Search Results

Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Fine Osteotomy disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy is a patient-specific device

Fine Osteotomy™ is a system for planning osteotomies of the distal femur and proximal tibia, and for stabilizing the bone with bone screws and a patient-specific bone plate that fits the patient's anatomy " consists of patient-specific surgical planning and instrument guides designed from images of the patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, single-use, and discarded after surgery. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing osteotomies and implanting hardware to stabilize the resection, 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a patient specific bone plate and screws for stabilizing a bone resection or fracture. When used as a system, Fine Osteotomy™ enables the surgeon to perform and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting guides and bone plate. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee the presurgical plan using the patient-specific cutting guident's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to quide placement of the implants and alignment of bone. The Fine Osteotomy System is provided clean, not sterile to the user.

Materials: Wrought Titanium-6Alum ELI Alloy (Ti6AV ELJ; ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.

The provided text does not contain the requested information regarding acceptance criteria and the study that proves the device meets them.

The document is an FDA 510(k) Premarket Notification clearance letter for the "Fine OsteotomyTM" device. While it mentions some non-clinical tests were conducted (Mechanical Engineering Analysis, Sawbone Model Testing, Reprocessing Instructions Validation), it does not provide details about acceptance criteria or specific performance metrics achieved that would go into a table.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details about standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on the regulatory aspects of the device, its intended use, a comparison to a predicate device, and the changes made since the previous clearance (K240066). The non-clinical tests mentioned are very brief summaries and do not include the detailed performance data asked for.

Ask a specific question about this device

Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine OsteotomyTM is a patient-specific device.

Fine Osteotomy™ is a system for planning and performing osteotomies of the distal femur and proximal tibia and for stabilizing the bone with bone screws and a patientspecific bone plate that fits the patient's anatomy. Fine Osteotomy™ consists of patientspecific surgical planning and instrument guides designed from images of the patient's bones, a patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, single-use. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing osteotomies and implanting hardware to stabilize the resection, 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a patient specific bone plate and screws for stabilizing a bone resection or fracture.

When used as a system, Fine Osteotomy™ enables the surgeon to perform an osteotomy and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting guides and bone plate. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee that matches the pre-surgical plan using the patientspecific cutting guides designed from the patient's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of the implants and alignment of bone. Fine Osteotomy is provided clean, non-sterile.

The purpose of this Special 510(k) Device Modification is to notify the FDA of changes and additions to the single use instruments and added software option for segmentation of images and creation of STL files of the bone models.

Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6Al4V ELI: ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.

The provided text does not contain detailed information about specific acceptance criteria, a study that proves the device meets those criteria, or the performance of the device in relation to such criteria. The document is a 510(k) summary for a medical device (Fine Osteotomy™) being submitted to the FDA, asserting substantial equivalence to a previously cleared predicate device.

Here's what can be extracted and what information is missing based on your request:

Missing Information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications used to establish ground truth for the test set.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size of human reader improvement with AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

Information provided in the document related to performance/validation:

The document mentions "Verification and validation (V&V) activities" but details are limited.

G. PERFORMANCE DATA

Verification and validation (V&V) activities included the following:

• Engineering analyses of updated and new single-use instruments demonstrating "no new risks and no new worst case." (This is a safety assessment, not a performance metric against acceptance criteria).
• Surgeon user evaluations demonstrating the new and updated instruments "to work as intended." (This is a qualitative statement, lacking specific metrics or criteria).
• Validation of the new software option for segmentation of patient image files and creation of STL files and virtual models "with similar resolution as previously 510(k) cleared Bodycad segmentation software." (This hints at a comparative resolution study, but no specific acceptance criteria or quantitative performance data are provided).

In summary, the provided FDA 510(k) summary focuses on establishing substantial equivalence for device modifications rather than detailing a comprehensive clinical or performance study with defined acceptance criteria and quantitative results, which would typically be included in a more extensive study report.

Ask a specific question about this device

The patient-specific BC Reflex 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 deformitv of the knee, and

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

The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized to a SAL of 10-6.

