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This device is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.

This submission describes self drilling bone screws intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Self Drilling Screw is available in 1.2 and 1.7 mm diameters with lengths ranging from 4-7 mm and in a 2.0 mm diameter with lengths ranging from 5-8 mm.

The provided document is a 510(k) summary for the Leibinger® Self-Drilling Screw and the FDA's response letter indicating substantial equivalence. This type of submission is for medical devices and focuses on demonstrating equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, the information typically requested for AI/device performance studies (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document. The document highlights the device's intended use, materials, design, and operational principle to establish similarity with predicate devices.

Here's why the requested information isn't available and what the document does provide:

• Acceptance Criteria & Reported Performance: This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a study comparing the device's performance against such criteria. The "performance" being evaluated here is primarily whether the new device is substantially equivalent to existing legally marketed devices based on its characteristics.
• Study Details (Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone): These are all elements of a clinical or technical performance study, which is not described. The 510(k) pathway often relies on bench testing, material characterization, and comparison to predicate devices rather than de novo clinical performance trials, especially for low-to-moderate risk devices like bone screws, if substantial equivalence can be shown.
• Training Set Information: This product is a physical medical device (a screw), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

Based on the provided text, here is what can be extracted, acknowledging that most of the requested fields are not applicable to this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as numerical performance metrics. The underlying "acceptance criteria" for a 510(k) submission are met if the FDA determines the device is substantially equivalent to a predicate device. This is based on similarities in intended use, materials, design, and operational principles, and that it doesn't raise different questions of safety and effectiveness.
• Reported Device Performance: The document states that "Equivalence for this device is based on similarities in intended use, material, design and operational principle" to the KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and the Leibinger® Luhr Small Bone Screws [K963739, K963740 and K963741]. This is the "performance" shown: it is sufficiently similar to devices already on the market.

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

• Not Applicable. This document does not describe a "test set" in the context of performance evaluation for an AI or diagnostic device. The evaluation is based on device specifications and comparison to predicates.

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

• Not Applicable. No ground truth establishment by experts is described for a performance study.

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

• Not Applicable. No adjudication method is described.

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 physical bone screw, not an AI-assisted diagnostic device.

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

• Not Applicable. This is a physical bone screw, not an algorithm.

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

• Not Applicable. There is no "ground truth" established for performance evaluation in a clinical study detailed in this document. The "truth" in this context is the FDA's regulatory determination of substantial equivalence based on the provided technical information and comparison to predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI algorithm.

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

• Not Applicable. This is a physical medical device, not an AI algorithm.

Summary of what the document does provide:

• Device Name: Leibinger® Self-Drilling Screw
• Intended Use: Internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.
• Device Description: Available in 1.2, 1.7, and 2.0 mm diameters with various lengths. Manufactured from titanium alloy. Self-drilling, one-step insertion.
• Predicate Devices: KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and Leibinger® Luhr Small Bone Screws [K963739, K963740, K963741].
• Basis for Equivalence: Similarities in intended use, material, design, and operational principle.
• Regulatory Outcome: FDA found the device "substantially equivalent" to predicate devices, allowing it to be marketed.

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This product is intended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive oscotomy and segment are indicated. This includes conditions such as, syndromic cramosynostosis, midfacial cetrusion, hemifacial microsomia, und mandibular micrognathia. The device is mended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones

This device is a distraction system consisting of the following major components; distractor frame, plates, machine screws, flexible shaft, and distraction key. The plates and frame initially stabilize and then gradually distract the osteotomy. The flexible shaft, covered with a protective sheath, is connected to the frame and provides the point of attachment for the key used to initiate the distraction of the osteotomy.

The Cohen Distractor is a bone distraction system intended for use in the treatment of cranial, midfacial, or mandibular conditions requiring reconstructive osteotomy and segment advancement. These conditions include syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular micrognathia. The device's purpose is to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones.

The provided text focuses on the device's mechanical performance rather than clinical efficacy studies. Therefore, acceptance criteria and performance are reported for mechanical characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The number of Cohen Distractor units, Vazquez-Diner Distractor units, and MULTI-GUIDE™ distractor units tested for static cantilever bend testing is not explicitly stated. The text only mentions "the Cohen Distractor and two currently available and legally marketed distraction devices."
• Data Provenance: The data is from mechanical testing conducted as part of the 510(k) submission process. This is a controlled engineering study, not
  clinical data from patients.

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

• Not applicable. The "ground truth" for this study is based on objective measurements from static cantilever bend testing, not expert interpretation or consensus of clinical data. The mechanical properties are physical characteristics.

4. Adjudication method for the test set:

• Not applicable. This was a mechanical engineering study, not an evaluation of clinical outcomes requiring adjudication. The results would be quantitative measurements.

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 was a pre-market submission for a physical medical device (bone distractor), not an AI-powered diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or is relevant to this submission.

