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The Newdeal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometarsal joints (Lisfranc joints).

The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints (Lisfranc joints). It is available in different sizes, and is implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

This 510(k) summary describes a medical device, the Lisfranc Plate, and its mechanical testing for substantial equivalence to a predicate device. It is not a study of an AI/ML device, and therefore the requested information regarding AI/ML device performance, ground truth, and expert evaluation is not applicable.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a quantitative manner as one might expect for an AI/ML device's diagnostic performance. Instead, the acceptance criterion for this medical device (Lisfranc Plate) is based on demonstrating substantial equivalence in mechanical properties to a predicate device.

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

• Sample Size: Not specified. The document states "Mechanical tests have been carried out," but does not provide details on the number of samples tested.
• Data Provenance: Not specified, but implied to be from laboratory mechanical testing of the device itself.

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

• Not Applicable. This is a mechanical device test, not a diagnostic or AI/ML evaluation requiring expert-established ground truth on patient data. The "ground truth" here is the physical performance of the device under specific mechanical testing conditions, compared to the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. This is a mechanical device test. The comparison is made against the known performance data of the predicate device.

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

• No. This is not an AI/ML or diagnostic device; it's a fixation plate. Therefore, an MRMC study is not relevant.

6. If a Standalone Performance Study Was Done

• Yes, implicitly. Mechanical tests were performed on the modified Lisfranc Plates in a "standalone" fashion (i.e., the device itself was tested). The performance was then compared to data from the predicate device, K060474.

7. The Type of Ground Truth Used

• Mechanical Test Data: The ground truth for comparison was the established mechanical performance characteristics of the predicate Lisfranc Plates (K060474) and the scientific principles of mechanical engineering.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires training data.

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

• Not Applicable. As above, no training set for an AI/ML algorithm was involved.

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The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as: - Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1* tarsometatarsal joint, available in different sizes, which will be fixed using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking System includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single plate/screw unit fixed into the bone. The ostedsynthesis screws must be driven into the bone through the holes in the mo one. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

The provided text describes a 510(k) summary for Lapidus Plates and a letter from the FDA. It does not contain information about acceptance criteria, device performance metrics, or details of a study that would demonstrate the device meets such criteria in the way typically seen for AI/ML medical devices (e.g., sensitivity, specificity, AUC).

Instead, this document pertains to a traditional medical device (bone fixation plates) and its equivalence to a predicate device based on mechanical testing.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

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: Not specified. "Mechanical tests" were performed, but the number of plates tested is not mentioned.
• Data Provenance: Not applicable. This refers to mechanical testing, not clinical data or patient data.

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 defined for AI/ML devices (e.g., expert labels on images) is not relevant for mechanical testing of bone plates. The "truth" here is the physical measurement of mechanical properties.

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

• Not applicable. This concept is for resolving disagreements among human readers or labelers in diagnostic studies.

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 mechanical device, not an AI/ML diagnostic aid.

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

• Not applicable. This is a mechanical device.

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

• Ground Truth: For mechanical testing, the "ground truth" would be the objectively measured physical properties (e.g., strength, stiffness, fatigue resistance) of the devices, compared against the known properties of the predicate device.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it's not a machine learning model.

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

• Not applicable. This device does not involve a training set.

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The Newdeal TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the foot and ankle.

The NEWDEAL® TTC Plates consists of a tibiotalocalcaneal plate, available in different sizes, dedicated to be fixed using NEWDEAL® locking system fixation screws and washers. It is available in different sizes, and is implanted using NEWDEAL® locking system fixation screws and washess. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates extemporaneously a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socked at the top of each hole, thus blocking each screw head.

This document describes a 510(k) submission for the TTC Plates by Newdeal SAS. The submission is a "traditional" 510(k) given its age, and predominantly focuses on the substantial equivalence of modifications to an already cleared device.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study, formatted to your request:

Acceptance Criteria and Device Performance

Study Details:

This submission is for a modified medical device. The "study" here is a set of mechanical tests designed to demonstrate that the modified device is substantially equivalent to its predicate. It is not a clinical study involving human or animal subjects, nor is it related to AI/algorithm performance.

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

   • Sample Size: Not explicitly stated for the mechanical tests. The description indicates "mechanical tests have been carried out." For mechanical testing, samples typically refer to a specified number of physical units of the device tested under various conditions to ensure statistical significance, but this specific number is not provided in the summary.
   • Data Provenance: The tests were conducted to compare the modified device to the predicate device. The summary does not specify the country of origin for the testing, but the submitting company (Newdeal SAS) is based in France. The data is retrospective in the sense that it's comparing a new version to an existing one, but the mechanical testing itself is a prospective evaluation of the new device's properties.