The primary reasons for this 510(k) notification are to notify the FDA: (1) that the tibial insert will be manufactured from vitamin E stabilized and 100 kGy crosslinked UHMWPE (Vit-E HXLPE), (2) that a 5 mm thick tibial insert was added as a thickness option, and (3) of minor design updates to the implants and single use instruments.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6AI4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the tibial insert.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The text describes a 510(k) premarket notification for a knee system, detailing its features, intended use, and comparison to predicate devices, along with performance data related to material properties and wear testing. However, it does not specify any acceptance criteria in numerical or qualitative terms, nor does it present a study designed to demonstrate performance against such criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details.
6. Stand-alone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

The patient-specific BC Reflex 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 BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software that are based on MRI or CT images of the patient's knee and surgeon input.

This FDA 510(k) summary does not contain information about an AI-powered device or software. It pertains to a physical medical device, the BC Reflex Uni™ Knee System, which is a patient-specific unicompartmental knee system. The submission focuses on changes to sterilization methods and minor design updates, not on a diagnostic or prognostic algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies for an AI device. The document does not discuss:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).
• Any study that proves an AI device meets such criteria.
• Sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for AI ground truth.
• MRMC studies or standalone AI performance.
• Training set details for an AI model.

The "performance data" section (G) in the document refers to validation and verification activities for device sterilization, biocompatibility, packaging, and cleaning processes, which are standard for physical medical devices and unrelated to AI performance.

Ask a specific question about this device

Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Fine Osteotomy disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy is a patient-specific device.

Fine Osteotomy™ is a system for planning and performing osteotomies of the distal femur and proximal tibia, and for stabilizing the bone with bone screws and a patient-specific bone plate that fits the patient's anatomy. Fine Osteotomy™ consists of patient-specific surgical planning and instrument quides designed from images of the patient's bones, a patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, single-use, and discarded after surgery. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing osteotomies and implanting hardware to stabilize the resection. 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a patient specific bone plate and screws for stabilizing a bone resection or fracture.

When used as a system, Fine Osteotomy™ enables the surgeon to perform an osteotomy and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting guides and bone plate. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee that matches the pre-surgical plan using the patient-specific cutting quides designed from the patient's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of the implants and alignment of bone. The Fine Osteotomy System is provided clean, not sterile to the user.

The purpose of this 510(k) is to notify the FDA of changes to the software, implants, single use instruments, packaging, and labeling of the Fine Osteotomy System cleared in K193614.

Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6AI4V ELI; ASTM F136-13) for the bone plates and screws, ADM Nylon-12 for patient specific resection guides and models.

I am sorry, but the provided text does not contain the detailed information necessary to fully address all aspects of your request regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report or explicit acceptance criteria for device performance.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance. While it mentions mechanical performance testing and engineering analysis, it doesn't quantify specific targets (e.g., "accuracy within X mm") or provide numerical results for those targets.
• Sample sizes used for the test set. The performance data section refers to "testing" and "engineering analysis" but does not specify sample sizes for any experimental validation or testing.
• Number of experts used to establish ground truth or their qualifications. The document does not describe any studies involving human experts establishing ground truth.
• Adjudication method for the test set. Given that no human expert evaluation is described, no adjudication method is mentioned.
• Details on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size regarding AI assistance, or standalone performance. This document describes a surgical planning system and instruments, not an AI/Software as a Medical Device (SaMD) that typically undergoes MRMC studies to evaluate AI assistance.
• The type of ground truth used. The validation discussed is engineering analysis and mechanical testing, not a ground truth derived from clinical outcomes or expert consensus in an AI context.
• Sample size for the training set or how ground truth for the training set was established. This information would be relevant for an AI/machine learning device, which this submission does not explicitly describe. The "software re-validation" is mentioned but without details on its nature (e.g., whether it involves machine learning model training).

What the document does convey regarding device performance and validation:

The document states that the "changes to the software and implant and instrument design were analyzed, tested, and validated." The performance data summarized relates to demonstrating that the modified device (Fine Osteotomy™ K211646) is substantially equivalent to its predicate (K193614), not necessarily a comprehensive clinical performance study.

Here's a summary of the performance data and validation mentioned, organized to implicitly address parts of your request where information is available:

1. Acceptance Criteria and Reported Device Performance (Implicit/Inferred):

While a specific table isn't present, the document implies the following "acceptance criteria" through its performance testing descriptions, with the "reported performance" being that these were met sufficiently to demonstrate substantial equivalence.

