Search Results
Found 18 results
510(k) Data Aggregation
(274 days)
Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions.
One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.
Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand.
Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius)
Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required.
The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures.
The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius.
One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.
Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus
Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula.
Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia.
The Clavicle Superior Plates 3.5 are indicated for:
- Fractures of the clavicle shaft
- Fractures of the lateral clavicle
- Malunions of the clavicle
- Non-unions of the clavicle
The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus.
The Tibia Proximal Lateral Plates 3.5 are indicated for:
- Split-type fractures of the lateral tibial plateau
- Lateral split fractures with associated depressions
- Pure central depression fractures
- Split or depression fractures of the medial plateau
The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.
The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.
The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for
- Intraarticular fractures of the distal humerus
- Supracondylar fractures of the distal humerus
- Non-unions of the distal humerus
The Humerus Distal Medial Plates 2.7/3.5 are indicated for
- Intraarticular fractures of the distal humerus
- Supracondylar fractures of the distal humerus
- Non-unions of the distal humerus
The Ulna Proximal Olecranon Plates 3.5 are indicated for
- Complex extra- and intra-articular olecranon fractures
- Non-unions of the proximal ulna
- Osteotomies
- Simple olecranon fractures
Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.
Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.
Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia.
T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.
T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.
LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.
Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur
Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.
The Genostis Osteosynthesis System comprises of fracture fixation plates, corresponding screws and required surgical instruments. Different shapes and sizes are available to accommodate for different anatomical regions and locations of fractures. The plate screw interface is either locking, non-locking or, for some plates, realized by a combination hole offering both options (locking and non-locking).
All plates and screws are made of titanium alloy (Ti 6Al 4V ELI) according to ASTM F136 and ISO 5832-3.
The implants of the Genostis Osteosynthesis System are sterilized by radiation and are delivered sterile.
The provided FDA 510(k) clearance letter for the Genostis Osteosynthesis System does not describe a study involving an AI/software device or human readers. Instead, it describes a traditional medical device (bone fixation plates and screws) and primarily references non-clinical (biomechanical and biocompatibility) testing to demonstrate substantial equivalence to predicate devices.
Therefore, many of the requested criteria related to AI/software performance, human reader studies, and ground truth establishment in a diagnostic context are not applicable to this document.
However, I can extract and structure the information that is relevant to the device's acceptance criteria based on the provided text, particularly concerning non-clinical testing.
Here's the breakdown based on the information available:
Acceptance Criteria and Study for Genostis Osteosynthesis System
The Genostis Osteosynthesis System is a traditional medical device (bone fixation plates and screws), not an AI/software diagnostic device. As such, the "acceptance criteria" and "study" proving it meets them are primarily based on non-clinical engineering and biological tests, not AI performance metrics or human-in-the-loop diagnostic studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Material Biocompatibility | Cytotoxicity (ISO 10993-5) | Satisfactory bio-compatibility endpoints | Performed; results satisfactory. |
| Sensitization (ISO 10993-10) | Satisfactory bio-compatibility endpoints | Performed; results satisfactory. | |
| Irritation/Intracutaneous Reactivity (ISO 10993-23) | Satisfactory bio-compatibility endpoints | Performed; results satisfactory. | |
| Chemical Characterization (ISO 10993-18) | Satisfactory bio-compatibility endpoints | Performed; results satisfactory. | |
| Toxicological Risk Assessment | Satisfactory bio-compatibility endpoints | Performed; results satisfactory. | |
| Bacterial Endotoxin Testing | Acceptable endotoxin levels | Performed; results satisfactory. | |
| Mechanical Performance | Screw Performance (ASTM F543) | Satisfactory mechanical performance | Performed; results satisfactory. |
| Plate Performance (ASTM F382) | Satisfactory mechanical performance | Performed; results satisfactory. | |
| Packaging & Sterilization | Sterility (Radiation) | Device must be sterile at delivery | Implants are sterilized by radiation and delivered sterile. Test conducted on final sterile product. |
| General | Substantial Equivalence to Predicates | All non-clinical testing demonstrates substantial equivalence. | All testing indicates substantial equivalence to predicates. |
Note: The document states "All results were satisfactory" for all tests, indicating the device met the pre-defined acceptance criteria for each test.
