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The components of the EOS Small Bone Fixation System are indicated for use in osteosynthesis, osteotomy, and arthrodesis of the following areas of the bodv:

Large Cannulated Compression Screws – bones in the foot

Cannulated Compression Screws – small bones in the hand and foot

AND/OR

Snap-Off Screws - small bones in the foot

Bone Plates - first metatarso-phalangeal joint

Staples & Pins - small bones in the hand and foot

The TriMed EOS Small Bone Fixation System components are designed to provide internal fixation of various bones. The Cannulated Compression Screws are available in 7.3mm, 3.0mm, and 2.5mm diameters while the Snap-Off Screws are available in a 2.0mm thick Bone Plates utilize 2.7mm Bone Screws to secure the plate to the bone, and both items are available in various lengths. All screws and plates are available in implant grade Ti6AL4V Titanium. Staples and Pins are available in diameters ranging from 1.0mm to 2.5mm and are available in implant grade Ti6AL4V Titanium. 316L Stainless Steel, or Nitinol (N(T),

The provided document is a 510(k) summary for the TriMed EOS Small Bone Fixation System. It describes the device, its indications for use, and claims substantial equivalence to predicate devices. However, this document does not contain the type of information requested regarding acceptance criteria and a study proving a device meets those criteria.

Specifically, the document lacks details such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about training sets.
• The number and qualifications of experts for ground truth establishment.
• Information on adjudication methods or multi-reader multi-case studies.
• Results from standalone performance studies.
• The type of ground truth used.

Instead, the document highlights:

• Indications for Use: The system is indicated for osteosynthesis, osteotomy, and arthrodesis in specific small bones of the hand and foot.
• Device Description: It comprises various screws, bone plates, staples, and pins made of Ti6AL4V Titanium, 316L Stainless Steel, or Nitinol.
• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through substantial equivalence to previously cleared predicate devices (Omnitech Large Compression Screws, Omnitech Compression Screws, SPIN Snap-Off Screws, Hallu Plates, EasyLock Osteosystem Plates, Uni-Clip Staple, Memory Staple, Varisation Staples).
• Supporting Evidence for Substantial Equivalence: An engineering analysis, mechanical tests, functional implant and instrumentation tests, corrosion testing, and biocompatibility tests were performed to support this claim.

To answer your prompt, I would need a document that presents the results of a specific performance study (e.g., a clinical trial or a validation study) with defined acceptance criteria for a medical device's performance, along with the detailed methodology for that study. The current document is a regulatory submission focused on demonstrating substantial equivalence rather than reporting on a specific performance study with acceptance criteria.

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The Small Bone Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.

The Small Bone Fixation System is a sterile, single use, disposable device that is delivered non-toxic. The Small Bone Fixation System consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, polymer Nail Cap and Exchange Guide and Bend Tube.

Prior to use, the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone.

The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed.

In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without losing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide.

An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed. The polymer nail cap may be placed over the end of the nail during the healing period.

Here's an analysis of the provided text regarding the Small Bone Fixation System, focusing on acceptance criteria and the study proving it:

Summary of Acceptance Criteria and Device Performance for the Small Bone Fixation System

The provided documentation does not detail specific, quantitative acceptance criteria for the device's clinical performance (e.g., fracture healing rates, complication rates). Instead, the acceptance criteria are rooted in compliance with recognized consensus standards and demonstrating substantial equivalence to predicate devices through technological characteristics, biocompatibility, and bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes a 510(k) premarket notification which, by its nature, relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive de novo clinical trials to prove safety and effectiveness from scratch.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" here refers to the actual device itself being evaluated against standards and predicate comparison, not a human clinical trial test set.
• Data Provenance: The data provenance is primarily from bench testing and biocompatibility assessments conducted by Hand Innovations, Inc. (the manufacturer). It is internal company data derived from their design, material selection, and testing processes. There is no mention of data from human subjects or external clinical studies.

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

• Not applicable. Ground truth, in the traditional sense of clinical outcomes or expert consensus on medical images, is not established for a clinical test set in this 510(k) submission. The "ground truth" for material properties and technological characteristics is established by the specifications of the ASTM standards themselves and the design documentation/testing of the manufacturer.

4. Adjudication Method for the Test Set:

• Not applicable. There is no mention of an adjudication process in the context of a clinical test set. The substantial equivalence determination is made by the FDA's Office of Device Evaluation based on the submission dossier.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC comparative effectiveness study was not performed. This type of study typically involves comparing the diagnostic or prognostic performance of different medical devices or AI algorithms when interpreted by multiple human readers, often with or without AI assistance. This submission focuses on the physical and material equivalence of a surgical implant.

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

• No. This device is a physical surgical implant, not an algorithm or software-as-a-medical-device (SaMD). Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is primarily technical specifications defined by recognized consensus standards (ASTM standards) for materials and fixation pins/wires. Additionally, the technological characteristics of legally marketed predicate devices serve as a "ground truth" for comparison.
• Biocompatibility uses "long history of biocompatibility" of the selected materials as part of its evidence base.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

• Not applicable, as there is no training set for this device.

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The Small Bone Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges.

The Small Bone Fixation System is a sterile, single use, disposable device that is delivered non-toxic. The Small Bone Fixation System consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, polymer Nail Cap and Exchange Guide and Bend Tube.

Prior to use, the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone.

The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed.

In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide.

An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed. The polymer nail cap may be placed over the end of the nail during the healing period.

This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI or diagnostic device would.

Based on the provided text, the "acceptance criteria" and "device performance" are primarily framed around compliance with recognized consensus standards and demonstrating "substantial equivalence" to existing, legally marketed devices.

Here's an analysis of the provided information, structured around the requested points, with observations where information is not explicitly available:

Acceptance Criteria and Device Performance

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

• The document describes bench testing for material and mechanical properties, not a clinical "test set" in the sense of patient data. There is no mention of a specific sample size for a test set of patient data.
• Data provenance for the bench testing is not specified beyond "Hand Innovations design review policy." There is no mention of country of origin or whether a "test set" involved retrospective or prospective data from human subjects.

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 a mechanical fixation system, not a diagnostic or AI device that requires expert-established ground truth for a test set of patient data. The "ground truth" here is compliance with engineering and material standards.

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

• Not applicable as there is no mention of a test set involving human judgment or interpretation.

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 medical device for bone fixation, not an AI or diagnostic tool that would involve human readers or AI assistance.

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

• Not applicable. This is a mechanical medical device, not an algorithm. Bench testing was performed on the device itself.

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

• The "ground truth" for this submission is adherence to recognized consensus standards (ASTM F138, F899, F86, F366) for material properties and manufacturing practices, and technological equivalence to predicate devices. There is no mention of clinical outcomes data in the context of this 510(k) submission for establishing ground truth.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing follow established engineering principles and quality system regulations.

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

• Not applicable for the same reason as point 8.

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