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The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

The specific indications for the Para-Fix External Fixation System include:

· Bone fracture fixation
· Osteotomy
· Arthrodesis
· Correction of deformity
· Revision procedure where other treatments or devices have been unsuccessful
· Bone reconstruction procedures

The New Paradigm Biomedical (NPB) Para-Fix External Fixation System is intended for use in external fixation of various long bone fractures, including tibial, femoral, pelvic, and humeral fractures in adults. The Para-Fix system consists of implants, & instrumentation for external fixation. The system features implants (Schanz Screws) in various diameters (05 – 6mm) and lengths (120 – 300mm) to accommodate different anatomic sizes of patients. Schanz Screws are manufactured from medical grade stainless steel per ASTM F138. Para-Fix frame components include Clamps are available in Combination (pin to rod, rod to rod) or Multi-Pin clamps are manufactured from stainless steel. Ø11mm rods are available in lengths ranging from 65 – 500mm and are manufactured from carbon fiber. The Para-Fix system is provided non-sterile.

The provided text describes a 510(k) premarket notification for the "Para-Fix External Fixation System." This is a medical device for orthopedic use, specifically for stabilizing bone fractures and other orthopedic conditions.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than describing a study to prove acceptance criteria for a new AI/software-based medical device. Therefore, much of the requested information regarding "acceptance criteria," "device performance," "sample sizes," "ground truth," "expert readers," and "MRMC studies" is not applicable or present in this specific 510(k) summary.

Here's how the provided information relates to the request:

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

• Acceptance Criteria: The primary acceptance criterion for a 510(k) submission like this is substantial equivalence to a predicate device. This is typically demonstrated through a comparison of technological characteristics, intended use, and performance data (often non-clinical in this case).
• Reported Device Performance: The performance is reported in terms of mechanical testing showing substantial equivalence to the predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a number of patients or clinical cases. For mechanical testing, the "sample size" would refer to the number of devices or components tested. This information (e.g., number of replicates for each mechanical test) is not detailed in the summary but would be part of the full test reports.
• Data Provenance: The mechanical testing was performed by "Element Materials Technology (Fairfield, OH)" and "NexTek Innovations (Logan, UT)". This is laboratory-based testing, not human clinical or retrospective/prospective data collection from patients.

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

• This question is not applicable to this type of device (an external fixation system). "Ground truth" in the context of mechanical testing is established by the test standards (ASTM F1541-17) and the results obtained from the testing equipment, not by expert human interpretation like in diagnostic AI.

4. Adjudication method for the test set

• This question is not applicable. There is no human adjudication for mechanical test results; the results are quantitative measurements against defined standards.

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 question is not applicable. This device is a mechanical external fixation system, not an AI-assisted diagnostic tool. No human reader studies (MRMC) were conducted or are relevant.

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

• This question is not applicable. There is no algorithm or software for "standalone performance" in this context.

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

• The "ground truth" for demonstrating substantial equivalence for this device is based on pre-defined mechanical testing standards (ASTM F1541-17) and the measured performance of both the subject device and the predicate device under these standardized conditions.

8. The sample size for the training set

• This question is not applicable. This device does not involve machine learning or a "training set."

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

• This question is not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.

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The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.

The Acumed Polarus® Connect System of bone plates, intramedullary nails, screws and accessories are designed to provide fixation for fractures of the humerus while they heal. The Polarus® Connect System also includes instruments to facilitate placement of implants.

This document seems to be a 510(k) summary for a medical device called the "Acumed Polarus® Connect System," which is a humerus intramedullary nail and plate fixation system. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than conducting new clinical performance studies in the way you might for novel AI/software devices.

Therefore, the provided text does not contain the detailed information required to describe acceptance criteria and a study proving a device meets those criteria for software or AI-driven medical devices.

Specifically, it lacks information about:

• Performance metrics like sensitivity, specificity, AUC, etc., which are typical for software/AI.
• Test sets in terms of patient data (images, clinical records).
• Ground truth establishment by experts.
• Human reader studies (MRMC).
• Standalone algorithm performance.
• Training set details.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical and material testing standards for orthopedic implants, and the "proof" is that the device met these engineering standards and demonstrated substantial equivalence in design, materials, and intended use to existing cleared devices.

