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The TriMed Distal Xtremities System is indicated for use in stabilization of fractures, malunions and non-unions of the small bones of the foot.

The TriMed Distal Xtremities System includes 2.0mm and 2.3mm locking screws and six new plate configurations designed for distal extremity fixation. The titanium plates vary in hole count and geometric profile (straight and T-shaped) to accommodate a range of anatomical and clinical needs. The Distal Xtremities plates represent variations in design to TriMed's current Xtremities plate, with additional sizes and removal of the PEEK inserts.

The provided FDA 510(k) Clearance Letter for the TriMed Distal Xtremities System does not contain any information about an acceptance criteria table, a study proving the device meets acceptance criteria, or any details related to AI/algorithm performance.

The document describes a medical device (bone fixation appliances) and its regulatory clearance process, which relies on demonstrating substantial equivalence to a predicate device based on material properties, design comparisons, and non-clinical engineering analyses (FEA analysis, theoretical calculations, and retrospective review of physical testing data for screws).

Therefore, I cannot provide the requested information for acceptance criteria and study proving meeting those criteria from the given text.

The following points are what the document does include regarding performance evaluation:

• Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b)):
  • Subject device screws were evaluated against TriMed predicate screws for performance and found to be substantially equivalent. Analysis included theoretical calculations along with retrospective review of physical testing data to show that the new 2.0 and 2.3mm screws did not create a new worst case within the TriMed screw families. Therefore physical testing of the new screws was not necessary.
  • FEA analysis was completed comparing material performance between the new Distal Xtremities plates and the current Easy Lock and Xtremities plates. The analysis showed that the dimensional differences and the change in plate materials does not impact performance.
  • Engineering analysis and physical test data show that the Distal Xtremities Screws are substantially equivalent to other TriMed screws used in the fixation of small bones of the foot. FEA analysis comparing the Distal Xtremities Plates to the predicates, showed that the dimensional and material changes did not impact mechanical performance.

This content indicates that the "study" proving the device meets the criteria was primarily non-clinical engineering analysis (FEA, theoretical calculations, and retrospective review of existing physical test data), not a clinical study involving human or AI performance. The criteria for acceptance were likely based on demonstrating comparable mechanical performance and material properties to the predicate devices.

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TriMed RipCord devices are intended for use to supplement repair or reconstruction during healing of ligament injuries or deficiencies of the extremities.

The TriMed RipCord device is indicated to be used as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma, such as fixation of syndesmosis disruptions in connection with Weber B and C ankle fractures.

The TriMed RipCord Screw is a single-use, sterile, non-absorbable implantable device designed to aid in the treatment of syndesmotic injuries of the lower extremities. The device consists of a far button, an ultra-high molecular weight polyethylene (UHMWPE) suture, and a cannulated screw.

The provided document K251134 is an FDA 510(k) Clearance Letter for a medical device called "RipCord." This document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through non-clinical testing. It does not contain information related to software, imaging, or AI-assisted diagnostic tools. Therefore, many of the requested elements, such as those pertaining to AI model performance, human reader studies, and AI-specific ground truth establishment, are not applicable to this documentation.

However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets them, based on the provided text, while acknowledging the limitations for an AI-centric request.

Acceptance Criteria and Study Proving Device Meets Criteria

The device in question, the TriMed RipCord Screw, is a mechanical implant for bone fixation. The study proving its performance is based on non-clinical bench testing, demonstrating mechanical properties, rather than clinical efficacy or diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria were established to demonstrate performance equivalence to the predicate device cleared under K220650. However, the specific numerical acceptance criteria values are not detailed in this public FDA clearance letter. Similarly, the exact numerical reported performance values are not provided; only a qualitative statement that the device "successfully met the established acceptance criteria" is present.

Here's a generalized table based on the information provided:

Note: The document explicitly states: "Clinical studies were not conducted for the subject devices." This means the "acceptance criteria" and "device performance" relate solely to the mechanical properties as demonstrated through bench testing, not clinical outcomes or diagnostic accuracy.

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

• Sample Size: The specific sample sizes for the non-clinical tests (static loading, cyclic endurance, torsional strength, driving torque, axial pullout) are not specified in the provided document. The document simply states "TriMed RipCord Screw devices were subjected to static loading and cyclic endurance testing" and "TriMed Cannulated Hex 3.2mm screws were subjected to torsional strength, driving torque and axial pullout tests."
• Data Provenance: The data provenance for this in-vitro, non-clinical bench testing does not involve patient data or geographical origin in the context of clinical studies. It is based on laboratory testing performed by the manufacturer (TriMed, Inc.). The testing is by its nature prospective in the sense that the tests were designed and executed to evaluate the new device.