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units or samples used for each biomechanical or biocompatibility test. It generally states that testing was "performed" and "conducted on final sterile product."
- Data Provenance: Not explicitly stated as "country of origin," but testing would be performed in a controlled laboratory environment. The tests are non-clinical (biomechanical and biocompatibility), not data from patients. The study is by nature prospective in that new manufactured devices were tested to meet the standards, not a retrospective analysis of existing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a medical device (hardware) clearance, not an AI/software diagnostic device that requires expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" here is the adherence to established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical mechanical and biocompatibility testing, there is no "adjudication" in the sense of reconciling expert opinions on diagnostic findings. The results are quantitative and objective measurements against established standard thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Not Applicable. MRMC studies are for evaluating clinical interpretation of diagnostic results, typically with AI assistance. This device is a physical implant, not a diagnostic tool or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This pertains to AI algorithm performance. The device is a bone fixation system and does not rely on an algorithm for its primary function.
7. The Type of Ground Truth Used
- Pre-defined Standards and Controls: The "ground truth" for this device's performance is established by well-defined, internationally recognized (ISO) and American (ASTM) standards for material properties, mechanical strength, and biocompatibility. The device must perform within the specified parameters of these standards. For example, screws must meet certain torque resistance (ASTM F543), and plates must meet specific load-sharing characteristics (ASTM F382).
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no "training set" for this type of medical device clearance. The design and manufacturing processes are established based on engineering principles and existing predicate device designs, with performance validated against the standards mentioned above.
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(127 days)
DePuy Synthes VOLT™ Mini Fragment Plating System:
The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.
The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.
If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ Mini Fragment Plating System can only be used for non-load bearing stabilization and reduction.
DePuy Synthes VOLT™ Small Fragment Plating System:
The VOLT Small Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.
The VOLT Small Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.
If used in the femur the VOLT Small Fragment Plating System can only be used for non-load bearing stabilization and reduction.
DePuy Synthes VOLT™ Mini Fragment Plating System
The DePuy Synthes VOLT™ Mini Fragment Plating System is a family of implantable devices, consisting of non-contoured, non-anatomic straight and shaped plates (Adaption, Adaption Combi, Compact Straight, Straight Condylar, Hook, T-Plate, Tine, Y-Plate and Triangle), with variable angle screw holes, and two screw types (cortex and locking screws). The system is available in three sizes; 2.0mm, 2.4mm and 2.7mm. The Triangle Plate is available in 2.4mm and 2.7mm sizes only.
The plates of this system are available in Stainless Steel and Commercially Pure Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV) respectively. Plates and screws within the VOLT™ Mini Fragment Plating System are available either sterile or non-sterile and are single-use only.
DePuy Synthes VOLT™ Small Fragment Plating System
The DePuy Synthes VOLT™ Small Fragment Plating System is a family of implantable devices consisting of 3.5mm non-contoured, non-anatomic plates with variable angle screw holes. and 3.5mm locking, 3.5mm cortex, and 4.0mm cancellous screws.
The plates of this system are available in Stainless Steel and Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV). Plates and screws within the VOLT™ Small Fragment Plating System are available either sterile or non-sterile and are single-use only
The provided text is a 510(k) summary for the DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System. This document describes the device, its indications for use, and a comparison to predicate devices, focusing on non-clinical performance testing (mechanical and engineering analyses) to demonstrate substantial equivalence.
Crucially, this document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), which are typically found in clinical performance studies validating AI/ML-based medical devices, is not applicable to this submission.
This 510(k) clearance is based on the devices being "substantially equivalent" to existing predicate devices, primarily demonstrated through non-clinical performance testing (mechanical simulations and analyses), rather than clinical trials or studies involving human data and AI algorithm performance.
Therefore, I cannot provide the requested information as it is not present in the provided text. The device in question is a physical orthopedic implant, not an AI/ML software device that would require such performance evaluations.
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(58 days)
APTUS® Forearm Shaft Plates are intended for management of fractures and osteotomies of the radius and ulna shaft.
