performs as well as the predicate device with respect to version, inclination, and entry point." This implies that the acceptance criteria were met if the subject device's performance was comparable to the predicate device in these key metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The Smart SPACE Shoulder System was validated through non-clinical studies performed on cadaveric specimens." However, it does not specify the number of cadaveric specimens used as the test set.

• Sample Size: Not specified.
• Data Provenance: Non-clinical studies performed on cadaveric specimens. The country of origin is not mentioned, and due to the nature of cadaveric studies, it would be considered prospective data collection for the validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing the ground truth for the cadaveric studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth in the cadaveric studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device focuses on a surgical planning software and patient-specific instrumentation, not on image interpretation by human "readers" in the traditional sense of an MRMC study for diagnostic imaging. While the software assists surgeons (human users), the document does not describe an MRMC comparative effectiveness study directly measuring the improvement of human surgical performance with AI assistance versus without AI assistance. It compares the device's output (implant placement accuracy) to a predicate device, but not human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The planning software component itself is "algorithm only" in the sense that it processes CT images to generate a surgical plan and 3D files. The "3D positioner" and "Cubit Guidance" are physical instruments derived from these plans. The statement "Post-operative implant placement was compared with the executed implant position captured by the Guidance System" suggests that the accuracy of the guidance system itself (which is algorithm-driven in its generation and subsequent validation through its use) was assessed in placing the implants in the cadaveric study. This implies a standalone performance evaluation of the system's ability to achieve planned implant positioning.

So, yes, a form of standalone performance was assessed through the cadaveric studies, focusing on the accuracy of the system's output (planned vs. executed implant placement).

7. The Type of Ground Truth Used

The ground truth for the cadaveric studies was established by comparing "Post-operative implant placement... with the executed implant position captured by the Guidance System." This suggests that the "true" or desired implant position was defined by the executed plan generated by the Smart SPACE Shoulder Planner software and then assessed against the actual placement in the cadaver. It's a form of system-defined ground truth related to the accuracy of implementing the surgical plan. This is not pathology, outcomes data, or expert consensus on a diagnostic image.

8. The Sample Size for the Training Set

The document does not provide any information about the training set size for the software component of the Smart SPACE Shoulder System.

9. How the Ground Truth for the Training Set Was Established

Since information regarding the training set is not provided, the method for establishing its ground truth is also not specified.

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Smart SPACE Shoulder 3D Positioners

Smart SPACE Shoulder System instrumentation consists of patient-specific 3D positioners. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Smart SPACE Shoulder Planner software

Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.

The Smart SPACE Shoulder System consists of the Smart SPACE Shoulder Planner software and 3D Positioners which assist the user in planning reverse and anatomic total shoulder arthroplasty and gives the user the ability to translate the surgical plan intraoperatively using 3D positioners for glenoid K-wire placement and humeral head resection.

The provided text is a 510(k) summary for the "Smart SPACE Shoulder System," a medical device used for pre-surgical planning in shoulder orthopedic surgery and for creating patient-specific 3D positioners.

After reviewing the document, it's clear that the included text does not contain the specific information requested regarding acceptance criteria and a detailed study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by the request's structure (e.g., "human readers improve with AI vs without AI assistance," "standalone algorithm only").

The document focuses on the regulatory submission process, comparison to a predicate device, and general performance data (sterilization, biocompatibility, software verification, mechanical, and a cadaveric study for the 3D positioners).

Here's a breakdown of what can be extracted and what information is missing based on your specific questions:

Information Present (or implied):

• Device Name: Smart SPACE Shoulder System
• Device Type: Pre-surgical planning software and patient-specific 3D positioners for shoulder arthroplasty.
• Regulatory Class: Class II (Product Codes: OHE, KWS, MBF)
• Performance Data Mentioned (but lacking detail for acceptance criteria):
  • Sterilization & Shelf-life Testing
  • Biocompatibility Testing (ISO 10993-1)
  • Software Verification and Validation Testing (IEC 62304 and FDA guidance documents: General Principles of Software Validation, Off-The-Shelf Software Used in Medical Devices, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software, Postmarket Management of Cybersecurity in Medical Devices, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices)
  • Mechanical and Acoustic Testing (not applicable for this submission)
  • Animal Study (not required)
  • Clinical Studies (Performed on cadaveric specimens, focused on accuracy and precision of humeral head cut using the 3D Positioner. Stated that the device "performs as well as existing traditional instrumentation" and "translated the humeral head resection in a more accurate and precise manner compared to traditional instrumentation.")

Information NOT Present (or not in sufficient detail to answer your specific questions):

The bulk of your questions relate to AI/algorithm performance studies, which are not described in this 510(k) summary. The "Smart SPACE Shoulder Planner software" is described as a "pre-surgical planner" that allows surgeons to "visualize, measure, reconstruct, annotate and edit anatomic data" and "design shoulder patient-specific instrumentation." While this involves computational processing, the document does not depict it as an AI/ML algorithm that requires the types of performance studies you've outlined for diagnostic or AI-assisted interpretation tasks.

