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The SUMMIT® SI OCT Spinal Fixation System and MOUNTAINEER® OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):

• · traumatic spinal fractures and/or traumatic dislocations;
• · instability or deformity;
• · failed previous fusions (e.g. pseudarthrosis);
• · tumors involving the cervical/thoracic spine;

• and degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· degenerative disease of the facets with instability.

The SUMMIT and MOUNTAINEER Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The SONGER® Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.

The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA®, MONARCH®, MOSS® MIAMI, VIPER® and EXPEDIUM® Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.

The SUMMIT and MOUNTAINEER Systems are posterior spinal fixation systems intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3). The systems are composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The systems consist of bone anchors including hooks, SONGER® cables and screws, longitudinal members including rods and occipital plates, transverse connectors including cross connectors and interconnection mechanisms including lateral offset connectors, cable connectors, set screws, nuts, axial and wedding band connectors. The system components are implanted using class I exempt manual surgical instruments. This premarket notification expands the indications for use of the SUMMIT and MOUNTAINEER Systems to include posterior cervical screw fixation.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML device performance. This document is a 510(k) premarket notification for a spinal fixation system, focusing on its substantial equivalence to predicate devices based on technological characteristics and mechanical performance testing, rather than an AI/ML driven device and its performance metrics.

Therefore, I cannot extract the requested information from the provided text.

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SyntheCel® Dura Onlay is intended for use as a dura replacement for the repair of dura mater in adults.

SyntheCel® Dura Onlay is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Onlay functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Onlay is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.

The provided document is a 510(k) summary for the SyntheCel® Dura Onlay device. It primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a standalone study proving those criteria.

Therefore, many of the requested items cannot be definitively extracted from this document, as the submission relies on previous studies for the predicate device to establish safety and effectiveness.

Here's what can be gathered:

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

The document does not list specific numeric acceptance criteria for performance such as sensitivity, specificity, or AUC, as it's not a performance study of a diagnostic AI device. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a predicate device in terms of technological characteristics and safety/effectiveness data.

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Synthes Patient Specific Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery.

Specific Indications for Use:

• Primary mandibular reconstruction with bone graft
• Temporary bridging until delayed secondary reconstruction
• Secondary mandibular reconstruction
• Comminuted mandibular fractures
• Fractures of edentulous and/or atrophic mandibles
• Unstable mandibular fractures
• Maxillary reconstruction with or without bone graft
• Maxillary trauma

Synthes Patient Specific Plates are a metallic bone plates used in conjunction with metallic bone screws for the internal fixation of maxillofacial bone, specifically in the areas of the mandible and maxilla. The design and dimensions (number and placement of holes, hole angulation, plate length, etc.) of each plate are based on of the patient's anatomic (CT scan) data, the surgical plan, and input from the surgeon. Synthes Patient Specific Plates are not intended to be further bent or contoured during surgery. Synthes Patient Specific Plates are manufactured from commercially pure titanium, are provided non-sterile, must be sterilized prior to use, and are intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synthes Patient Specific Plates (K122647):

This submission is a 510(k) for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than full clinical trials. Therefore, the "study" described is primarily focused on non-clinical (bench) testing to support this equivalence.

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The tests were "cross-sectional analysis" and "mechanical testing," suggesting multiple samples were tested for each device type (proposed and predicate). The exact number of plates or test specimens is not provided.
   • Data Provenance: Not explicitly stated, but as this is bench testing for a device manufactured by Synthes (USA), it's implied that the testing was performed in a controlled laboratory environment, likely within the US or a facility affiliated with the manufacturer. It is retrospective in the sense that the device design already existed and was being tested against established predicate devices.

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

   • Not applicable. This was non-clinical bench testing, not a study involving human interpretation or clinical data where expert ground truth would be established. The "ground truth" here is the physical performance of the devices as measured by standardized mechanical tests.

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

   • Not applicable. As above, this was non-clinical bench testing. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints.

4. 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 conducted. This device is a custom-fit bone plate, not an AI-assisted diagnostic or therapeutic tool. The comparison was between the physical performance of the proposed plate and existing predicate plates.

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

   • No. This device is a physical medical implant, not a software algorithm. Its performance is inherent to its material and design, not an algorithm's output.

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

   • The "ground truth" for this non-clinical study was based on objective mechanical measurements of physical properties (bending resistance, fatigue life) compared against established performance characteristics of legally marketed predicate devices. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in this context.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its design is based on patient-specific CT data and surgical plans, which is a different concept from a machine learning training set.

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

   • Not applicable. As there is no training set for an AI/ML algorithm involved, there is no ground truth for a training set to establish. The design of the individual patient-specific plate uses the patient's anatomical CT scan data and the surgeon's input as its 'blueprint'.

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The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:

• . Trauma
• . Reconstructive surgery
• . Orthognathic surgery (surgical correction of dentofacial deformities)

The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient.

This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile (non-sterile implants must be sterilized prior to use).

MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only.

The provided document is a 510(k) Summary for a medical device (MatrixMANDIBLE Plate and Screw System) and does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device.

