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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.

The Fine Osteotomy™ System is an orthopedic fixation system used to stabilize bone fragments during corrective osteotomies of the distal femur or proximal tibia. The system supports proper alignment and promotes bone healing through rigid internal fixation.The system includes:Metallic bone plates (femoral and tibial) in open- and closed-wedge configurations.Bone screws compatible with the plates.Reusable surgical instruments for positioning and fixation.The plates and screws are made of titanium alloy Ti-6Al-4V ELI, a biocompatible material widely used in orthopedic implants.

The closed-wedge plates now include an oblong hole to enable controlled axial compression at the osteotomy site. An additional glass-bead-blasted surface finish for the plates has been validated to meet the same smoothness requirement as the existing polished finish.The plates are low-profile, anatomically contoured, and fixed with compatible self-tapping screws. The device functions as a load-sharing internal fixation system to maintain alignment during healing.

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Fine TTO™ is a patient-specific system intended for tibial tuberosity osteotomies (TTO) in skeletally mature patients.

The device is intended to assist in pre-operative planning and in guiding surgical instruments during the procedure, and should be used only when the anatomical landmarks required for planning can be clearly identified on the patient's radiographic images.

The Fine TTO™ system is designed specifically for tibial tuberosity osteotomies to adjust the alignment and positioning of the tibia for improved knee mechanics in skeletally mature patients. This system uses advanced imaging techniques, such as X-rays and CT scans, to create precise, patient-specific surgical guides. These guides assist surgeons in accurately cutting and repositioning the tibial tuberosity, ensuring the adjustments closely match the pre-surgical planning.

The primary function of Fine TTO™ is to facilitate precise bone cuts and ensure optimal placement according to the surgical plan, which is tailored to the patient's unique anatomy. The scientific concept behind Fine TTO™ relies on biomechanical principles of bone alignment and load distribution in the knee joint, aiming to restore the natural mechanics.

Device design and materials:

• Cutting Guides: Made from medical-grade polymers that are biocompatible and capable of providing the necessary rigidity and precision for bone cutting operations. These guides are designed for single use to ensure sterility and accuracy.
• Implants (Screws): Made from titanium alloy (Ti-6Al-4V ELI), known for its strength, biocompatibility. This material is standard in orthopedic applications and helps in the fixation process post-osteotomy.

Physical and performance characteristics:

• The system's design ensures that the cutting guides fit precisely to the patient's bone structure, reducing the risk of intraoperative errors and improving the predictability of the surgical outcome.
• The titanium screws used in the system provide strong, durable fixation that can withstand the mechanical forces exerted by the body weight and movement, supporting proper bone healing.

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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.

The Fine Osteotomy™ System is a patient-specific orthopedic device designed to assist surgeons in planning and performing precise osteotomies around the knee. It utilizes patient imaging data to create 3D anatomical models used for the design of cutting guides and fixation implants tailored to the individual anatomy. The system includes single-use cutting guides manufactured from PA 12 polymer and fixation components made of titanium alloy (Ti-6Al-4V ELI). The implants are designed to support stable bone fixation following the osteotomy. The device operates without an energy source and relies on mechanical alignment and rigid fixation principles. Minor refinements have been incorporated to improve compatibility with surgical planning and instrument design, without affecting the intended use or fundamental function of the system. The device is supplied non-sterile and includes a combination of patient-specific and reusable components.

This FDA 510(k) clearance letter for the Fine Osteotomy™ system does not contain the detailed information required to describe the acceptance criteria and the specific study that proves the device meets those criteria.