2. Sample Sizes and Data Provenance:

• Test Set Sample Sizes: Not specified. The document mentions "testing" (e.g., mechanical) and "engineering analysis" but does not provide numbers of devices or simulations.
• Data Provenance: Not specified. The manufacturing and submitting companies are Canadian (Quebec), but the origin of any data used for design or validation (e.g., patient imaging data that the software processes) is not mentioned. The studies are retrospective in the sense that they are engineering and mechanical tests based on device design, not prospective human trials.

3. Number of Experts and Qualifications:

• Not applicable as the described validation is primarily engineering and mechanical testing, not a human reader study for an AI device.

4. Adjudication Method:

• Not applicable for the reasons above.

5. MRMC Comparative Effectiveness Study:

• No MRMC or human-in-the-loop study is mentioned. This device is a surgical planning and instrument guide system, not an AI for image analysis or diagnosis. Therefore, a comparative effectiveness study showing human readers improve with AI assistance is not relevant to this submission type.

6. Standalone Performance:

• The "performance data" section details the device's mechanical and software performance attributes as a standalone product (e.g., screw strength, bone plate strength, software function), but not "standalone algorithm performance" in the context of an AI device. The device itself (the surgical guides, plates, and screws) has performance characteristics validated.

7. Type of Ground Truth Used:

• For mechanical testing, the "ground truth" is established by physical measurement and standardized test methods (e.g., ASTM F543) and engineering principles (e.g., section modulus calculations).
• For software, the "ground truth" for re-validation would likely involve software verification and validation protocols ensuring that the software performs its intended functions (e.g., designing guides/implants from CT images) accurately according to specifications.
• For biocompatibility and sterilization, the "ground truth" is adherence to international standards (ISO 10993-1, ISO 17665-1, ISO 14937) and achieving specified safety levels (e.g., SAL of 10⁻⁶).

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning model where a "training set" in that sense would exist. The software develops patient-specific designs from patient CT images, implying it's a rule-based or algorithmic design system, not a trained neural network.

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

• Not applicable for the reasons above.

In summary, the provided FDA 510(k) document focuses on demonstrating substantial equivalence for a modified surgical device through mechanical and engineering analyses, rather than detailing a rigorous clinical study with patient outcomes, human expert review, or AI model performance validation that would typically include the requested criteria.

Ask a specific question about this device

The patient-specific BC Reflex Uni™ 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 deformitv of the knee, and

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

The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized by gamma radiation.

The subject device of this 510(k) is the same as the primary predicate device. The purpose of this Special 510(k) Device Modification is to notify the FDA of minor changes to the design and contents of the patient specific kits and reusable instruments for the BC Reflex Uni™ Knee System.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

This document, a 510(k) Premarket Notification from Bodycad Laboratories, Inc., describes a medical device, the BC Reflex Uni™ Knee System, and its substantial equivalence to previously cleared devices. However, it does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven medical device requiring performance metrics like sensitivity, specificity, or human reader improvement.

The document primarily focuses on demonstrating substantial equivalence (a regulatory pathway for medical devices) for a traditional knee implant, not an AI-powered diagnostic or therapeutic tool. The "Performance Data" section mentions "Software V&V accounting for all changes" and "Verification testing of usability of updated devices," but these are general statements about engineering and design controls, not clinical performance studies with acceptance criteria for an AI system.

Here's why the provided text cannot fulfill your request, along with what would be needed if this were an AI device:

Missing Information & Why it's Absent from This Document:

1. A table of acceptance criteria and the reported device performance: This document is about a physical knee implant. Acceptance criteria for such devices typically revolve around mechanical properties (fatigue, wear, strength), biocompatibility, and sterilization, along with manufacturing process validation. It wouldn't include AI performance metrics like sensitivity, specificity, or AUC.
2. Sample sizes used for the test set and data provenance: Not relevant for this type of device submission.
3. Number of experts used to establish ground truth & qualifications: Not relevant. Ground truth for an implant is its physical and material properties meeting specifications, and clinical outcomes for safety and effectiveness.
4. Adjudication method for the test set: Not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: MRMC studies are for evaluating diagnostic image interpretation by humans, often with and without AI assistance. This device is an implant, not an imaging interpretation tool.
6. If a standalone (algorithm only) performance was done: Not relevant, as there is no standalone algorithm being validated here in the typical AI sense. The "Bodycad software" mentioned is for design and manufacturing, not for making diagnostic or treatment decisions.
7. The type of ground truth used: For this knee implant, ground truth would be based on engineering specifications, material standards (ASTM), and potentially clinical outcomes from previous versions or similar devices. It's not based on expert consensus on image interpretation or pathology in the way an AI diagnostic would be.
8. The sample size for the training set: Not applicable. The "Bodycad software" is a design tool, not a machine learning model that undergoes "training."
9. How the ground truth for the training set was established: Not applicable.

What little "performance data" is mentioned:

• "Software V&V accounting for all changes per Bodycad procedures, which are the same procedures presented to FDA previously for the predicate and reference devices."
• "Risk analysis and design control review confirming no new or changed risks relative to the indications for use and efficacy of product."
• "Verification testing of usability of updated devices."

These indicate standard regulatory steps for medical device changes, focusing on ensuring the software and design changes for the manufacturing and design of the physical implant do not introduce new safety or effectiveness concerns. They do not describe performance evaluation of an AI-driven decision-making system in a clinical trial context.

In summary, the provided document is a 510(k) clearance letter for a mechanical knee implant system and does not contain the information requested about AI device acceptance criteria and performance studies.

Ask a specific question about this device

Fine Osteotomy is a system intended for osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Specifically,

• The Fine Osteotomy tibial plates are indicated for open- and closed-wedge osteotomies of the medial tibia, treatment of bone and joint deformities, fractures, non-unions, and malalignment caused by injury or disease, such as osteoarthritis, of the proximal tibia.

• The Fine Osteotomy femoral plates are indicated for open- and closed wedge osteotomies of the medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur.

• Fine Osteotomy instrument guides are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy is a patient-specific device.

Fine Osteotomy™ for the knee is a system for planning and performing osteotomies of the distal femur and proximal tibia, and for stabilizing the bone with bone screws and a patient-specific bone plate designed to fit the patient's anatomy. Fine Osteotomy™ consists of patient-specific surgical planning and instrument guides designed from long-standing x-ray and computed tomography (CT) images of the patient's bones, a patient-specific bone plate designed from the CT images, compression and/or locking bone screws, and manual reusable instruments. The bone plate is a patient-specific, single-use implant; the patient-specific surgical planning and instrument guides are single-use and discarded after surgery. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing the osteotomy and implanting hardware to stabilize the resection. 2) as patient specific single use instrumentation for performing an osteotomy alone, and 3) as patient specific bone plate and screws for stabilizing a bone resection or fracture.

When used as a system, Fine Osteotomy™ enables the surgeon to perform an osteotomy and stabilize the bone around the knee that matches the pre-surgical plan via the patient-specific cutting guides and bone plate designed from the patient's CT images. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy the bone around the knee that matches the pre-surgical plan via the patient-specific cutting guides designed from the patient's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of the implants and alignment of bone.

Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6A14V ELI; ASTM F136-13) for the bone plates and screws. ADM Nylon-12 for patient specific resection quides and models.

Here's a breakdown of the acceptance criteria and study information for the "Fine Osteotomy" device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list distinct "acceptance criteria" with numerical targets in the same way a diagnostic AI device might. Instead, it details that pre-clinical performance testing was conducted according to various standards and guidance documents, and the results demonstrated substantial equivalence to predicate and reference devices.

Therefore, the "acceptance criteria" are implicitly defined by compliance with these standards and the achievement of "substantial equivalence." The reported device performance is the affirmation that these criteria were met.

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

The summary does not provide specific numerical sample sizes for the mechanical testing or cadaver studies. It mentions:

• "Evaluation of biomechanical characteristics of subject devices in simulated HTO model"
• "Cadaver simulation of use of the Fine Osteotomy system"

The provenance of this data is implicitly from pre-clinical lab testing and cadaver studies, conducted by or for Bodycad Laboratories Inc.

