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510(k) Data Aggregation
(49 days)
The LINOS MOH Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
The LINOS MOH Hand Plating System consists of plates of various shapes and thicknesses for bone fixation. Plate features include a low profile with angulated-locking threaded screw holes. The system also includes locking and non-locking screws of various lengths and diameters and the necessary instruments to facilitate placement of the implants. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the existing plates and screws in the previously cleared KLS Martin Hand Plating System.
Here's a breakdown of the acceptance criteria and the study details for the LINOS MOH Hand Plating System, based on the provided documents:
The provided documents describe a Special 510(k) submission for the LINOS MOH Hand Plating System, where the device is considered substantially equivalent to a previously cleared predicate device (KLS Martin Hand Plating System, K040598). This type of submission focuses on demonstrating equivalence to an existing device rather than proving de novo performance against a new set of clinical acceptance criteria. Therefore, the "acceptance criteria" discussed here relate to the device meeting performance requirements comparable to its predicate, rather than independently established goals for a new kind of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirements) | Reported Device Performance |
|---|---|
| Material Composition (matching predicate) | CP Titanium or Ti-6Al-4V Titanium Alloy (Matches predicate) |
| Intended Use (matching predicate) | Stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes. (Matches predicate) |
| Anatomical Sites (matching predicate) | Small bones of the hand, wrist, fingers, feet, ankles, toes (Matches predicate) |
| Sterilization Method (matching predicate) | Provided Nonsterile (Steam) (Matches predicate) |
| Plate Geometry (matching predicate for core feature) | Pre-curved to follow natural curves of hand and feet bones (Matches predicate. The new system expands to include threaded plates, while predicate was non-threaded, but this is a modification and not a change to the core pre-curved geometry.) |
| Plate Thickness Range (matching predicate) | 0.6mm – 3.0mm (Matches predicate) |
| Screw Diameter Range (matching predicate) | 1.0mm – 2.7mm (Matches predicate) |
| Screw Length Range (matching predicate) | 2mm – 32mm (Matches predicate) |
| Mechanical Performance (Fatigue, Bending, Torsion strengths) (per ASTM F382-99 and ASTM F543-13) | Met performance requirements and demonstrated to be as safe and effective as their predicate devices through mechanical testing. (Specific values are not provided, only stating compliance with standards and equivalence to predicate) |
| Risk Management (per ISO 14971:2007) | Evaluation demonstrated design change did not present hazards outside acceptability criteria, and risk-related issues were controlled and verified during design control review process. (Demonstrates adherence to risk management standards and internal controls) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The documents do not specify a "test set" in the context of clinical data. The evaluation was primarily based on nonclinical mechanical testing and comparison of technological characteristics to a predicate device.
- Data Provenance: The nonclinical mechanical testing was performed in accordance with ASTM (American Society for Testing and Materials) standards. The results from these tests are generally from laboratory settings, not patient data. No "country of origin of the data" or "retrospective/prospective" study design is applicable as this was not a human clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as there was no clinical test set requiring expert ground truth or human readers. The evaluation was based on engineering and performance specifications and comparison to a predicate device.
4. Adjudication Method for the Test Set
- This information is not applicable as there was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This submission is for a medical implant (bone plating system) and its modifications, not a diagnostic imaging or AI-assisted device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- No standalone algorithm performance study was done. This device is a physical medical implant, not an algorithm or software-based device.
7. Type of Ground Truth Used
- The "ground truth" for the nonclinical testing was defined by the performance requirements outlined in ASTM F382-99 and ASTM F543-13, demonstrating that the device meets safety and efficacy standards by performing comparably to the predicate device under mechanical stress. For the substantial equivalence claim, the ground truth was the established characteristics and performance of the legally marketed predicate device.
8. Sample Size for the Training Set
- This information is not applicable. "Training set" typically refers to data used to train machine learning models. This submission is for a physical medical device, not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
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(77 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength for Intended Use (Implicit, based on substantial equivalence to predicate devices) | Adequate and Substantially Equivalent Mechanical Strength. The submission states that "Flower Orthopedics has conducted engineering analysis to demonstrate that the modifications to the Flower Small and Medium Implants set provides adequate and substantially equivalent mechanical strength for its intended use." This is considered sufficient to demonstrate compliance by the FDA for the purpose of 510(k) clearance, as it addresses the primary functional requirement for bone plating systems. |
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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(130 days)
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 use in long bones in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extraaticular 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, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments. All plates are made of pure titanium (ISO 5832-2).
The Flower Small and Medium Implants set provides fixed-angle lockable screws and plates to assist with internal fixation of fractures and reconstruction of bones. The principles of operation of the device are similar to other bone plating systems. The plates are comprised of various shapes. alignments, thicknesses, widths, and lengths designed to contour to different bones and locations on the body for internal fixation or reconstruction following fracture. .Each of the plates contains several locking holes that allow for the insertion of Flower Small and Medium Implants locking screws. To use the Flower Small and Medium Implants set, the surgeon first selects an implant of the appropriate size and shape based on the intended site of use. The plate should be placed in an appropriate location on the given bone or anatomical location in need of repair.
The provided text describes a 510(k) premarket notification for the "Flower Small and Medium Implants" a bone plating system. It details the device's intended use, technological characteristics, and compares it to predicate devices to establish substantial equivalence.
However, the document does not contain information related to acceptance criteria, diagnostic performance metrics (like sensitivity, specificity, AUC), or a study design to measure these. The "Performance Data" section lists only:
- Biocompatibility testing (ISO 10993-1, ISO 10993-5)
- Sterilization validation
- Packaging validation and shelf life testing
These are general safety and manufacturing aspects, not data on the clinical or diagnostic performance of the device in the context of typical AI/software-as-medical-device studies. The device is a physical orthopedic implant, not an AI or software device that would have metrics like sensitivity or specificity.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample sizes, ground truth establishment, expert adjudication, or MRMC studies for diagnostic accuracy, as this information is not present in the provided 510(k) summary.
The summary states: "Engineering analysis has been performed to demonstrate that the Flower Small and Medium Implants system provides appropriate mechanical strength for its intended use." This suggests mechanical testing was done, but the specific acceptance criteria and results for this are not detailed beyond a general statement of "functional as intended."
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