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The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion

MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER new device designs are single-use bone fixation appliances intended to be permanently implanted. Intramedullary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy.

The provided text refers to a 510(k) summary for a medical device called the "MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE)". This document is a premarket notification to the FDA, not a study report. It states that the device is substantially equivalent to a previously cleared predicate device based on performance data and a comparison to established standards. Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, a specific study proving it, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a study set.

However, based on the information available in the 510(k) summary, here's an attempt to structure an answer, highlighting what is and is not present:

The provided document is a 510(k) summary for a medical device and thus does not describe a clinical study in the typical sense with discrete acceptance criteria and a detailed study report. Instead, it demonstrates substantial equivalence to a predicate device based on compliance with recognized standards.

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

The document does not present a table of specific acceptance criteria from a clinical study for device performance. Instead, it states that the device conforms to established industry standards:

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

This information is not provided in the 510(k) summary. The document focuses on material and design conformance to standards, not a specific clinical testing sample.

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 information is not provided in the 510(k) summary, as it describes a regulatory submission based on engineering and material standards, not a clinical study involving expert ground truth assessment.

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

This information is not provided in the 510(k) summary.

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

An MRMC study is not mentioned and is not relevant to this type of device (a bone fastener) or the context of a 510(k) submission based on substantial equivalence through material and design standards. This device is not an AI-powered diagnostic tool.

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

This concept is not applicable to the described medical device, which is a physical implant, not an algorithm.

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

The "ground truth" here is the conformance to established engineering and material standards. This is verified through laboratory testing against the specifications outlined in ASTM F564-02 and ASTM F2063-05. The document does not refer to clinical outcomes or expert consensus for "ground truth" in the context of diagnostic accuracy.

8. The sample size for the training set

This information is not provided and is not applicable to the type of device or the regulatory submission. There is no machine learning model involved that would require a training set.

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

This information is not provided and is not applicable, as there is no training set mentioned or implied.

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The Navis® radius Plate is indicated for the fixation of fractures and osteotomies involving the distal radius.

MEMOMETAL Navis® Bone Plating System is single use bone fixation appliances intended to be permanently implanted. They are designed with anatomical shape plates made of biocompatible titanium alloy. The Bone Plating System use 2.5 mm locking, unlocking screws and 1.8 mm smooth locking pegs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different lengths, widths, number of plate holes, left and right shapes.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Key Takeaways:

• This document describes a 510(k) premarket notification for the Memometal Navis® Bone Plating System.
• The primary method for demonstrating substantial equivalence was mechanical testing comparing the new device to legally marketed predicate devices.
• No clinical tests were used or presented, meaning there's no information on human reader performance, AI assistance, or related clinical metrics.
• The focus is on mechanical properties of the implants themselves, not diagnostic or AI performance.

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: Not specified in terms of number of plates/pegs tested. The document refers to "mechanical characterization of plates" and "mechanical characterization of pegs," implying a sample was used, but the exact number isn't stated.
• Data Provenance: The tests were "performed to demonstrate equivalence," indicating a controlled lab setting rather than clinical data. The ASTM F382-99 standard for the 3-point bending test suggests standardized laboratory conditions. No country of origin for the test data is explicitly mentioned, but the submitter is based in France. The data is entirely retrospective in the sense that it evaluates the manufactured device; there's no prospective patient follow-up mentioned.

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

• Not applicable. This study did not involve human experts establishing ground truth for a test set, as it was a mechanical performance study of an implantable device, not a diagnostic or AI-driven imaging study. The "ground truth" was established by the physical properties and performance metrics of the predicate devices as measured under standardized test conditions.

4. Adjudication Method for the Test Set

• Not applicable. There was no subject interpretation or clinical assessment requiring adjudication. The study involved objective mechanical measurements.

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, an MRMC study was NOT done. This document pertains to a bone plating system, which is an implantable device, not a diagnostic imaging AI tool. Therefore, there's no concept of human readers or AI assistance in this context.