Instead, this document describes a conventional medical device (bone plates and screws) and seeks to demonstrate substantial equivalence to previously cleared predicate devices based on:

• Identical/similar Indications for Use.
• Technological Similarities (principles of operation, configurations, material, screw compatibility).
• Technological Differences (slight width difference, absence of a straight configuration, one more hole in single angle configurations compared to one predicate).
• Non-Clinical Performance Data: An engineering assessment including cross-section analysis and finite element analysis was used to compare mechanical properties to predicate devices. This assessment determined the mechanical properties were comparable.
• No Clinical Performance Data: The document explicitly states, "No clinical testing was performed to support this submission."

Therefore, it is not possible to fill out the requested table and information as it pertains to an AI/ML device, as the provided input describes a different type of medical device submission.

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The Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required.

The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old.

The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger.

The Synthes Curvilinear Distraction System is intended for single use only.

The Synthes Curvilinear Distraction System is a family of internal distraction osteogenesis devices that gradually advance the mandible along a specific trajectory of distraction. The system features various curved and straight distractors in two sizes; the 1.3mm Curvilinear Distractor and the 2.0mm Curvilinear Distractor. The distractors accept extension arms which move the point of activation to a location that is easily accessible with the activation instrument. Synthes Curvilinear Distraction System devices are manufactured from titanium alloy and chromium cobalt alloy. Devices are supplied non-sterile and must be sterilized prior to use.

The distractor features a worm gear that is activated to move the distractor along a curved or straight track. The distractor consists of three main components: Track, Worm gear activation assembly, and Housing.

Acceptance Criteria and Device Performance Study for Synthes Curvilinear Distraction System (K121502)

This report details the acceptance criteria and the study that proves the Synthes Curvilinear Distraction System meets these criteria, based on the provided 510(k) summary (K121502).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a distinct "test set" in the context of clinical data for performance evaluation. The performance data is derived from non-clinical mechanical testing.

• Sample Size for Test Set: Not applicable as a clinical test set was not used. The mechanical testing involved specific test articles (Synthes Curvilinear Distraction System, specifically the 1.3 mm Curvilinear Distractor). The exact number of units tested for each mechanical test is not specified in this summary.
• Data Provenance: The data is from non-clinical mechanical testing conducted by Synthes (USA), a company located in West Chester, PA, United States of America.

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

Not applicable. Since clinical testing was not performed and performance was evaluated through mechanical testing, there was no ground truth established by human experts for a clinical test set. The "ground truth" for the mechanical tests would be the established engineering standards and physical properties for medical devices of this type, as measured by standard laboratory equipment and procedures.

4. Adjudication Method for the Test Set

Not applicable. As stated above, clinical testing with a human-in-the-loop component was not conducted, rendering an adjudication method unnecessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." Therefore, no assessment of human readers' improvement with or without AI assistance was conducted.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a mechanical distraction system, not an algorithm or AI-powered system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used for Performance Evaluation

The ground truth used for evaluating the performance of the Synthes Curvilinear Distraction System was based on:

• Established engineering standards and benchmarks for mechanical strength (four-point bend testing) to demonstrate the ability to withstand mastication forces and resist permanent deformation.
• Physiological requirements and existing clinical understanding of anatomical resistance to distraction, which served as the basis for the acceptance criterion for the torque-force testing.
• ASTM standards for material composition and biocompatibility.

8. Sample Size for the Training Set

Not applicable. There was no "training set" as this device is a mechanical system and does not involve machine learning or AI that requires training data.

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

Not applicable. As there was no training set, there was no ground truth established for it.

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The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:

• Trauma
• Reconstructive surgery
• Orthognathic surgery (surgical correction of dentofacial deformities)

The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only.
The MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the MatrixMANDIBLE Plate and Screw System.
These devices are offered non-sterile and must be sterilized prior to use. MatrixMANDIBLE screws are intended for single use.

Here's an analysis of the provided text regarding the Synthes MatrixMANDIBLE Plate and Screw System, focusing on acceptance criteria and the supporting study:

The provided document describes a 510(k) premarket notification for a medical device. This type of submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy trials. Therefore, the "acceptance criteria" and "study" described will primarily revolve around mechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the mechanical tests. Instead, it states that the performance of the proposed devices is "equivalent to or better than" the predicate devices. The reported device performance is presented as the results of the mechanical tests, which are implicitly compared against the predicate's performance.

Note: The summary document only states that the device's performance was "equivalent to or better" than the predicate. Specific numerical values for the predicate or the proposed device's performance are not provided in this 510(k) summary. For a full understanding of the acceptance criteria (e.g., specific thresholds or statistical equivalence margins) and the detailed results, one would typically need access to the full test report submitted to the FDA.

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

• Sample Size: The document does not specify the exact sample sizes used for each mechanical test (e.g., how many screws were tested for pull-out strength).
• Data Provenance: The testing was "Non-Clinical Testing" performed by the submitter, Synthes (USA), which is based in West Chester, PA, United States of America. The data is retrospective in the sense that it's generated for the submission, but it's new data specific to the device.

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

This section is not applicable as the study described is non-clinical mechanical testing, not a clinical study involving expert judgment of medical images or patient outcomes. The "ground truth" here is objective physical force measurements.

