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The TriMed Threaded IM Nail System is indicated for the treatment of select fractures and corrective osteotomies of short tubular bones. Specific indications for TriMed Small Threaded IM Nails include:

1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies
2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

TriMed Threaded Intramedullary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F 136 or 316L Stainless steel per ASTM F138. TriMed is adding 3.6mm Threaded IM Nails with length ranges between 30 and 70mm to the already cleared 1.8mm – 3.0mm diameter ranges

The provided document is a 510(k) summary for a medical device (TriMed Threaded Intramedullary Nail System), which primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical performance testing. It does not describe acceptance criteria for an AI/software device or a study involving human readers or AI performance in a clinical context.

Therefore, most of the requested information (items 2-9) regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document as it pertains to AI/software performance, which is not the subject of this 510(k) submission.

However, I can extract the information related to the non-clinical performance testing conducted for this device to demonstrate its safety and effectiveness.

Here's the relevant information that can be extracted:

1. Table of acceptance criteria and the reported device performance:

The document refers to performance testing based on FDA guidance and ASTM standards. While specific numerical acceptance criteria (e.g., "must withstand X N-mm of torque") and the exact reported values are not provided in this summary, the types of tests and the conclusion can be presented.

Conclusion: The technological characteristics, indications for use, and performance testing support the substantial equivalence of the Threaded IM Nail System with the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the summary for the non-clinical tests.
• Data Provenance: Not applicable as these are non-clinical, in-vitro mechanical tests, not clinical data from patients.

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 based on objective, quantifiable physical properties and test methods, not expert consensus.

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

• Not applicable for non-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 for a physical medical device (intramedullary nail), not an AI/software device.

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

• Not applicable. This is for a physical medical device (intramedullary nail).

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

• For the non-clinical tests, the "ground truth" is derived from the objective physical measurements obtained through standardized mechanical testing methods (e.g., torsional strength, driving torque, axial pullout strength) as defined by ASTM standards and FDA guidance.

8. The sample size for the training set

• Not applicable. This is for a physical medical device.

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

• Not applicable. This is for a physical medical device.

In summary, the provided document details a 510(k) submission for a physical orthopedic implant (a threaded intramedullary nail system), and the "study" referred to is a series of non-clinical, in-vitro mechanical performance tests to demonstrate substantial equivalence, not a clinical study involving AI or human readers.

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The TriMed Threaded IM Nail System is intented for the treatment of select fractures and corrective of short tubular bones.

Specific indications for TriMed Small Threaded IM Nails include:

1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies

2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

TriMed Threaded Intramedulary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F136 or 316L Stainless steel per ASTM F138. TriMed Threaded IM Nails are offered in diameters ranging from 1.8mm - 3.0mm in diameter and lengths between 12mm and 70mm.

The provided text describes a 510(k) premarket notification for the "TriMed Threaded Intramedullary Nail System." This documentation focuses on establishing substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a study with acceptance criteria in the typical sense of a diagnostic or AI device.

Therefore, many of the requested details about acceptance criteria, test set, ground truth, and human reader performance are not applicable to this type of submission. The device is a bone fixation fastener, not a diagnostic tool or an AI-powered system where such metrics would be relevant.

However, I can extract information related to the non-clinical performance data that was used to demonstrate substantial equivalence, which can be seen as meeting "acceptance criteria" related to mechanical properties.

Here's a breakdown of the available information based on your request:

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

The submission refers to meeting the recommendations of specific standards and guidance documents, which inherently contain "acceptance criteria" for mechanical performance. The document doesn't explicitly state the numerical acceptance criteria values or the reported device performance values in a direct table format within the provided text. Instead, it states that tests were performed "per the recommendations" and "per ASTM F543-17." This implies that the device met the criteria outlined in those documents.

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

• Sample size for test set: Not explicitly stated. For mechanical tests like these, sample size would typically be determined by the specific ASTM standard (e.g., ASTM F543-17) and internal quality control procedures.
• Data provenance: Not explicitly stated in terms of country of origin of data. The tests are "non-clinical evidence" conducted on the device itself.

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

• Not Applicable. This is a mechanical device, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement of the device's properties.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 a bone fixation fastener, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a bone fixation fastener, not an algorithm.

7. The type of ground truth used

• Physical Measurements/Engineering Standards: The ground truth for mechanical tests like Torsional Strength, Driving Torque, and Axial Pullout Strength is established by standardized physical measurements according to validated testing methods outlined in documents like ASTM F543-17.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

• Not Applicable. See point 8.

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The TriMed Threaded IM Nail System is intented for the treatment of select fractures and corrective of short tubular bones.

Specific indications for TriMed Small Threaded IM Nails include:

1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies

2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

TriMed Threaded Intramedullary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F136 or 316L Stainless steel per ASTM F138. TriMed Threaded IM Nails are offered in diameters ranging from 1.8mm - 3.0mm in diameter and lengths between 20mm and 70mm.

The provided document is an FDA 510(k) clearance letter and associated summary for the "TriMed Threaded Intramedullary Nail System." This document pertains to a medical device (a physical object), specifically an orthopedic implant, and not a software-as-a-medical-device (SaMD) or an AI/ML-based device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-based device evaluation (which would involve test sets, expert ground truth, MRMC studies, etc.) is not applicable to this submission.

The document discusses the following types of performance data for this physical medical device:

• Non-Clinical Evidence Performance Data:

  • Torsional Strength
  • Driving Torque
  • Axial Pullout Strength Calculation
  • These tests were conducted according to FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" and ASTM F543-17.

• Clinical Evidence: "Clinical testing was not necessary for the determination of substantial equivalence." This is common for 510(k) submissions of devices demonstrated to be substantially equivalent to existing predicate devices.

In summary, none of the questions related to AI/ML device validation can be answered from this document because it describes a traditional hardware medical device.

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