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

• No. This is not an AI algorithm. It is a physical bone plating system.

7. The Type of Ground Truth Used

• The "ground truth" for this study was the established mechanical performance and design characteristics of legally marketed predicate devices (Medartis Aptus®, TRIMED Bone plates, and STRYKER variax®). The new device's mechanical properties were measured and compared against these established benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This study did not involve a training set as it was not an AI/machine learning study.

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

• Not applicable. As stated above, there was no training set.

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The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are indicated for fixation of bone fracture, for bone reconstruction or arthrodesis in presence of appropriate immobilization. The size of the implant should be adapted to the specific indication.

MEMOMETAL implants are single-use bone fixation appliances intended to be permanently implanted. MEMOMETAL implants are available in 2 different designs: - Snap-off pin, smooth with a stop and a sharp self drilling tip - Notched with a T-shaped head.

The provided 510(k) Premarket Notification for MEMOMETAL Technologies Osteosynthesis implants (K102072) describes performance data related to the mechanical properties of the implants. This submission focuses on demonstrating substantial equivalence to predicate devices through engineering rationale and mechanical testing, rather than clinical outcome studies involving human or animal subjects that would typically involve acceptance criteria for a study with a test set, ground truth, and expert evaluation as you've outlined.

Therefore, many of the requested categories (2-9) are not applicable to the type of information presented in this regulatory submission. The performance data provided is primarily engineering-based.

Here's a breakdown of the relevant information from the provided text:

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

Study Description (based on available information):

This submission relies on engineering rationale and mechanical testing to demonstrate the substantial equivalence of the MEMOMETAL implants (K-Snap® & Ti-Fuse®) to their predicate devices. The study is a comparative mechanical performance study rather than a clinical trial.

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

• Sample Size: Not specified in the summary (typical for mechanical testing, where the number of test samples for each mechanical property is usually defined by a standard).
• Data Provenance: The study was conducted by MEMOMETAL Technologies (a French company). The testing is likely prospective in nature (i.e., designed and performed for this submission).

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)

Not applicable. Ground truth as typically understood for clinical or image-based studies (e.g., expert consensus on diagnoses) is not relevant for this type of mechanical testing. The "ground truth" here is physics and engineering principles, with measurements taken from the devices and comparator.

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

Not applicable. This is not a human-reader-based study.

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

Not applicable. This is not a human reader or AI-assisted study.

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

The "stand-alone" performance is the mechanical performance of the devices themselves, as tested. There is no algorithm involved in the clinical sense.

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

The ground truth is based on objective mechanical measurements (e.g., force, displacement, material properties) as defined by established engineering and materials science standards for such implants. There is no expert consensus, pathology, or outcomes data used as ground truth for this mechanical study.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical performance testing for medical devices.

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

Not applicable.

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The Memometal Technologies' SubFix Arthroereisis Implant is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing subtalar joint motion but blocking excessive pronation and the resulting sequela.

The SubFix Arthroereisis Implants are intended for single use only.

The Memometal Implant is a one-piece device made of medical grade Titanium Alloy, Ti6A14V. The implant is available in 5 sizes ranging from 6.5 mm to 11.5 in diameter. No new materials or processes are used in the development of this implant.

The provided text is a 510(k) summary for the SubFix Arthroereisis Implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a PMA (Pre-Market Approval) submission would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, as it relies on a different regulatory pathway.

Specifically, it states: "An engineering analysis and a material comparison to various predicate devices were used to help demonstrate equivalence." This indicates that the primary "study" for this 510(k) was a comparison to existing devices, not a new performance study with specific acceptance criteria.

Let me address each point based on the information available and not available in the provided text:

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

• Not available. The document does not define specific acceptance criteria or report performance data against such criteria in the context of a new efficacy study. The document focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, engineering analysis, and material comparison.

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

• Not applicable / Not available. Since no performance study demonstrating efficacy against acceptance criteria is described, there is no "test set" in that context. The "test" for this 510(k) was an engineering and material comparison to existing predicate devices.

