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arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.

arcad® 2.0 Duo & Quadro osteosynthesis compressive staple implants with two-leg and four-leg configurations with multiple bridge and leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant ready to implant assembled in open legs position on its dedicated disposable insertor forceps and instruments for implantation. The implant is designed to facilitate bone fusion with Nitinol pseudoelastic behavior.

This is a medical device submission, not a submission for an AI-powered device or software. Therefore, the provided information does not contain the details typically associated with acceptance criteria and study designs for AI systems. The document describes a traditional medical device, specifically osteosynthesis compressive staples.

However, I can extract the acceptance criteria related to the device's performance as tested and the general approach to proving substantial equivalence.

Acceptance Criteria and Device Performance (based on non-clinical testing for substantial equivalence):

Study Information (Non-Clinical Performance Testing):

The device is a physical medical implant (osteosynthesis compressive staples), not an AI system. Therefore, the questions related to AI-specific study design (test set size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable.

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

• Sample size used for the test set and data provenance: The document does not specify exact sample sizes for each non-clinical test conducted (static bending, fatigue, pullout, corrosion, thermal analysis). The testing was conducted by the manufacturer, Novastep SAS, in France.
• Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for mechanical and material properties of an implant is established through standardized testing methodologies, not expert consensus as in AI image interpretation.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable to a physical implant.
• If a standalone performance study was done: The "standalone" performance here refers to the device's intrinsic mechanical and material properties. The non-clinical tests (bending, fatigue, pullout, corrosion, thermal analysis) are essentially standalone performance evaluations against established standards and comparison to a predicate device.
• The type of ground truth used: The ground truth is defined by recognized industry standards (e.g., ASTM F564-17 for mechanical properties, ASTM F2129-19a for corrosion, ASTM F2004-17 for thermal analysis) and comparison to the performance of a legally marketed predicate device (ARCAD compressive osteosynthesis staple, K142111).
• The sample size for the training set: Not applicable (no training set for a physical implant).
• How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Performance Testing Approach:

The manufacturer conducted functional testing to demonstrate that the arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are substantially equivalent to their predicate device (ARCAD compressive osteosynthesis staple, K142111). This was done by evaluating the device's properties against relevant FDA guidance for Nitinol products ("Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol") and established ASTM standards. The tests covered:

• Mechanical properties: Static bending, bending fatigue, and pullout strength (referencing ASTM F564-17).
• Material properties: Corrosion resistance (referencing ASTM F2129-19a) and thermal analysis by Differential Scanning Calorimetry (referencing ASTM F2004-17).

The document explicitly states: "Performance testing and engineering analysis demonstrated substantial equivalence to the predicate device in the following..." meaning the device met the criteria for similarity in performance to the predicate device under these tests.

Clinical Study Information:

The document explicitly states: "Not applicable. Clinical studies were not required for this submission." This means that the FDA determined that the non-clinical testing was sufficient to establish substantial equivalence for the device.

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Nexis® compressive screws system is a single use device indicated for the fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients. The system is indicated for:

Ø5.0mm compressive screw:

• Os Calcis and talar fractures
• Calcaneus osteotomies
• Arthrodesis of the tarsals

Ø7.0mm compressive screw:

• Ankle arthrodesis
• Calcaneus osteotomies

Nexis® is a range of osteosynthesis compressive single use screws, made of titanium alloy, designed to address foot and ankle indications. These devices are designed for stable fixation and have quick insertion features.

They are implantable medical devices intended to be used in orthopedics for foot and ankle surgery. The device is sold sterile. The shelf life is 5 years.

This FDA 510(k) premarket notification summary for the Nexis® compressive screws describes non-clinical testing to demonstrate substantial equivalence to predicate devices. It does not involve AI or algorithms, and therefore, an analysis of the device's performance based on AI/ML criteria is not applicable. The provided document focuses on mechanical and biological properties of the screws.

Here's an analysis of the available information regarding acceptance criteria and the study (non-clinical) that proves the device meets them:

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

Notes on Acceptance Criteria: The document primarily relies on demonstrating substantial equivalence to predicate devices through established industry standards (ASTM, ISO) and relevant guidance (FDA Guidance "orthopedic non-Spinal metallic bone screw and washers – Performance Criteria for safety and Performance based pathway"). The specific quantitative acceptance criteria (e.g., minimum torque values, pull-out strength in Newtons) are not explicitly stated in this summary but would have been defined within the full test reports submitted to the FDA and would align with the predicate device's performance or standard requirements.