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
The subject device includes a total of 10 bone plates for internal fixation of the radius and ulna, and hook plates for fixation of avulsed fragments of the distal radius or ulna. All plates have anatomical designs that are appropriate for either the left or right forearm.
The plates for the shaft of the radius and ulna have similar designs, are provided in designs with 10, 14, 18, or 22 holes, with overall lengths ranging from 80 mm to 160 mm. All plates for the radius and ulna have a maximum width of 10 mm, a maximum thickness of 3.4 mm, and the width and thickness taper at the ends of the plates. The radius shaft plates have a slight curvature to match the anatomy of the radius; the ulna shaft plates are straight.
The subject device hook plates are provided in two designs: a design with two curved hooks and six (6) holes, and a design with four (4) curved hooks and twelve (12) holes. The hook plates have approximate overall dimensions of 8.5 mm width by 17.5 mm length, or 18.5 mm width by 17.5 mm length; both plates are 0.6 mm thick.
The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS® System. The compatible screws are 2.8 mm in diameter (shaft plates) and 1.5 mm in diameter (hook plates) and were previously cleared in K091479, K103332, and K142906. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.
All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.
This is a 510(k) premarket notification for a medical device (bone fixation plates), not an AI/ML-powered device. Therefore, the sections for AI/ML-specific criteria (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable and cannot be extracted from the provided text.
The document discusses acceptance criteria and proof of device performance in the context of demonstrating substantial equivalence to predicate devices, which is common for traditional medical devices under 21 CFR 888.3030.
Here's an analysis based on the available information:
Acceptance Criteria and Study to Prove Device Meets Criteria
The acceptance criteria for this medical device (APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System) are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices, primarily K142906, APTUS® Wrist 2.5 System, and reference devices K000684, K103332, and K151468. The study aims to show that the new device is as safe and effective as these predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Substantial Equivalence Justification) | Reported Device Performance / Justification |
|---|---|
| Intended Use Equivalence | The subject device and predicate/reference devices have the same intended use: internal fixation of bones of the upper extremity. Minor differences in IFUs (e.g., specific language for radius/ulna shaft, additional bones, osteopenic bone) do not impact substantial equivalence as they all express equivalent intended use. |
| Technological Characteristics Equivalence (Design Principles) | The subject device and predicate/reference devices have similar technological characteristics and design principles, including screw holes for locking and non-locking screws. |
| Material Equivalence | The subject device plates, K142906, and K103332 are manufactured from identical unalloyed titanium (ASTM F67). The reference device K000684 uses titanium alloy, but this difference is deemed not to impact safety or effectiveness. |
| Physical Dimensions Equivalence | The subject device, predicate, and reference devices encompass a similar range of physical dimensions (overall width, length, thickness) appropriate for the anatomy. Specific mention of similar designs and dimensions for radius/ulna shaft plates (subject device and K000684) and hook plates (subject device and K142906). |
| Compatibility with Screws/K-Wires | The subject device plates accommodate appropriately sized bone screws (2.8mm for shaft, 1.5mm for hook plates) and 1.6mm K-wires previously cleared as part of the APTUS® System (K091479, K103332, K142906, K092038). |
| Biocompatibility | Biocompatibility referenced from K142906 and K103332; all subject device components are manufactured using identical materials and processes as previously cleared Medartis devices. |
| Sterilization | Sterilization referenced from K142906 and K103332; identical packaging materials and sterilization methods are used. |
| Mechanical Performance | Mechanical testing performed according to ASTM F382. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of this 510(k) summary. This submission relies on engineering analysis and mechanical testing of the device itself and comparison to predicates, not a "test set" of patient data for an AI/ML algorithm.
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/ML algorithm's test set is not relevant here. The "ground truth" for this submission is demonstrating that the device meets defined engineering specifications and is substantially equivalent to existing, safe, and effective devices.
4. Adjudication method for the test set
Not applicable. There is no AI/ML 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
No. This is not an AI-assisted device.
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
The "ground truth" for this submission is based on:
- Established engineering standards: ASTM F382 for mechanical testing.
- Regulatory compliance: Adherence to 21 CFR 888.3030.
