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The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.

The Xpert Knee range consists of plates and screws designed for the fixation of fractures, nonunions and malunions of the proximal tibia in adults. The plates and screws of the Xpert Knee range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use. The instruments of the Xpert Knee range will be provided non sterile for sterilization by health care professionals prior to use. Materials: CP Titanium grade 4 (conform to ASTM F67 and ISO 5832-2) for the plates, and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3) for the screws. Function: The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.

I apologize, but the provided FDA 510(k) clearance letter for the "Xpert Knee" device does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially not in the context of an AI/algorithm-based medical device.

The document primarily focuses on:

• Identity of the device: Xpert Knee, a metallic bone fixation appliance (plates and screws).
• Intended Use: Fixation of fractures, non-unions, and malunions of the proximal tibia in adults.
• Substantial Equivalence: Comparing the Xpert Knee to legally marketed predicate devices (other bone plates and screws) based on material, design, and indications for use.
• Non-clinical testing: Mechanical tests (static and dynamic tests on plates, pullout and torsional tests on screws) to demonstrate performance against the predicate devices.
• Lack of clinical studies: Explicitly states "No clinical studies were performed."

The categories you've asked about (acceptance criteria for algorithms, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are all highly relevant to the evaluation of AI or software-as-a-medical-device (SaMD). The Xpert Knee, as described in this 510(k), is a physical medical device (implants), not an AI software. Therefore, the information you're looking for about AI performance is not present in this document.

To answer your request, I would need a 510(k) (or similar regulatory document) for an AI/algorithm-based device.

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The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy, High Tibial Lateral Closing Osteotomy, High Tibial Anterior Closing Osteotomy, Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting guides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The purpose of this 510(k) notification is to add PSI Guides for High Tibial Lateral and Anterior Closing osteotomies. Material: Polyamide (PA2200).

The provided document is a 510(k) Summary for the Newclip Patient-matched instrumentation non sterile PSI. It includes information on the device, its intended use, and a comparison to a predicate device (K240415). The document also outlines the performance data used for verification and validation but lacks specific quantitative acceptance criteria or detailed study results for objective efficacy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it describes acceptance in qualitative terms, primarily relying on comparison to the predicate device and satisfactory outcomes in simulated use.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the "worst-case guide design and manufacture" or the "simulated use" scenarios. It mentions "worst-case guide design" and "worst-case and subject PSI guides." This implies a limited, representative set rather than a large statistical sample.
• Data Provenance: The studies were conducted by Newclip Technics, a French company (Sponsor Address: F-44115 Haute-Goulaine, FRANCE). The studies were internal verification and validation activities. The country of origin of the data subjects (if any beyond the guides themselves) is not specified, nor whether it was retrospective or prospective. Given the nature of a 510(k) submission for mechanical surgical guides, it's likely a laboratory/simulated environment and not involving human patient data directly for performance validation at this stage.

3. Number of Experts and Qualifications for Ground Truth

• Manufacturing Validation: "Three NewClip operators with low, medium, and high levels of experience (novice, intermediate, expert)" were involved in the manufacturing validation. Their specific qualifications (e.g., years of experience, specific certifications) beyond their experience level are not detailed.
• Simulated Surgery: "The same three novice surgeons" performed the simulated use. Their specific qualifications (e.g., years of surgical experience, board certification) are not detailed other than being designated "novice."

4. Adjudication Method

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating performance. For the manufacturing validation, it involved comparison of dimensions, design, correction, and placement, presumably against predefined design specifications or an established 'true' state. For the simulated surgery, it seems the observation of the three novice surgeons' ability to achieve the desired outcomes (positioning, correction, hinge preservation) against unnamed criteria formed the basis of acceptability.

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

• No MRMC comparative effectiveness study was done. The performance data section describes internal verification and validation activities rather than a comparative study of human readers with and without AI assistance. The device is a surgical guide, not an AI diagnostic tool that assists human readers in interpreting images.

6. Standalone Performance Study

• The performance data described focuses on the device itself (manufacturing precision and simulated usability) and its comparison to a predicate device. It is a standalone assessment of the algorithmic design and physical manufacturing of the guides, though its use is demonstrated in a simulated human-in-the-loop context (by surgeons). The "algorithm" here refers to the design software that creates the patient-matched guides.
  • Manufacturing Test: The assessment of "precision and accuracy of design, correction, and manufacture" of the PSI guides can be considered a standalone algorithm/device performance evaluation as it assesses the output of the CAD/CAM process.
  • Simulated Use: This evaluates the physical guides in use by surgeons, which is a human-in-the-loop scenario, but the performance of the guide itself (its fit, its ability to guide instruments correctly) is the primary focus.

