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The proposed Mini Fragment Plates are intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton.

The proposed Mini Fragment Plates are a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Fragment Plates that are provided in the following design configurations: Straight, Y, Right Hockey Stick, and Left Hockey Stick. Pegs; Screws; and K-Wires. Included in the sterilization tray are the following re-useable instruments: Peg drivers, Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: F.A.S.T. Guide Technology™ Drill Guide, Drill bits.

The provided text is for a 510(k) premarket notification for "Mini Fragment Plates", a type of orthopedic implant. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of device performance metrics like sensitivity, specificity, or reader studies.

Therefore, the requested information, such as acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, are not present in the provided document.

Instead, the document details:

• Device Name: Mini Fragment Plates
• Manufacturer: Hand Innovations, LLC
• Predicate Device: Fragment Plate System (K041081)
• Classification: Class II
• Indications for Use: Stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
• Device Description: Orthopedic plates and fasteners (Straight, Y, Right Hockey Stick, Left Hockey Stick), pegs, screws, K-wires, reusable instruments (peg drivers, standard surgical tools), and non-reusable instruments (F.A.S.T. Guide Technology™ Drill Guide, drill bits).
• Biocompatibility: Not required as the material (Ti-6Al-4V ELI per ASTM F 136-00) is the same as the previously approved predicate device and has a long history of safe use.
• Summary of Substantial Equivalence: The proposed Mini Fragment Plates have the same indications for use, intended use, basic shape/design, operating principle, and materials as the predicate device. The changes do not alter the fundamental scientific technology.

This document is a regulatory submission focused on confirming that the new device is "substantially equivalent" to an already approved device, meaning it doesn't raise new questions of safety and effectiveness. It does not involve performance testing against specific clinical or system-level acceptance criteria in the way a novel diagnostic or AI-driven device would.

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The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.

The proposed Multidirectional Threaded Peg is manufactured from Cobalt Chromium (CoCr) and is available in 2.5 mm diameter and in a variety of lengths, ranging from 10 – 30 mm in 2 mm increments to accommodate varying patient anatomies and fracture morphologies.

This submission describes a medical device, the Multidirectional Threaded Peg, which is a component of a bone fixation system. The FDA 510(k) summary provided indicates that this is a substantially equivalent device filing, meaning the device's performance is compared to an already legally marketed predicate device. Therefore, a comprehensive "study that proves the device meets the acceptance criteria" in the sense of a standalone clinical trial with acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy for an AI system) is generally not applicable for this type of submission.

Instead, the "acceptance criteria" and "study" for this type of device revolve around demonstrating substantial equivalence to the predicate device through pre-clinical testing, primarily mechanical testing, to ensure that the new device performs at least as well as the predicate for its intended use.

Here's the breakdown of the information requested, tailored to this device type and the provided documents:

1. Table of Acceptance Criteria and the Reported Device Performance:

Regarding the other requested points (2-9), these are mostly relevant for diagnostic AI/software devices or clinical studies with human subjects, not for demonstrating substantial equivalence for a new mechanical implant component via pre-clinical testing as seen in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for an implantable medical device undergoing pre-clinical mechanical testing for substantial equivalence. The "test set" would refer to physical prototypes or engineering samples.
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. Ground truth for mechanical testing is established by engineering standards, test methods, and quantitative measurements, not expert human assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for pre-clinical 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 not an AI device or a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant component, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective physical properties and performance measured against established ASTM standards and benchmarked against the predicate device's known performance.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical pre-clinical testing for substantial equivalence.
9. How the ground truth for the training set was established: Not applicable.

In summary, for this particular medical device (Multidirectional Threaded Peg), the "study" demonstrating its meeting of "acceptance criteria" is a series of pre-clinical mechanical tests (implicitly, as detailed test reports are not in the summary) comparing its performance to a legally marketed predicate device, ensuring substantial equivalence in material, design, and function for its stated indications for use. The acceptance criteria primarily centered on material compliance (ASTM F 1537-00) and comparable mechanical performance to the predicate device.

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The proposed Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.

