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510(k) Data Aggregation
(77 days)
CoLink Plating System
CoLink® 2 Plating System -
The In2Bones USA, CoLink® Plating System/CoLink® View Plating System/CoLink ® Mini Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
CoLink® Afx Plating System -
The In2Bones USA, CoLink® Afx Plating System is indicated for stabilization of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
The In2Bones USA CoLink® Afx Plating System screws are intended to be used as stand-alone bone screws, or in a plate-screw system for fracture fixation.
The In2Bones CoLink® 2 Plating System is a system of plates and screws and surgical instruments used to treat fractures and reconstruction of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® 2 Plating System. In addition, a washer is being added to the CoLink® Afx Plating System.
This looks like a 510(k) premarket notification for a medical device, specifically the CoLink Plating System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting the results of clinical performance studies of an AI/ML device.
Therefore, many of the requested categories for a study proving device performance (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of submission. This submission primarily relies on mechanical performance testing and a comparison of materials, geometry, and indications for use to predicate devices.
Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a bone fixation system and not an AI/ML device, the "acceptance criteria" are not related to diagnostic performance metrics but rather to mechanical properties and substantial equivalence to predicate devices. The document refers to existing ASTM standards for testing.
| Acceptance Criteria (Implicit for mechanical devices based on predicate equivalence) | Reported Device Performance |
|---|---|
| Mechanical performance for plates (e.g., bending strength) per ASTM F382 (consistent with predicate devices). | A rationale was conducted related to the CoLink® Plating four-point bend testing per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. (Implies performance is comparable and acceptable). |
| Mechanical performance for screws (e.g., axial pullout, torque capacity, insertion torque) per ASTM F543 (consistent with predicate devices). | A rationale was conducted related to the plate screws of the predicate CoLink® system for axial pullout, torque capacity and insertion torque characteristics per ASTM F543. (Implies performance is comparable and acceptable). |
| Sterilization, biocompatibility, shelf life, and pyrogenicity (consistent with predicate devices). | The CoLink® 2 Plating System components and CoLink® Afx washers are not considered a worst case for sterilization, biocompatibility, shelf life and pyrogenicity and were adopted into the previous validations for the CoLink® Afx System (K181113). Bacterial endotoxin testing (LAL) is performed on each lot. (Implies compliance with established validations and testing). |
| MR environment compatibility, including RF induced heating (consistent with predicate devices). | An assessment was conducted regarding MR environment and labeling, including RF induced heating simulation, and it was determined that the CoLink® 2 components are not considered a worst case compared to K163293. (Implies acceptable MR compatibility). |
| Overall substantial equivalence in indications, materials, and geometry to predicate devices. | The subject CoLink® Plating System is made of Titanium Alloy and has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry. (This is the overarching conclusion of the submission, demonstrating all criteria for substantial equivalence were met). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket notification (510(k)) where substantial equivalence is demonstrated primarily through mechanical testing and comparison to predicate devices, not through a clinical "test set" of patient data as would be used for an AI/ML device.
- Sample Size: Not applicable in the context of this 510(k). The "samples" would be physical devices subjected to mechanical stress tests. The document doesn't specify the number of devices tested for each mechanical property, but rather refers to rationales and existing validations.
- Data Provenance: Not applicable. The data is from mechanical testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no "ground truth" establishment by medical experts in this type of submission. The ground truth for mechanical performance is established by adherence to engineering standards (ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device involving expert interpretation.
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 bone fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by:
- Adherence to recognized mechanical testing standards (e.g., ASTM F382 for bending, ASTM F543 for screws).
- Demonstration of substantial equivalence in materials, design, and intended use to predicate devices that have already been cleared by the FDA and are presumed safe and effective.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(28 days)
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating
The In2Bones USA LLC, CoLink® Plating System / CoLink® View Plating System / CoLink® Mini Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
The In2Bones USA LLC, CoLink™ Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.
The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metatarsals, and phalanges).
The In2Bones CoLink® Plating System / CoLink® View Plating System / CoLink® Mini Plating System and Fracture and Correction System are previously cleared plate and screws systems. The scope of this submission is to add a new packaging system for the previously cleared screws. The screws are all made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V). The implants are MR conditional.
This document is a 510(k) Premarket Notification from the FDA regarding orthopedic plating and screw systems. It does not describe an AI/ML medical device or a study proving that an AI/ML device meets acceptance criteria. The document explicitly states that the submission's scope is to "add a new packaging system for the previously cleared screws" and mentions that the products are "identical in indications, materials and geometry." The "Performance Testing" section lists validations related to sterilization, packaging, shelf life, and biocompatibility, which are standard for physical medical devices, not AI/ML performance.
Therefore, I cannot extract the requested information about acceptance criteria or a study proving an AI/ML device meets them from this document. The provided text does not contain any information related to AI/ML device performance, ground truth establishment, expert adjudication, or MRMC studies.
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(170 days)
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple
The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
The In2Bones USA LLC, CoLink™ Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.
The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metatarsals, and phalanges).