Here's how I can describe what is available in the document, framed against your request, and explicitly stating what is not present:

Analysis of the Provided 510(k) Summary:

The Acumed Polarus® Connect System is a hardware medical device (bone plates, intramedullary nails, screws, and accessories) designed for humerus fracture fixation. The regulatory submission (510(k)) for such a device primarily focuses on demonstrating "substantial equivalence" to predicate devices already on the market, rather than novel clinical performance studies or AI/software evaluations.

Therefore, the "acceptance criteria" and "study" described in this document are related to mechanical performance and material compatibility, not diagnostic accuracy or AI performance.

Acceptance Criteria and Reported Device Performance (Based on Mechanical Testing for Hardware):

Information Not Applicable or Not Found in This Document (as it pertains to software/AI studies):

This submission is for an orthopedic implant, not an AI/software device. Therefore, the following points in your request are not applicable or details are not provided within this hardware 510(k) summary:

• 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to
  • Mechanical test specimens (e.g., number of nails, plates, screws tested). This is not detailed in the summary.
  • No patient data/images as it's not a diagnostic AI device.
• 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 mechanical testing is based on engineering specifications and measurements, not expert consensus on clinical data.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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-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 implant.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM F382, F543, F1264) and the physical properties observed during testing. Not clinical expert consensus or pathology.
• 8. The sample size for the training set: Not applicable. There is no "training set" as it's not an AI/ML model.
• 9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary successfully demonstrates substantial equivalence of the Acumed Polarus® Connect System to predicate devices based on design, materials, intended use, and adherence to relevant mechanical testing standards (ASTM F382, F543, F1264). It is important to note that this device is a physical orthopedic implant, and as such, the regulatory evidence focuses on engineering performance and safety, not on the type of clinical performance or AI evaluation metrics you've inquired about.

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The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.

The Distal Radius Volar Rim Plating System consists of a series of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr used in bone fixation and the management of fractures and reconstructive surgeries in narrow to standard head widths.

The provided text is a 510(k) summary for a medical device (Distal Radius Volar Rim Plating System). It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies using a test set of data (clinical or otherwise) to demonstrate a specific level of performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Specifically, the document lacks the following information required to answer your questions:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method for a test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone algorithm performance study.
• Type of ground truth used (clinical outcomes, pathology, expert consensus, etc.).
• Sample size for a training set.
• How ground truth for a training set was established.

The "Summary of Substantial Equivalence" section only mentions "pre-clinical data including axial load construct testing, evaluation of galvanic corrosion potential, tab bending and function" to demonstrate similarity to predicate devices, but these are general engineering tests, not studies assessing diagnostic or clinical performance against acceptance criteria using patient data or expert consensus.

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The Sterile DVR Anatomic Plating System is intended for fixation of fractures and osteotomies of the distal radius.

The Sterile DVR Anatomic Plating System offers the DVR plating system of plates and screws in a sterile configuration.

The provided text is a 510(k) summary for the DePuy Sterile DVR Anatomic Plating System. This document focuses on establishing substantial equivalence to a predicate device, primarily through bench testing, rather than presenting a clinical study with detailed acceptance criteria for an AI/device performance.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable or available in this specific document.

However, I can extract the following information:

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

Since this is a submission for a bone fixation device, the "acceptance criteria" are not reported as statistical performance metrics of an AI or diagnostic device. Instead, the acceptance criterion for substantial equivalence is met through bench testing, demonstrating that the device performs comparably to the predicate device.

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/Not provided. This document refers to "bench testing," which typically involves mechanical or physical tests on the device hardware, not a "test set" of patient data in the context of an AI or diagnostic study.

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/Not provided. The ground truth for bench testing is typically based on engineering specifications and physical measurements, not expert consensus on medical images or patient outcomes.

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

• Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation of data, which is not described for this 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:

• No. An MRMC study was not done, as this is a physical medical device (bone plating 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/No. This is a physical medical device, not an algorithm.

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

• Not explicitly stated, but implied from "bench testing": For a medical device like a bone plate, ground truth would relate to the mechanical properties, material composition, and functional performance (e.g., strength, fatigue resistance, fixation stability) derived from engineering standards and test protocols.

8. The sample size for the training set:

• Not applicable/Not provided. This document describes a physical medical device, not a machine learning model.

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

• Not applicable/Not provided. This document describes a physical medical device, not a machine learning model.

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Fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft.

