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The OsteoCoil™ Nitinol Compression System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of the small bones for wrist, hand, and foot.

This Traditional 510(k) is submitted to introduce the OsteoCoil™ Nitinol Compression System. The system consists of a 4.5mm, 6.5mm and 7.3mm screw available in 30mm in 5mm increment lengths and appropriate instrumentation to support implantation of the OsteoCol™ Nitinol Compression screws. The the OsteoCol™ Nitinol Compression System have the same technological characteristics as the predicate device, the Dynafuse Fixation System (K203595).

The provided text is related to a 510(k) premarket notification for the OsteoCoil™ Nitinol Compression System. It describes the device, its intended use, and a summary of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving device performance against such criteria in the context of a clinical or standalone performance study involving AI or human readers.

Instead, the document details physical and material properties testing for a medical implant (bone fixation fastener).

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided text.

The closest information available is a list of non-clinical mechanical and material tests conducted to demonstrate substantial equivalence:

Non-Clinical Test Summary:

The following non-clinical tests were performed:

• ASTM F543:
  • Torsional Strength
  • Driving and Removal Torque
  • Axial Pullout Strength
  • Self-tapping Force
• ASRM F1264:
  • Bending Fatigue
  • Static 4Pt Bending
• ASTM F2129: Pitting Corrosion Testing
• ASTM F2004: Transformation Temperature Testing
• Additionally:
  • Extension and Compression Force Testing
  • Bacterial endotoxin testing based on an endotoxin limit of 20EU/device per ANSI/AAMI ST72:2011
  • Applicable testing per ISO 10993

Conclusion from the document: "The results demonstrate that the OsteoCoil™ Nitinol Compression System is substantially equivalent to the legalicate devices."

This document focuses on the mechanical and material safety/performance of a physical medical device, not a software or AI-driven diagnostic tool. Therefore, the concepts of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity), ground truth establishment by experts, adjudication, or AI performance studies are not applicable here.

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The Flex-Thread™ Ulna Intramedullary Nail System is intended for use in the fixation of fractures and osteotomies of the ulna.

The Flex-Thread™ Ulna Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the intramedullary canal of the ulnar diaphysis from an antegrade approach and cortical screws to provide stability and articular support in the proximal ulna and olecranon.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for software or AI/ML.

The document is a 510(k) premarket notification for a medical device called "Flex-Thread™ Ulna Intramedullary Nail System". It focuses on establishing substantial equivalence to a predicate device through mechanical testing, not through performance metrics of a software or AI/ML component.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as these are not discussed in the context of the provided text. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that "[n]on-clinical performance testing demonstrates that the Flex-Thread™ Una Intramedullary Nail System is substantially equivalent to the predicate device." The tests mentioned are mechanical tests such as static four-point bend, static torsion, bending fatigue, and bending fatigue of interlocking screws, along with insertion torque and implant tip deflection. These are physical product performance tests, not AI/ML performance evaluations.

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The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.

The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.

This FDA 510(k) summary describes a modification to an existing medical device, the Flex-Thread™ Distal Fibula Intramedullary Nail System, rather than the initial clearance of a novel AI/Ml medical device. Therefore, the information typically requested regarding acceptance criteria, study design for AI performance, sample sizes, and ground truth establishment, as it pertains to AI algorithms, is not applicable in this context.

The submission is a Special 510(k) to introduce a larger diameter nail (5.5mm) and an additional end cap (1mm) to an already cleared system. The focus of the provided text is on demonstrating the substantial equivalence of these mechanical modifications to the predicate device, not on the performance of a software algorithm.

Here's a breakdown of why this information is not present and what was done instead:

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

• Not Applicable. This document does not describe performance metrics for an AI algorithm. Instead, it states that "Mechanical testing was performed on the modified Flex-Thread™ Distal Fibula Intramedullary Nail System using the same protocols as those used to verify the Flex-Thread™ Distal Fibula Intramedullary Nail System design as part of K202858." The tests included "Tip Reaction Force, Insertion Torque, and Simulated Use Cadaver Lab." The conclusion is that "The results design inputs meet design outputs and substantial equivalence of the subject device to the predicate." This implies that the acceptance criteria were met for these mechanical tests, but specific quantitative acceptance criteria or detailed results are not provided in this summary.