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

   • This question is not applicable as the "study" involves mechanical testing, not a human-interpreted diagnostic or clinical outcome. Ground truth in this context would be engineering specifications and established testing methodologies.

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

   • Not applicable. Mechanical tests generally follow standardized procedures and results are objectively measured, rather than adjudicated by experts.

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 a bone fixation plate, not an AI or imaging diagnostic tool. No MRMC study was conducted.

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

   • Not applicable. This device is a bone fixation plate, not an AI or algorithm.

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

   • Mechanical Specifications/Engineering Standards: The ground truth for mechanical tests would be established engineering standards, material properties, and performance benchmarks derived from the predicate device and relevant international standards for bone fixation devices. The goal was to prove "similarity" to the predicate, implying the predicate's performance served as the benchmark.

7. The sample size for the training set:

   • Not applicable. This device is a bone fixation plate, not an AI system that requires a training set.

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

   • Not applicable. As above, no training set is relevant for this type of device.

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The NEWDEAL Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints (Lisfranc joints)

The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints (Lisfranc joints). It is available in different sizes, and is implanted using screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

Here's an analysis of the provided 510(k) summary regarding the Newdeal Lisfranc Plates, focusing on acceptance criteria and supporting studies:

This 510(k) summary describes a traditional device clearance process for a new medical implant, not an AI/ML-driven diagnostic device. Therefore, many of the requested categories (such as sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or not provided in this type of submission. The focus for mechanical devices like bone plates is on performance testing against a predicate device and material specifications.

Here's a breakdown of the available information:

Description of Acceptance Criteria and Study Findings

1. Table of Acceptance Criteria and Reported Device Performance

Study that proves the device meets acceptance criteria:

The primary study cited is performance testing conducted compared to a legally marketed predicate device. The key finding is that the Lisfranc Plates demonstrated "comparable results" in all mechanical aspects relevant to the intended use when compared to the predicate device. This implies that the device met the mechanical performance standards set by the predicate.

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

• Not Applicable / Not Provided. For mechanical performance testing of an orthopedic implant, "test set" typically refers to the number of devices or constructs tested in a laboratory setting. This 510(k) summary does not specify the number of samples tested biomechanically. The concept of "data provenance" (country of origin, retrospective/prospective) is not relevant for this type of mechanical testing submission.

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

• Not Applicable / Not Provided. "Ground truth" established by experts is typically for diagnostic imaging or clinical outcome data. For mechanical devices, the "ground truth" is defined by established engineering and biomechanical standards and the performance of predicate devices.

4. Adjudication method for the test set

• Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are used for expert review of clinical cases or diagnostic interpretations, which is not relevant for a mechanical device performance study described here. The "adjudication" for mechanical testing would be the interpretation of engineering data by qualified biomechanical engineers.

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, not an AI-driven diagnostic or assistive technology. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This device is a physical bone plate, not an algorithm.

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

• For this type of device, the "ground truth" is based on:
  • Biomechanical engineering standards: Established testing protocols for strength, fatigue, pull-out strength, etc., relevant to bone fixation.
  • Predicate device performance: The performance characteristics of the legally marketed predicate device serve as the benchmark for substantial equivalence.
  • Material standards: Compliance with recognized standards for biocompatibility and material properties.

8. The sample size for the training set

• Not Applicable / Not Provided. The concept of "training set" applies to AI/ML models. This is a mechanical device.

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

• Not Applicable / Not Provided. As there is no training set mentioned, this question is not relevant.

In summary: The 510(k) for the Lisfranc Plates relies on the principle of substantial equivalence to existing, legally marketed predicate devices. The "study" proving this equivalence is mechanical performance testing that demonstrates comparable results to the predicate. The detailed methodologies commonly found in AI/ML or clinical trial submissions (like expert panels, detailed sample sizes, adjudication, etc.) are not part of this type of traditional device submission.

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The KALIX® II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

• flat foot treatment in children and adolescents
• congenital flat foot
• non successful long term orthopaedic treatment (shoes, insoles ... )
• tarsal coalitions
• painfully flat foot
• supple deformity in posterior tibial tendon dysfunction
• paralytic flat foot
• subtalar instability.

