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The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

· varus deformity of the knee, and

· as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended for cemented fixation. The Bodycad screws must be used for fixation of the femoral and tibial components.

The Bodycad Unicompartmental Knee System (Bodycad UKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from validated Bodycad software, which are based on MRI images of the patient's knee and input from the surgeon. The femoral component is fabricated from wrought Cobalt-Chrome alloy (CoCr) with a centrally located peg and provision for ancillary fixation with a CoCr bone screw. The tibial implant consists of a Titanium (Ti) alloy baseplate with one to three posterior spikes and provision for ancillary fixation with a Tit alloy bone screw. The polyethylene insert is fabricated from Ultra-High-Molecular-Weight- Polyethylene (UHMWPE), compression molded and machined GUR 1020. The tibial-femoral articulation is an unconstrained design. This device is for cemented use.

Materials: CoCrMo (ASTM F1537-11) for the femoral component. Ti6Al4V ELI (ASTM F136-13) for the tibial component, UHMWPE (F648-14) for the tibial insert

The provided text is a 510(k) Summary for the Bodycad Unicompartmental Knee System. It describes the device, its indications for use, and a comparison to predicate devices, as well as a list of performance tests conducted.

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning data provenance, expert adjudication, MRMC studies, or training/test set details for an AI/algorithm-driven device performance study.

The "Performance Data" section lists various mechanical and material tests performed on the knee system components (fatigue strength, range of motion, constraint testing, screw strength, contact pressure, etc.), as well as cadaver laboratory testing for surgical technique and implant fit, and evaluation of single-use cutting guides. This section focuses on the physical and functional characteristics of the medical device itself, not on the performance of a diagnostic algorithm or AI system for which the requested details about ground truth, expert readers, and sample sizes would be relevant.

The closest mention of software is that the patient-specific implant components and cutting guides are manufactured from CAD-CAM models created from the patient's MRIs and input from the surgeon, using proprietary software. It states: "This software, and off-the-shelf software, were validated per the FDA guidance document 'Guidance for the content of premarket submissions for software contained in medical devices'." However, this refers to validation of the manufacturing software workflow, not a diagnostic AI system predicting disease state or lesion characteristics.

Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria and a study proving the device meets them in the context of an AI/algorithm-driven diagnostic performance study.

The document details the regulatory clearance of a medical device (a knee implant system), not an AI software as a medical device (SaMD). The acceptance criteria mentioned are related to the physical performance, material integrity, and surgical fit of the implant, not the diagnostic performance of an AI.

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MySpine is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of T1 to L5.

MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use.

MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws.

Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine Screw placement guides are intended for single use only.

MySpine Pedicle Screw Placement Guides - LP are a design modification to MySpine Pedicle Screw Placement Guides (K132788). MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided K-wire placement. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans. Then, the K-wire is guided through the patient's anatomically matched MySpine LP Guides in order to provide positioning according to the surgeon's preoperative planning.

For the standard guides introduced and cleared by FDA in K132788, the holes guide the instruments used to open and prepare the pedicle to the planned entry point. After pedicle preparation, the pedicle screws will be inserted through the guiding hole into the pedicle and the vertebrae respectively. For the LP guides introduced with this 510(k), the guiding holes allow placement of the K-wire. Then, the MySpine guide is removed and the wires are used to insert cannulated implants. As an intermediate step, the surgeon can also use the cannulated awl and/or tap to better prepare the entry point in order to simplify the screw tightening.

The components of the MySpine Pedicle Screw Placement Guides - LP include a Drill Guide (PA12 Medical Grade) and Vertebral Bone Models (PA12 Medical Grade). The MySpine Pedicle Screw Placement Guides – LP are single use, external communicating devices with limited (

The provided text describes a 510(k) premarket notification for the MySpine Pedicle Screw Placement Guides - LP. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against acceptance criteria for a novel device. Therefore, much of the requested information (such as specific acceptance criteria and detailed study designs for a new device's performance) is not explicitly present.

However, I can extract information related to the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the available information and what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly stated in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence, meaning the device performs as safely and effectively as the predicate, rather than providing numerical acceptance criteria for a new device's performance. The "Performance Testing" section lists types of tests conducted (e.g., mechanical testing, cadaver testing), but not specific acceptance criteria or quantitative performance results.

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

• Sample Size for Test Set: Not explicitly stated for each test listed.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. The mention of "cadaver testing" implies prospective testing on cadavers, but further details are absent.

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

This information is not provided in the document. The document refers to "surgical planning software used pre-operatively to plan the surgical placement... on the basis of patient radiological images." However, it does not detail how the ground truth for any performance testing (e.g., accuracy of screw placement) was established or by whom.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This information is 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:

This is not applicable/not reported. The device described is a physical pedicle screw placement guide, not an AI-driven diagnostic or interpretative system that would involve human "readers" or "AI assistance" in the context of diagnostic performance.