7. Type of Ground Truth Used

• Manufacturing Validation: The ground truth for manufacturing precision and accuracy would be the original digital design specifications of the patient-matched instrumentation. The manufactured guides were compared against these known dimensions and design elements.
• Simulated Surgery: The ground truth for the simulated surgery was the planned surgical correction and the expected function of the guide (e.g., correct positioning, preservation of the hinge). This is established based on the pre-operative planning and surgical goals.

8. Sample Size for the Training Set

• The document does not mention a "training set" in the context of an AI/machine learning model. The device (Patient-matched instrumentation) leverages CT images to create customized physical guides, which are then 3D printed. There is no indication of an AI algorithm being "trained" on a dataset in the typical sense. The "training" here would be for the CAD/CAM software to accurately generate the patient-specific geometry based on the CT scan data, which is typically a deterministic process rather than a machine learning one.

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

• As no training set for an AI/ML model is indicated, this question is not applicable based on the provided text. The "ground truth" for the device's function relies on accurate anatomical segmentation from CT scans and precise mechanical design parameters encoded in the CAD/CAM software.

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The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy. Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting quides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The primary purpose of this 510(k) notification is to add PSI Guides for closingwedge and derotation osteotomies.

The provided text describes the Newclip Patient-matched instrumentation non sterile PSI, a device used in osteotomy procedures around the knee. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, but it does not include explicit acceptance criteria, detailed study designs, or specific performance metrics typically expected for AI/Machine Learning-enabled devices.

The device is described as "patient-matched instrumentation," which implies that the design process involves processing patient imaging data (CT scans) to create custom surgical guides. However, the document does not elaborate on the algorithmic aspects of this patient-matching process or how its accuracy is evaluated in a standalone or comparative study setting.

Given the information provided, here's an attempt to answer the questions, highlighting the limitations due to the lack of specific details concerning AI/ML evaluation as per your request:

1. Table of acceptance criteria and the reported device performance

Based on the provided document, explicit quantitative acceptance criteria for the "Newclip Patient-matched instrumentation non sterile PSI" are not stated. The performance is broadly described in terms of "precision and accuracy" in simulated-use cadaver surgeries. No specific numerical thresholds or target values are provided.

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

The document mentions "simulated-use cadaver surgeries" for performance verification. However:

• Sample Size for Test Set: Not specified. The number of cadavers or surgical approaches evaluated is not provided.
• Data Provenance: Not specified, but given the nature of cadaver studies, it would be laboratory-based rather than from real-world patient data. The study is described as "simulated-use," suggesting a prospective evaluation within a controlled environment.

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

The document states "Surgeon evaluation of precision and accuracy."

• Number of Experts: Not specified.
• Qualifications of Experts: Identified as "Surgeon," but no further details such as specialty (e.g., orthopedic surgeon), years of experience, or specific board certifications are provided.

4. Adjudication method for the test set

The document only states "Surgeon evaluation." There is no mention of an adjudication method (such as 2+1, 3+1 consensus, or independent review) for establishing ground truth or assessing outcomes in the simulated-use cadaver surgeries.

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

• MRMC Study: Not mentioned. The study described is a "Surgeon evaluation of precision and accuracy based on simulated-use cadaver surgeries." This focuses on the performance of the device itself in guiding surgical actions, rather than an MRMC study comparing human reader performance with and without AI assistance for tasks like diagnosis or planning.
• Effect Size of AI/Human Improvement: Not applicable, as no such MRMC study is described. The device's role is to guide surgical instruments, not to assist human readers in interpreting images or making diagnostic decisions.