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)

• Not applicable / Not available. No ground truth establishment by experts is mentioned, as the submission relies on comparison to predicate devices, not on a new clinical study requiring ground truth.

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

• Not applicable / Not available. No adjudication method is mentioned as there's no clinical test set requiring it.

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 a medical implant, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.

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

• No. This is a medical implant, not a standalone algorithm.

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

• Not applicable / Not available. No ground truth is established for a new clinical study. The "ground truth" for this 510(k) is implicitly the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

• Not applicable / Not available. This is a medical implant, not a machine learning model, so there is no training set.

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

• Not applicable / Not available. As above, no training set for a machine learning model is involved.

Summary of the "Study" provided in the document:

The submission for the SubFix Arthroereisis Implant is a 510(k) Premarket Notification based on substantial equivalence to legally marketed predicate devices. The "performance data" section states:

• "An engineering analysis and a material comparison to various predicate devices were used to help demonstrate equivalence."

This indicates the study was a technical comparison, not a clinical trial with specific performance metrics and acceptance criteria for the new device's efficacy. The relevant aspect explored was the similarity in design, materials, and intended use to existing, approved devices.

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The MEMOMETAL ANCHORAGE® Bone Plate Systems are indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist and ankles, fingers and toes. The system may be used in both adults and pediatric patients.

MEMOMETAL ANCHORAGE® Bone Plate Systems are single use bone fixation appliances intended to be permanently implanted. They are designed with different shape plates made of biocompatible titanium. The Bone Plate Systems use either 3mm or 3,5mm screws. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, lengths, number of plate holes and shape.

The provided document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) Premarket Notification for the ANCHORAGE® Bone Plate System, primarily focused on establishing substantial equivalence to a predicate device.

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

• Performance Data: The document explicitly states under "Performance data": "No clinical or non clinical tests were used in the claim of substantial equivalence." This means no studies were conducted by the manufacturer to demonstrate the device's performance against specific criteria, as they were relying on the equivalence to an already approved device.
• Substantial Equivalence: The basis of this 510(k) submission is that the ANCHORAGE® Bone Plate System is "substantially equivalent" to the predicate device (K061808 DARCO locking bone plate system) in terms of intended use, indications for use, material, design, and function. This pathway allows a device to come to market without new clinical studies if it can be shown to be as safe and effective as a legally marketed predecessor.

Therefore, for each of your requested points, the answer based on this document is as follows:

1. Table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data are reported in this submission as no new tests were performed to support substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable. No test set was used as no new studies were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment was conducted as no new studies were performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication was performed.
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: Not applicable. This device is a bone plate system, not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a bone plate system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established as no new studies were performed.
8. The sample size for the training set: Not applicable. This device is a physical medical device, not a machine learning model, and therefore had no "training set."
9. How the ground truth for the training set was established: Not applicable. Same reason as above.

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The MEMOMETAL Micro ARIM® is indicated for

• Hand: Ligament reconstruction
• Ankle: Midfoot reconstruction
• Foot: Hallux Valgus reconstruction
• Wrist: Scapholunate Ligament reconstruction
• Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence

MEMOMETAL Micro ARIM® anchors are single-use bone fixation appliances intended to be permanently implanted. Micro ARIM® anchors made of shape memory nickel titanium alloy. MEMOMETAL Micro ARIM anchors can be used in 2 versions with USP2-0 to USP 4-0 sutures (1 or 2 needles) listed below: Anchors Micro ARIM® th. 1mm - Length 3,8mm polyester suture (K012201) Anchors Micro ARIM® th. 1mm - Length 3,8mm Fiberwire suture (K041589) MEMOMETAL Micro ARIM® Anchors adopt an opened position after introducing into bone which allows a permanent fixation, thus supporting a secure ligament restoration.