The KALIX® II Flat Foot implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. This is the same indication for use as the Kalix® II Implant, K053093.
The KALIX® II Flat Foot implant is a combination of three components. Two of them are made from Titanium alloy (Ti-6Al-4V) that conforms to both ISO 5832-3 and ASTM F136 standards. The outer sleeve is made from Ultra High Molecular Weight Polyethylene (UHMWPE) is an conforms to ASTM F648-00 standard. These are the same materials as the unmodified device, KALIX® II Flat Foot implant, K053093.

This document (K061765) is a 510(k) premarket notification for a medical device called the KALIX® II Flat Foot implant. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and does not pose new questions of safety or effectiveness.

Therefore, this document does not describe acceptance criteria for device performance in the way you might find in a clinical trial or performance study, nor does it present a study that proves the device meets such criteria. Instead, the "acceptance criteria" here are regulatory criteria for substantial equivalence to a predicate device. The "study" is the submission itself, which primarily focuses on demonstrating similarities to a previously cleared device.

Specifically, the device is being cleared based on its substantial equivalence to the KALIX® II Flat Foot implant, K053093. The modifications to the new device are minor (anodization of the device) and are stated not to change the intended use or fundamental scientific technology.

Given this context, I cannot populate all the fields in your request directly as they pertain to a performance study with defined acceptance criteria and detailed study methodology. However, I can interpret the document's information in relation to a "regulatory acceptance" framework for substantial equivalence.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This is a 510(k) submission based on substantial equivalence to a predicate device, not a performance study on live subjects or retrospective data with a "test set" in the typical sense. The "test" is the comparison of characteristics against the predicate device.
• Data Provenance: Not applicable. The data provenience is the comparison of the characteristics of the proposed device against the predicate device (K053093) as reported by the manufacturer.

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

• Not applicable. There was no "test set" with a ground truth requiring expert consensus for this submission. The "ground truth" for the predicate device's safety and effectiveness was established during its own 510(k) clearance (K053093). For this submission, the "ground truth" is primarily based on the documented specifications and characteristics of both the new and predicate devices.

4. Adjudication method for the test set

• Not applicable. No "test set" requiring adjudication.

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 a surgical implant, not a diagnostic imaging device with human readers or AI components.

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

• Not applicable. This is a surgical implant, not an algorithm.

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

• The "ground truth" for demonstrating substantial equivalence is the predicate device (K053093) and its previously established safety and effectiveness. The comparison relies on documented device specifications, materials standards (ISO, ASTM), and the manufacturer's assessment that changes are minor.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of submission.

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

• Not applicable. No "training set." The "ground truth" for the predicate device and its characteristics as a basis for comparison was established through its prior 510(k) clearance process.

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The LARGE UNI-CLIP® STAPLE is indicated for fixation of bone fractures or for bone reconstruction.

Examples include:

• Arthrodesis in hand or foot surgery
• Fractures management in the foot or hand
• Mono or Bi-cortical osteotomies in the foot or hand
• Distal or proximal metatarsal or metacarpal osteotomies
• Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

The size and number of staple(s) used should be adapted to the specific indication.

The LARGE UNI-CLIP® STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs.

The surgeon can obtain a true compression, adjustable and controlled with many choice of size.

The LARGE UNI-CLIP® STAPLE is made from 316L Stainless Steel that conforms to ISO 5832-1 and ASTM F138 & F139 standards.

Here's a breakdown of the acceptance criteria and study information for the LARGE UNI-CLIP® STAPLE based on the provided 510(k) summary:

This device is not an AI/ML device, so many of the requested fields regarding AI/ML specific studies (like MRMC, standalone performance, training set details) are not applicable. The device is a bone fixation staple and the submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria (e.g., minimum tensile strength, maximum deformation). Instead, it relies on a comparative assessment of mechanical properties to the predicate device.

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

• Sample Size: Not explicitly stated. The document mentions "Mechanical tests have been carried out," implying a set of samples were tested, but the exact number isn't provided.
• Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer (Newdeal SAS). The document does not indicate country of origin for the data or if it was retrospective/prospective in a clinical context. Given it's mechanical testing of a device, it is typically laboratory-generated.

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

This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is derived from instrumentation and engineering standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for objective mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human performance (e.g., radiologists reading images) with and without AI assistance, which is not applicable to a bone staple.

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

No, a standalone algorithm performance study was not done. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used was objective mechanical measurements (e.g., load-to-failure, stiffness, deformation) obtained through laboratory testing, compared against the predicate device.

8. The Sample Size for the Training Set

This is not applicable. There is no AI/ML algorithm involved, so no training set was used.

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

This is not applicable as there is no training set for an AI/ML algorithm.

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The NEWDEAL® TTC Plates are intended for use in arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones including the foot and ankle.