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

The document describes the "patient-matched instrumentation" as derived from CT images and used to guide surgical instruments. This implicitly means there is computational work done to generate these custom guides. However, no specific standalone algorithm-only performance study results are provided. The evaluation mentioned is "Surgeon evaluation of precision and accuracy based on simulated-use cadaver surgeries," which represents a human-in-the-loop scenario where the surgeon uses the device. A standalone validation of the algorithm's ability to precisely match anatomy or generate optimal guide designs is not explicitly detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "precision and accuracy" evaluation in cadaver surgeries, the ground truth or reference standard against which the device's performance was measured is not explicitly stated. It's likely an assessment by the evaluating surgeon(s) based on intra-operative observation or post-operative measurements of the osteotomy characteristics (e.g., angles, cuts) against the pre-operative plan, but the method for establishing this ground truth is not detailed.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This suggests that if an algorithm is used for patient-matching guide design, it was either not developed using a distinct "training set" in the machine learning sense, or the details of its development and validation outside of the simulated-use cadaver study are not included in this summary. The process likely involves computational design based on individual patient CT data rather than a generalizable AI model trained on a large dataset.

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

Not applicable, as no information about a training set is provided.

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The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening Wedge Osteotomy and Distal Femoral Lateral Opening Wedge Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices. The subject devices are surgical drilling/cutting quides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or guiding surgical instruments in orthopaedic surgery (High Tibial Medial Opening Wedge Osteotomy and Distal Femoral Lateral Opening Wedge Osteotomy). They are single-use devices provided non sterile for sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of Newclip High Tibial Osteotomy System or the Newclip Activmotion Range devices.

The provided text is a 510(k) summary for the Newclip Patient-matched instrumentation non sterile PSI. It does not contain the specific acceptance criteria or details of a study structured to prove the device meets said criteria as requested.

The document states that "Verification and validation (V&V) activities included... Surgeon evaluation of precision and accuracy based on human clinical cases." It further mentions that "Precision and accuracy of the subject device was demonstrated in published human clinical studies by surgeon-users on patients in Europe using Newclip Patient-matched instrumentation non sterile PSI guides." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance. (It refers to "human clinical cases" and "published human clinical studies" but gives no numbers or details on whether the data was retrospective or prospective, or from which specific countries beyond "Europe.")
• Number and qualifications of experts for ground truth.
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers improving with/without AI assistance. (This device is a patient-matched surgical guide, not an AI or imaging diagnostic tool, so an MRMC study is unlikely to be relevant in the traditional sense, but the question was asked.)
• If a standalone performance (algorithm only) was done. (Again, not directly applicable as this is a physical surgical guide.)
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides). It lists verification and validation activities conducted, but these are described in broad terms rather than as a detailed study report with specific metrics and results.

Therefore, based solely on the provided text, I cannot fulfill the request for detailed information about acceptance criteria and a study proving those criteria were met.

If this were a medical imaging AI device, the lack of such details in an FDA 510(k) summary would be a red flag. However, for a patient-matched surgical instrument, the V&V activities mentioned (surgeon evaluation, precision/accuracy in design/manufacturing, wear testing, cleanliness/sterilization, dimensional verification) are typical, though the specific data from these activities is not included in this summary.

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The implants of the Footmotion Plating System are intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.

The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.

The implants of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization.

The instruments of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use.

This FDA 510(k) summary is for a medical device called the Footmotion Plating System, which is a metallic bone fixation device. As such, the "acceptance criteria" and "device performance" are typically related to mechanical and material properties rather than diagnostic accuracy or clinical outcomes. The study described is a non-clinical, benchtop study.

Here's the breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not explicitly state the number of plates or screws tested. However, mechanical testing typically involves a sufficient number of samples to achieve statistical significance.
• Data Provenance: The studies are non-clinical (benchtop) tests performed by the manufacturer, Newclip Technics, as part of their 510(k) submission. There is no mention of country of origin for the data or if it's retrospective/prospective as these terms are not applicable to non-clinical bench testing.

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

• Not Applicable. For mechanical and material testing of this nature, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO, FDA guidance documents) and the results of the physical tests themselves. Human experts are involved in designing and conducting the tests, interpreting the raw data, and comparing it to the performance of predicate devices, but they are not establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies or studies involving human assessment of clinical data, especially in diagnostic accuracy claims. For benchtop mechanical testing, the results are typically quantitative and objective, directly compared against established standards or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

• Not Applicable. This device is a bone fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and the concept of "human readers improving with AI vs. without AI assistance" are not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This device is a physical medical implant (plating system), not a software algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical performance of the device is established by:
  • Adherence to recognized industry standards: ASTM F382 (for plate bending), ASTM F543 (for screw torsion), and FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway-2020" (for screw axial pull-out).
  • Comparison to predicate devices: The subject device's mechanical and material properties are demonstrated to be "substantially equivalent" to legally marketed predicate devices.
  • Biocompatibility testing: Endotoxin levels assessed by LAL quantitative kinetic chromogenic method.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this device because it is a physical hardware device, not a machine learning or AI algorithm that requires training data.