The In2Bones NeoSpan® Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
The RTS® Flexible 1ST MPJ Implant w/Grommets is intended for use in the treatment of:
- · Hallux limitus or hallux rigidus
- Painful rheumatoid arthritis
- Hallux abducto valgus associated with arthritis
- · Unstable or painful joint from previous surgery
The RTS® Lesser MTP Implant is intended for use in the treatment of:
- · Partial or complete dislocation of the lesser metatarsophalangeal joint
- · Pain associated with either rheumatoid or osteoarthritis
- · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
- · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
- · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
The In2Bones CoLink® Plating System / CoLink® View Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The CoLink® Afx Plating System is a system of plates and surgical instruments used to treat traumatic fractures and osteotomies of the ankle. The products are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) and the CoLink® View System has inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK).
The Fracture and Correction System consists of the 5MS® Plate and Screw System and the CoLag® cannulated lag screws used to treat fracture and reconstruction of the bones of the extremities. The products are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6A14V).
The RTS® Lesser MTP Implant System is a double stem silicone implant which is placed into the intramedullary canals of the first metatarsal and proximal phalangeal bones of the forefoot. The RTS® Flexible 1* MPJ Implant w/Grommets System is a flexible silicone great toe implant. Titanium grommets are also available for use in the first metatarsal (only) if the option is desired by the surgeon. The implant is used in the treatment of arthritis of the metatarsophalangeal joint. The implants are made from silicone elastomer NuSil Med 4755 from NuSil.
The In2Bones NeoSpan® Compression Staple Implant is a super elastic compression staple made of superelastic Nitinol (ASTM F2063). The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs.
I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for various orthopedic implant systems. It discusses the substantial equivalence of these devices to previously cleared predicate devices, primarily based on indications, materials, and geometry.
The "Performance Testing" section states that "MR Testing per ASTM Standards (ASTM F2052, ASTM F2213, ASTM F2182 and ASTM F2119) was conducted on worst case products to cover all In2Bones product families." This refers to testing for Magnetic Resonance (MR) compatibility and labeling, not a study that proves the device meets specific acceptance criteria in a clinical or performance effectiveness context directly comparable to an AI/algorithm-based medical device.
Therefore, I cannot extract:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information about MRMC studies, human reader improvement, or standalone algorithm performance.
- Type of ground truth, training set size, or how its ground truth was established.
This document focuses on regulatory clearance for traditional medical devices (implants), not AI/ML-based software as a medical device (SaMD) which would typically involve the types of studies and criteria you've requested.
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(164 days)
Colink Plating System
The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
The In2Bones CoLink™ Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the bones of the extremities.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bacterial Endotoxin | Device meets biocompatibility requirements. | Testing performed; results demonstrate substantial equivalence. |
| Static Driving Torque | Device components (screws) can be appropriately driven without failure, supporting the intended fixation. | Testing performed; results demonstrate substantial equivalence. |
| Static Pullout | Screws maintain adequate fixation in bone material under static axial loads, ensuring stability. | Testing performed; results demonstrate substantial equivalence. |
| Static Torsion | Screws and plates withstand torsional forces without failure, relevant for rotational stability. | Testing performed; results demonstrate substantial equivalence. |
| Screw/Plate Push Through | Screws do not "push through" the plate, maintaining the integrity of the fixation construct. | Testing performed; results demonstrate substantial equivalence. |
| Static Bending | Plates and screws maintain mechanical integrity and resist deformation under static bending loads, crucial for fracture stabilization. | Testing performed; results demonstrate substantial equivalence. |
| Pullout Fixation (General) | The overall construct (plate and screws) provides secure and stable fixation in bone. | Testing performed; results demonstrate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each mechanical test. It only generally refers to "testing" being performed. The data provenance is pre-market (regulatory submission for 510(k) clearance), suggesting it's from studies conducted by the device manufacturer, In2Bones USA, LLC. The country of origin of the data is not specified but would typically be where the manufacturer's testing facilities are located or where contract research organizations (CROs) performed the tests. The studies are prospective in nature, meaning they were designed and conducted specifically to generate data for this regulatory submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The device being described is a mechanical bone fixation system (plates and screws), not a diagnostic or AI-driven device that requires expert-established ground truth for performance evaluation in a clinical or imaging context. The "ground truth" for this type of device is established through engineering and mechanical testing standards and simulations rather than expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons mentioned in point 3. The evaluation of mechanical test results typically involves adherence to recognized standards and objective measurements, not adjudication by human experts in the way clinical studies are adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers in interpreting medical images or data. The Colink™ Plating System is a surgical implant, and its effectiveness is assessed through mechanical testing and, if applicable, clinical performance data (which is not detailed here beyond the substantial equivalence claim).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Colink™ Plating System is a physical medical device, not an algorithm. Therefore, there is no "standalone" algorithm-only performance to assess.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established through objective, standardized mechanical testing data (e.g., measurements of force, torque, displacement) against pre-defined engineering specifications and relevant industry standards for orthopedic implants. It is not based on expert consensus, pathology, or outcomes data in the context of this 510(k) summary, which focuses on substantial equivalence based on technological characteristics and mechanical performance.
8. The Sample Size for the Training Set
This information is not applicable. The Colink™ Plating System is an orthopedic implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data acquisition for AI model development.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons mentioned in point 8.
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