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

This question is not applicable as the document describes a mechanical device cleared based on non-clinical bench testing. There is no "ground truth" derived from expert interpretation of medical images or patient data. The "ground truth" for these tests would be the measured physical properties of the materials and device, compared against pre-defined engineering and performance specifications.

4. Adjudication Method for the Test Set

This question is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or adjudication of medical data. The results of mechanical tests are objective measurements, not subjective interpretations requiring adjudication.

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

This question is not applicable. The device is a bone fixation implant, not an AI-assisted diagnostic tool. No MRMC study was conducted, as confirmed by the statement "Clinical studies were not conducted for the subject devices."

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

This question is not applicable. The device is a bone fixation implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance is based on engineering specifications and mechanical property measurements. The device's performance was compared to that of a predicate device (K220650) to demonstrate "performance equivalence." This is an in-vitro, physical/mechanical ground truth, not a clinical, pathological, or outcomes-based ground truth.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as the device is a mechanical implant, not an AI model or software algorithm that undergoes machine learning training.

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

This question is not applicable for the reasons stated in point 8.

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The TriMed Total Wrist fusion system is indicated for the following:

1. Wrist arthrodesis
2. Fractures of the wrist
3. Osteotomies of the wrist

The TriMed Total Wrist Fusion products are devices which are to be used as an aid to fixation of bone for treatment of certain fractures, osteotomies, or arthrodesis that lend themselves to the principle of plate and/or screw fixation.

The TriMed Total Wrist Fusion System implants are made from implant grade stainless steel.

The provided FDA 510(k) clearance letter is for a medical device (TriMed Total Wrist Fusion System) andではありません a software/AI product. Therefore, the questions related to acceptance criteria, study details, expert involvement, and ground truth establishment for AI performance are not directly applicable.

However, I can extract the information relevant to the device's testing and acceptance criteria as described in the document, which focuses on mechanical performance rather than AI performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical or qualitative acceptance criteria from these guidance documents are not detailed in the provided FDA letter. The letter only states that the device met them.

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

• Sample Size: Not explicitly stated. The document refers to "All test samples," indicating that a set of samples were tested, but the exact number is not provided.
• Data Provenance: Not applicable in the context of clinical data for AI. For mechanical testing, the data would originate from laboratory testing of manufactured devices.

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

• Not applicable. This relates to AI model evaluation, not the mechanical testing of a physical medical device.

4. Adjudication Method for the Test Set

• Not applicable. This relates to AI model evaluation, not the mechanical testing of a physical medical device.

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

• No. The document explicitly states: "Clinical studies were not conducted for the subject devices." MRMC studies are typically for evaluating the clinical effectiveness of diagnostic tools, often involving AI.

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

• Not applicable. This refers to AI algorithm performance. The device is a physical fusion system.

7. The Type of Ground Truth Used

• For mechanical testing: The "ground truth" implicitly refers to the specified performance requirements and limits outlined in the FDA guidance documents (e.g., strength, fatigue life, stiffness). The device's performance is measured against these engineering standards.

8. The Sample Size for the Training Set

• Not applicable. This refers to AI model training data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This refers to AI model training data.

Summary specific to the provided document:

The TriMed Total Wrist Fusion System underwent non-clinical (mechanical) testing based on FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws/washers. The key finding is that all tested samples of the device met the specified acceptance criteria outlined in these guidance documents. No clinical studies were performed. The "ground truth" in this context refers to the engineering performance standards set by the FDA for such devices.

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TriMed Ulnar Osteotomy Plates are indicated for use in osteotomy procedures of the Ulna.

TriMed Ulnar Osteosystem System includes plates and screws indicated for osteotomies of the ulna. TriMed Ulnar Osteotomy System plates and screws are manufactured from medical grade stainless steel. Ulnar Osteotomy Compression Plates accept 3.2mm locking and non-locking screws. The lag screw hole in the plate accepts a 3.2mm lag screw that helps achieve additional compression across the osteotomy site.

This 510(k) clearance letter pertains to a medical device, specifically an Ulnar Osteotomy System (plates and screws), not an AI/software device. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/software device meets those criteria (such as MRMC studies, ground truth establishment for AI training sets, sample sizes for test sets, expert consensus, etc.) is not applicable to this document.

The document discusses non-clinical testing performed on the physical implants (plates and screws) to demonstrate their safety and effectiveness.

Here's a breakdown of the relevant information provided in the letter regarding how the device meets acceptance criteria:

Acceptance Criteria and Device Performance (for a Medical Device - Implants)

Since this is a physical medical device (implants), the acceptance criteria are met through non-clinical testing (mechanical, material, and performance testing) rather than clinical studies or AI algorithm performance metrics.

