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The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the system can be used in both adult and pediatric patients. In the foot, the system can be used for the following specific examples:

• First metatarsal osteotomies for hallux valgus correction such as:
• · Opening base wedge osteotomy
• · Closing base wedge osteotomy
• · Crescentic osteotomy
• Proximal Chevron osteotomy
• · Distal Chevron osteotomy (Austin)
• First metatarsal fracture fixation
• Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
• Flatfoot Osteotomies
• · Lateral Column Lengthening (Evans Osteotomy)
• · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton
• Osteotomy)
• Mid / Flatfoot Fusions
• · LisFranc Arthrodesis and/or Stabilization
• · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• · Intercuneiform Fusions
• · Navicular-Cuneiform (NC) Fusion
• · Talo-Navicular (TN) Fusion
• Calcaneo-Cubiod (CC) Fusion
• Medial Column Fusion
• Arthrodesis of the first metatarsophalangeal joint (MTP)

This traditional 510(k) is to obtain clearance for expanded indications for the Treace Medical Concepts (TMC) Plating System implants. The subject TMC Plating System implants include a variety of previously cleared bone plates and screws. The plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136.

The Treace Medical Concepts (TMC) Plating System is a medical device intended for stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet in both adult and pediatric patients.

Acceptance Criteria and Device Performance:

Since this submission aimed to expand the indications for use to include pediatric patients and the device itself (implants) had been previously cleared in other 510(k)s, no new performance testing was provided for this specific submission (K183321). This is explicitly stated: "Performance testing was not required to support the expanded indications for the subject device." The substantial equivalence determination was based on the similarity of the revised indications to those of predicate devices that already included pediatric use.

Therefore, for this specific 510(k) submission, a table of acceptance criteria and reported device performance (in terms of specific quantitative outcomes like accuracy, sensitivity, specificity, etc.) is not applicable as no new performance testing was conducted or provided to prove the device meets new acceptance criteria. The acceptance was based on demonstrating substantial equivalence to already cleared devices with similar expanded indications.

Details of the Study (or lack thereof for this submission):

• 1. A table of acceptance criteria and the reported device performance: Not applicable for this specific submission as no new performance testing was conducted. The acceptance was based on substantial equivalence.

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new test set data was provided.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set was used.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set was used.

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a plating system, not an AI-assisted diagnostic or treatment planning tool.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a plating system.

• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No new ground truth data was generated for this submission. The substantial equivalence was based on existing predicate devices.

• 8. The sample size for the training set: Not applicable. This device is a plating system, not an AI/machine learning device requiring a training set.

• 9. How the ground truth for the training set was established: Not applicable. This device is a plating system.

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The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:

• · Fracture fixation, including single, segmental, and comminuted fractures
• · Revision, including nonunion and malunion
• · Intra- and extra-articular fractures
• · Compression fracture
• · Displaced fracture
• · Reconstruction
• · Replantation
• · Arthrodesis
• · Osteotomy

VariAx 2 is a system used for internal fixation applications and is composed of sterile and nonsterile screws, washers, and instruments. In addition to independent use, screws of this system are also used with compatible, internal fixation plating systems. These devices are made of titanium alloy, with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.

This submission builds on K140769 by simplifying and clarifying the indications statement, and by expanding the treatment population to include pediatric patients.

I am sorry, but the provided text from the FDA 510(k) K173135 for the "VariAx 2 System" does not contain any information about acceptance criteria, device performance data (from a study), or details about a study design (like sample size, ground truth establishment, expert qualifications, etc.) for an AI/algorithm-based medical device.

This FDA submission is for a bone fixation system (screws, plates, washers), which is a physical medical device, not a software or AI-based device. The document explicitly states:

• "No new devices were introduced with this submission. No mechanical testing was presented."
• "Clinical testing was not a requirement of this submission."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text pertains to a hardware medical device and does not detail performance studies in the way you are asking about (which are typical for AI/ML or diagnostic devices).

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The CLAW® II Polyaxial Compression Plating System is intended to be used for fixation such as:

• · Midfoot and hindfoot arthrodeses or osteotomies
• · Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocubid, Lapidus)
• · Intercuneiform arthrodeses
• · Naviculocuneiform arthrodeses
• · Talonavicular arthrodeses
• · Calcaneocuboid arthrodeses
• · Lisfranc arthrodeses
• · Mono- or bi-cortical osteotomies in the forefoot, midfoot and hindfoot
• · Fixation of osteotomies for hallux valgus treatment (Scarf and Chevron)
• · Akin osteotomies
• · First metatarsophalangeal arthrodeses

The CLAW® II Polyaxial Compression Plating System consists of plates and screws of various anatomic configurations and lengths. All plates and screws are manufactured from implant grade stainless steel. The plates accept 2.7mm and 3.5mm ORTHOLOCTM 3DSi locking screws.
The ORTHOLOC™ 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.

The provided text describes a 510(k) premarket notification for the CLAW® II Polyaxial Compression Plating System, demonstrating substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria with performance metrics. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be directly extracted or are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format of specific, measurable acceptance criteria and corresponding performance data. The device demonstrates "substantial equivalence" to predicate devices through non-clinical testing.

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

• Sample Size: Not specified for any test sets. The document describes "worst-case plate analysis, plate mechanical testing, and polyaxial performance testing," but does not detail the number of samples or specimens used in these tests.
• Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer, Wright Medical Technology, Inc. There is no information on country of origin of data or whether it's retrospective or prospective, as these terms usually apply to clinical studies.

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

Not applicable. This device is cleared based on non-clinical substantial equivalence, not on expert-adjudicated ground truth from a clinical data set. The "ground truth" here is the performance of the predicate devices.

4. Adjudication method for the test set

Not applicable, as no external experts were used to establish a ground truth for a clinical test set. The determination of substantial equivalence was made by the FDA based on the presented non-clinical evidence.

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/software device, but a physical orthopedic plating system. No MRMC studies or AI involvement are mentioned.

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

Not applicable, as this is a physical medical device, not an algorithm or AI.

7. The type of ground truth used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The subject device's performance (mechanical, polyaxial performance) was assessed to be "at least as well as" the predicate devices. The ground truth for the predicate devices themselves would have been established through their original clearance processes, likely including non-clinical testing and potentially clinical data depending on their classification and introduction date.

8. The sample size for the training set

Not applicable, as this is not a machine learning or AI device that requires a training set.

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

Not applicable, as this is not a machine learning or AI device that requires a training set with established ground truth.

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