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The implants are intended to support normal bone healing for osteotomies, non-unions and reconstructions.

The RECON system consists of various system components and it is indicated for the treative fixation, nonunions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.

The RECON system -compression screws are intended for internal fracture fixation. The system consists of the following screws:

• Microcan 1.8/2.3 ●
• . Maxican 4.5
• CBS Micro Compression ●
• CBS High Compression
• CBS 4.5/7.5 ●
• V-TEK Micro 2.0 ●
• V-TEK Standard 3.0 ●

screws of different sizes and designs.

The screws and washers are made of titanium alloy Ti-6AI-4V (ASTM F136).

The implants are offered in various sizes to accommodate the variations of bone size and geometry as well as plate sizes and configurations.

The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.

This document is a 510(k) premarket notification for the RECON system - Compression Screws. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device (bone fixation fasteners), acceptance criteria are typically related to mechanical performance and biocompatibility. The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance values. Instead, it states that the device's performance was found to be "similar" or "substantially equivalent" to predicate devices.

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

The document does not explicitly state the sample sizes used for mechanical testing or biocompatibility. It only mentions "testing on screws, and washer material" and "self-tapping performance, driving and removal torque, torgue to failure and axial pullout of the RECON system- compression screws and the predicate devices."

• Test Set Sample Size: Not explicitly provided.
• Data Provenance: Not explicitly stated, but it can be inferred that the testing was conducted by or for Normed Medizin-Technik GmbH, likely in Germany (based on their address). The data is retrospective in the sense that it evaluates a completed device design against established benchmarks.

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

This type of information is generally not applicable to mechanical and biocompatibility testing for a bone fixation device. Ground truth, in this context, refers to a definitively correct answer, which for mechanical properties is determined by physical measurements and for biocompatibility by laboratory assays. The "experts" would be the engineers and scientists conducting and interpreting these tests, whose qualifications are implied by their role in such studies (e.g., biomedical engineers, materials scientists, toxicologists). No specific number or qualifications are given beyond the fact that the tests were performed according to recognized standards (ISO 10993-1).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies where human interpretation of ambiguous data is involved to establish a consensus ground truth. For mechanical and biocompatibility tests, results are typically objective measurements against defined pass/fail criteria.

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

No. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data. This device is a surgical implant (bone fixation fastener), and its effectiveness is primarily assessed through mechanical performance and biocompatibility, not by human reader interpretation. Therefore, there is no mention of such a study or an effect size of human readers improving with or without AI assistance.

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

Not applicable. This device is a physical surgical implant, not an algorithm or software. It does not have "standalone performance" in the context of an algorithm.

7. Type of Ground Truth Used

• Mechanical Testing: The ground truth for mechanical testing is based on objective physical measurements (e.g., torque values, pullout strength) compared against established performance characteristics of predicate devices and relevant engineering standards.
• Biocompatibility: The ground truth for biocompatibility is based on laboratory test results (e.g., cytotoxicity, sensitization, irritation) evaluated against the criteria outlined in ISO 10993-1.

8. Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI or machine learning model. Therefore, there is no "training set" in the conventional sense. The design and manufacturing processes are likely informed by years of engineering knowledge and experience with similar devices, but not a data-driven training set for an algorithm.

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

Not applicable, as there is no training set for this type of device.

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The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.

The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.

Gruber Lapidus

The Gruber Lapidus Plates 2.7 combined with the Standard/Locking/ MiniCAN screws 2.7 are indicated for TMT I joint arthrodesis with cuneiforme transfixation for correction of hallux valgus deformity.

Plantar Lapidus

The Plantar Lapidus Plates 2.7 combined with the Standard/Locking Screws 2.7 and the MiniCAN screws 3.5 are indicated for TMT I joint arthrodesis.

Tarsalis

The Tarsalis Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for Lisfranc fusions and fracture fixation of the forefoot and midfoot.

The RECON system – Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:

• Gruber Lapidus Plates 2.7, .
• . Plantar Lapidus Plates 2.7,
• Tarsalis Plates 2.7, ●
• Locking Screws 2.7 ●
• Standard Screws 2.7
• Minican Screws 2.7/3.5

of different sizes and designs.

The plates and screws are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.

This document describes a 510(k) premarket notification for the RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics. Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and detailed ground truth establishment) are not applicable to this type of regulatory submission.

However, based on the provided text, here's an attempt to address your request:

Acceptance Criteria and Study for the RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a standalone performance study with predefined clinical acceptance criteria, the "acceptance criteria" are implied by the performance characteristics demonstrated to be "similar" or "substantially equivalent" to legally marketed predicate devices. The "reported device performance" is characterized by meeting these similarity benchmarks.

The non-clinical performance data aimed to demonstrate that the subject device's mechanical properties and biocompatibility are comparable to those of the predicate devices, thereby ensuring similar safety and effectiveness.