- Comparison to predicate devices: Demonstrating similar intended use, technological characteristics, materials, dimensions, and performance as devices already cleared by the FDA. This implicitly means the predicate devices' safety and efficacy, established through their own clearance processes, serve as a reference.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(105 days)
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula, in patients with normal bone density and osteopenic bone, for the following indications:
· osteotomies, mal-unions, and non-unions
· single, segmental, and comminuted fractures
The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-271mm in length.
The provided text is related to a 510(k) premarket notification for the "VariAx 2 Compression Plating System". This document is a regulatory submission for a medical device (bone fixation appliance), not an AI/ML powered device, and therefore does not contain information about acceptance criteria or studies as they relate to AI/ML device performance.
The document states: "Clinical testing was not required for this submission."
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device from this text. The questions posed in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are specific to AI/ML device evaluation, which is not applicable to the content of this regulatory submission.
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(128 days)
The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulpa, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).
The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel. All implants are for single use only.
This document is a 510(k) Summary for the ANTHEM™ Fracture System, a medical device. Based on the provided text, there is no study described that proves the device meets specific acceptance criteria based on AI/algorithm performance, nor is there any mention of an AI device. The document explicitly describes the ANTHEM™ Fracture System as a system of "plates and screws designed to be used for internal bone fixation."
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance related to AI/algorithmic accuracy.
- Sample size and data provenance for an AI test set.
- Number of experts and qualifications for AI ground truthing.
- Adjudication method for an AI test set.
- MRMC comparative effectiveness study for AI assistance.
- Standalone AI performance.
- Type of ground truth used for AI.
- Sample size for training set for AI.
- How ground truth for a training set was established for AI.
The document focuses on the mechanical and material performance of bone fixation devices, not on diagnostic or AI-driven performance.
Here's a summary of the performance data that is mentioned in the document, which pertains to the physical device itself:
1. Acceptance Criteria and Reported Device Performance (for the physical device):
- Acceptance Criteria (Implicit Standard Performance): The device's performance was evaluated in accordance with recognized ASTM standards for bone fixation devices. This implies that the device had to meet performance benchmarks defined by these standards to demonstrate substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated (e.g., "minimum bending strength of X N-m"), the adherence to these standards serves as the implicit acceptance criteria for mechanical performance.
- Reported Device Performance:
- Tests Conducted: Engineering analysis, bending strength tests (for plates and screws), pullout strength tests (for screws), and insertion/removal torque tests (for screws).
- Outcome: "Performance data demonstrates substantial equivalence to the predicate devices."
- Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011 to ensure sterility or low endotoxin levels.
2. Sample Size and Data Provenance (for the physical device testing):
- The document does not specify the sample sizes used for the mechanical performance tests (e.g., how many plates or screws were tested for bending strength).
- The data provenance is not mentioned (e.g., where the tests were conducted, whether the materials were from specific batches, etc.).
3. Number of experts used to establish the ground truth... and qualifications of those experts:
- Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm requiring expert review for ground truth.
4. Adjudication method for the test set:
- Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...:
- Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the physical device, "ground truth" would be the objective measurements obtained from standardized mechanical tests (e.g., actual force at failure, actual torque values) against the requirements of the ASTM standards.
8. The sample size for the training set:
- Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/machine learning device.
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(114 days)
The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.
Subject of this premarket notification is an extension to the EVOS family of plates and screws, the EVOS Small Fragment Plating System. This system features similarities to existing Smith & Nephew small fragment plates (TC-100 Small Bone Plating System, PERI-LOC Plating System) and also shares some instruments and implants from the existing EVOS MINI Plating System. It is comprised of a variety of locking and non-locking 2.7mm and 3.5mm straight plates as well as 3.5mm locking and non-locking screws and 4.7mm non-locking osteopenia screws.
The provided document is a 510(k) premarket notification for a medical device (EVOS Small Fragment Plating System), not a study analyzing AI performance. Therefore, I cannot extract information related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance.
However, I can extract the acceptance criteria and study descriptions for the mechanical performance of the physical EVOS Small Fragment Plating System, as detailed in the document.