The proposed Diaphyseal Plate is fabricated from 316L Stainless Steel and is available in five configurations - 6, 8, 10, 12, and 14 hole plate configuration. The proposed Diaphyseal Plate has both slotted holes, for accommodating the Multi-Directional Screws, and round holes for accommodating either Multi-Directional or 90° Lock Screws. 90° Set Screws are used to secure the 90° Lock Screws within the plate to prevent backout.

The provided text describes a medical device, the "Hand Innovations Diaphyseal Plate," and its regulatory clearance process, including information on its intended use, design, and comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, specifically concerning AI/algorithm performance.

The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics against predefined acceptance criteria for an AI or algorithm.

Therefore, I cannot provide a response to your request, as the necessary information regarding acceptance criteria and a study demonstrating algorithmic performance is absent from the provided text.

Here's why each numbered point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria in the context of an AI or algorithmic output, nor does it report such performance.
2. Sample sized used for the test set and the data provenance: No test set for an AI/algorithm is described. The "testing" mentioned refers to pre-clinical testing for substantial equivalence, not algorithmic validation data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI/algorithm test set.
4. Adjudication method: Not applicable as there is no AI/algorithm test set requiring ground truth 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: This is a traditional mechanical implant, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm described.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as there is no AI or algorithm discussed.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Testing" mentioned in the "Summary of Substantial Equivalence" section refers to pre-clinical (e.g., mechanical) testing to ensure the device's physical properties are comparable to the predicate device, not the performance of an AI or algorithm.

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The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Shoulder Plates Shoulder Nail Plates Multidirectional and 90° Lock Screws 90° Set Screws Pegs Included in the sterilization tray are the following re-useable instruments: Peg drivers Other standard surgical tools.

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for a medical device called the "Modified Shoulder Fixation System." It details administrative information such as the device name, predicate device, classification, indications for use, and a general description of the system. It also includes a letter from the FDA confirming substantial equivalence to a predicate device.

Specifically, the document does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or study design for testing.
3. Information on experts, ground truth establishment, or adjudication methods.
4. Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
5. Information about training sets or how ground truth for training was established.

Instead, the summary states: "The Modified Shoulder Fixation System is substantially equivalent to the predicate Shoulder Fixation System. The equivalence was confirmed through pre-clinical testing." This implies that the basis for approval was a demonstration of substantial equivalence to an already legally marketed device, often involving comparison of design, materials, and potentially certain mechanical tests, rather than clinical performance studies against specific acceptance criteria.

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The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

The bilaterally symmetric Shoulder Nail Plate is intended to treat fractures in both left and right Humerus. The plate segment of the Shoulder Nail Plate is intended to be attached to the metaphysis of the humerus. The nail segment of the Shoulder Nail Plate is intended to be inserted into the humeral diaphysis for optimal stabilization of the fracture.

The provided text is a 510(k) summary for a medical device called the "Shoulder Nail Plate." This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a clinical study report detailing acceptance criteria for performance verification with data.

Therefore, many of the requested elements about acceptance criteria, device performance metrics, study design, and ground truth establishment are not applicable. The document focuses on demonstrating equivalence to predicate devices through intended use, materials, biocompatibility, and overall performance characteristics, and not on establishing specific performance metrics against a set of acceptance criteria in a clinical or analytical study.

Here's an assessment based on the available information:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary states, "The Shoulder Nail Plate is substantially equivalent to the predicate Shoulder Side Plate of the Shoulder Fixation System with regards to the intended use, materials, biocompatibility, and overall performance characteristics. The equivalence was confirmed through pre-clinical testing." This indicates that performance was assessed relative to the predicate, but specific acceptance criteria and detailed quantitative performance data are not included in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions "pre-clinical testing" but does not detail the nature of these tests, sample sizes, or data provenance.

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)

This information is not applicable/not provided. The device is a bone fixation plate, not an AI or diagnostic device that requires expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed for this 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

This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretation devices, which this is not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided in the context of typical "ground truth" as described for diagnostic or AI devices. The substantial equivalence relies on demonstrating similar physical and mechanical properties, biocompatibility, and intended use as predicate devices. The "ground truth" for non-AI medical devices generally refers to established scientific principles, consensus standards regarding material properties, and clinical outcomes for predicate devices. The document states biocompatibility was based on meeting ASTM F 138-03, which serves as a standard for stainless steel, indicating compliance with a recognized material standard.