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 for Test Set: Not explicitly stated for each test. The testing involved various mechanical and biological evaluations of the screws. Typically, mechanical testing involves a statistically relevant number of samples to ensure reproducibility and confidence in results (e.g., 5-10 samples per test condition), but this detail is omitted from the summary.
• Data Provenance: The studies are non-clinical, so "country of origin of the data" in the sense of patient data is not applicable. The testing was performed in the context of the manufacturer (Novastep® S.A.S.) who is based in France. The studies are by nature prospective, as they are conducted specifically to support the 510(k) 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. This is a medical device (screw) clearance based on mechanical, material, and biological properties, not an AI/ML diagnostic or prognostic device that requires expert-established ground truth from medical images or patient data.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation of data, typically in diagnostic or screening contexts, often with images. This submission is for a physical orthopedic implant and does not involve such an adjudication process.

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 an AI/ML-driven device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

Not applicable. This is not an AI/ML-driven device or an algorithm.

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

Not applicable. For this type of device, "ground truth" is established through engineering principles, material science, and conformance to recognized standards (e.g., ASTM, ISO), rather than medical consensus or clinical outcomes data. The performance of the device itself (e.g., its strength, sterility, biocompatibility) is the "ground truth" being assessed against predefined engineering and quality specifications.

8. The sample size for the training set

Not applicable. This involves non-clinical testing of physical devices, not an AI/ML algorithm that requires a training set.

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

Not applicable. As noted in point 8, there is no training set for an AI/ML algorithm in this submission.

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Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes.

Examples include:

• 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.)
• Calcaneus/cuboid arthrodesis
• Talar/navicular arthrodesis

The system may be used in adult patients.

Airlock® Centrolock® osteosynthesis implant systems are single-use bone fixation devices intended to be permanently implanted. implant systems are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 2mm cortical screws or 2,5mm locking screws. The drill holes are aligned to make sure there is no risk of conflict between the screws. The implant vary essentially through different curvatures and shapes.

Here's a breakdown of the acceptance criteria and study information for the Airlock® Centrolock® osteosynthesis implant system based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K192356) is a 510(k) summary for a medical device. For such devices, "acceptance criteria" are typically met through performance testing that demonstrates substantial equivalence to a predicate device, rather than specific numerical performance metrics for an AI algorithm. The document emphasizes mechanical and material characteristics.

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

This is not an AI/software device submission. The "test set" in this context refers to the samples used for mechanical and biocompatibility testing.

• Sample Size: Not explicitly stated in terms of specific numbers of implants or screws tested for mechanical properties. Biocompatibility would involve various test samples, also not specified numerically.
• Data Provenance: Not applicable in the context of clinical data. The tests are material and mechanical characterization tests conducted in a laboratory setting. No country of origin for clinical data is relevant here as no clinical studies were performed. The tests are prospective in the sense that they were designed and executed for this submission.

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

Not applicable. This is not an AI device where expert ground truth is typically established. The "ground truth" for mechanical testing is based on established engineering standards (ASTM, ISO).

4. Adjudication Method for the Test Set

Not applicable. This is not an AI device with human expert interpretation or 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 medical implant, not an AI-powered diagnostic or assistive device. No MRMC study was performed.

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

Not applicable. This is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Engineering Standards: Established international standards for material composition (ISO 5832-3), mechanical testing (ASTM F382-17, ASTM F543-17), and biocompatibility (ISO 10993-1).
• Substantial Equivalence: Comparison to legally marketed predicate devices in terms of intended use, indications for use, material, design, and function. The "truth" is that the new device is as safe and effective as the predicate.

8. The Sample Size for the Training Set

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

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

Not applicable.

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Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.

Airlock® osteosynthesis plate systems are single-use bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.

This document is a 510(k) Premarket Notification for the Airlock® osteosynthesis plate system. It describes the device, its intended use, and demonstrates its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request for acceptance criteria and study information:

Key Finding: This document is concerned with demonstrating substantial equivalence of a new medical device (Airlock® osteosynthesis plate system) to an existing legally marketed device (Anchorage® Bone Plate System) based on similar technological characteristics and performance data. It explicitly states that clinical studies and animal studies were not required for this submission. Therefore, it does not describe a clinical study of the device to meet specific performance acceptance criteria in the way you might expect for an AI algorithm or diagnostic tool.

Instead, the "acceptance criteria" and "study" are focused on demonstrating that the new device is as safe and effective as the predicate device through bench testing and material characterization to meet recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device submission, the "acceptance criteria" relate to material composition, mechanical properties, and biocompatibility, as established by recognized standards. The "performance" refers to the device meeting these standards.