Synthes Hybrid External Fixator Modifications are components of the Synthes Hybrid External Fixator, a ring and wire based external fixator that forms a construct intended for the stabilization of complex proximal and/or distal tibial fractures. It is designed for use with the Synthes Large Exernal Fixator and may be used in conjunction with other fixation methods. The proposed components consist of an Adjustable Wire/Pin Clamp, a Low-Profile Adjustable Wire/Pin Clamp and Ring-To-Rod Clamp.

The provided text is a 510(k) summary for the Synthes (USA) Hybrid External Fixator Modifications device. It describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document does NOT contain information regarding:

• Acceptance criteria and reported device performance (Table 1)
• Study details (sample size, data provenance, expert numbers/qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training set ground truth establishment).

The 510(k) summary focuses on demonstrating substantial equivalence based on the device's design, materials, and intended use being similar to a previously cleared device (Synthes Hybrid External Fixator, K950384). It is a regulatory submission, not a study report detailing performance metrics against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. This type of information is typically found in design validation reports, clinical study reports, or detailed performance testing summaries, which are not part of this 510(k) public abstract.

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The Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability.

The indications for guided joint bridging with external fixators are:
-Delayed treatment of dislocated and stiff elbows
-Chronic, persistent joint instability
-Acute joint instability after complex ligament injuries
-Unstable elbow fractures
-Additional stabilization of post-operative unstable internal fixation

The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator for adults, and with the components of the Synthes Medium External Fixator for children and small stature adults.

The Synthes Elbow Hinge Fixator consists of two rods, which are interconnected through a riveted joint, allowing a hinge-like movement. The rods are made of carbon fiber reinforced PEEK, and the joint is made of stainless steel. The overall length of the device is 180mm and the achievable range of motion averages 270 degrees.

The provided text [K063832] is a 510(k) summary for the Synthes (USA) Elbow Hinge Fixator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include details about acceptance criteria, specific device performance studies with sample sizes, expert ground truth establishment, or any AI-related information (such as MRMC studies, standalone algorithm performance, or training set details).

Based on the provided information, I can only provide the following:

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

The document does not specify quantitative acceptance criteria or reported device performance in the manner typically found in a clinical or performance study report. Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Stryker-Dynamic Joint Distractor II.

2. Sample sized 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 in the 510(k) summary. The document does not describe a test set or data provenance for a performance study. The 510(k) process for this device relies on demonstrating substantial equivalence, which often involves engineering testing, material characterization, and comparison to the predicate device's specifications rather than a clinical trial with a "test set" as might be used for AI/diagnostic devices.

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 provided as the document does not detail a study involving expert-established ground truth.

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

This information is not provided as the document does not detail a study involving 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical orthopedic fixator, not an AI-based diagnostic or assistive software, so such a study would not be applicable.

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

No, a standalone performance study of an algorithm was not done. This device is a mechanical orthopedic fixator, not an AI algorithm.

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

This information is not provided as the document does not describe a study involving ground truth. The basis for clearance is substantial equivalence to a predicate device, supported by engineering considerations and functional comparisons.

8. The sample size for the training set

This information is not provided. This device is a mechanical medical device, not an AI system, so there is no concept of a "training set" in this context.

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

This information is not provided. As explained above, there is no "training set" for this type of device.

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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 PTA (Progressive Tibial Alignment) external fixation system is a modular system with the components of: joints, bars, clamps or screws. Such components form a device indicated for reconstruction and corrections of bone segments of the human body.

The PTA is for progressive realignment of the knee.

The PTA has multiple components of metallic bone fixation appliances and accessories. It is designed for a progressive correction of the lower limb using tibial osteotomy. This device is composed of a main section of a bar and proximal distraction unit upon which are connected the clamps and grasping components. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316 LVM, ISO 5832-1.

The provided text is a 510(k) Summary for the PTA (Progressive Tibial Alignment) external fixation system. This document is for a medical device that realigns bone segments, primarily for progressive realignment of the knee, and it's seeking clearance based on substantial equivalence to a predicate device (FEP, K032427).

Crucially, the provided text DOES NOT contain the type of information requested about acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes related to an AI/algorithm-based device.

The document describes a physical medical device (an external fixation system) and its components, materials, and intended use. It focuses on demonstrating substantial equivalence to a previously cleared device, not on evaluating the performance of a software algorithm.

Therefore, I cannot extract the requested information. The prompt specifically asks for details related to acceptance criteria and a study proving device meets these criteria, typically found in submissions for AI/ML-driven devices or diagnostic tools. This document is for a mechanical orthopedic 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 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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