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

This is a non-clinical (bench) testing study, not a clinical trial. Therefore, the concept of a "test set" for clinical performance, with associated data provenance, is not applicable. The non-clinical tests involved physical samples of the devices. The document does not specify the exact number of physical samples used for each mechanical test. Data provenance is internal to Normed Medizin-Technik GmbH in Germany, as described in the "Submission Sponsor and Correspondent" section. The data is prospective, generated specifically for this submission.

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

Not applicable. Ground truth for non-clinical engineering tests is established by standardized testing methods and measurement instruments, not by expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as it's a non-clinical bench testing study.

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

No, a MRMC comparative effectiveness study was not done. This device is not an AI/software device that would typically undergo such a study.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

For non-clinical performance, the "ground truth" is defined by the physical properties of the materials and designs, measured through standardized mechanical tests. For biocompatibility, it's adherence to international standards (ISO 10993-1).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a training set.

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

Not applicable, as there is no training set for this type of device.

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The implants are intended to support normal bone healing for osteotomies, fractures, non-unions and reconstructions.

The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, non-unions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in both adult and pediatric patients.

The RECON system – V-TEK-IVP Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:

• V-TEK™ IVP Micro XS Plate 2.7, ●
• V-TEK™ IVP S Plate 2.7, .
• V-TEK™ IVP S. L-Plate 2.7 .
• . V-TEK™ IVP M Plate 2.7
• V-TEK™ IVP M Plate 3.5 .
• . V-TEK™ IVP L Plate 2.7
• V-TEK™ IVP L Plate 2.7 / 3.5
• . Titanium Screw Fully Treaded 2.7/3.5

of different sizes and designs.

The plates and screws are made of titanium alloy Ti-6AI-4V (ASTM F136).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.

This document is a 510(k) premarket notification for the RECON system - V-TEK-IVP Plates and Screws. It describes the device and its intended use, and argues for its substantial equivalence to several predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail sense for device performance. Instead, it relies on comparison to predicate devices and established standards. The reported device "performance" is primarily described as having "similar mechanical properties and performance" to the predicate devices.

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

The document describes non-clinical performance data which includes biocompatibility and mechanical testing.

• Sample Size: The document does not specify the exact sample sizes used for the mechanical testing or biocompatibility studies. It only states that testing was "conducted and evaluated."
• Data Provenance: The data is from non-clinical laboratory testing performed on the devices themselves, not from human or animal subjects. Thus, there is no country of origin of data or retrospective/prospective classification in the clinical sense.

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

This document does not involve a study with a "test set" requiring expert ground truth establishment in the context of diagnostic or interpretive performance. The studies are engineering and biocompatibility tests of a physical medical device (bone plates and screws).

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" requiring expert adjudication for ground truth.

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 submission for a physical orthopedic implant (bone plates and screws), not a diagnostic or AI-assisted device. Therefore, no MRMC study or AI performance evaluation was conducted or is relevant.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance data, the "ground truth" is based on:

• Biocompatibility: Adherence to the Pass/Fail criteria defined within the ISO 10993-1 standard for biological evaluation of medical devices.
• Mechanical Testing: Comparison of the measured mechanical properties (proof load, bending strength, fatigue strength, torque, pullout, etc.) of the subject device against those of the legally marketed predicate devices, with the aim of demonstrating "similar" performance. The implicit ground truth here is that the predicate devices have established safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or AI, and therefore has no "training set."

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

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

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The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.

The RECON system – MPJ Plates consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used for adult patients. Additional information is provided in the corresponding surgical techniques.

MP-Joint Fusion Plates 2.7

The MP-Joint Fusion Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for the arthrodesis of the first metatarso-phalangeal joint.

• Plate size S is indicated for standard MP-Joint fusions.
• . Plate Sizes M/L are indicated for standard MP-Joint fusion and interpositioning / revision fusions with bone graft (f.e. for revision of Keller-Brandes).

Universal Reconstruction Plates 2.7

The Universal Reconstruction Plates 2.7 combined with Standard/Locking Screws 2.7 are indicated for revision of MP-joint fusion and for reconstruction procedures in forefoot and midfoot.

docPrice Revision Plates 2.7/3.5

The docPrice Revision Plates 2.7/3.5 combined with the Standard/Locking Screws 2.7/3.5 are indicated for MTP I lengthening osteotomy and/or arthrodesis, especially indicated for cases of Keller-Brandes revisions, revisions after MTP I prosthesis and lengthening of short first toe.

The RECON system – MPJ plates is a plate system intended for internal fracture fixation. The system consists of the following plates:

• MP - Joint Fusion Plates 2.7,
• . Universal Reconstructions Plates 2.7,
• . docPrice Revision Plates 2.7/3.5

of different sizes and designs.

The plates are either made of titanium alloy Ti-6Al-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.

The provided document is a 510(k) premarket notification for the RECON System - MPJ Plates, a metallic bone fixation appliance. This type of document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel study with specific acceptance criteria and detailed performance metrics of a new AI/software device.