8. The sample size for the training set

This information is not applicable/not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This information is not applicable/not provided.

In summary:

The provided document is a 510(k) summary, which is a regulatory submission focused on demonstrating substantial equivalence to existing legally marketed devices. It does not contain details of a clinical or analytical study with defined acceptance criteria and performance metrics in the way these questions are framed for, for example, diagnostic or AI devices. The "study" mentioned is "pre-clinical testing" to confirm equivalence, but no specific data or methodology from this testing is provided in this summary.

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The Dorsal Nail Plate™, Anatomical is intended for the fixation of fractures and osteotomies involving the distal Radius.

The Dorsal Nail Plate™, Anatomical is intended to treat fractures in both left and right Radius. The distal segment of the nail plate is intended to be attached to the dorsal surface of the distal Radius. The proximal segment of the nail plate is intended to be inserted into the Radial shaft.

This document describes a medical device called the "Dorsal Nail Plate™, Anatomical" for bone fixation, and not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device, such as sample size, ground truth establishment, expert qualifications, and AI-specific comparative effectiveness studies, is not applicable to this submission.

The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval.

Here's an analysis of the provided information in relation to the query:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit): Substantial equivalence to the predicate device in terms of intended use, materials, biocompatibility, and overall performance characteristics.
• Reported Device Performance: The document states that "The equivalence was confirmed through pre-clinical testing." No specific performance metrics or thresholds are explicitly provided in the summary.

2. Sample sized used for the test set and the data provenance

• Not Applicable: This pertains to clinical studies for AI/ML devices. For this orthopedic implant, the "test set" would typically refer to mechanical or bench testing. The document mentions "pre-clinical testing" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: This relates to expert annotations for AI/ML models. For this device, "ground truth" would be established through engineering specifications, material standards (e.g., ASTM F 136 for Titanium Alloy), and results of mechanical testing. No expert panel for "ground truth" establishment as understood in AI/ML is described.

4. Adjudication method for the test set

• Not Applicable: This is relevant for expert disagreement resolution in AI/ML performance evaluation. Not mentioned for this orthopedic 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

• Not Applicable: This is specific to AI-assisted human performance studies. No such study was conducted or is relevant for a bone plate.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable: This refers to the performance of an AI algorithm itself. Not relevant for a physical medical device.

7. The type of ground truth used

• Type of "Ground Truth": For this device, the "ground truth" is based on:
  • Material Standards: ASTM F 136 (for Titanium Alloy) for biocompatibility and material properties.
  • Engineering Specifications: Implicit in the design and manufacturing of the plate to meet the functional requirements for fixation.
  • Pre-clinical Testing Results: Physical and mechanical testing to demonstrate performance equivalence.

8. The sample size for the training set

• Not Applicable: This is a concept for AI/ML model development.

9. How the ground truth for the training set was established

• Not Applicable: This is a concept for AI/ML model development.

In summary, the provided document is a 510(k) submission for a traditional medical device (bone plate) and does not contain the kind of information requested for an AI/ML-based device.

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The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Shoulder Plates • Multidirectional and 90° Lock Screws • 90° Set Screws • Pegs Also, provided in the sterilization tray are the re-useable instruments

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain explicit acceptance criteria and device performance metrics in the format of a table. Instead, it describes a "Summary of Substantial Equivalence" and states that "The equivalence was confirmed through pre-clinical testing."

2. Sample size used for the test set and the data provenance:

The document does not specify a distinct "test set" or its sample size. The substantial equivalence was confirmed through "pre-clinical testing," which typically involves mechanical and/or bench testing rather than studies with patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable as patient data was not used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. Given that the equivalence was based on "pre-clinical testing," ground truth would likely be established through engineering specifications and test standards, not expert medical consensus on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. As mentioned, the evaluation was based on pre-clinical testing, making formal adjudication methods for a medical test set irrelevant.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical orthopedic implant (Shoulder Fixation System) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

A "standalone" performance study in the context of an algorithm or AI was not done. The device is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for demonstrating substantial equivalence was based on pre-clinical testing which would involve engineering and mechanical performance data, often compared against established standards for material properties and mechanical strength of similar devices. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

The concept of a "training set" is not applicable as this is a medical device (implant) clearance, not an AI or machine learning model.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

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