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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.

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 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.

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 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 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).

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

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

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.

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