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510(k) Data Aggregation
(168 days)
InFix Cannulated Screw System is generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. InFix Cannulated Screw System is also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections.
Accessories implants:
The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
The InFix Cannulated Screw System includes eight cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:
This document is a 510(k) premarket notification for the InFix Cannulated Screw System, which is a Class II medical device. The primary purpose of this submission is to demonstrate substantial equivalence to existing predicate devices, rather than to prove de novo safety and effectiveness through extensive clinical trials.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Testing (ASTM F543) | Self-tapping performance | Results indicate substantial equivalence to legally marketed devices. |
| Torsional strength | Results indicate substantial equivalence to legally marketed devices. | |
| Axial pullout strength | Results indicate substantial equivalence to legally marketed devices. | |
| Driving torque | Results indicate substantial equivalence to legally marketed devices. | |
| Cleaning Validation | AAMI TIR30:2011 guidance requirements | Test result shows that the acceptance criteria is met. |
| Sterilization Validation | ANSI/AAMI/ISO 17665-1 requirements | Test result shows that the acceptance criteria is met. |
Details Regarding the Study and Acceptance Criteria:
This submission relies heavily on non-clinical tests to demonstrate substantial equivalence. Clinical effectiveness studies as one might find for a novel AI device are not presented here because this is a hardware medical device for which the FDA determination is about substantial equivalence to already approved devices. Therefore, the "acceptance criteria" here are largely benchmarks against the performance of predicate devices and adherence to recognized standards.
2. Sample size used for the test set and the data provenance:
- Biomechanical Test: The document states "The biomechanical tests ASTM F543 were performed". It does not specify the exact number of screws or test samples used for each performance metric (self-tapping, torsional, axial pullout, driving torque).
- Cleaning Validation & Sterilization Validation: Similarly, the document does not specify the number of samples used for these validation tests.
- Data Provenance: Not explicitly stated, but typically these tests would be conducted in a laboratory setting by the manufacturer or a contracted lab. The tests are non-clinical, so "country of origin of the data" in terms of patient demographics is not applicable. These are prospective tests performed to meet regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. For a hardware device demonstrating substantial equivalence through non-clinical testing, ground truth is established by objective engineering measurements against specified physical properties and performance standards (e.g., ASTM F543). There isn't a need for expert consensus on an interpretation of an output, as would be the case for an AI diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used for expert review of images or data to establish a ground truth or resolve discrepancies in diagnostic labeling. This is not relevant for biomechanical or validation testing of a physical device.
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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or software that assists human interpretation. The InFix Cannulated Screw System is a physical bone fixation device, not a diagnostic tool or AI-assisted product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant. The concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the biomechanical tests (ASTM F543), the "ground truth" is established by engineering standards and direct physical measurements. The performance of the InFix Cannulated Screw System is compared against the known performance characteristics of the predicate devices and the requirements of the ASTM standard.
- For cleaning and sterilization validations, the "ground truth" is adherence to the specified industry standards (AAMI TIR30:2011 and ANSI/AAMI/ISO 17665-1).
8. The sample size for the training set:
- Not applicable. This device is hardware and 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. As there is no training set for this hardware device, there is no ground truth to be established for it.
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(117 days)
The EXTREMITY MEDICAL Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.
The EXTREMITY MEDICAL Screw and Washer System consists of a lag screw of five various diameters and lengths ranging from 10 to 100mm, as well as a mating washer component consisting of five various diameters and lengths ranging from 14 to 50mm. Both implant components are manufactured from Titanium alloy.
The EXTREMITY MEDICAL Screw and Washer System is a medical device intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The device received 510(k) clearance (K101700) from the FDA on October 12, 2010.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Similar design, materials, and equivalent mechanical properties to predicate devices. Pull-out strength, torque, and bending performance at least as good as predicate devices. | "Mechanical Testing and calculations have been completed supporting substantial equivalence to the predicate devices listed. The implants in the EXTREMITY MEDICAL Screw and Washer system have a similar design; are made of similar materials, have the same indications for use, and have equivalent mechanical properties. Bench testing, including pull-out strength, torque, and bending, was performed and compared to the predicate devices. The results of the testing show the subject device, Extremity Medical Screw and Washer system, performed at least as well as the predicate devices." |
| Clinical Simulation | Verification of surgical technique in cadavers. | "Clinical simulations in cadavers were performed to verify the surgical technique. The results of the testing show the subject device, Extremity Medical Screw and Washer system, performed at least as well as the predicate devices." |
| Safety and Effectiveness | Constitutes a safe and effective medical device, meeting all declared requirements of its intended use, with no adverse health effects or safety risks. | "The EXTREMITY MEDICAL Screw and Washer System, subject of this submission, as supported by both mechanical testing and clinical simulation, constitutes a safe and effective medical device, meeting all the declared requirements of its intended use. The device presents no adverse health effects or safety risks to patients when used as intended." |
| Substantial Equivalence | Demonstrates substantial equivalence to predicate devices. | "The EXTREMITY MEDICAL Screw and Washer System performed as well as the predicate devices." (Conclusion); "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." (FDA Letter) |
Study Proving Acceptance Criteria:
The device's acceptance criteria were primarily met through non-clinical bench testing and clinical simulations in cadavers, demonstrating substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size for the bench testing (e.g., number of screws/washers tested for pull-out strength, torque, bending). For clinical simulations, it mentions "cadavers," implying a biological sample, but the specific number is not provided.