Here's the information based on the provided text, focusing on the mechanical testing of the device itself:
1. A table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Finite Element Analysis (FEA) | The subject bone plates exhibited similar or superior structural strength compared to the existing predicates. Results of the FEA demonstrated that the plates identified for mechanical testing were the appropriate bone plates because they possessed the highest stress concentrations. | The acceptance criteria were met. |
| Four-point Bend Fatigue Testing | The bending fatigue performance achieved by the proposed bone plates met the acceptance criteria in that they were found to be similar to the bending fatigue performance of a previously cleared predicate. | The acceptance criterion was met. |
| Torque to Failure Testing (Bone Screws) | The static torsional performance of the EVOS screws was found to be similar to the static torsional performance of a previously cleared predicate device. | The acceptance criterion was met. |
| Axial Pull-out Testing (Osteopenia Screws) | The subject screws that were tested showed similar or superior (higher) pull-out strength compared to the predicates. | The acceptance criterion was met. |
| Static Cantilever Bending Performance (Locking Mechanism) | The results met the acceptance criteria in that they were similar or superior (higher) than the predicates. (Evaluated through threaded locking mechanism and variable angle locking holes for 3.5mm and 2.7mm screws). | The acceptance criteria were met. |
| Packaging Testing | The product will not be damaged during shipment and will adequately maintain sterility post shipment. | The results of this testing showed that the product will not be damaged during shipment and will adequately maintain sterility post shipment. |
| Bacterial Endotoxin Testing | Met acceptable endotoxin limits as stated in FDA Guidance documents ("Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72). | Completed and met the acceptable endotoxin limits. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each mechanical test. The document mentions "worst-case designs" for FEA and fatigue testing, and specific sizes of screws (3.5mm, 4.7mm) for others. Typically, mechanical testing involves a limited number of samples (e.g., 5-10 per test condition) to satisfy a statistical confidence level or regulatory requirement, but the exact numbers are not provided here.
- Data Provenance: Not applicable as these are pre-clinical (benchtop) tests of the device's physical properties, not clinical data from patients. The testing was conducted by Smith & Nephew, Inc.
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. These are engineering and mechanical tests, not analyses requiring expert human interpretation or ground truth establishment in a clinical sense. The "ground truth" is defined by the objective measurement of mechanical properties against predetermined performance standards, often based on existing predicate devices or industry standards like ASTM.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication. The results are quantitative measurements against objective criteria.
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 describes the mechanical testing of a medical implant, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes the mechanical testing of a medical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical testing is based on:
- Performance of legally marketed predicate devices. The acceptance criteria consistently refer to being "similar or superior" to predicates.
- Adherence to industry standards (e.g., ASTM F543 for screw testing).
- Compliance with FDA Guidance documents for sterility and endotoxin testing.
8. The sample size for the training set
Not applicable. This is not an AI study requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI study requiring a training set or its associated ground truth establishment.
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(370 days)
The Alians Elbow Locking Plating System is intended for the fixation of fractures and ostectornies of the distal humerus and proximal ulna in adults.
The Alians Elbow Locking Plating system consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
The plates and screws are manufactured from titanium alloy and are color anodized.
The Alians Elbow Locking Plating system will be provided non-sterile for sterilization by health care professionals prior to use. A sterile version of the Alians Elbow Locking Plating System is provided in single use sterile kits, called Initial O kits, including one plate, screws and single use instrumentation necessary for the implantation.
I am sorry, but based on the provided text, there is no information about an AI/ML-driven device or study parameters that would allow me to populate the requested table and describe the study proving the device meets acceptance criteria.
The document is a 510(k) premarket notification for a medical device called the "Alians Elbow Locking Plating System," which is a metallic bone fixation appliance. It discusses the regulatory review process, device description, indications for use, and a comparison to predicate devices, including mechanical testing (non-clinical tests).
There is no mention of:
- Acceptance criteria for an AI/ML device
- Device performance reported for an AI/ML device
- Test set sample sizes, data provenance, or the number/qualifications of experts involved in establishing ground truth for AI/ML
- Adjudication methods, MRMC studies, standalone AI performance, or types of ground truth for an AI/ML system
- Training set sample size or how ground truth for a training set was established for an AI/ML system
Therefore, I cannot fulfill your request for this specific document.