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 refers to sample sizes for mechanical testing (e.g., number of nails tested, number of cadavers). The document mentions "Simulated Use Cadaver Lab" but does not specify the number of cadavers or the origin of the cadaveric material.

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 relevant for AI image analysis or diagnostic devices. No expert review for ground truth is described for this mechanical device modification.

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

• Not Applicable. This pertains to expert review in AI 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:

• Not Applicable. This is specifically for AI-assisted diagnostic devices.

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

• Not Applicable. This is for AI algorithm performance.

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

• Not Applicable. Ground truth for AI algorithms. For a mechanical device, performance is evaluated against engineering specifications and biomechanical principles.

8. The sample size for the training set:

• Not Applicable. No AI model training is described.

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

• Not Applicable. No AI model training is described.

In summary, the provided document is a regulatory submission for a modification to a mechanical orthopedic implant, not an AI/ML medical device. Therefore, questions related to AI algorithm performance, training, and ground truth are not relevant to this content.

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The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease.

The FlowerAnchor. 3.0mm is indicated for use in soft tissue reattachment procedures in the shoulder, elbow, wristhand. foot/ankle and knee. Specific indications are as follows:

· Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.

• · Wrist/hand indications: Scapholunate ligament reconstruction.
  · Foot/Ankle indications: Tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.

• · Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
  • Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The FlowerAnchor, 5.0mm and FlowerAnchor, Knotless is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation,deltoid repair, biceps tenodesis.

• Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
  · Foot/Ankle indications: Achilles tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.

· Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.

• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The Flower Suture Anchor Set consists of FlowerAnchor, 3.0mm, FlowerAnchor, 5.0mm, and FlowerAnchor, Knotless with lengths of 10mm and 17mm, respectively. The anchors are screw-like in shape and made of PEEK. The anchors are threaded with ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures. The 3.0mm and 5.0mm anchors, USP Size 0 and Size 2 sutures, and inserters and the Knotless anchor and inserter are supplied as a single assembly, sterilized by ethylene-oxide, nonpyrogenic, and ready-for-surgery.

Accessories of Taps and Drill Bit Kits are supplied sterile by means of gamma radiation with the Flower Suture Anchor Set.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Flower Suture Anchor Set." It does not present a study proving the device meets acceptance criteria in the context of an AI/ML-driven solution or diagnostic tool. Instead, it demonstrates substantial equivalence to existing predicate devices based on mechanical and biological performance testing for hardware.

Here's why the requested information about AI model acceptance criteria and study data cannot be provided from this document:

• Device Type: The "Flower Suture Anchor Set" is a physical orthopedic surgical device (suture anchors made of PEEK for soft tissue reattachment). It is not an AI/ML diagnostic tool, an image analysis algorithm, or any software-based medical device.
• Regulatory Pathway: The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering testing, material compatibility, and comparison of physical characteristics and intended use. It does not typically involve clinical studies with human readers or AI performance metrics.
• Performance Data Section: The "Performance Data" section describes mechanical testing (insertion, pull-out, fatigue), biocompatibility testing (cytotoxicity), and adherence to sterilization standards for the physical device. These are standard engineering tests for implants and surgical tools, not AI model validation.