The NEWDEAL® TTC Plates consists of a plate, available in different sizes, and implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

The provided document is a 510(k) summary for the NEWDEAL® TTC Plates, which are bone fixation devices. It details the device's description, intended use, and substantial equivalence to existing devices.

Crucially, this document describes a medical device clearance based on substantial equivalence, not a study evaluating an AI algorithm's performance. Therefore, many of the requested elements pertaining to AI studies (such as acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable and cannot be extracted from this text.

The document only states that "The results of performance tests demonstrate that the TTC Plates have mechanical properties compatible with the predicate devices and intended use." This indicates that mechanical testing was performed to demonstrate an equivalence of physical properties, not diagnostic performance.

Here's what can be extracted and what cannot:

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

Explanation: The document does not provide specific numerical acceptance criteria (e.g., tensile strength, fatigue life) or exact performance values. It only states that the performance tests demonstrated compatibility.

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

• Not Applicable. This document does not describe a study involving an AI algorithm or a "test set" in the context of diagnostic performance evaluation. The "performance tests" mentioned are mechanical tests of the physical device. Therefore, no information on sample size for a test set or data provenance is provided.

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. There is no "ground truth" to be established by experts for a mechanical bone fixation plate in the context of this 510(k) submission.

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

• Not Applicable. No ground truth establishment for a diagnostic test set is mentioned.

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 not an AI diagnostic device. No MRMC study was conducted or is relevant for this type of device.

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

• No. This is not an AI algorithm.

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

• Not Applicable. For a bone fixation plate, "ground truth" relates to its mechanical integrity and biocompatibility, which are assessed through engineering standards and material science, not clinical diagnostic ground truth. The "ground truth" for showing substantial equivalence relies on comparing the device's mechanical properties to those of the predicate devices and demonstrating that they meet the same functional requirements.

8. The sample size for the training set

• Not Applicable. This is not an AI algorithm.

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

• Not Applicable. This is not an AI algorithm.

In summary: The provided text is a regulatory submission for a medical device (bone fixation plates) seeking clearance based on substantial equivalence. It does not involve an AI algorithm, and therefore the extensive information requested about AI study design and performance metrics is not present in this document. The "study" mentioned refers to mechanical performance tests of the physical device, not an evaluation of diagnostic accuracy.

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The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as:

• arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus,
• Lisfranc arthrodesis -
• mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1st tarsometatarsal joint, available in different sizes, which are implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system oreates a single /screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.

The provided 510(k) premarket notification for the Newdeal SAS Lapidus Plates describes a medical device, not an AI/ML-enabled device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test sets in AI studies, expert qualifications for AI ground truth, multi-reader multi-case studies, and training set details, are not applicable.

The document demonstrates the device's substantial equivalence through mechanical testing and comparison to predicate devices, rather than clinical efficacy against acceptance criteria derived from AI performance metrics.

Here's an analysis of the provided text in the context of the device's regulatory submission:

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

• Acceptance Criteria: The document does not explicitly state numerical acceptance criteria in the way an AI/ML device would. Instead, the primary acceptance criterion for this 510(k) submission is substantial equivalence to legally marketed predicate devices. This means that the device must perform at least as well as or be equivalent in function and safety to the predicate devices.
• Reported Device Performance:

  Performance Metric	Reported Device Performance
  Bending Resistance	"greater than predicate devices (Synthes Modular Foot System)"
  Equivalence	"substantially equivalent to commercially marketed devices" (Acumed K033639, Synthes K010321, Synthes K001941)
  Novel Issues	"do not raise any new issues of scientific technology, safety or effectiveness"

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

• Not Applicable (N/A): This is a mechanical device, not an AI/ML device that uses data for performance evaluation. The "test set" here refers to the physical devices tested.
• Sample Size: Not explicitly stated as "sample size" in relation to a patient cohort. The "Testing and Test Results" section refers to an "evaluation of the bending resistance based upon mechanical calculations." This implies a mechanical engineering analysis, likely involving a limited number of physical prototypes or simulations.
• Data Provenance: N/A for this type of device. The "data" pertains to mechanical properties.

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 (N/A): As this is not an AI/ML device, there's no need for experts to establish a "ground truth" for a test set in the conventional sense of image or data interpretation. The "ground truth" for mechanical performance criteria would be established through engineering standards and testing protocols.
• Qualifications of Experts: Not specified, but would typically involve mechanical engineers or materials scientists for the design and testing of such implants.