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(264 days)
NET Brand Small Fragment and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.
NET Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric, pertrochanteric or intertrochanteric zones.
NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System consists of plates and screws in a variety of designs and sizes and made from Ti-6Al-4V alloy or stainless steel. Plates are provided in straight designs and in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws designs. Screws are provided in, 3.5mm Cortex Self-tapping, 4.5 mm Cortex self-tapping and 2.7mm self-tapping cortex locking, 3.5mm selftapping Cortex Locking, 5.0 mm cortex Locking thread designs in various lengths. This system is not indicated for use in spine.
NET Brand of DHS/DCS Plating System made from Ti-6Al-4V alloy or stainless steel and consist of DHS/DCS Plates, lag Screw, compression screw, and 4.5 Cortex screw Self Tapping, The DHS plates are available with barrel length 25mm (short barrel) and 38mm (Standard barrel) and barrel angels varies in 130° to 150°. The DCS plate is having angle of 95°
The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7 mm and outer diameter of 12.5. The thread of DHS/DCS Screw has a buttress type.
The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 36mm and outer diameter 4.0 mm.
The provided document is a 510(k) Premarket Notification for the "NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System." This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria through a standalone study with acceptance criteria.
Therefore, the document does not contain the requested information about acceptance criteria and a study proving the device meets those criteria, as it is not a performance study in that sense.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This is achieved by comparing the new device's technological characteristics, intended use, materials, and performance (via testing against established ASTM standards) to those of already approved predicate devices.
Here's an explanation based on the provided text, addressing the points where information is available or noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not define specific "acceptance criteria" for clinical performance in terms of sensitivity, specificity, accuracy, or similar metrics for a new diagnostic or prognostic device. Instead, it demonstrates compliance with recognized engineering and material standards to show that the device performs equivalently to previously approved devices.
The "reported device performance" is essentially a confirmation of conformance to established ASTM standards for bone plates and screws.
| Characteristic | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Material | ASTM F 136, ASTM F 138, ASTM F 139 | Conforms |
| Bone Plates (Static) | ASTM F 382, ASTM F 384 (Static Four Point Bend Test) | Conforms |
| Bone Plates (Dynamic) | ASTM F 382, ASTM F 384 (Dynamic Four Point Bend Test) | Conforms |
| Bone Screws (Torsional) | ASTM F 543 (Torsional Properties) | Conforms |
| Bone Screws (Driving) | ASTM F 543 (Driving Torque) | Conforms |
| Bone Screws (Pull-out) | ASTM F 543 (Pull-out Test) | Conforms |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a "sample size" in terms of patient cases or images, as it is a mechanical device submission. The testing involves mechanical specimens (e.g., plates and screws) tested according to the cited ASTM standards. The specific number of specimens tested for each standard is not detailed in this summary.
- Data Provenance: Not applicable as it's not a clinical or imaging study. The tests are mechanical and presumably conducted in a laboratory setting.
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 submission for a bone fixation device, not a diagnostic device requiring expert interpretation for ground truth establishment. Mechanical testing relies on standardized methodologies, not expert consensus on clinical cases.
4. Adjudication method for the test set:
Not applicable for a mechanical device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device for bone fixation, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device for bone fixation, not an algorithm.
7. The type of ground truth used:
The "ground truth" in this context is the established performance benchmarks defined by recognized industry standards (ASTM F382, ASTM F384, ASTM F543 for performance, and ASTM F136, ASTM F138, ASTM F139 for materials). The device is deemed acceptable if it conforms to these standards, indicating mechanical properties are comparable to legally marketed devices.
8. The sample size for the training set:
Not applicable. This is a mechanical device, not a machine learning model requiring 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 submission. The "ground truth" for demonstrating substantial equivalence rests on adherence to material and performance standards, which are developed and accepted by the scientific and engineering community.
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(59 days)
The aap LOQTEQ® Olecranon Plates are indicated for fixation of fractures, osteotomies and nonunions of the olecranon, particularly in osteopenic bone.