- Data Provenance: The data provenance is retrospective, as it involves testing performed on the device and comparator devices rather than on human patients in a prospective clinical trial. The country of origin of the data is not explicitly stated but is implied to be within the scope of the submitting company's operations, likely the USA given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. The study primarily relies on objective mechanical testing and cadaveric simulations, not expert interpretation of results to establish ground truth in the way it would be for diagnostic imaging.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. "Adjudication method" typically refers to how disagreements are resolved among multiple human reviewers when establishing a ground truth, often in the context of diagnostic studies. The studies performed here (mechanical bench testing, cadaveric simulations) do not involve such a 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human performance is compared with and without AI assistance. This device is a surgical implant system, not a diagnostic AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a physical implant; it does not have an "algorithm-only" mode. The device's performance is inherently linked to its physical properties and how it's used in a surgical context by a human.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance was established through:
- Bench Test Standards: Mechanical properties (pull-out strength, torque, bending) were measured against established engineering standards or direct comparison to the performance of legally marketed predicate devices. The "truth" is that the new device's performance met or exceeded the predicate device's performance.
- Cadaveric Verification: The "truth" in clinical simulation was the successful verification of the surgical technique in cadavers, confirming the device's usability and appropriate mechanical behavior within a biological model.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical medical implant, not an AI/ML algorithm, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As explained above, there is no training set for this type of medical device.
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(54 days)
Cortical Screws are intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.
Large Cannulated Screws (4.5mm diameter and larger) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5mm and larger are intended for large bones and large bone fragments such as femoral neck fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.
Small Cannulated Screws (4.0mm diameter and smaller) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
Cannulated screws are machined, metallic screws with a cannulation that are self drilling and self tapping, which can be guided into position by a guide wire.
Cortical and cancellous screws are machined, metallic screws and are self tapping.
All screws utilize a hex shaped recess that accepts a standard hex drive. Each type is offered in a variety of diameters and lengths, as well as short, medium, and fully threaded options.
Materials: The devices are manufactured from 316L Stainless Steel which meets ASTM F138 standards.
Function: Bone screws functions are to provide immediate stability and temporary fixation during the natural healing process.
The provided text is a 510(k) premarket notification for OrthoPediatrics Bone Screws. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than presenting a study against specific acceptance criteria for the new device's performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.
Key reasons for this include:
- 510(k) Premarket Notification Focus: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). This is typically achieved by demonstrating "substantial equivalence," not by conducting new clinical studies or setting and meeting new performance acceptance criteria for the device itself.
- Lack of Performance Data: The document describes the device, its materials, function, and indications for use. It lists predicate devices. However, there is no mention of specific performance metrics (e.g., strength, durability, fatigue life, accuracy) for the OrthoPediatrics Bone Screws, nor any study data (sample sizes, ground truth, expert opinions) that would demonstrate the device meets such criteria.
- No Mention of AI/Algorithm: The context of "AI," "test set," "training set," "experts," "adjudication," "MRMC," and "standalone algorithm performance" strongly suggests a request related to an AI/Machine Learning device. The OrthoPediatrics Bone Screws are described as machined, metallic screws, which are physical hardware devices, not software or AI-driven systems.
In summary, this document is for a medical device (bone screws) seeking market clearance through substantial equivalence, and as such, it does not include performance studies with acceptance criteria in the manner described for software or AI-based diagnostic/assistive devices.
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(23 days)
The Asnis™ III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
This Special 510(k) submission is a line extension to address modifications to the Asnis™ III Cannulated Screw System. This line extension is to add additional sizes of screws to the system.
The provided text describes a Special 510(k) submission for a line extension of the Asnis™ III Cannulated Screw System, specifically to add additional sizes of screws. This type of submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than conducting extensive new clinical studies with established acceptance criteria as would be typical for novel devices.
Therefore, many of the standard elements you've requested regarding acceptance criteria and detailed study information are not applicable in this context. The primary "study" performed here is mechanical testing to prove the new screw sizes are as strong as the predicate devices.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strength of new screw sizes is substantially equivalent to predicate systems. | Mechanical testing demonstrated that the subject components are substantially equivalent in strength to the predicate components. |
Explanation: For a 510(k) submission, especially a line extension like this, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence. The key performance metric is the mechanical strength of the new screw sizes compared to the legally marketed predicate devices. The submission asserts that this equivalence was met through mechanical testing. Specific numerical thresholds for "strength" are not provided in this summary but would have been part of the underlying test reports submitted to the FDA.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided summary. Mechanical testing typically involves a set number of samples for each size and material tested, but the exact count isn't given here.
- Data Provenance: Not explicitly stated, but mechanical testing is usually performed in a laboratory setting by the manufacturer or a contracted testing facility. Given the manufacturer (Howmedica Osteonics Corp.) is based in Mahwah, New Jersey, USA, the testing likely occurred in the US. The data is prospective in the sense that it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. For mechanical testing of this nature, "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists, pathologists) are not involved. The ground truth is established by standardized mechanical testing protocols and measurements, typically interpreted by engineering and quality control professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for clinical reads (e.g., imaging studies) where human interpretation is involved. This submission focuses on objective mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a mechanical device, not an AI or imaging device. Therefore, MRMC studies and concepts of human reader improvement with AI are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A (for clinical ground truth). The "ground truth" in this context is the objective measurement of mechanical properties (e.g., strength, stiffness) as defined by engineering standards and specifications. The performance of the new devices is compared against the measured performance of the predicate devices.
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- N/A. There is no "training set" and thus no ground truth for it to be established.
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