Therefore, the information required to answer your questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/software device is not present in this document.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is a medical device clearance based on substantial equivalence, not a performance study against predefined criteria for an AI/software. The document mentions "similar mechanical properties and performance" to predicate devices.
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. The "testing" referred to is biocompatibility and engineering analysis, not a clinical study with a test set in the context of AI performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device is not relevant here.
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 document pertains to a physical medical implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states:

• "Non-Clinical Performance Data: Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1. All testing passed. Cross sectional engineering analysis of the plates, proof load, bending strength, bending stiffness, equivalent bending stiffness and fatigue strength of the RECON System-MPJ plates and the predicate devices... resulted in similar mechanical properties and performance."
• "Clinical Performance Data: There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

This indicates the device's acceptance was based on non-clinical (biocompatibility and mechanical) testing and demonstration of substantial equivalence to existing devices, not on a clinical performance study with AI-specific metrics.

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The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.

The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.

The RECON system is a plate and screw system intended for internal fracture fixation. The system consists of the following plates:

• Reconstruction Plates 3.5, ●
• Medialis Plates 3.5, ●
• Universal Plates 3.5
• Universal Plates 3.5, H-shaped .
• USG Plates 3.5 ●
• Interpositioning Arthrodesis Plates ●
• Lapidus Plates ●
• . Dwyer Plates

screws and washers of different sizes and designs.

The plates, screws, and washers are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.

The provided text describes the RECON system, a plate and screw system for internal fracture fixation, and its substantial equivalence to predicate devices, as reviewed by the FDA in a 510(k) submission. However, this document does not contain acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner described in your request for a medical AI/software device evaluation.

The information provided is typical for a 510(k) submission for a physical medical device (implants), which primarily focuses on demonstrating substantial equivalence to already legally marketed predicate devices through material testing and performance comparison, rather than human-in-the-loop or standalone algorithm performance for AI/software.

Here's an breakdown of why the information you requested cannot be fully extracted and what can be said based on the provided text:

1. Table of acceptance criteria and the reported device performance

• Not Applicable in the provided text. The document describes a physical medical device (implants), not an AI/software device. Therefore, there are no "acceptance criteria" related to AI performance metrics (like accuracy, sensitivity, specificity, AUC) or "reported device performance" in that context.
• Instead, the "performance" demonstrated is mechanical:
  • Biocompatibility: Passed all testing per ISO 10993-1.
  • Mechanical Properties (Plates): Cross sectional engineering analysis, proof load, bending strength, bending stiffness, equivalent bending stiffness, and fatigue strength were "similar" to predicate devices.
  • Mechanical Properties (Screws): Self-tapping performance, driving and removal torque, to failure, and axial pullout were "similar" to predicate devices.
  • Washers: Substantially equivalent to previously cleared washers.

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 describes mechanical testing of physical implants, not a clinical study or a study involving a "test set" of patient data for an AI. The "samples" would be the physical plates, screws, and washers subjected to mechanical loads. The document does not specify the number of individual components tested but states "all testing passed" for biocompatibility and that analysis resulted in "similar mechanical properties and performance" for the other tests.

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

• Not applicable. There is no "ground truth" establishment by experts in the context of an AI/software evaluation for this device. The "ground truth" for mechanical testing would be the physical properties and performance measured by engineering standards.

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

• Not applicable. No adjudication method is described because there's no expert interpretation of data relevant to AI performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was not done. This is a physical implant, not an AI-powered diagnostic or assistive device.

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

• Not applicable. There is no algorithm to perform a standalone performance evaluation.

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

• Mechanical testing standards and measurements. For a physical device, the "ground truth" is typically defined by established engineering and material science standards (e.g., ASTM, ISO). The results of the mechanical tests (e.g., tensile strength, fatigue life) are compared against these standards or against predicate device performance.

8. The sample size for the training set

• Not applicable. No AI "training set" is relevant to this device.

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

• Not applicable. No AI "training set" or corresponding ground truth establishment is relevant to this device.

Summary of what the document does provide regarding "performance":

The study described is a non-clinical performance evaluation comparing the RECON System's mechanical properties and biocompatibility to predicate devices.

• Tests Conducted:
  • Biocompatibility (ISO 10993-1)
  • Cross sectional engineering analysis of plates
  • Proof load, bending strength, bending stiffness, equivalent bending stiffness, fatigue strength of plates
  • Self-tapping performance, driving and removal torque, to failure, axial pullout of screws
• Results: All tests indicated "similar mechanical properties and performance" or that the device "passed." This led to the conclusion of "substantial equivalence" to the predicate devices.
• Clinical Data: No clinical testing was required as the device's indications for use are equivalent to predicate devices with a proven safety and efficacy record on the market for many years.

In conclusion, your request focuses on criteria relevant to the evaluation of AI/software as a medical device. The provided FDA 510(k) document is for a physical orthopedic implant (RECON System) and thus addresses mechanical and biocompatibility testing, not AI performance metrics.

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