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

• Not Applicable. As there is no training set for this type of device, this question is not relevant.

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The implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.

The Activmotion S DTO range consists of plates and screws designed for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula. The Activmotion S DTO range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use. Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3).

The provided text is a 510(k) summary for a medical device called the "Activmotion S DTO range." This document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical testing. It explicitly states that no clinical studies were performed. Therefore, this document does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies.

Here's a breakdown of what can be gleaned from the text regarding the required information:

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

• Acceptance Criteria: Not explicitly stated as pass/fail values for specific performance metrics in the provided text. The document generally implies equivalence to predicate devices.
• Reported Device Performance:
  • "Engineering analysis and comparative 4-point-bending tests in static and dynamic condition were conducted to compare the bending strength of the subject device plates to the predicates."
  • "Static and dynamic tests were conducted according to according to ASTM F382."
  • "Engineering analysis: torsional, driving torque, and pullout tests according to ASTM F543 were performed on the subject screws."
  • "Endotoxin testing is performed using LAL quantitative kinetic chromogenic method."
  • "The analysis showed that the Activmotion S DTO range is as safe and as effective as the predicates."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• The sample sizes for the engineering tests (e.g., number of plates, screws tested) are not specified in this document.
• The data provenance is not explicitly stated as country of origin or retrospective/prospective. These were non-clinical, lab-based engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This is not applicable as the study involved non-clinical engineering tests, not clinical data requiring expert review for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This is not applicable as the studies were non-clinical engineering tests.

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 study was done. The document explicitly states "No clinical studies were performed."

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

• This is not applicable as the device is a metallic bone fixation appliance, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• For the non-clinical tests, the "ground truth" would be established by engineering standards and measurements, as defined by ASTM F382 and ASTM F543, and the LAL quantitative kinetic chromogenic method for endotoxin testing. There is no expert consensus, pathology, or outcomes data involved.

8. The sample size for the training set:

• This is not applicable as the device is a physical medical device, not an AI/machine learning model that requires a training set.

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

• This is not applicable for the same reason as point 8.

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The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

The Xpert Wrist range consists of plates and screws, designed for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults. The implants of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. The instruments of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use. Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

This FDA 510(k) summary is for a medical device called "Xpert Wrist," which consists of plates and screws for fixing hand and forearm fractures, osteotomies, and arthrodeses in adults.

The document explicitly states: "No clinical studies were performed." This means that the device was not evaluated through a study to prove its acceptance criteria in the typical sense of measuring device performance against clinical outcomes or human reader performance.

Instead, the substantial equivalence to predicate devices is based on non-clinical tests comparing the Xpert Wrist to previously cleared devices.

Here's an breakdown of the information requested, based only on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a GHTF Type A submission (based on substantial equivalence to predicate devices and no clinical studies), the acceptance criteria are based on mechanical properties being comparable or superior to the predicate devices. The document does not provide specific numerical acceptance criteria (e.g., minimum bending strength in N-mm) or exact performance values from the tests in an easily digestible table format. It states that the analysis "showed that the Xpert Wrist range is substantially equivalent to cleared predicates."

However, we can infer the types of performance assessed:

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

• Test Set Sample Size: Not explicitly stated. The non-clinical tests would involve a certain number of manufactured plates and screws (e.g., n=5 or n=10 per test for mechanical testing).
• Data Provenance: Not applicable in the context of human studies. For mechanical testing, the "data provenance" would refer to tests conducted in a laboratory setting, likely by the manufacturer or a contracted testing facility. No country of origin for the mechanical test data is specified. The tests are non-clinical and conducted to support substantial equivalence.

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

Not applicable. No clinical studies were performed, and thus no expert ground truth for a clinical test set was established. The "ground truth" here is based on established engineering standards for mechanical performance.

4. Adjudication Method for the Test Set

Not applicable. No clinical studies were performed, and thus no adjudication method for a clinical test set was used.

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

No. The document explicitly states: "No clinical studies were performed."

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

Not applicable. This is a physical medical device (plates and screws), not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" refers to established engineering standards (e.g., ASTM F382, ASTM F543) and comparative data from legally marketed predicate devices. The performance of the Xpert Wrist was compared against these benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. This is not an AI/machine learning device, so there is no "training set" or ground truth for it.

