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510(k) Data Aggregation
(59 days)
The Hercules® Syndesmosis Implant System is intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures and as an adjunct in external and intramedullary fixation systems. The Hercules® Syndesmosis Implant System is also intended to provide fixation during healing process after joint reconstruction in the midfoot and forefoot including correction of hallux valgus deformity.
The In2Bones Hercules® Syndesmosis Implant System is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two low profile titanium alloy buttons, designed to complement plate fixation or to allow use as a stand-alone device. This device is also packaged with various ancillary instruments to aid in insertion.
The provided text describes a 510(k) premarket notification for the "Hercules® Syndesmosis Implant System." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets clinical acceptance criteria.
Therefore, the information required to answer the prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, is not present in the provided text.
The document primarily focuses on:
- Regulatory Clearance: Announcing the FDA's determination of substantial equivalence for the Hercules® Syndesmosis Implant System (K220260) to previously cleared predicate devices.
- Device Description: A sterile, single-use system composed of UHMWPE suture and titanium alloy buttons, intended to stabilize syndesmotic trauma of the ankle.
- Indications for Use: Providing fixation during healing after syndesmotic trauma (e.g., Weber B and C ankle fractures) and as an adjunct in other fixation systems, as well as for fixation after joint reconstruction in the midfoot and forefoot.
- Basis for Substantial Equivalence: Similarities in indications, materials, and geometry to predicate devices (e.g., Arthrex Tightrope, Wright Medical Gravity Syndesmosis LP, Arthrosurface KISSLoc Suture System).
- Performance Testing (Bench Testing): Mentions "Cyclic displacement and load to failure bench testing (mechanical testing)" was performed and "The Hercules® Syndesmosis Implant System was validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization, ISO 11135 for ETO sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72." This refers to engineering/mechanical/biocompatibility testing, not clinical performance data or studies involving human subjects/readers.
In summary, there is no information in this document about studies that prove the device meets acceptance criteria in a clinical or AI-assisted context, as the questions imply. The document pertains to the regulatory clearance process for a medical implant based on substantial equivalence, relying on mechanical and material testing, not diagnostic performance or human reader studies.
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(154 days)
The GRAVITY™ Syndesmosis LP System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C.
The subject GRAVITY™ Syndesmosis LP is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two titanium alloy buttons.
This document is a 510(k) summary for a medical device called GRAVITY™ Syndesmosis LP. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any performance metrics, sample sizes, or expert involvement as requested.
Therefore, I cannot provide the requested information based on the provided text. The document states that "Performance testing and analysis demonstrated substantial equivalence in side by side construct static and dynamic tensile testing" and "Bacterial endotoxin levels on the final finished form of the device were evaluated using LAL pyrogen testing," but it does not provide any details on the acceptance criteria or results of these tests. It also explicitly states "N/A" for clinical evidence.
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(106 days)
Tensyn Plug is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn Plug apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn Plug is used in conjunction with, but not connected to, supplemental fixation. The subject device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Tensyn Plug is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle. The Tensyn Plug, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
The Tensyn Plug is a knotless system for fixation of syndesmosis disruptions, acromio-clavicular repair, tarasometatarsal injury, hallux valgus reconstruction, and carpal metacarpal joint arthroplasty. The Tensyn Plug is a low profile system comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly. The Tensyn Plug is available in stainless steel.
The provided document is a 510(k) summary for the Tensyn™ Plug, a medical device for fixation during healing processes. It discusses the device's indications for use, technical characteristics, and performance data for demonstrating substantial equivalence to predicate devices. However, the document does not include specific acceptance criteria, detailed results of the studies, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about multi-reader multi-case studies.
Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.
Here's an overview of what is available and what is missing:
What is present in the document:
- Device Name: Tensyn™ Plug
- Device Description: Knotless system for fixation, comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly, available in stainless steel.
- Indications for Use: Detailed for various conditions (syndesmotic trauma, acromioclavicular separations, fracture repair, Lisfranc injury, Hallux Valgus reconstruction, Carpal Metacarpal (CMC) joint arthroplasty).
- Predicate Devices: Tensyn Band (K141264, K131850), Arthrex, Inc. Mini TightRope Repair Kit (K061925), Arthrex, Inc. CMC Mini TightRope (K140328), Biomet, Inc. ToggleLoc System (K083070).
- Types of Performance Testing: Rotational loading, cyclic loading, ultimate load, load at 3mm, and shear test.
- Conclusion from Testing: "The testing demonstrated that the Tensyn Plug is substantially equivalent to the predicate devices."
What is missing from the document (and therefore cannot be provided in the answer):
- Table of Acceptance Criteria and Reported Device Performance: While types of tests are listed, the specific quantitative acceptance criteria (e.g., "ultimate load must be > X N") and the numerical results obtained for the Tensyn™ Plug are not provided.
- Sample Size Used for the Test Set and Data Provenance: No information is given regarding the number of devices or units tested for each performance test, nor the origin or nature (retrospective/prospective) of any clinical data, as this is a mechanical testing report, not a clinical study report.
- Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable, as this involves mechanical testing, not a diagnostic or AI-driven device requiring expert adjudication of ground truth from images or clinical data.
- Adjudication Method for the Test Set: Not applicable for mechanical testing.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No information is provided about such a study. This is a mechanical device, not an AI or imaging diagnostic tool that would typically involve human readers.
- Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: No information is provided about such a study. This is not an algorithm-driven device.
- Type of Ground Truth Used: For mechanical testing, the "ground truth" would be the measured physical properties or failure points, not expert consensus, pathology, or outcomes data. The document does not detail the specific ground truth metrics or methods used for "ultimate load," "load at 3mm," etc.
- Sample Size for the Training Set: Not applicable, as this is a mechanical device, not an AI system that requires a "training set."
- How the Ground Truth for the Training Set was Established: Not applicable.
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(71 days)
Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware.
The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn "M Band is a low profile system comprised of a polymer coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in titanium and stainless steel.
The provided text, K133858, describes a 510(k) submission for the Tensyn™ Band, a medical device for syndesmosis fixation. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for a diagnostic or AI-driven device.
Therefore, many of the requested elements for acceptance criteria and study details for an AI/diagnostic device are not available in the provided text. The submission primarily relies on demonstrating similar technical characteristics and performance through mechanical testing compared to existing predicate devices.
However, I can extract the information that is present and indicate where information is not provided.
Acceptance Criteria and Study for Tensyn™ Band (K133858)
The submission for the Tensyn™ Band focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing, rather than establishing specific diagnostic acceptance criteria or conducting a clinical study with human readers, as would be typical for an AI or diagnostic device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Rotational loading performance
- Cyclic loading performance
- Ultimate load
- Load at 3mm
- Shear test performance | "All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices." (Specific numerical performance metrics are not provided in the summary.) |
| Similar Technical Characteristics: - Physical characteristics
- Design
- Materials | "The Tensyn™ Band has similar physical and technical characteristics to the predicate devices since all devices achieve fixation through a suture between two metal fasteners." |
| Intended Use: - Fixation of syndesmosis disruptions in ankle fractures. | "Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The studies mentioned are mechanical performance tests on the device itself, not a test set of patient data.
- Data Provenance: Not applicable in the context of mechanical testing. The testing would have been conducted in a laboratory setting by Dallen Medical, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The "ground truth" for mechanical testing is based on established engineering standards and measurements, not expert clinical interpretation.
4. Adjudication method for the test set
- This is not applicable. Mechanical testing results are objective measurements against predefined 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
- No, an MRMC comparative effectiveness study was not conducted. This is not an AI or diagnostic device as described in the submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This is not an AI device.
7. The type of ground truth used
- The "ground truth" for this device, in the context of demonstrating substantial equivalence, is based on established mechanical engineering test standards and performance of predicate devices. The aim is to show that the Tensyn™ Band performs mechanically in a comparable manner to legally marketed devices for the same intended use.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the sense of machine learning. The design and manufacturing would be based on engineering principles and material science.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set" for an algorithm.
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(147 days)
The Tensyn™ Band is intended to provide fixation during the healing process following a isolated syndesmotic trauma, such as fixation of syndesmosis disruptions).
The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn™ Band is a low profile system comprised of a flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in stainless steel.
The Tensyn™ Band is a medical device intended for fixation of syndesmosis disruptions during the healing process following isolated syndesmotic trauma. The device's performance was evaluated through various mechanical tests to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Rotational Loading | Demonstrated substantial equivalence to predicate devices. |
| Cyclic Loading | Demonstrated substantial equivalence to predicate devices. |
| Ultimate Load | Demonstrated substantial equivalence to predicate devices. |
| Load at 3 mm | Demonstrated substantial equivalence to predicate devices. |
| Shear Test | Demonstrated substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each mechanical test. The data provenance is not explicitly stated in terms of country of origin but is implicitly from Dallen Medical, Inc. The nature of the testing (mechanical tests on the device itself) means it is not retrospective or prospective in the clinical sense, but rather laboratory-based testing on the device prototypes.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The ground truth for this device's performance is established through mechanical engineering principles and laboratory testing, not expert clinical consensus or interpretation of medical images.
4. Adjudication Method for the Test Set:
Not applicable. As the device evaluation is based on mechanical testing, there is no need for expert adjudication of results in the traditional sense. The results are quantitative measurements against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The Tensyn™ Band is a surgical implant, and its performance is evaluated through mechanical testing.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a mechanical implant and does not involve an algorithm. The performance is the inherent mechanical properties of the device itself.
7. Type of Ground Truth Used:
The ground truth used is based on mechanical engineering principles and physical measurements from laboratory testing. The device's performance is compared against the known performance characteristics of legally marketed predicate devices.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance evaluation focuses on the physical properties and mechanical behavior of the device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of medical device.
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