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The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include:

• · Hammer toe deformity
• · Claw toe deformity
• Mallet toe deformity
• Other deformities of the feet and hands

The DigiFuse® implants are intended for single use only.

The Integra® DigiFuse® Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options.

This document is a 510(k) premarket notification for the Integra® DigiFuse® Cannulated Intramedullary Fusion System. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a separate, extensive study to define new acceptance criteria and prove performance against them.

Therefore, the requested information regarding acceptance criteria, device performance from a specific study, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not typically present or required in this type of submission.

Instead, the submission relies on demonstrating substantial equivalence to existing devices, meaning it performs as safely and effectively as a legally marketed device that does not require premarket approval (PMA).

Here's an analysis based on the provided document:

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

This document does not present a table of specific acceptance criteria (e.g., specific clinical outcomes, sensitivity/specificity thresholds) and reported device performance against those criteria. The acceptance is based on demonstrating substantial equivalence to predicate devices, not on meeting new quantitative performance metrics from a distinct study.

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

• No specific "test set" and corresponding sample size for clinical or AI performance evaluation are mentioned.
• The document states "Non-clinical evaluation and dimensional analysis was done to confirm substantial equivalence." This refers to engineering and material testing, not a clinical trial or performance study on a "test set" of patient data in the context of AI or diagnostic performance.

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

• Not applicable. There is no mention of a "test set" requiring ground truth established by experts in the context of clinical or diagnostic performance.

4. Adjudication method for the test set:

• Not applicable. No such test set or adjudication 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 study or AI assistance is mentioned. This device is a physical implant (Cannulated Intramedullary Fusion System), not a software or AI-powered diagnostic tool.

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

• Not applicable. This is a medical device, not an algorithm, so standalone AI performance is irrelevant.

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

• For a traditional 510(k) submission like this, the "ground truth" for the device's equivalence isn't clinical outcomes from a new study, but rather the established safety and effectiveness of the identified predicate devices. The "proof" is in demonstrating that the new device shares fundamental technological characteristics and has similar intended use, materials, and design principles to the predicates without raising new questions of safety or effectiveness. "Non-clinical evaluation and dimensional analysis" would be used to ensure the physical properties meet engineering standards applicable to the predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of AI or machine learning for this physical implant device.

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

• Not applicable. As there is no training set mentioned, this question is not relevant.

Summary of what the document does provide regarding equivalence:

• Predicate Devices:
  • Metasurg DigiFuse Implant – K111536
  • OsteoMed Extend 2.0/2.4 Cannulated Screw System – K062863
  • NewDeal K-Wire – K022599
• Basis for Equivalence:
  • The Integra® DigiFuse® Implant is made of the same material (Titanium Alloy (Ti 6A1-4V ELI)) as the Metasurg predicate device (K111536).
  • The only difference with the Metasurg predicate is the addition of two new lengths for the Integra® DigiFuse® implant.
  • These two new lengths are already within the length range of the Osteomed predicate device (K062863).
  • The submission explicitly states: "There are no design, material, or indication differences between the proposed device and predicate devices." (This is crucial for 510(k) acceptance).
  • Substantial equivalence was confirmed through "Non-clinical evaluation and dimensional analysis." This refers to engineering tests to ensure physical and mechanical properties are comparable to the predicates, not a clinical trial on patient-specific data.

In essence, the "acceptance criteria" for this specific 510(k) clearance are derived from the characteristics and performance of the legally marketed predicate devices. The study proving this "acceptance" is the non-clinical evaluation and dimensional analysis demonstrating that the Integra® DigiFuse® device is fundamentally the same as or comparable to its predicate devices, especially regarding materials, design, and intended use, and that any minor differences (like additional lengths) do not introduce new safety or effectiveness concerns.

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The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

The Vilex Trident Fusion Implant is a single-piece cannulated bone screw intended for the fixation of PIP joints in lesser toes and digits. The device is offered straight or with a 10° bend at the joint. It is available in either stainless steel or titanium.

The provided text is a 510(k) Summary for the Vilex Trident™ Fusion Implant. This document is a premarket notification to the FDA, demonstrating that a new device is as safe and effective as a legally marketed predicate device.

It does not contain information about acceptance criteria, device performance, or human study results. The document focuses on establishing substantial equivalence based on indications for use, material, sizes, shapes, and technological characteristics compared to predicate devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding studies with human participants, expert ground truth, sample sizes, or MRMC studies, as none of this information is present in the provided text.

The closest information to "device performance" is the statement repeated under "Technological Characteristics" and "Substantial Equivalence" that: "The technological characteristics for the Trident Fusion Implant are the same as the characteristics of the predicate devices." and "The design features of the Trident Fusion Implant are substantially equivalent to the design features of other predicate devices previously cleared for market." This implies that its performance is expected to be similar to legally marketed devices.

The document states that "The safety and effectiveness of the Trident Fusion Implant are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." However, the details of this "analysis data" proving safety and effectiveness are not included in the provided text.

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The TOEGRIP® is intended for toes for general use in skeletally mature individuals undergoing surgery limited to interdigital fusion.

The TOEGRIP® device is intended to be permanently implanted without any other additional device as an intramedullary bone fastener device for toes or fingers.