The provided text is a 510(k) Premarket Notification for a medical device (MEMOMETAL Micro ARIM® anchor), not a study assessing AI software performance. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to a predicate device based on material, design, function, and intended use, rather than presenting a clinical study with detailed performance metrics against acceptance criteria that would typically be associated with software or AI claims.

Here's what can be extracted and what cannot:

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

• Cannot be extracted. This document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) against a clinical outcome. It focuses on conforming to a material standard and substantial equivalence to a predicate device.

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

• Cannot be extracted. This document does not describe a clinical study with a test set.

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)

• Cannot be extracted. This document does not describe a clinical study requiring expert-established ground truth.

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

• Cannot be extracted. This document does not describe a clinical study with an adjudication method.

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

• Cannot be extracted. This document is for a physical bone anchor, not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or reported here.

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

• Cannot be extracted. This document is for a physical bone anchor, not an algorithm.

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

• Cannot be extracted. This document does not describe a clinical study requiring ground truth.

8. The sample size for the training set

• Cannot be extracted. This document does not describe an AI training set.

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

• Cannot be extracted. This document does not describe an AI training set or its ground truth establishment.

What can be inferred from the document regarding "acceptance criteria" and "study":

The document focuses on demonstrating that the MEMOMETAL Micro ARIM® anchor meets general safety and effectiveness requirements by:

• Material Conformance: "THE MEMOMETAL Micro ARIM® conform to ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants." This is the primary acceptance criterion explicitly stated for the material. The "study" proving this would be material testing to verify compliance with this ASTM standard.
• Substantial Equivalence: "[THE MEMOMETAL Micro ARIM®] are substantially equivalent to their predicate devices MITEK MiniQUICKANCHOR Plus in terms of intended use and indications for use, material, design and function. Any minor differences between these two devices do not raise new questions of safety and effectiveness." This is the overarching "acceptance criterion" for 510(k) clearance. The "study" demonstrating this involves a comparison of the new device to the predicate across various attributes as detailed in the submission, confirmed by the FDA's review.

In summary, for K071941, the "acceptance criteria" revolve around conforming to an industry standard for the material and demonstrating substantial equivalence to a legally marketed predicate device, rather than specific clinical performance metrics from a device-specific study against a defined ground truth.

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The MEMOMETAL INTRA MEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion

MEMOMETAL INTRAMEDULARY MEMORY BONE FASTENER are single-use bone fixation appliances intended to be permanently implanted. Intramedulary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy.

The provided text describes a 510(k) premarket notification for a medical device, not a study evaluating software or AI performance. Therefore, many of the requested categories (such as sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this document.

The document indicates that the device's performance was assessed against established industry standards.

Here's a summary based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not applicable. This is a premarket notification for a physical device, and the "test set" in this context refers to the device itself undergoing standard material and performance tests, not a dataset for software evaluation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/software evaluation is not relevant here. The "ground truth" for this device's performance is compliance with ASTM standards.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for conflicting expert opinions in data labeling, not for material and performance testing of a physical implant.
4. 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. This device is an intramedullary bone fastener, not an AI or software product.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance is adherence to established industry-wide ASTM standards for metallic bone staples and nickel-titanium shape memory alloys (ASTM F564-02 (2006) and ASTM F2063-05).
7. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

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The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

MEMOMETAL FIXOS SCREWS are single-use bone fixation appliances intended to be permanently implanted. Screws are cannulated compressive screws made of titanium alloy (Ti - 6Al -4V ELI) and snap-off screws made of titanium alloy (alloy (Ti - 6Al -4V ELI)

The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes performance testing against established industry standards (ASTM F543-02 and ISO 5832-3) and a claim of substantial equivalence to predicate devices.

• Sample Size for Test Set: The document does not specify the sample size for the mechanical performance tests conducted to meet ASTM and ISO standards. These standards typically define the minimum sample sizes for various tests.
• Data Provenance: Not explicitly stated as country of origin, but the company is based in France (MEMOMETAL TECHNOLOGIES, 35170 BRUZ - France). The testing would have been conducted to international standards. The document only mentions performance data without specifying if it was a retrospective or prospective study on human subjects; it appears to be laboratory-based engineering performance testing.