The document primarily focuses on the regulatory aspects of the 510(k) submission, confirming substantial equivalence to a predicate device. While it mentions "non-clinical testing" was performed, it provides a high-level summary and lacks the specific data points requested in your prompt.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance: The document states, "All tests confirmed that the device meets applicable requirements and continues to perform as intended." However, it does not specify what those "applicable requirements" or performance metrics are, nor does it provide a table of actual results against specific acceptance criteria.
• Sample Size and Data Provenance: The document does not mention sample sizes for any tests, nor the country of origin of data, or whether it was retrospective or prospective.
• Experts for Ground Truth Establishment: There is no mention of experts, ground truth establishment, or any details related to human interpretation or readings.
• Adjudication Method: Not applicable as there's no mention of expert review or ground truth establishment requiring adjudication.
• Multi-Reader Multi-Case (MRMC) Study: The document explicitly states, "No clinical testing was necessary, as the modifications do not alter the intended use, safety, or effectiveness of the device." Therefore, no MRMC study was conducted. There is no information about human readers or AI assistance.
• Stand-alone (Algorithm Only) Performance: While the device has a software component("support usability through a software update"), the document does not break down performance specific to an algorithm's standalone performance. It focuses on the overall system (hardware and software).
• Type of Ground Truth Used: Not applicable, as no ground truth for diagnostic accuracy is discussed. The testing mentioned appears to be related to mechanical/dimensional properties and software verification.
• Training Set Sample Size: No information about a training set is provided, as the document mainly describes the device and its regulatory clearance process, not its development or training of any AI/ML components.
• How Ground Truth for Training Set was Established: Not applicable as no training set is discussed.

Conclusion:

This 510(k) clearance letter for Fine Osteotomy™ is a regulatory approval document. It confirms that the device is substantially equivalent to a previously cleared predicate and that non-clinical testing was sufficient to demonstrate this. However, it does not provide the detailed scientific study results, acceptance criteria, ground truth methodology, or clinical performance metrics (especially for diagnostic accuracy or human-AI interaction) that you are requesting. These details would typically be found in a more comprehensive clinical study report or a detailed design verification and validation document, which are not part of this public FDA clearance letter.

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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 patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of bone. The Fine Osteotomy System is provided clean, not sterile to the user.

This 510(k) submission is intended to notify the FDA of the mechanical locking system, the addition of new screw lengths, and option to use a new in-house for planning and cutting quide design in the Fine Osteotomy System, previously cleared in K240703.

Materials: Wrought Titanium-6Alum ELI Alloy (Ti6A4V 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 is a U.S. FDA 510(k) summary for the "Fine Osteotomy™" device. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices, including non-clinical testing. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence based on:

1. Technological comparison: The device retains the same intended use and technological characteristics as predicate devices, with enhancements to the mechanical locking system, additional screw lengths, and a new in-house tool for planning and cutting guide design.
2. Non-clinical tests: Mechanical testing was conducted to demonstrate performance.

Here's an attempt to extract and format the information based on the provided text, highlighting what is available and what is explicitly not available:

Acceptance Criteria and Device Performance Study for Fine Osteotomy™

The provided 510(k) summary focuses on demonstrating substantial equivalence through technological comparison and non-clinical mechanical testing. It does not present specific quantitative acceptance criteria or a detailed study report in the requested format (e.g., with effect sizes for human readers, sample sizes for test sets with detailed provenance, or adjudication methods for ground truth). The information below is extracted or inferred from the available text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document describes non-clinical mechanical testing and software validation. It does not specify a "test set" in the context of patient data or clinical images. The tests were performed on the device components themselves (locking screws, bone plates) and through software validation. Therefore:

• Sample size for test set: Not applicable in the context of patient or image data. The "sample" would be the device components tested, but specific numbers are not provided.
• Data provenance: Not applicable. The data is generated from laboratory mechanical testing and software validation.

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

This information is not applicable as the described tests are non-clinical mechanical and software validation. There is no "ground truth" derived from expert review of patient data in this context.

4. Adjudication Method for the Test Set

This information is not applicable as the described tests are non-clinical mechanical and software validation, not involving human expert adjudication of a test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or described in the provided document. The submission focuses on device performance and substantial equivalence based on physical and software characteristics, not on the effectiveness of human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

The device includes "patient-specific surgical planning and instrument guides" and "in-house for planning and cutting guide design." While the document mentions "software validation," it does not specifically detail a standalone algorithm-only performance study with quantitative metrics for its planning or design components. The software's role is to aid in creating physical instruments and implants.