The TOEGRIP® device is indicated for small bone reconstruction limited to interdigital fusion of toes in the following cases, listed in random order:

• . Rigid PIP joints deformities
• . Rigid hammertoes deformities
• . Claw toes deformities (PIP and DIP joints)
• Revision hammertoes surgeries .
• . Shortening osteotomies of the proximal phalanx

The TOEGRIP® device consists of a monobloc implant with three flexible prongs inserted intramedullary into each part of phalanx The prongs are linked by a T-shaped beam. The fixation concept is based on a press-fit contact due to its tapered shape and the sharp macrostructures once impacted.
The TOEGRIP® device is intended for single use only, and is available in a range of 5 sizes with 3 possible degrees: 0°, 10° or 20°.
The TOEGRIP® device is manufactured with material according to the ISO-10993, ZENIVA® PEEK.
The feature design of the TOEGRIP® is substantially equivalent to the design features of other devices previously cleared for market.

The Synchro-Medical Toe Grip Device underwent nonclinical testing to demonstrate its substantial equivalence to predicate devices.

1. Acceptance Criteria and Device Performance:

The document states that the Synchro-Medical Toe Grip Device met the acceptance criteria for the tests performed. However, the specific quantitative acceptance criteria or the reported device performance metrics are not detailed in the provided text.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: The document does not explicitly state the sample size used for the nonclinical tests (Static Four-point Bending Test and Dynamic Four-point Bending Test).
• Data Provenance: The tests were nonclinical (bench testing) and therefore do not have data provenance related to country of origin or retrospective/prospective human data.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The study involved nonclinical mechanical testing, not human expert assessment for ground truth.

4. Adjudication Method for Test Set:

Not applicable. The study involved nonclinical mechanical testing, not human expert assessment requiring adjudication.

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

No. The document explicitly states, "No clinical tests were performed." Therefore, an MRMC comparative effectiveness study was not conducted.

6. Standalone Performance Study:

Yes, a standalone study (nonclinical mechanical tests) was performed for the algorithm/device. The device's performance was evaluated through:

• Static Four-point Bending Test
• Dynamic Four-point Bending Test

7. Type of Ground Truth Used:

The "ground truth" for these nonclinical tests would be the established engineering standards and specifications for bone fixation devices, against which the device's mechanical properties (e.g., bending strength, fatigue resistance) were measured.

8. Sample Size for Training Set:

Not applicable. This device is a physical implant, not a software algorithm that requires a training set in the context of machine learning.

9. How Ground Truth for Training Set was Established:

Not applicable. This device is a physical implant, not a software algorithm that requires ground truth for a training set.

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The Newdeal Interphalangeal Implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes.

Examples include:

• rigid or semi-rigid hammertoe deformity .
• revision of failed arthroplasty or arthrodesis .
• 2nd toe shortening .

The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of:

• . Fixed or semi-fixed hammer toe
• Revision of failed arthrodesis or arthroplasty ●
• . Shortening due to length excess of the second toe

This interphalangeal implant configuration will be offered in two different sizes.

The provided text describes the Newdeal® Interphalangeal implant and its substantial equivalence to other devices. It focuses on the regulatory submission (510(k) summary) for this medical device. As such, the information required to populate the table (acceptance criteria and device performance based on a study of AI/algorithm performance) and subsequent questions about AI/algorithm-related studies are not present in the document. This document is a regulatory submission for a physical medical implant, not an AI or algorithm-based device.

Therefore, I cannot provide the requested information.

Here's why:

• Acceptance Criteria & Device Performance: The document mentions "Static and Fatigue Bending tests were performed comparing the mechanical properties" but does not detail specific quantitative acceptance criteria or the reported device performance against those criteria. It only states that the results "helped to support substantial equivalence."
• AI/Algorithm Related Questions (2-7): The entire submission is for a physical orthopedic implant. It does not involve an AI or algorithm. Therefore, there are no test sets, data provenance, experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types related to AI.
• Training Set (8-9): Similarly, the concept of a "training set" and establishing ground truth for it is irrelevant for a physical mechanical implant.

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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 PRO-TOE™ VO Hammertoe Implant system is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The PRO-TOE™ VO Hammertoe Implant System will be offered in two sizes and two different blade angles. The implants will be manufactured from stainless steel.

Here's a breakdown of the acceptance criteria and the study that proves 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:

• Sample Size: Not specified in the provided text. The study involved a cantilever bend test on the PRO-TOE™ VO Hammertoe Implants and the newdeal® K-wires, but the number of implants/wires tested is not detailed.
• Data Provenance: The study appears to be an in-vitro (laboratory) test, not involving human or animal data. Thus, "country of origin" or "retrospective/prospective" are not applicable in the typical sense for clinical studies. It was conducted by Wright Medical Technology, Inc., located in Arlington, TN, USA.

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

Not applicable. This was a mechanical engineering test (cantilever bend test) where the "ground truth" is determined by the physical properties and performance measured, not by expert interpretation.

4. Adjudication Method for the Test Set:

Not applicable. Mechanical tests do not typically involve adjudication methods like those used for expert consensus in medical imaging studies. The results are obtained directly from instrumental measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI or imaging diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance refers to the device's mechanical integrity as tested in the cantilever bend test.

7. The Type of Ground Truth Used:

The ground truth used was the mechanical performance (specifically, strength under cantilever bend) of both the subject device (PRO-TOE™ VO Hammertoe Implants) and the predicate device (newdeal® K-wires) as measured in a controlled laboratory setting.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, and the evaluation involved mechanical testing, not a machine learning model requiring a training set.

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

Not applicable. As above, there was no machine learning training set for this device evaluation.

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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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