Specifically, the following cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: No specific, quantified acceptance criteria (e.g., X% sensitivity, Y% specificity, Z mm accuracy) are provided for the software or the 3D positioners' performance in the summary, other than a general statement about the cadaveric study demonstrating "accuracy and precision" and performing "as well as existing traditional instrumentation."
2. Sample sized used for the test set and the data provenance: The cadaveric study is mentioned, but the number of cadavers/cases used is not specified. Data provenance (country, retrospective/prospective) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 done/Not described. The device is a planning tool and guide, not an AI diagnostic assistant for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not done/Not described for an AI algorithm. The software is a planning tool for surgeons. The cadaveric study assessed the 3D positioner's performance in executing a plan.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the cadaveric study, the "ground truth" for the humeral head cut would likely be based on physical measurements against a predefined surgical plan, but the method is not detailed.
8. The sample size for the training set: This refers to AI model training. Since an AI model is not described, training set size is not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory submission summary for a medical device that includes software for surgical planning and 3D printed guides. It does not present data in the format of an AI/ML performance study as detailed in your questions. The performance data mentioned (cadaveric study) relates to the physical accuracy of the 3D positioners in aiding a surgical cut, not the diagnostic performance or AI-assisted interpretation of medical images.

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SmartSPACE Shoulder 3D Positioner

SmartSPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

SmartSPACE Shoulder Planner software

SmartSPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.

SmartSPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system.

The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the SmartSPACE Shoulder Planner software.

SmartSPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.

It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan. The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.

SmartSPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.

SmartSPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.

The SmartSPACE Shoulder System consists of the SmartSPACE Shoulder Planner software and a 3D positioner which assists the user in planning reverse and anatomic total shoulder arthroplasty and gives the user the ability to translate the surgical plan intraoperatively using a 3D positioner for glenoid K-wire placement.

The provided text is a 510(k) Summary for the SmartSPACE Shoulder System, which includes software and a 3D positioner. It describes the device's intended use and compares it to a predicate device, BLUEPRINT Patient Specific Instrumentation (K162800). The summary discusses various performance data but does not outline specific acceptance criteria in a quantitative table or details of a study that explicitly proves the device "meets acceptance criteria" in the way a clinical study typically would for performance metrics like sensitivity, specificity, accuracy, or reader improvement in AI contexts.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical studies and verification/validation activities. The "Performance Testing" section serves as the closest equivalent to a study proving the device meets certain criteria, but these are primarily engineering and software validation tests, not a traditional clinical performance study with human readers and ground truth as might be expected for an AI device in a Multi-Reader Multi-Case (MRMC) study.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in the available information and explicitly state when information is not present.

Here's the analysis based on the provided document:

Device: SmartSPACE Shoulder System (SmartSPACE Shoulder Planner software and SmartSPACE Shoulder 3D Positioner)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with numerical performance targets and corresponding results for the "SmartSPACE Shoulder System" as a whole system in the context of clinical accuracy or reader performance typically discussed for AI/software devices. Instead, it lists types of validation tests with a general requirement for "compliance" or "should be compliant."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified quantitatively. The document mentions studies "performed on cadaveric specimen or performed by using patients' data." It does not provide the number of cadavers or patient datasets used for any specific test.
• Data Provenance: Not specified (e.g., country of origin). The document mentions "cadaveric specimen" and "patients' data," but does not specify if data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not specified. The document refers to "reference method" in the validation tests but does not detail how this reference or "ground truth" was established, nor does it mention the number or qualifications of any experts involved in defining it for the testing.

4. Adjudication Method for the Test Set

Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned, nor are any effect sizes for human reader improvement. The device's validation is focused on technical accuracy of planning and positioning components, not on aiding human interpretation or diagnosis.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The software component (SmartSPACE Shoulder Planner software) has "standalone" validation in terms of its calculations and functionality (e.g., Glenoid Version and Inclination Angle Validation Test, Patient-Specific Guiding Wire Test, Segmentation Accuracy Test) compared to a "reference method". However, the overall device is an instrumentation system that includes both software for planning and a patient-specific 3D positioner for intraoperative use. The validation tests (e.g., Cadaver Validation Study) involve both components in a practical setting.

7. The Type of Ground Truth Used

The ground truth or "reference method" for the validation tests seems to be based on:

• Engineering measurements/calculations (for glenoid angles, guiding wire parameters, segmentation accuracy).
• Comparison of pre-operative plans with post-operative implant positions in cadaveric studies.
  The document does not indicate the use of pathology or outcomes data as a ground truth, which is typical as this is a surgical planning and guiding system, not a diagnostic one.

8. The Sample Size for the Training Set

Not applicable/Not specified. The document does not describe the use of machine learning or AI models developed using a training set. This is a software and instrumentation system that relies on pre-programmed algorithms and patient-specific anatomical data derived from CT scans for planning, not a learning algorithm that would require a "training set" in the conventional machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no machine learning training set is described.

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