Regarding items 2 through 9:

Due to the nature of this 510(k) submission for a mechanical implant and the explicit statement that "Clinical studies was not required for this submission" and "Animal Study was not required for this submission," the following points related to clinical or AI algorithm performance studies are not applicable (N/A) in this context:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (No clinical test set described)
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): N/A (No clinical ground truth described)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set 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: N/A (This is a mechanical implant, not an AI or diagnostic tool)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is a mechanical implant, not an AI algorithm)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (The "ground truth" here is compliance with engineering and material standards through laboratory testing, not medical diagnostic ground truth.)
8. The sample size for the training set: N/A (No AI training set described)
9. How the ground truth for the training set was established: N/A (No AI training set described)

In summary: This document is an FDA 510(k) premarket notification for a bone plate system. It demonstrates substantial equivalence to a predicate device through engineering tests (material, mechanical properties, biocompatibility) and compliance with established industry standards (ISO, ASTM), rather than through clinical trials or performance studies on a test set of patient data, which are typically required for diagnostic software or AI algorithms.

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Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.

Airlock® osteosynthesis plate systems are bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.

This document is a 510(k) premarket notification for the "Airlock® osteosynthesis plate system." It's a review by the FDA to determine substantial equivalence to a legally marketed predicate device, not a study proving device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving it cannot be extracted from this document, as it outlines regulatory approval based on equivalence rather than detailed performance study results.

Here's what can be extracted based on the provided text:

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

Not applicable. This document is a 510(k) summary for regulatory clearance, not a performance study report with acceptance criteria and measured performance. It states that the device has "similar technological characteristics" and "mechanical characteristics" to the predicate device, implying equivalence rather than direct performance measurement against specific acceptance criteria.

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. This document does not detail a test set sample size or data provenance from a performance study.

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. This document does not describe a process for establishing ground truth using experts.

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

Not applicable. This document does not describe an adjudication method for a test set.

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 document is for a mechanical medical device (osteosynthesis plate system), not an AI-assisted diagnostic device. Therefore, an MRMC study with human readers and AI assistance is irrelevant and not mentioned.

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

Not applicable. This document is for a mechanical medical device (osteosynthesis plate system), not an algorithm.

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

Not applicable. This document does not describe the establishment of a ground truth for a performance study. The approval is based on substantial equivalence to a predicate device, supported by material and mechanical properties comparisons.

8. The sample size for the training set

Not applicable. This document does not describe a training set as it pertains to a mechanical medical device and regulatory clearance based on equivalence.

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

Not applicable. This document does not describe a training set or its ground truth establishment.

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The Lync® intramedullary implants are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion.

Lync® intramedullary implants are single-use bone fixation devices intended to be permanently implanted. Lync® intramedullary implants are made of unalloyed titanium.

The provided text is a 510(k) Summary for the Lync® intramedullary implant by Novastep, which is a medical device. This document does not pertain to an AI/ML device, but rather a physical implant. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth, training set details) is not applicable or cannot be extracted from this type of regulatory submission.

The document discusses the substantial equivalence of the Lync® intramedullary implant to predicate devices based on mechanical characteristics, material, intended use, and indications for use. It references compliance with ASTM F564-10 for metallic bone staples and ISO 5832-2 for unalloyed titanium. Biocompatibility was evaluated according to ISO 10993-1.

Key points from the document regarding device testing:

• Mechanical characteristics: Tested according to ASTM F564-10 Sections A1, A2, and A4 (Standard Specification and Test Methods for Metallic Bone Staples). These tests would likely involve static bending, dynamic bending, and pull-out resistance.
• Material: Conforms to ISO 5832-2 (Implants For Surgery - Metallic Materials – Part 2: Unalloyed Titanium).
• Biocompatibility: Evaluated in accordance with ISO 10993-1.

Since this is a 510(k) submission for a non-AI medical device, a direct mapping to the requested AI/ML specific criteria (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone algorithm performance, training set details) is not possible. The document explicitly states: "Clinical studies were not required for this submission" and "Animal studies were not required for this submission." The basis for clearance is demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics, materials, and mechanical performance.

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The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.

Nexis® osteosynthesis compressive screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis compressive screws are canulated compressive screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis compressive screws are compressive canulated bone screws which allow a permanent compression, thus supporting a secure osseous restoration.

The provided text describes the 510(k) premarket notification for the Nexis® osteosynthesis compressive screws. This is a medical device application for bone fixation, and the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and testing for a new or novel device's performance against specific metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for a software algorithm/AI device is not applicable to this document.