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. For pre-clinical mechanical and cadaver studies, "ground truth" often refers to measurements against established physical standards or surgical outcomes in a simulated environment, rather than expert consensus on medical images.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple human readers, often for AI or diagnostic devices. This document describes pre-clinical engineering and cadaver testing.

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

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The document focuses on pre-clinical performance and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

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

The device includes "patient-specific surgical planning and instrument guides designed from long-standing x-ray and computed tomography (CT) images." The summary mentions "Validation and verification of software per FDA guidance documents."

This indicates that the software component (which creates the patient-specific guides and plates) was evaluated in a standalone manner (algorithm only) to ensure it performs according to specifications. However, no specific performance metrics for the standalone algorithm (e.g., accuracy of measurement extraction, segmentation accuracy) are provided in this summary. The "acceptance criteria" for the software are broadly stated as "validation and verification per FDA guidance documents."

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

For the pre-clinical studies, the "ground truth" would be established by:

• Engineering Specifications/Standards: For mechanical testing (e.g., ASTM, ISO standards).
• Physical Measurements: In the cadaver study, the "accuracy of correction and position of implants" would be measured directly against the pre-surgical plan and possibly conventional surgical outcomes, serving as the ground truth.
• Design Specifications: For the software, the ground truth would be the intended design output when processing CT images (e.g., correct anatomical measurements, precise guide designs).

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the traditional sense. The device is not learning from a "training set" of medical images for diagnostic purposes. Instead, the software is programmed based on algorithms to generate patient-specific designs from individual CT images. If any "training" occurred, it would be in the development and refinement of the design algorithms, not in the context of a machine learning training set for diagnostic output.

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

As above, this information is not provided and likely not applicable as there's no mention of a traditional machine learning "training set" for diagnostic classification. The software's "ground truth" would be its ability to accurately translate CT image data into precise, patient-specific surgical plans, instrument guides, and implant designs according to engineering and anatomical principles. This would be established through internal design validation and verification processes.

Ask a specific question about this device

The patient-specific BC Reflex 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 BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patientspecific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from Bodycad and off the shelf software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized by gamma radiation.

The subject of this 510(k) is an updated / new design of the femoral component and instruments for implantation, relative to the femoral component described in K163700 and K181302 for the predicate BUKS.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6A4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

The provided text is a 510(k) summary for the BC Reflex Uni™ Knee System, a medical device for unicompartmental knee arthroplasty. It describes the device, its intended use, and the performance data that supports its substantial equivalence to predicate devices. However, the document does not contain information about an AI/ML-based device, nor does it detail acceptance criteria or a study with human-in-the-loop or standalone AI performance, ground truth establishment, or expert involvement in a way that aligns with the questions posed in the prompt.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment from the provided document. The document discusses the substantial equivalence of the knee system based on mechanical testing and cadaver surgeries, not on the performance of a diagnostic AI system.

Ask a specific question about this device

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 fixation. A Bodycad screw must be used for fixation of the femoral component.

The Bodycad Unicompartmental Knee System (BUKS) 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 quides are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BUKS is for cemented use only and is sterilized by gamma radiation.
The subject of this 510(k) notification is a line extension and design update that includes a new tibial baseplate that is compatible with the BUKS system (K163700, K181302) and instruments that are compatible with the new tibial baseplate.
Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component and screw, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI; ASTM F136-13) for the tibial baseplate, locking pin, and screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

The provided text is a 510(k) summary for the Bodycad Unicompartmental Knee System. This document is a regulatory submission for a medical device and describes its intended use, technological characteristics, and a comparison to predicate devices to demonstrate substantial equivalence.

Based on the content, the document does NOT describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device. This document is for a physical medical implant (a knee system) and the performance data presented relates to mechanical testing and surgeon-user validation for the physical device, not an AI or software algorithm.

Therefore, I cannot extract the requested information regarding AI/algorithm performance, acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.

The document primarily focuses on demonstrating the substantial equivalence of a physical knee implant (Bodycad Unicompartmental Knee System) to previously cleared predicate devices through design comparison and mechanical performance testing, not on the performance of a software algorithm or AI.

Ask a specific question about this device

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.

Ask a specific question about this device