4. Adjudication Method for the Test Set

This section is not applicable for non-clinical mechanical testing. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in clinical or image-based studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed to support this submission."

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

This section is not applicable. This device is a bone plate and screw system, a physical medical device, not an AI algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance are not relevant concepts here.

7. Type of Ground Truth Used

The ground truth used for the non-clinical testing was objective physical measurements of mechanical properties (e.g., force, torque) under controlled laboratory conditions, as defined by engineering standards. The "truth" is established by the direct measurement of these physical properties rather than by expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.

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

This section is not applicable for the same reasons as #8.

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The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

The acceptance criteria and study proving device performance are described below based on the provided text.

Acceptance Criteria and Device Performance

Study Details

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not specified. The abstract mentions "dynamic and static testing" but does not give specific sample numbers for these tests.
   • Data Provenance: The testing was "non-clinical testing" conducted by Synthes. The country of origin for the data is not explicitly stated, but Synthes is based in West Chester, PA, USA, implying the testing likely occurred there. The data is retrospective in the sense that it's reported after the tests were conducted, but it's new data generated for this specific submission, not historical patient data.

2. Number of Experts and Qualifications for Ground Truth (Test Set): Not applicable. This was non-clinical mechanical testing, not a study requiring expert interpretation of medical images or conditions.

3. Adjudication Method (Test Set): Not applicable due to the nature of the non-clinical mechanical testing.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This was a non-clinical study assessing mechanical properties, not a reader study.

5. Standalone (Algorithm Only) Performance Study: Not applicable. This device is a bone plate, so there is no algorithm or AI component. The performance was assessed through physical mechanical testing.

6. Type of Ground Truth Used: The ground truth was established by the physical measurements and results obtained from the dynamic and static mechanical testing under controlled laboratory conditions, comparing the new plates to a predicate device's performance.

7. Training Set Sample Size: Not applicable. This was non-clinical mechanical testing; there was no training set in the context of machine learning or AI.

8. How Ground Truth for Training Set was Established: Not applicable.

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Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Specific indications (SynPOR HD Ocular Spheres):
• Ocular reconstruction
• Socket preservation
Specific indications (SynPOR HD Facial Shapes):
• Enhancement of the malar and chin
• Correction of deficiencies of the malar and chin

SynPOR HD Porous Polyethylene Three Dimensional Implants are devices intended for ocular reconstruction and socket preservation, enhancement of the midface and mandibular skeleton, and correction of deficiencies of the midface and mandible. The porous structure of the HDPE material allows for fibrovascular ingrowth.
The implants include facial shapes (chin and malar implants for aesthetic and reconstructive surgery to augment the contours of the craniofacial skeleton) and ocular spheres (for restoring the volume of an eviscerated or enucleated eye globe).
SynPOR HD Porous Polyethylene Implants are delivered sterile for single patient use and should not be resterilized.

The requested information about the acceptance criteria and the study proving the device meets them is not available in the provided text. The document is a 510(k) summary for a medical device (Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants), and it primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria or a study designed to meet them.

The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. The type of ground truth used or the sample size for a training set.

The document states that the new device is "substantially equivalent" to predicate devices based on "indications, materials, principles of operation, dimensions, and device design," and that "none of the modifications impact safety and effectiveness." This indicates a regulatory clearance pathway that relies on comparison to existing legally marketed devices, rather than a new study with explicit acceptance criteria for novel performance claims.

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The Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The Synthes (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The Synthes (USA) Sternal Fixation System consists of machined titanium plates, a quick-release pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.

The provided text is a 510(k) summary for the Synthes Sternal Fixation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for an AI/device study is not available in these documents.

Here's a breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states: "Clinical data was not needed for this device." The submission is for a medical device (Sternal Fixation System), not an AI/software device that would typically have performance metrics like sensitivity, specificity, or AUC. The "performance" assessment for this type of device usually involves mechanical testing and comparison to predicate devices, which is not detailed here in terms of acceptance criteria and results.

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

Not applicable. No test set for performance evaluation of an AI model is mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth establishment for an AI model is mentioned.

4. Adjudication Method

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI-assisted device, and no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device (plates and screws), not an algorithm.

7. Type of Ground Truth Used

Not applicable.

8. Sample Size for the Training Set

Not applicable.

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

Not applicable.

Information Available from the Document:

• Device Trade Name: Synthes Sternal Fixation System
• Intended Use/Indications for Use: Primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
• Comparison to Predicate Device: "The design features, material, and indications for use of the subject Sternal Fixation System are substantially equivalent to the predicate devices identified. Additionally, the safety and effectiveness of this system is adequately supported by documentation within this premarket notification."
• Performance Data (Nonclinical and/or Clinical): "Clinical data was not needed for this device." This implies that non-clinical data (e.g., mechanical testing, material biocompatibility) was used to establish substantial equivalence, though the details of these tests and their criteria are not provided in this summary.

In summary, the provided document is a 510(k) summary for a physical medical device aiming for substantial equivalence. It does not contain the type of AI-related performance data, acceptance criteria, or study details requested in the prompt.

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