Here's why and what information is provided:

• Device Type: The Nexis® osteosynthesis compressive screws are physical implants (canulated compressive screws made of Titanium). They are not an AI/software device.
• Regulatory Pathway: The 510(k) pathway demonstrates that the new device is "substantially equivalent" to predicate devices already on the market. This involves comparing characteristics like material, mechanical properties, and intended use. It does not typically require the establishment of new, performance-based acceptance criteria in the way an AI/software device would, nor does it conduct studies to prove the device meets such criteria in terms of diagnostic accuracy or output performance.
• "Performance data" in this context refers to engineering and biocompatibility testing, not diagnostic performance. The document states:
  • "The biocompatibility evaluation for new devices Nexis® osteosynthesis compressive screws was conducted in accordance with Blue Book Memorandum #G95-1... and International Standard ISO 10993-1..."
  • "The new devices Nexis® osteosynthesis compressive screws have similar technological characteristics in terms of design and mechanical characteristics (Driving and removal torque, pull-out strength, torsional resistance) and thus are believed to be substantially equivalent to the predicate Memometal Fixos screws (device references: S-Fix/C-Fix/P-Fix) (K070039) and SBI Autofix™ System (K052576)."
• Clinical and Animal Studies: The document explicitly states: "Clinical studies were not required for this submission. Animal studies were not required for this submission."

In summary, none of the requested information regarding acceptance criteria, study design for performance metrics, sample sizes for test/training sets, expert ground truth establishment, or AI-specific study types (MRMC, standalone algorithm performance) can be extracted from the provided text because it pertains to a different type of medical device and regulatory submission.

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The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.

Nexis® osteosynthesis snap-off screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis snap-off screws are non canulated snap-off screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis snap-off screws are non canulated snap-off bone screws which allow a permanent compression, thus supporting a secure osseous restoration.

The document describes a 510(k) premarket notification for the "Nexis® osteosynthesis snap-off screws" device, comparing it to a predicate device, the "Memometal Fixos screws." This type of submission relies on demonstrating substantial equivalence to a legally marketed device rather than conducting extensive new clinical trials. Therefore, the information provided does not align with the typical structure of acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

However, I can extract and structure the available information regarding the "performance data" that NOVASTEP provided to demonstrate substantial equivalence, framing it in terms of "acceptance criteria" and "reported device performance" as much as possible for this specific type of device (an orthopedic screw).

Acceptance Criteria and Reported Device Performance for Nexis® osteosynthesis snap-off screws

1. Table of Acceptance Criteria and the Reported Device Performance

• Driving and removal torque
• Pull-out strength
• Torsional resistance |
  | Biocompatibility | Evaluation conducted in accordance with Blue Book Memorandum #G95-1 (Use of International Standard ISO-10993) and International Standard ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process) as recognized by FDA. |
  | Design Characteristics | Similar design characteristics to the predicate device. Nexis® screws are described as non-cannulated snap-off screws designed for permanent compression and secure osseous restoration. |
  | Intended Use & Indications for Use | Identical intended use: fixing and stabilizing elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only. |

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

• Sample Size: Not explicitly stated. The performance data for mechanical testing and biocompatibility study typically involves a certain number of samples for each test, but the specific quantities are not detailed in this summary.
• Data Provenance: Not explicitly stated. These tests are usually conducted in specialized labs.
• Retrospective or Prospective: Not applicable in the context of comparing a new device's material and mechanical properties to a predicate and recognized standards.

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

• Not applicable. This is not a study involving expert assessment of data like in AI/ML performance evaluation. The "ground truth" here related to engineering standards and material properties.

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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• The "ground truth" in this context refers to established engineering standards (e.g., ISO 5832-3 for material, ASTM F543-13 for mechanical tests, ISO 10993 for biocompatibility) and the known characteristics of the legally marketed predicate device (Memometal Fixos screws). The testing confirms the new device's properties align with these standards and the predicate.

8. The sample size for the training set

• Not applicable. No training set is used for this type of device submission.

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

• Not applicable. No training set is used for this type of device submission.

Summary Explanation:

The "study" demonstrating the device meets the acceptance criteria is detailed under "Performance data" in the 510(k) summary. It states that NOVASTEP's Nexis® osteosynthesis snap-off screws have been evaluated for biocompatibility according to FDA-recognized ISO 10993 standards and for mechanical characteristics (driving and removal torque, pull-out strength, torsional resistance) to demonstrate similarity with the predicate device, Memometal Fixos screws. The material (Titanium Alloy Ti-6Al-4V ELI) is also stated to be in accordance with ISO 5832-3 and similar to the predicate.

Crucially, the document explicitly states: "Clinical studies were not required for this submission" and "Animal Studies were not required for this submission." This is typical for 510(k) submissions where substantial equivalence is primarily demonstrated through comparison to a predicate device's design, materials, and mechanical performance, and adherence to recognized standards, rather than new human clinical efficacy trials. The "acceptance criteria" are effectively the established standards and the characteristics of the predicate device that the new device must match or be equivalent to.

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