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

• No. As stated above, this device is a bone distractor, not an algorithm or AI system.

7. The type of ground truth used:

• The "ground truth" here is the objective measurement of mechanical properties (frame stiffness and yield strength) obtained through controlled laboratory testing (static cantilever bend testing) on the devices.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not a machine learning algorithm. There is no concept of a "training set" in this context.

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

• Not applicable. There is no training set for this type of device.

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This product is mended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive osteolority and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular microgradhia. The device is monded to provide temporary stubilization and gradual lengthening of the crawial, midfacial, or mandibular bones.

This device is a distraction system consisting of the following major components; distractor frame, extension rods, connector forks, distraction port or flexible shaft and distraction key. Depending on the frame is connected to either a distraction port or a flexible shaft, which is covered with a protective sheath.

Here's a breakdown of the acceptance criteria and the study that proves the Guerrero - Bell Distractor meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Yield Strength: The submission explicitly states, "It is not anticipated that this difference will have any relevance in the clinical setting because of the low forces observed in patients who are treated with all of these devices." This implies that even though the yield strength was lower than one of the predicates, it still met an implicit (but not explicitly stated as a numerical threshold) clinical relevance criterion.

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes in vitro mechanical testing, not a clinical study involving human or animal subjects. Therefore, the concept of "test set" in terms of patient data or clinical samples (and associated provenance) is not directly applicable.

• Test Set: Multiple instances of the Guerrero - Bell Distractor, Vazquez-Diner Distractor, and MULTI-GUIDE™ distractor were used for the static cantilever bend testing. The exact number of devices tested for each model is not specified, but the use of "average yield strength" implies multiple samples.
• Data Provenance: Not applicable as it's mechanical in vitro testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for mechanical testing is established by engineering standards and measurement accuracy, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to clinical studies where ambiguity in observation or diagnosis requires external review. For mechanical testing, the results are directly measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is a clinical study involving multiple human readers interpreting medical images or data. The study described is mechanical in vitro testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a conceptual sense. The testing performed on the device was "standalone" in that it assessed the mechanical properties of the device itself, without human interaction influencing its performance during the test (other than setting up the experiment). This is not an AI algorithm, so the "algorithm only" part is not relevant.

7. The Type of Ground Truth Used

The ground truth used for this study was objective mechanical measurements (e.g., force, displacement) obtained through standardized engineering testing (static cantilever bend testing).

8. The Sample Size for the Training Set

Not applicable. This refers to the data used to train an AI algorithm. The described study is mechanical testing of a medical device, not an AI product.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

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The Epitec system can be used for the fixation of diverse kinds of craniofacial prostheses, including the following examples:

• Ear prostheses Orbital prostheses Nose prostheses Cheek prostheses Hair Pieces
  Although the Epitec system will primarily be used for the alloplastic reconstruction of craniofacial defects caused by genetic anomalies, tumor resections, or trauma, it can also be used in other craniofacial cases best treated with surgical anchoring.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Epitec™ Titanium Implant System. It does not contain the acceptance criteria or details of any study proving the device meets acceptance criteria.

The letter states that the device has been found substantially equivalent to predicate devices, allowing it to be marketed, but does not include information about performance studies or acceptance criteria.

Therefore, I cannot provide the requested information based on the input document.

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The Lee Plate is intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). The basic operational principle is to provide fixation/stabilization of an anterior mandibular bone segment that is freed during a corrective osteotomy procedure.

This submission describes a bone plate intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). It is designed to provide fixation to an advanced anterior mandibular bone segment. Screw holes allow for attachment to the anterior mandible and the osteotomized segment. 1.7 mm and 2.0 mm diameter screws are used to attach the plate to bone.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification summary for a device called the "Lee Plate," which is a bone plate used for internal fixation in mandibular osteotomies.

While it mentions the intended use, material, and design, it lacks the specific study details such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

The document primarily focuses on establishing substantial equivalence to a predicate device (Profil-O-Plastic Chinplate) based on similarities in intended use, material, design, and operational principle, rather than presenting a performance study against specific acceptance criteria.

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This submission describes a small bone screw intended for use in temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both.

The Leibinger® IMF Screw is 2.0 mm in diameter and ranges from 10.5-18.5 mm in total length (6-14 mm in threaded length). There is a hole in the screw head through which a wire can be passed to fix the maxilla and mandible. The device is for single use only.

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or details about ground truth establishment.

The document is a 510(k) premarket notification letter from the FDA to Howmedica Leibinger, Inc. regarding their Leibinger IMF Screw. It confirms the substantial equivalence of the device to legally marketed predicate devices. It lists the device's proprietary name, common name, classification, and manufacturing details. It also mentions the basis for equivalence (similarities in intended use, material, design, and operational principle to other existing devices).

Therefore, I cannot provide the requested table and study details.

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intended for use in internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction.

