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510(k) Data Aggregation
(86 days)
The Arthrex Pilon Fusion Plates are intended to be internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous.
The Arthrex Low Profile Screws (3.5mm and larger, solid) 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 in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates and Osteotomy Plates.
The Arthrex Pilon Fusion Plate System are a family of contoured plates and screws. The Arthrex Pilon Fusion Plates are manufactured from Titanium conforming to ASTM F136 and are available in a variety of configurations. The Arthrex Pilon Fusion Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed plates are sold sterile or non-sterile and single use.
The proposed Arthrex Low Profile Screws are offered in a 3.5mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The screws are manufactured from Titanium conforming to ASTM F136 and are sold sterile or non-sterile and single-use.
The provided FDA 510(k) clearance letter and summary for the Arthrex Pilon Fusion System do not contain information about a study proving that a device meets acceptance criteria related to artificial intelligence (AI) or software performance.
The document describes a medical device, which is a system of plates and screws for internal bone fixation. The performance data presented refers to mechanical testing of the plates and screws (e.g., insertion torque, failure torque, 4-point bend testing, pull-out testing) to demonstrate substantial equivalence to predicate devices. There is also mention of MR compatibility testing.
Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/software device meets acceptance criteria from the provided text.
Based on the nature of the document (510(k) for orthopedic implants), it is highly unlikely to contain such information. This type of submission focuses on the physical and mechanical properties of the device, biocompatibility, and substantial equivalence to existing predicate devices, not AI or software performance.
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(57 days)
K103705: Arthrex Low Profile Screws
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws are a family of screws that are offered in a 3.5 mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The Arthrex Low Profile Screws are manufactured from Stainless Steel materials conforming to ASTM F138. The screws are sold sterile or non-sterile and single-use.
This document is a 510(k) summary for the Arthrex Low Profile Screws. It describes mechanical testing performed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating device performance against pre-defined acceptance criteria for a diagnostic algorithm. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical integrity and performance statistically equivalent to predicate devices for insertion torque/failure torque | Insertion torque/failure torque demonstrated to be statistically equivalent to the predicate. |
| Design modifications to previously cleared 3.5 mm Arthrex Low Profile Screws do not affect safety or performance (evaluated via pull-out testing and insertion torque/failure torque testing) | Pull-out testing and insertion torque/failure torque testing conducted on previously cleared 3.5 mm screws demonstrated that design modifications do not affect safety or performance. |
| MR compatibility per ASTM F2052-15 (displacement force), ASTM F2213-17 (torque), ASTM F2119-13 (image artifact) | MR compatibility testing successfully conducted per specified ASTM standards. |
2. Sample sized used for the test set and the data provenance:
- Sample size: Not specified. The document mentions "mechanical testing data" but does not quantify the number of screws or tests performed.
- Data provenance: Not explicitly stated, however, as mechanical testing, it would be laboratory-generated data, not from human subjects or clinical settings, thus neither retrospective nor prospective in the typical sense for clinical data. It would be considered prospective for the testing itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes mechanical testing of a physical device, not the evaluation of a diagnostic tool against a ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for clinical studies involving reader interpretations, not for 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:
- Not Applicable. This is a 510(k) for a medical screw, 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 is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For mechanical testing, the "ground truth" would be the measured physical properties and performance metrics of the previous devices as a benchmark for comparison.
8. The sample size for the training set:
- Not Applicable. This document describes mechanical testing, not a machine learning model or algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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(112 days)
The Double ENDOBUTTON Fixation Device is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).
The subject of this Traditional 510(k) is the Double ENDOBUTTON Fixation Device. The Smith & Nephew Double ENDOBUTTON Fixation Device is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of three components: two stainless steel fixation devices and a UHMW polyethylene suture. This device is provided sterile, for single use only.
The provided document is an FDA 510(k) clearance letter and associated summary for a medical device (Double ENDOBUTTON Fixation Device). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a digital health device or AI/ML device meets those criteria.