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The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.

The Activ Fuse range consists of plates and screws designed for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus. The system includes a modular plate design for a lateral calcaneal extension. The Activ Fuse range will be provided non-sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.

This document is a 510(k) Summary for the Activ Fuse range of orthopedic implants. It describes the device, its intended use, and substantial equivalence to predicate devices, focusing on non-clinical testing. It explicitly states that no clinical studies were performed.

Therefore, it is not possible to provide the requested information regarding:

• Acceptance criteria and reported device performance related to a study proving the device meets acceptance criteria. The document refers to engineering analysis and comparative static and dynamic tests, but not to a study with acceptance criteria in the context of AI/software performance or human-in-the-loop studies.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document centers on demonstrating substantial equivalence through non-clinical tests (engineering analysis, mechanical testing) rather than clinical performance or AI/software validation.

Here's a summary of what is available in the document regarding the device's evaluation:

1. Table of acceptance criteria and reported device performance:

The document doesn't present "acceptance criteria" and "reported device performance" in the context of a study proving the device meets the acceptance criteria as typically understood for AI/software or clinical trials. Instead, it discusses the safety and effectiveness of the medical device (implants) based on non-clinical testing.

2. Sample sized used for the test set and the data provenance: Not applicable. The document discusses mechanical tests of physical devices, not a test set of data.

3. Number of experts used to establish the ground truth... and qualifications: Not applicable. The ground truth for mechanical testing is derived from engineering standards and physical measurements.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. "No clinical studies were performed."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a physical medical device (orthopedic implants), not software/AI.

7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be the engineering and material specifications, and the results of standardized mechanical tests (e.g., strength, durability, fatigue).

8. The sample size for the training set: Not applicable. There is no training set for a physical implant device.

9. How the ground truth for the training set was established: Not applicable.

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The implants of the Footmotion Hammer Toe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

The Footmotion HammerToe range consists of intramedullary implants designed for proximal interphalangeal arthrodeses of lesser toes in adults. The Footmotion HammerToe range will be provided non sterile for health sterilization bv care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136-13 and ISO 5832-3). Function: The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

This document is a 510(k) Summary for a medical device called the "Footmotion HammerToe." It's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not include acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML device, as this is a traditional medical device (an implant).

Here's an analysis based on the provided text, aligning with your request, but highlighting the differences for a non-AI/ML device:

1. Table of acceptance criteria and reported device performance:

Since this is an orthopedic implant, the "acceptance criteria" and "device performance" are not about AI model metrics like sensitivity or specificity. Instead, they refer to the physical and mechanical properties of the implant. The document states that the device is substantially equivalent to predicate devices based on:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample size for test set: Not applicable in the context of an AI/ML model. The "tests" mentioned are biomechanical tests on the device itself, not clinical data.
• Data provenance: Not applicable for this type of device. The tests were performed on the physical implant. The manufacturer, NEWCLIP TECHNICS, is based in France.

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

• Not applicable. "Ground truth" in the context of this device refers to established engineering standards (ASTM, ISO) for material properties and performance. Biomechanical testing doesn't typically involve human experts establishing "ground truth" for the test results in the same way an AI model might. The "experts" would be engineers designing and conducting the tests according to established protocols.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This concept applies to human review of data to establish ground truth, not to physical device testing.

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. This is an orthopedic implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical tests (flexion, pull-out), the "ground truth" is defined by established engineering standards and material specifications (ASTM F136-13 and ISO 5832-3 for the material) and the expected mechanical behavior for an implant of this type, as demonstrated by predicate devices. The tests aimed to show that the device meets these physical and mechanical performance expectations.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

Summary of the study/evidence for device acceptance:

The device's acceptance is based on a non-clinical study involving mechanical testing:

• Flexion tests
• Pull out tests

The purpose of these tests was to demonstrate the mechanical safety and performance of the Footmotion HammerToe range. The conclusion drawn is that the device is substantially equivalent to legally marketed predicate devices (Memometal Intra-medullary Bone Fastener, Pro-Toe Vo Hammertoe Implant System, Nextra Ti Hammertoe Correction System) based on:

• Similar principles of operation
• Similar technology
• Similar materials
• Similar indications for use

The submission explicitly states: "No clinical studies were performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.

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