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

• Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI evaluations to resolve discrepancies in expert opinions on ground truth. This is a mechanical device submission. The "adjudication" for mechanical testing would involve engineering verification against established test standards.

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: A multi-reader multi-case (MRMC) study is typically performed for imaging or diagnostic devices where human readers interpret data, often with or without AI assistance. This is a bone fixation plate, a passive implant, and such a study is irrelevant for its clearance.

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

• No: This question is specifically for AI/ML algorithms. The Lapidus Plate is a physical surgical implant, not an algorithm.

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

• Mechanical Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance relies on established mechanical engineering principles, calculations, and the safety and effectiveness profile of the legally marketed predicate devices. The "Conclusion" explicitly states that the device "do not raise any new issues of scientific technology, safety or effectiveness," implying its performance meets accepted industry benchmarks and regulatory requirements for similar devices.

8. The sample size for the training set

• Not Applicable (N/A): This is a mechanical device, not an AI/ML device that requires a training set.

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

• Not Applicable (N/A): This is a mechanical device, not an AI/ML device that requires a training set or ground truth in this context.

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The KALIX II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

• flat foot treatment in children and adolescents -
• congenital flat foot -
• non successful long term orthopaedic treatment (shoes, insoles ... ) -
• tarsal coalitions -
• painfully flat foot -
• supple deformity in posterior tibial tendon dysfunction -
• paralytic flat foot -
• subtalar instability. -

The KALIX® II Flat Foot implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. This is the same indication for use as the Kalix Implant, K001231.

This document is a 510(k) summary for the KALIX® II Flat Foot implant, which is a metallic bone fixation fastener. It does not describe an AI/ML device, nor does it contain information about acceptance criteria, device performance metrics, or study designs typically associated with such devices.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document primarily focuses on establishing substantial equivalence to a predicate device (KALIX® implant, K001231) based on similar intended use, materials, basic design, instructions for use, and manufacturing processes.

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The B-BOP® plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include:

• Moderate to severe hallux valgus
• Hallux varus

Newdeal has developed a plate dedicated to the fixation of basal osteotomy of the 1st metatarsal by designing the B-BOP® plate which allow to meet at best the specifications of that kind of surgical procedure.

Characteristics of the plate have taken into account all the requirements associated with basal osteotomy:

• Plantar positioning to obtain the best stability and resistance and allowing to reduce bulk
• Anatomical shape adapted to the plantar curve of the 1st metatarsal (pre-bent), available in right or left side and in two angulations (5° and 10°) for medium or large deformation.

The B-BOP® plate is made from titanium alloy (Ti-6AI-4V ELI) and the part of the plate in contact with bone is sandblasted for a better adherence of the plate.

Plates and screws are also available which are color-coded for ease of identification.

Fixation of the plate is provided by four Snap-Off screws, already present with the HALL 0 -Fix system (cleared under K021626).

With the B-BOP® plate, screws are available in 2 diameters (2.7mm and 3.0mm) and in a length range from 14mm to 26mm (2 mm increment). The screws are provided sterile with the B-BOP® plate.

Here's an analysis of the provided text regarding the acceptance criteria and study for the B-BOP® plate, structured according to your request.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify the sample size used for the test set for either the bending strength or fatigue testing.
The data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests. It can be inferred that the testing was conducted by or on behalf of Newdeal SAS, a French company, but the specific location of the testing is not stated.

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

This document describes mechanical testing (bending strength and fatigue testing) of a medical device (B-BOP® plate). Mechanical testing does not typically involve human experts to establish ground truth in the same way clinical studies or diagnostic AI algorithms do. Instead, performance is measured against engineering specifications and industry standards. Therefore, this section is not applicable to the type of study described.

4. Adjudication Method for the Test Set

As the study involves mechanical testing and not human interpretation or clinical outcomes, an adjudication method in the sense of expert consensus for ground truth is not applicable. The "adjudication" is inherent in the measurement and comparison against predefined engineering acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This document describes mechanical testing of a medical implant and does not involve human readers or AI assistance.

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

Not Applicable. This document details the mechanical testing of a physical medical device (a plate), not a software algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for this study appears to be predetermined engineering specifications and industry standards for bending strength and fatigue life of bone fixation plates. The document states, "The B-BOP® plate meets our acceptance criteria," implying that these criteria (standards for mechanical performance) served as the "ground truth."

8. The Sample Size for the Training Set

Not Applicable. This document describes mechanical testing of a physical device. There is no "training set" in the context of an AI algorithm or statistical model.

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

Not Applicable. As there is no training set, the method of establishing its ground truth is irrelevant.

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