Therefore, since the document pertains to a physical medical device and not an AI/ML system, the following requested information cannot be extracted or inferred:

1. A table of acceptance criteria and the reported device performance: The acceptance criteria relate to mechanical strength, biocompatibility, and sterilization for a surgical anchor, not diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) typically associated with AI.
2. Sample size used for the test set and the data provenance: Not applicable to AI testing. The "test set" here refers to physical samples of the suture anchors subjected to mechanical and biological tests.
3. Number of experts used to establish the ground truth...: Not applicable. Ground truth for a physical device is established through engineering and laboratory measurements, not expert consensus on images.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable as there are no "human readers" involved in the performance of a suture anchor.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device performs a mechanical function.
7. The type of ground truth used: For a physical device, ground truth is based on physical measurements and material standards.
8. The sample size for the training set: Not applicable. This is a manufactured product, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is entirely outside the scope of AI/ML medical device regulation and testing. It provides information relevant to the substantial equivalence of a physical surgical implant, not the acceptance criteria or performance studies of an AI model.

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The Flower Bone Screw Set is intended to be used for the fixation of bone fractures, fusion of joints or bone reconstruction.

The subject Flower Bone Screw Set is an extension of the Flower Bone Screw Set (K132248) consisting of headless compression screws and cannulated bone screws, made of a titanium alloy compliant with ISO 5832-3. The device is provided with general purpose instruments.

This document is a 510(k) summary for the Flower Bone Screw Set, which is a medical device. It's important to note that this document describes a device (bone screws), not an AI/ML algorithm or software as a medical device. Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable to this type of device submission.

The "performance data" section for this hardware device focuses on mechanical testing and material compliance, not clinical performance in the way an AI/ML product would be evaluated.

Here's an analysis of the provided information, with N/A for criteria that don't apply to a physical device:

1. Table of Acceptance Criteria and 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 for Test Set: Not explicitly stated. The document refers to "worst case" testing for bacterial endotoxins and an "engineering analysis" for mechanical strength. For physical devices, "sample size" often refers to the number of units tested, but this level of detail is not provided.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The testing was performed on the device itself.

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

• Not applicable. This is a hardware device; ground truth in the context of clinical interpretation or diagnosis by experts is not relevant to its type of testing. Engineering and material science experts would have been involved in the design and testing, but their role is different from establishing clinical "ground truth."

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

• Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the types of tests (bacterial endotoxin, mechanical strength) performed on bone screws.

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 is not applicable as this is a physical medical device (bone screw), not an AI/ML diagnostic or assistive tool.

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

• No. This is not an AI/ML algorithm.

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

• For Bacterial Endotoxins: The "ground truth" is adherence to the ASTM/AAMI ST72 standard. The test itself determines the level of endotoxins.
• For Mechanical Strength: The "ground truth" is established through engineering analysis and comparison to the mechanical strength of predicate devices, ensuring it is "adequate and substantially equivalent" for its intended use. This is based on established biomechanical principles and regulatory guidances for similar devices.
• For Material Compliance: The "ground truth" is the ISO 5832-3 standard for titanium alloy composition.

8. The sample size for the training set

• Not applicable. This is a hardware device; there is no "training set" in the AI/ML sense.

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

• Not applicable. There is no "training set" for this physical device.

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The Flower Upper Extremity Plating Set is intended to be used for fixation of fractures, fusions, or osteotomies of the clavicle, humerus, radius and ulna.

The Flower Upper Extremity Plating Set consists of the following components and accessories: midshaft clavicle plates, distal clavicle plates, medial distal humerus plates, lateral distal humeral plates, posterior lateral distal humerus plates, olecranon plates, variable angle locking screws, variable angle non-locking screws. The plates are all made of pure titanium compliant with ASTM F67, the screws are made of titanium alloy compliant with ASTM F136. The system accepts locking and non-locking screws cleared via K123562 and K131657, the locking and non-locking screws included in this submission extend the length range of the previously cleared screws. The device is provided with general purpose instruments, including appropriately sized trials.

The provided FDA 510(k) summary for the Flower Upper Extremity Plating Set describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document primarily focuses on regulatory approval based on design and material equivalence to existing devices and adherence to general performance standards, rather than a clinical study evaluating its performance against specific acceptance criteria in a patient population.

Therefore, much of the requested information about clinical study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document as it pertains to a pre-market clinical performance evaluation, which is not the focus of this 510(k) summary for this type of device.