The aap LOQTEQ® Olecranon Plate consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap LOQTEQ® Olecranon Plate System consists of:
• LOQTEQ® Olecranon Plate (left and right)
to be used with
• LOQTEQ® Cortical Screw 2.7, small head T8, self-tapping
• Cortical Screw 2.5, small head T8, self-tapping
• LOQTEQ® Cortical Screw 3.5, T15, self-tapping
• Cortical Screw 3.5, self-tapping
• Set of Instruments aap LOQTEQ® Olecranon Plate
The provided documentation describes the aap LOQTEQ® Olecranon Plate, a metallic bone fixation appliance. The study conducted to demonstrate its acceptance criteria focuses on non-clinical mechanical testing to establish substantial equivalence to predicate devices.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance of the aap system to be substantially equivalent to predicate devices. | Customized 4-point bending tests (static and dynamic) based on ASTM F382-99 demonstrated substantial equivalence with respect to mechanical performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of aap LOQTEQ® Olecranon Plates or predicate devices tested for the mechanical evaluation. It refers to "tests" and "test results" in the plural, implying multiple tests were conducted, but the exact sample dimension is not provided.
- Data Provenance: The data is from non-clinical testing conducted by the manufacturer, aap Implantate AG, in Germany. This is a prospective evaluation of the device's mechanical properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This question is not applicable as the study described is a non-clinical mechanical testing study, not a study involving human diagnosis or interpretation where expert ground truth would be established. The "ground truth" here is the physical performance data against established ASTM standards.
4. Adjudication Method for the Test Set
- This question is not applicable for a non-clinical mechanical testing study. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- This question is not applicable. The provided document describes a medical device (bone plate), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. As mentioned above, the device is a physical bone plate, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for this non-clinical study is defined by established mechanical testing standards, specifically ASTM F382-99, and the performance of the legally marketed predicate devices. The acceptance criterion for the new device was to demonstrate "substantial equivalence" to the mechanical performance of these predicate devices.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" in the context of this non-clinical mechanical testing study. Training sets are relevant for machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reasons as #8.
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(79 days)
The Stryker VariAx 2 Compression Plating System is intended for internal fixation of bones in adult patients.
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:
- osteotomies, mal-unions, and non-unions
- single, segmental, and comminuted fractures
- normal bone density and osteopenic bone
The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.
The provided document is a 510(k) summary for the VariAx 2 Compression Plating System, which is a medical device for internal fixation of bone fractures. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting new clinical studies with detailed acceptance criteria and performance metrics for the new device as would be the case for a novel AI/software medical device.
Therefore, many of the specific questions regarding acceptance criteria, study design, expert involvement, and ground truth, as typically applied to AI/ML device evaluations, are not directly applicable or available in this document.
Here's an attempt to address your questions based on the provided text, highlighting where information is not present or not relevant to this type of device submission:
Acceptance Criteria and Device Performance (Based on provided text)
| Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated through non-clinical laboratory testing |
| Dynamic Fatigue Testing Performance | Not explicitly detailed, but part of non-clinical testing to demonstrate substantial equivalence. |
| Intended Use | Internal fixation of bones in adult patients. |
| Indications for Use | Internal fixation of fractures in Radius, Ulna, Humerus, Clavicle, Distal tibia, and Fibula for osteotomies, mal-unions, non-unions, single, segmental, and comminuted fractures, and in normal and osteopenic bone. |
Study Details (Based on provided text)
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The submission relies on non-clinical laboratory testing (dynamic fatigue testing) to demonstrate substantial equivalence, not a clinical test set with patient data.
- Data Provenance: Not applicable for a clinical test set. The non-clinical testing was performed for the VariAx 2 Compression Plating System components.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device underwent non-clinical testing, not a clinical study involving expert-established ground truth on a test set.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set.
-
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 traditional medical device (bone plating system), not an AI/ML powered device. Therefore, no MRMC study or AI-related effectiveness was assessed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware medical device; there is no algorithm or software for standalone performance evaluation in the context of AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the sense of clinical ground truth for AI/ML devices. The "ground truth" for this submission would be engineering standards and requirements for mechanical performance and materials, verified through non-clinical testing.
-
The sample size for the training set:
- Not applicable. There is no training set for this traditional medical device.
-
How the ground truth for the training set was established:
- Not applicable. There is no training set.
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