Specifically, the document discusses a mechanical fixation device used in orthopedic surgery, not a software device or an AI/ML algorithm. Therefore, the concepts of "acceptance criteria" for an AI/ML model, "sample size for test set," "ground truth establishment," "MRMC study," or "standalone performance" are not applicable to the content of this document.
The performance data mentioned in the document refers to:
- Mechanical testing: Interface pressure, suture construct tests.
- Bacterial endotoxin testing.
- Clinical literature review: Comparing complication rates and clinical outcome scores (ROWE, Walch-Duplay, ASES) between the device's usage and predicate screws.
Since the document provided does not describe an AI/ML device or its validation, I cannot fill in the requested table and information.
To answer your request, I would need a document describing the validation of an AI/ML or digital health device.
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(106 days)
The Arthrex Blunt Tip Screws are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used in conjunction with FiberTape, they can be used to treat patella fractures.
The Arthrex FiberTape suture products are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries. When used in conjunction with the Arthrex Blunt Tip Screws, Fiber Tape can be used to treat patella fractures.
The Arthrex Blunt Tip Screws with FiberTape is a construct that includes stainless steel, blunt tip, partially threaded, cannulated low profile screws and FiberTape.
The provided document is a 510(k) premarket notification for a medical device called "Arthrex Blunt Tip Screws with FiberTape." This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).
Unfortunately, this document does not contain the detailed information required to fill out all parts of your request regarding acceptance criteria and a study proving device performance.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the device is "substantially equivalent" to predicate devices based on "Geometrical analysis" and "the summary of data submitted." It does not provide a table with specific performance acceptance criteria (e.g., tensile strength thresholds, bending stiffness limits) or detailed reported device performance values for these criteria.
| Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|
| No specific criteria or performance values provided in text. | No specific criteria or performance values provided in text. |
| (Hypothetical: Tensile Strength > 100N) | (Hypothetical: 120N) |
| (Hypothetical: Fatigue Life > 1,000,000 cycles) | (Hypothetical: 1,500,000 cycles) |
2. Sample size used for the test set and data provenance:
The document mentions "Geometrical analysis" and a "summary of data submitted" but does not specify numerical sample sizes for any test sets. It also does not discuss data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and qualifications:
Not applicable to this type of submission. This document pertains to mechanical properties and substantial equivalence, not clinical diagnostic performance or expert consensus on a test set.
4. Adjudication method for the test set:
Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable. This is a medical device for internal bone fixation and soft tissue approximation, not a diagnostic imaging device typically evaluated with MRMC studies.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:
Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used:
The "ground truth" in this context is the performance of the legally marketed predicate devices. The submission implies that the Arthrex Blunt Tip Screws with FiberTape either meet or exceed the performance of these predicates, or that any differences do not raise new questions of safety or effectiveness. The methods used to establish this "ground truth" for the predicate devices would have been their own clearance processes, likely involving mechanical testing and potentially clinical data.
8. Sample size for the training set:
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is present in the document relevant to your query:
- Device: Arthrex Blunt Tip Screws with FiberTape
- Purpose of Submission: To obtain clearance for the device for internal bone fixation for bone fractures in the patella.
- Method for demonstrating equivalence: "Geometrical analysis" and "summary of data submitted" demonstrate substantial equivalence to predicate devices.
- Predicate Devices:
Conclusion Regarding your Request:
The provided 510(k) clearance letter and summary confirm the FDA's determination of substantial equivalence for the Arthrex Blunt Tip Screws with FiberTape to predicate devices. However, it does not contain the detailed study results, specific acceptance criteria, sample sizes, or expert involvement data that you requested. These details would typically be found in the manufacturer's internal test reports or the full 510(k) submission, portions of which are not public in this summary document. The document emphasizes mechanical and design equivalence rather than diagnostic performance assessed by human readers or algorithms.
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