Here's what can be extracted and what cannot:

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

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

• No clinical test set or patient data is mentioned in this 510(k) summary. The "testing" primarily refers to material, biocompatibility, and sterilization standards, and an engineering analysis, not clinical performance 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. The ground truth for this submission is based on adherence to recognized material and performance standards and comparison to predicate devices, not on expert consensus from clinical data.

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

• Not applicable. There was no clinical 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 device is a metallic bone fixation appliance, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a physical fixation device, not an algorithm.

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

• The "ground truth" here is compliance with recognized engineering, material, and biocompatibility standards (e.g., ASTM F67, F136, ISO 10993, ISO 11137), and the established performance and safety profiles of the cited predicate devices.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" for this type of medical device submission.

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

• Not applicable, as no training set is relevant here.

In summary:

This 510(k) notification for the Flower Upper Extremity Plating Set demonstrates substantial equivalence based on bench testing, material conformity, and design similarity to already approved devices. It does not involve a clinical study with patient data, expert reviews, or AI performance metrics as it's a traditional implantable medical device.

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The Flower Rearfoot Plating Set is intended to be used for internal fixation of fractures and reconstructions of bones of the rearfoot, including the calcaneus. Examples of these internal fixations and reconstructions include, but are not limited to extra-articular fractures, intra-articular fractures, joint depression fractures, tongue type fractures, severely comminuted fractures and osteotomies.

The Flower Rearfoot Plating Set consists of the following components and accessories: calcaneal plates, MIS calcaneal plates, and calcaneal step osteotomy plates, all made of pure titanium compliant with ASTM F67. The system accepts locking and non-locking screws cleared via K123562 and K131657. The device is provided with general purpose instruments.

The provided text describes a 510(k) premarket notification for the "Flower Rearfoot Plating Set," a medical device for internal fixation of rearfoot fractures and reconstructions.

However, the document does not contain the kind of information requested in the prompt, such as acceptance criteria, reported device performance in a clinical study, sample sizes, ground truth establishment methods, expert qualifications, or details about any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance study.

The primary purpose of this 510(k) summary is to demonstrate substantial equivalence to predicate devices through engineering analysis and Finite Element Analysis (FEA), focusing on mechanical strength and technological characteristics rather than clinical performance metrics in humans or AI-assisted diagnostic improvements.

Therefore, I cannot populate the requested table or answer the questions related to clinical study design, ground truth, or AI performance based on the provided text.

The information available from the text is:

• Device Name: Flower Rearfoot Plating Set
• Intended Use/Indications for Use: Internal fixation of fractures and reconstructions of bones of the rearfoot, including the calcaneus (e.g., extra-articular, intra-articular, joint depression, tongue type, severely comminuted fractures, and osteotomies).
• Method of Performance Demonstration:
  • Engineering analysis to demonstrate appropriate mechanical strength.
  • Finite Element Analysis (FEA) to compare physiological loading of the subject device and predicate devices, confirming at least equivalent strength.
• Ground Truth (for mechanical testing): The "ground truth" in this context is the expected mechanical behavior and strength of the predicate devices. The study aimed to show the subject device's mechanical equivalence to these established devices through engineering principles and simulation.

In summary, the provided document does not contain the information necessary to address the prompt's request for clinical acceptance criteria, device performance, or details of a study involving human readers or AI in a diagnostic context.

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The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults and adolescents (12-21) in whom the growth plates have fused, and particularly in osteopenic bone. Specifically,

• . Distal Medial and Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• . Distal Tibia A-Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• . Straight and Distal Lateral Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

The Flower Ankle Plating Set consists of the following components and accessories: distal medial tibia plates, distal lateral tibia plates, distal tibia A-plate, straight fibula plate, distal lateral fibula plate, all made of pure titanium compliant with ASTM F67. The system accepts locking and non-locking screws cleared via K123562 and K131657. The device is provided with general purpose instruments.

