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510(k) Data Aggregation
(30 days)
Trigon Trigon HA Stand-Alone Wedge Fixation System
The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
- · Evans Lengthening Osteotomies
- · Subtalar Fusion
- · First Metatarsal-Cuneiform Lengthening Arthrodesis
- · Calcaneocuboid Arthrodesis
- · Z-Calcaneal Lengthening Osteotomies
- · MTP Lengthening Arthrodesis
The Trigon HA Stand-Alone Wedge Fixation System is intended for use with ancillary fixation and is not intended for use in the spine.
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular, oval, and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. Lapidus, Calcaneocuboid, and MTP Wedges require additional fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
This FDA 510(k) clearance letter and summary describe a medical device, the Trigon HA Stand-Alone Wedge Fixation System, and its substantial equivalence to previously cleared predicate devices. However, it does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria.
Specifically, the document states:
- "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System."
- The "SUMMARY OF NON-CLINICAL TESTING" section indicates that "Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)" was performed.
- The conclusion is based on "comparison of device characteristics," "similar indications for use, technological characteristics, and performance characteristics" to predicate devices.
Therefore, I cannot provide the requested information because it is not present in the provided text. The submission relies on demonstrating substantial equivalence to predicate devices through engineering analysis and comparison, rather than an independent study with defined acceptance criteria for the new device's performance.
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(44 days)
Trigon HA Stand-Alone Wedge Fixation System
The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
- · Evans Lengthening Osteotomies
- · Subtalar Fusion
- · First Metatarsal-Cuneiform Lengthening Arthrodesis
- Calcaneocuboid Arthrodesis
The Trigon HA wedges are intended for use with ancillary fixation.
The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular oval and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating, except for the Lapidus and Calcaneocuboid Wedges which will require ancillary fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
This submission describes a medical device, the Trigon™ HA Stand-Alone Wedge Fixation System, and its claim of substantial equivalence to predicate devices. However, the provided document does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on demonstrating performance against specific clinical acceptance criteria through new clinical studies.
Therefore, I cannot provide the requested information for points 1 through 9.
Summary of missing information specifically related to acceptance criteria and performance studies:
- No acceptance criteria tables: The document does not specify any quantitative acceptance criteria for device performance.
- No reported device performance data: While there is a mention of "Engineer analysis comparing device characteristics," no specific performance metrics or data are provided.
- No clinical study details: There is no mention of a test set, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or ground truth types and their establishment.
- No training set details: Information on training set size or how ground truth was established for a training set is not present.
The document focuses on comparing the proposed device's characteristics (materials, intended use, processes) to those of previously cleared predicate devices to establish substantial equivalence. It explicitly states, "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System." and "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)". This indicates a non-clinical, comparative assessment rather than a clinical performance study against defined acceptance criteria.
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(28 days)
Trigon HA Stand-Alone Wedge Fixation System
The Trigon™ HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- . Evans lengthening osteotomies
The Trigon HA wedges are intended for use with ancillary fixation.
The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.
The provided text describes a 510(k) premarket notification for the "Trigon HA Stand-Alone Wedge Fixation System" but does not contain information about acceptance criteria or a study proving that the device meets those criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering analysis comparing device characteristics (materials, intended use, processes) and the addition of steam sterilization as an alternative method.
Therefore, for aspects related to acceptance criteria, device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, the requested information is not provided in the given text.
The text does mention:
- Summary of Non-Clinical Testing: An engineering analysis was performed comparing device characteristics including materials, intended use, and processes (cleaning and sterilization methods). No FDA performance standards have been established for this device.
- Conclusion: Based on the comparison of device characteristics, the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics are assessed to be substantially equivalent.
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(78 days)
Trigon HA Stand-Alone Wedge Fixation System
The Trigon™ HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- Evans lengthening osteotomies
The Trigon Ti wedges are intended for use with ancillary fixation.
The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.
This document describes the Nvision Biomedical Technologies, Inc. Trigon HA Stand-Alone Wedge Fixation System, which is intended for internal bone fixation for bone fractures or osteotomies in the foot, specifically Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. It is not intended for use in the spine.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not specify explicit quantitative acceptance criteria for device performance in the same way a clinical trial would for a new drug or diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing. The "acceptance criteria" are implicitly met if the test results demonstrate equivalence and do not raise new issues of safety or efficacy.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compression performance: Demonstrate mechanical integrity and resistance to compression forces. | Testing performed per ASTM F2077. The submission states: "The results of these tests indicate that the Trigon™ HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices." (Page 5) The conclusion reiterates this: "Based on the testing performed, including compression, expulsion, and engineering analysis, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Trigon™ HA Stand-Alone Wedge Fixation System are assessed to be substantially equivalent to the predicate devices." (Page 5) |
| Expulsion performance: Demonstrate resistance to expulsion under relevant forces. | Testing performed (expulsion). The submission states the same conclusion as above, indicating equivalence with predicate devices. |
| Screw mechanical strength: Ensure the ancillary screws possess adequate strength. | Engineering analysis performed. The submission states the same conclusion as above, indicating equivalence with predicate devices. |
| Screw pullout strength: Ensure the ancillary screws maintain adequate fixation within the bone/wedge. | Engineering analysis performed. The submission states the same conclusion as above, indicating equivalence with predicate devices. |
| Material Equivalence (HA PEEK vs. PEEK): Demonstrate that the use of HA PEEK does not negatively impact equivalence compared to predicates made of standard PEEK. | "Trigon™ wedges are manufactured from HA PEEK while the primary predicate is manufactured from standard PEEK, however testing, analysis, and comparison to reference devices also manufactured from HA PEEK demonstrated that this does not negatively impact equivalence." (Page 5) This is a specific point of comparison where the "performance" is the demonstration that changing a material property does not lead to a negative impact on equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical (bench) testing, not human studies or clinical trials with test sets involving patients.
- Sample size: The document does not specify the exact number of samples (e.g., number of wedges or screws) used for each non-clinical test (compression, expulsion, screw strength/pullout). It only lists the types of tests performed.
- Data provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective) as these are bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a 510(k) submission for a medical device cleared through substantial equivalence based on non-clinical (bench) testing, not a diagnostic algorithm requiring expert-established ground truth from patient data.
4. Adjudication Method for the Test Set
Not applicable for a non-clinical device submission based on bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool where human reader performance would be evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, it does not involve algorithms or AI.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by the objective measurements and engineering standards (e.g., ASTM F2077 for compression) against which the device performance is measured to demonstrate substantial equivalence to predicate devices. It is thus engineering and mechanical testing standards.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a mechanical implant.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth for it. The submission focuses on demonstrating equivalence of the mechanical properties of a new device to existing predicate devices.
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