This submission describes a system of small bone screws. Screws are available in diameters ranging from 0.8 to 2.4 mm and lengths ranging from 2 mm to 28 mm. These devices are for single use only.

This looks like a 510(k) summary for a medical device (bone screws), not a study evaluating an AI algorithm. Therefore, the questions about acceptance criteria for an AI device and an AI study are not applicable to the provided text.

The document describes:

• The device proprietary name: Leibinger® - Luhr® Small Craniomaxillofacial Bone Screw System
• Its intended use: internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction.
• Device characteristics: Screws in diameters ranging from 0.8 to 2.4 mm and lengths from 2 mm to 28 mm, for single use.
• Predicate devices: The submission establishes equivalence based on similarities in intended use, material, design, and operational principle to several existing bone screw systems (Howmedica Luhr® Fixation System, Wurzburg® Bone Screws, Steinhauser® Bone Screws, and Howmedica Leibinger Forefoot Reconstruction System).

To address your specific questions, this type of document typically relies on substantial equivalence to predicate devices rather than a performance study with acceptance criteria in the way an AI algorithm would be evaluated. For devices like bone screws, performance is generally established through:

• Material properties testing: Tensile strength, fatigue life, corrosion resistance, biocompatibility.
• Mechanical testing: Torsion, bending, pull-out strength, insertion torque, shear strength, and other appropriate biomechanical tests to ensure the screws can withstand expected physiological loads.
• Sterility validation: To ensure the device is sterile for use.
• Biocompatibility testing: To ensure the materials are non-toxic and do not cause adverse tissue reactions.

However, none of these specific tests or their acceptance criteria are detailed in this 510(k) summary; instead, the summary states that equivalence is based on similarities to previously cleared devices. If a study was performed, it would typically be a set of mechanical and material tests comparing the new device to the predicate devices, demonstrating that the new device performs equivalently or better within an acceptable margin.

Therefore, I cannot populate the table or answer the other questions as they pertain to an AI study.

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This submission describes an intraoral distraction device. It is intended for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.

The device consists of three major components: the threaded self drilling fixation pins, the mandibular distraction frame and the distraction rod and key. The pins attach the frame to the mandible. The distraction rod attaches to the frame and is rotated via the key to apply tension to the frame and osteotomy site. Directions regarding distraction are given to the patient by the physician. Frames are available for up to 18 mm or 28 mm of distraction depending upon the condition of the mandible. All components of this device are for single use.

The provided text is a 510(k) Summary for a medical device (Vazquez-Diner Intraoral Distraction Device). It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study demonstrating the device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and performance study details cannot be extracted from this document. The document explicitly states: "Equivalence for this device is based on similarities in intended use. material, design and operational principle to the Howmedica Mandibular Bone Lengthener (K945674). the Wells Johnson Fixation System (1945500), the Synthes Mini Lengthening Apparatus (K914558) and the Synthes Mandible Distractor (K962272)."

This indicates that clinical studies demonstrating performance against acceptance criteria, as one might find for a novel device, were not a requirement for this specific submission. The FDA clearance process for 510(k) submissions relies on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical performance studies in many cases.

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It is intended for use in internal fixation of small bones including the hand and foot secondary to trauma or for reconstruction.

This submission describes a system of small bone screws. Screws are available in diameters ranging from 0.8 to 3.5 mm and lengths ranging from 2 mm to 40 mm. These devices are for single use only.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and study information:

This 510(k) summary for the "Leibinger^(H) - Luhr^(H) Small Orthopedic Bone Screw System" does not contain any information about acceptance criteria or a study designed to prove the device meets those criteria.

Instead, this document is a predicate device comparison summary, a common approach for 510(k) submissions. In this type of submission, the manufacturer asserts substantial equivalence to a legally marketed device (the predicate device) by demonstrating similarities in:

• Intended Use: The purpose for which the device is used.
• Material: The components from which the device is made.
• Design: The physical specifications and configuration of the device.
• Operational Principle: How the device achieves its intended effect.

Since the submission relies on demonstrating equivalence rather than providing performance data against specific acceptance criteria, the detailed questions about studies, sample sizes, ground truth, and expert involvement are not applicable to the information provided.

Therefore, I cannot populate the table or answer the specific questions about studies from the given text.

However, I can explain why these details are missing based on the nature of the 510(k) submission:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission does not define specific performance acceptance criteria for this new device. It relies on the predicate devices having already met their regulatory requirements.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set data is presented.
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. No ground truth establishment for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set analysis requiring adjudication is described.
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 device is a bone screw system, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This question pertains to AI/software performance, which is not relevant to a bone screw.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth definition is provided as no primary performance study is described.
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. As above, no training set or ground truth for it is relevant here.

In summary, the provided 510(k) uses the "Substantial Equivalence" pathway, which means it demonstrates that the new device is as safe and effective as a legally marketed predicate device, rather than providing new performance study data against pre-defined acceptance criteria.

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