Here's an analysis of the provided text regarding the Flower Ankle Plating Set, focusing on the requested information about acceptance criteria and study details:

Summary of Acceptance Criteria and Device Performance (Based on provided text)

The document focuses on demonstrating substantial equivalence to predicate devices rather than setting specific numeric acceptance criteria for clinical performance. The "acceptance criteria" are implied by adherence to recognized standards and an engineering analysis confirming mechanical strength, which are used to show the device functions "as intended" and is equivalent to previously cleared devices.

Details of the Study:

The provided document describes a 510(k) Premarket Notification, which generally does not require clinical studies to demonstrate safety and effectiveness for devices seeking substantial equivalence to existing predicate devices. Instead, it relies on performance testing (benchtop, materials, biocompatibility) and engineering analysis.

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

   • Test Set Sample Size: Not applicable. No clinical test set data is presented. The "test set" refers to the components of the Flower Ankle Plating Set and materials that underwent physical, chemical, and biological testing according to the listed standards.
   • Data Provenance: Not applicable for clinical data. The performance data is derived from laboratory testing against recognized standards for materials (e.g., ASTM, ISO) and an engineering analysis. The location of these labs or the specific origin of these test results (e.g., specific country) is not detailed beyond the standards themselves being international.

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

   • Not applicable. There was no clinical "ground truth" established by experts in the context of this 510(k) submission, as it was not a clinical study requiring such ground truth for diagnostic or prognostic performance. The "ground truth" for the material and mechanical tests is defined by the passing criteria within the specified ASTM and ISO standards.

3. Adjudication method for the test set:

   • Not applicable. As there were no human readers or clinical expert interpretations involved in establishing ground truth for a test set, no adjudication method was used. The adjudication for the standard tests would be the pass/fail criteria of those specific test methodologies.

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:

   • No. An MRMC comparative effectiveness study was not performed. This device is a surgical implant (ankle plating set), not an AI-powered diagnostic or assistive tool.

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

   • No. This device is a surgical implant. "Standalone algorithm performance" is not relevant to this type of medical device submission.

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

   • The "ground truth" for this device's submission is based on adherence to recognized material and mechanical engineering standards (ASTM, ISO) and an engineering analysis demonstrating mechanical strength. The "ground truth" for safety and effectiveness is established by demonstrating substantial equivalence to predicate devices that have already been cleared.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of an algorithm or AI.

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

   • Not applicable, as no training set was used for an algorithm.

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The Flower Bone Screw set is intended to be used for the fixation of bone fractures, fusion of joints or bone reconstruction.

The Flower Bone Screw Set consists of the following components and accessories: solid, cannulated, and headless compression screws, as well as washers, all made of a titanium alloy compliant with ASTM F136. The device is provided with general purpose instruments.

Acceptance Criteria and Study for Flower Bone Screw Set (K132248)

This device, the Flower Bone Screw Set, is a Class II medical device, which means it requires a 510(k) Pre-Market Notification rather than a full PMA (Pre-Market Approval). For 510(k) devices, the primary goal is to demonstrate substantial equivalence to existing legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate devices.

For this specific device, the "acceptance criteria" are primarily based on established international and national standards for medical devices and a successful engineering analysis rather than specific numerical performance targets against a disease state or condition.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not specify a "test set" in the context of clinical data or patient samples as might be seen for diagnostic AI devices. Instead, the testing described is primarily bench testing and engineering analysis conducted on the device hardware itself.

• Sample Size: Not explicitly stated in terms of a discrete number of devices tested for each standard, but it would involve a sufficient number of samples to statistically demonstrate compliance with the relevant ASTM and ISO standards (e.g., destructive testing for mechanical properties, material composition analysis on multiple batches, etc.) and to support the "worse case" engineering analysis.
• Data Provenance: The data provenance is from bench testing and engineering analysis performed by the manufacturer, Flower Orthopedics Corporation. This is typically done in a controlled laboratory environment. It is not patient data, nor is it classified as retrospective or prospective clinical data.