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

This type of information is not applicable to the provided 510(k) summary. The "ground truth" for this device is based on objective engineering and material science standards (ASTM and ISO) and comparison to predicate devices, not on expert clinical interpretation of data that typically requires human "ground truth" establishment.

4. Adjudication Method for the Test Set

Not applicable. As the performance data relies on objective engineering and material standards, there is no need for an adjudication method in the context of clinical interpretation, which is what "adjudication method" typically refers to.

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

No. The provided document does not mention any MRMC comparative effectiveness study. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The FIXOS Screws are implantable bone fixation devices, and their performance is assessed through mechanical testing and material conformance.

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

Not applicable. This device is a physical medical implant (bone screw), not a software algorithm. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Objective Engineering Standards: Conformance to ASTM F543-02 (Standard Specification and Test Methods for Metallic Bone screw) and ISO 5832-3 (Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy). These standards define test methods and acceptance criteria for material properties and mechanical performance.
• Predicate Device Equivalence: The comparison of material, design, and function to previously legally marketed predicate devices (LANDOS CANNULATED BONE SCREW and TWIST-OFF SCREW) establishes the basis for demonstrating safety and effectiveness for a new device claiming substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and design are based on established engineering principles and materials.

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

Not applicable. As explained above, there is no "training set" for this device.

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The MEMOMETAL MEMORY STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

MEMOMETAL MEMORY STAPLES are single-use bone fixation appliances intended to be permanently implanted. Memory staples are bipodal or quadripodal compression staples made of shape memory nickel titanium alloy.

The provided text describes the regulatory clearance of a medical device (MEMOMETAL MEMORY STAPLES) and includes performance data based on adherence to industry standards, rather than a study against a specific set of acceptance criteria with reported device performance metrics in the format requested.

Here's an attempt to structure the information based on the request, extracting what is available and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

No information is available for the following points as the document pertains to a 510(k) submission for a physical medical device, not an AI/software device requiring a clinical study with image data and expert review.

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

• Not applicable for this type of device and submission. Performance is based on compliance with material and mechanical standards.

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)

• Not applicable.

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

• Not applicable.

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

• Not applicable. This device is a physical bone staple, not an AI/software for interpretation.

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

• Not applicable.

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

• Not applicable. The "ground truth" here is compliance with established engineering and material standards.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

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The MEMOMETAL varisation staple is intended to be implanted for fixation of small bone fractures or for small bone reconstruction. The MEMOMETAL varisation staple is indicated for Akin type osteotomy.

MEMOMETAL varisation staple is a staple with two self drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface

This submission is for a medical device (MEMOMETAL varisation staples), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable. The documentation focuses on demonstrating substantial equivalence to a predicate device, as required for traditional 510(k) submissions for non-AI medical devices.

However, I can extract the relevant performance data and the study type conducted for this medical device:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

Not applicable. The submission is for a non-AI medical device and relies on material and mechanical standard conformance rather than clinical or algorithmic data.

3. Number and Qualifications of Experts for Ground Truth

Not applicable for a non-AI device.

4. Adjudication Method

Not applicable for a non-AI device.

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

Not applicable. This type of study is relevant to AI-assisted diagnostic devices to assess the impact of AI on human reader performance, which is not the subject of this 510(k) submission.

6. Standalone Algorithm Performance

Not applicable as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

For this physical device, the "ground truth" is defined by established engineering standards for metallic implants and bone staples. This includes:

• Material composition and properties: Defined by ISO 5832-1.
• Mechanical performance (e.g., strength, fatigue): Defined by ASTM F564-02.

8. Sample Size for Training Set

Not applicable as there is no algorithm or training set for a physical medical device.

9. How Ground Truth for Training Set Was Established

Not applicable.

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