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

This is not applicable/not reported. The device is a surgical guide that assists a surgeon in placing K-wires; it's not a standalone algorithm. Its function inherently involves human intervention.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not explicitly specified in detail. For "cadaver testing," the ground truth would likely involve anatomical dissection or high-resolution imaging post-placement to assess accuracy, but the method is not described.

8. The Sample Size for the Training Set:

This information is not provided. The device uses "surgical planning software ... based on the patient's spinal CT scans" to create patient-specific guides. This implies patient-specific data for each case, but no "training set" in the machine learning sense is described for the device's development or validation.

9. How the Ground Truth for the Training Set was Established:

This information is not provided. As mentioned above, a "training set" for an algorithm in the typical sense is not described.

Summary of available information regarding performance testing for supporting substantial equivalence (not detailed acceptance criteria for a novel device):

• Performance Testing Leveraged or Conducted:
  • Sterilization validation (in accordance with ANSI/AAMI/ISO 11137-1 and -2)
  • Packaging validation (in accordance with ANSI/AAMI/ISO 11607)
  • Biocompatibility (in accordance with ISO 10993-1)
  • Mechanical testing
  • Cadaver testing

The document asserts that "The safety and effectiveness of the MySpine Screw Placement Guides - LP are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification," but does not elaborate on the specific results or acceptance criteria for these tests. The primary objective of the 510(k) is to demonstrate that the modified device (MySpine Pedicle Screw Placement Guides - LP) is substantially equivalent to its predicate (MySpine Pedicle Screw Placement Guides, K132788), implying that it meets the same safety and performance standards.

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The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X- rays and CT imaging scans.

The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches.

The Patient Specific Guides are intended for single use only.

The Corin Optimized Positioning System (OPS) consists of software and hardware components to assist the surgeon in the alignment of components during Total Hip Arthroplasty.

The software component assists the surgeon in determining a patient specific target orientation for the acetabular cup through a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.

The hardware components assist the surgeon in delivering the target orientation through the use of a Patient Specific Guide and bone model (replica of the patient's acetabulum, into which the guide fits), and associated reusable instrumentation.

The Corin OPS can be used with the Trinity Acetabular System and the respective compatible components.

Here's a breakdown of the acceptance criteria and study information for the Corin Optimized Positioning System (OPS), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text explicitly mentions a cadaver study for device performance verification. However, it does not specify the sample size (i.e., number of cadavers) used. The data provenance is implied to be a laboratory setting (cadaver study). No information is given about the country of origin. The study was conducted retrospectively or prospectively on cadavers for device verification.

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

The text does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver study. It states that the study measured "repeatability (intra-observer variability) and reproducibility (inter-observer variability) of the system," which suggests that multiple individuals (likely experts like surgeons or trained technicians) performed measurements to assess variability, but their specific roles in establishing a definitive "ground truth" for the test set are not detailed in the provided summary.

4. Adjudication Method for the Test Set

The text does not explicitly state an adjudication method (e.g., 2+1, 3+1, none). The mention of "repeatability (intra-observer variability) and reproducibility (inter-observer variability)" suggests a comparison among observers' measurements, but how discrepancies or a final "ground truth" were resolved is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not necessary for this Traditional 510(k)." The described studies focus on the device's technical performance and accuracy, not its comparative effectiveness with human readers.

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

Yes, a standalone performance evaluation of the algorithm (software component) was done. The text says:

• "Software verification and validation was completed in accordance with FDA guidance..."
• "Testing was also performed to verify that the FHA software module and acetabular quide design is reproducible and repeatable when processed by multiple operators."
• The system itself is described as assisting in "determining a patient specific target orientation for the acetabular cup through a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report." This implies the software's ability to generate these outputs on its own.

7. The Type of Ground Truth Used

For the cadaver study, the ground truth was based on the accuracy of the implanted cup orientation relative to the pre-operative plan. This implies that a pre-operative plan (generated by the device's software) served as the target, and the actual physical implantation in the cadaver was measured against this plan. The details of how this "actual" implantation was precisely measured and considered the "ground truth" are not expanded upon (e.g., whether it was through high-precision imaging, direct measurement, etc.).

For the software validation, the ground truth would typically be established through predefined specifications, expected outputs, and comparison against known correct computations or reference data.

8. The Sample Size for the Training Set

The document does not provide information regarding a specific "training set" or its size. This device's purpose (patient-specific surgical instrument based on pre-operative scans) suggests it might not rely on a conventional machine learning model that requires a distinct training/validation/test split of patient data in the typical sense. Instead, its software likely employs computational geometry and image processing algorithms.

If there was an underlying machine learning component used to develop parts of the software (e.g., for automated anatomical landmark identification), this information is not disclosed in the summary.

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

Since no training set information is provided, the method for establishing its ground truth is also not available in this document.

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