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

This type of information is not applicable for this device submission. The "ground truth" for this device's performance is established by:

• Industry Standards: Compliance with established international and national standards (ASTM, ISO). These standards themselves are developed by committees of experts in relevant fields (materials science, biomedical engineering, medical device manufacturing, etc.).
• Engineering Principles: The engineering analysis relies on established principles of biomechanics, materials science, and mechanical engineering.
• Comparison to Predicates: The ultimate "ground truth" for substantial equivalence is the proven safety and effectiveness of the legally marketed predicate devices.

There is no mention of individual clinical experts or "ground truth" labels for a test set of data in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" consists of bench testing and engineering analysis results against predefined standards and engineering principles, there is no need for human expert adjudication in the sense of reviewing diagnostic outcomes or clinical cases. The adjudication is based on whether the test results meet the specified criteria of the standards and the conclusions of the engineering analysis.

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

No. An MRMC comparative effectiveness study is not mentioned and would not typically be required or relevant for a device like a bone screw set. MRMC studies are employed primarily for diagnostic imaging devices or algorithms where the performance of human readers (with or without AI assistance) on a set of clinical cases is being evaluated. This device is a surgical implant, not a diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance evaluation of the device was conducted. This is represented by the "Performance Data" section which details:

• Compliance with various ASTM and ISO standards related to materials, biocompatibility, and sterilization.
• An engineering analysis to demonstrate appropriate mechanical strength.

These tests evaluate the device's inherent properties and performance against established benchmarks without direct human interaction as part of the performance metric.

7. Type of Ground Truth Used

The "ground truth" for evaluating the Flower Bone Screw Set is primarily:

• Compliance with Established Industry Standards: This includes material specifications (ASTM F136, ISO 7153-1), biocompatibility (ISO 10993-1, ISO 10993-5), and sterilization efficacy (ISO 11137-1).
• Engineering Principles and Analysis: The mechanical strength is validated through an engineering analysis based on accepted biomechanical principles and "worse case" testing scenarios.
• Substantial Equivalence to Predicate Devices: The overall "ground truth" for regulatory approval via 510(k) is that the device is shown to be as safe and effective as legally marketed predicate devices with the same intended use.

There is no mention of pathology, clinical outcomes data, or expert consensus on clinical cases being used as ground truth for this submission type.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical surgical implant, not an AI/ML algorithm that requires a "training set" of data. The manufacturing processes and design principles are based on established engineering and materials science, not on machine learning models.

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

Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for such a set.

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The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for long bone in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions.

This system can be used for palmar, ventral, dorsal or orthogonal application.

The Flower Small and Medium Implants set consists of the following components and accessories: pure titanium small straight plates, small and medium reconstruction plates, medium osteosynthesis plates, proximal humerus plates, distal radius plates, L-shaped plates, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments.

This submission is for a medical device called the "Flower Small and Medium Implant Set," which is a bone plating system. It's a 510(k) premarket notification for modifications to an already cleared device (K123562).

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

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

The provided text does not mention a clinical study or a test set involving patients or medical images. The performance data is based on "engineering analysis." Therefore, sample size and data provenance in the context of clinical or imaging data are not applicable here.

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

Not applicable. No clinical or image-based ground truth was established as there was no test set or clinical study. The ground truth for this device's performance is derived from engineering principles and comparison to predicate devices, rather than expert consensus on diagnostic interpretations.

4. Adjudication method for the test set

Not applicable. No test set was used that required expert 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 submission for a bone plating system, not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant to its clearance.

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

Not applicable. This device is not an algorithm or an AI system.

7. The type of ground truth used

The "ground truth" for the device's acceptable performance is based on engineering analysis and comparison to the mechanical properties of legally marketed predicate devices. The implicit ground truth is that if the modified device possesses "adequate and substantially equivalent mechanical strength" to its predicates, it meets the safety and effectiveness requirements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "training" for the device's design and engineering would be the existing knowledge and data from predicate devices and biomechanical principles, but not in the context of a "training set" for an algorithm.

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

Not applicable. As there is no training set mentioned, the method for establishing its ground truth is also not applicable.

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