7. Type of Ground Truth Used

For the non-clinical mechanical tests, the "ground truth" is established by standard engineering principles and test methodologies (e.g., ASTM standards for material properties and mechanical strength). For software validation, the "ground truth" refers to meeting predefined functional and non-functional requirements and safety standards. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

There is no mention of a "training set" in the context of machine learning or AI algorithm development. The software capabilities mentioned are for "converting medical into 3D models manually" and designing guides, implying a rule-based or CAD-like system rather than a machine learning model that requires a discrete training set.

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

As there is no mention of a training set for a machine learning model, this information is not provided.

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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 quides and bone planning quides 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 (Ti6A4V ELJ; ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.

This FDA 510(k) summary for the Fine Osteotomy™ system (K240066) explicitly states that the technological characteristics and indications for use of the subject device are identical to its primary predicate device (K231314), with the exception of updates and additions to single-use instrumentation and shelf-life.

Therefore, the document does not contain the detailed information necessary to answer some of the questions regarding acceptance criteria and performance studies, specifically:

• A table of acceptance criteria and the reported device performance: This is not provided because substantial equivalence is claimed based on identity to a cleared predicate, not on new performance data demonstrating meeting specific criteria.
• Sample sized used for the test set and the data provenance: No new test set data is reported.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Based on the provided text, here is what can be extracted regarding the "study" that proves the device meets acceptance criteria:

The "study" or rather the justification for meeting acceptance criteria is a demonstration of substantial equivalence to a previously cleared predicate device.

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the context of a new clinical or non-clinical performance study. Instead, the device's acceptance is based on its substantial equivalence to a predicate device already on the market.

2. Sample sized used for the test set and the data provenance

No new test set was used or described for this 510(k). The regulatory submission relies on the substantial equivalence to the predicate device K231314.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no new test set requiring expert ground truth establishment for performance evaluation is described.

4. Adjudication method for the test set

Not applicable, as no new test set is described.

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 is mentioned.

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

No standalone algorithm performance study is mentioned.

7. The type of ground truth used

Not applicable, as no new performance study is described. The acceptance is based on substantial equivalence.

8. The sample size for the training set

Not applicable, as no new algorithm development requiring a training set is described. The device is a patient-specific surgical guide system, not an AI/ML algorithm that identifies or diagnoses.

9. How the ground truth for the training set was established

Not applicable.

Summary of "Study" to Prove Acceptance:

The provided document indicates that the Fine Osteotomy™ system (K240066) achieves acceptance (i.e., substantial equivalence to a predicate device) through the following:

• Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b)):
  • Verification and validation (V&V) activities included:
    • Mechanical Engineering Analysis of updated and new single-use instruments demonstrating no new worst-case scenarios.
    • Modification of Shelf-Life Referential for Fine Osteotomy Systems.

This implies that the key "study" involved analyzing the updated and new single-use instruments (from an engineering perspective) and reassessing the shelf-life, to confirm that these changes do not alter the fundamental safety and effectiveness demonstrated by the predicate device. The performance data for the core technology is implicitly referenced as that of the predicate device (K231314).

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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 or CT images of the patient's knee and input from the surgeon. The Bodycad UKS is for cemented use only. The Bodycad UKS is sterilized by gamma radiation.

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 describes a medical device, the Bodycad Unicompartmental Knee System, and its regulatory clearance. However, it does not contain information related to specific acceptance criteria, a study proving the device meets those criteria, or performance data in terms of metrics like sensitivity, specificity, or accuracy.

The "performance data" section states: "Validation testing was performed for CT and MRI imaging modalities and demonstrated substantial equivalence of the 3D digital bone models being equivalent for data extracted from CT and MR images." This indicates a technical validation of the 3D model generation process from imaging, not a clinical performance study with defined acceptance criteria for device efficacy or outcomes.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is absent.

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