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

The document broadly states that the devices met acceptance criteria based on established FDA guidance documents for orthopedic implants. A detailed table of specific acceptance criteria values and reported performance values is not provided in this summary, as it would typically be part of the full submission, not the clearance letter.

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

• Sample Size: Not explicitly stated in the clearance letter. For non-clinical testing of medical devices, sample sizes are typically determined by statistical rationale to demonstrate a high degree of confidence in the device's performance, but specific numbers are not always included in the public-facing clearance summary.
• Data Provenance: Not applicable in the context of clinical data for AI. This refers to laboratory non-clinical testing.

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

• Not Applicable: This is not an AI/software device. The "ground truth" for physical implants is established through engineering standards, material science, and biomechanical principles, not expert human interpretation of images or clinical outcomes in the same way as AI.

4. Adjudication method for the test set:

• Not Applicable: This pertains to clinical data interpretation or AI model output, not mechanical testing of physical implants. The "adjudication" for mechanical tests would involve adherence to standardized test protocols and data analysis by qualified engineers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No: This type of study is relevant for diagnostic AI/software to assess human reader performance with and without AI assistance. Clinical studies, including MRMC, were explicitly not conducted for these physical devices.

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

• Not Applicable: This is an AI/software concept. The device is a set of physical implants.

7. The type of ground truth used:

• Engineering Standards and Biomechanical Principles: For physical implants, "ground truth" refers to meeting established performance benchmarks (e.g., strength, fatigue resistance, corrosion resistance) as defined by international and national standards (like ASTM, ISO) and specific FDA guidance documents for orthopedic devices. The materials used (medical grade stainless steel) and manufacturing processes also form part of this "ground truth" for safety and effectiveness.

8. The sample size for the training set:

• Not Applicable: This is for AI/software. The design and manufacturing of physical implants do not involve "training sets" in the AI sense.

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

• Not Applicable: As above, this is an AI/software concept. For physical devices, design validation and verification against engineering requirements and established specifications are the equivalent processes.

Summary of the Study Proving the Device Meets Acceptance Criteria (as described in this document):

The manufacturer, TriMed, Inc., performed non-clinical tests on the TriMed Ulnar Osteotomy System components (plates and screws). These tests were conducted according to the recommendations and criteria outlined in specific FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws.

• Ulnar Osteotomy Plates: Tested per "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff."
• Ulnar Osteotomy Screws: Tested per "Orthopedic Non-Spinal Metallic Bone Screws and Washers –Performance Criteria for Safety and Performance Based Pathway."

The core finding reported is that "All test samples met the acceptance criteria" for both the plates and screws, as specified in the respective FDA guidance documents. This indicates that the physical and mechanical properties of the devices (e.g., strength, fatigue life, material compatibility) were demonstrated to be safe and effective for their intended surgical use, based on these standardized engineering tests.

Clinical studies were explicitly stated as "not conducted" for these devices, meaning the clearance was based entirely on the non-clinical (laboratory) testing, comparison to a predicate device, and the established regulatory pathway for such orthopedic implants.

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The TriMed Fifth Metatarsal System is indicated for use in stabilization of fractures, malunions and non-unions of the fifth metatarsal.

The TriMed Fifth Metatarsal System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and non-unions that lend themselves to the principle of plate and/or screw fixation. The TriMed Fifth Metatarsal System consists of fixation plates and screws as well as stand-alone screws. The TriMed Fifth Metatarsal System implants are made from implant grade stainless steel.

This is a 510(k) clearance letter for a medical device called the "TriMed Fifth Metatarsal System." This type of document is for physical medical devices and does not pertain to AI/software. Therefore, the questions related to AI/software performance criteria and studies are not applicable.

The provided document describes the device, its intended use, and a summary of non-clinical (mechanical) tests performed to demonstrate substantial equivalence to predicate devices. It does not contain information about acceptance criteria or studies related to AI algorithms, human readers, ground truth establishment, or training sets.

Since the provided text pertains to a physical medical device and not an AI/software device, I cannot fill in the requested information about acceptance criteria and studies typical for AI/software.

However, I can provide the information available in the document regarding the non-clinical testing for this physical device:

The "TriMed Fifth Metatarsal System" consists of fixation plates and screws designed for stabilizing fractures, malunions, and non-unions of the fifth metatarsal.

Summary of Non-Clinical Testing for the Physical Device:

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

The document states that all subject devices "passed and met all acceptance criteria" but does not explicitly list the quantitative acceptance criteria. It only describes the type of tests and general outcomes.

Table of Acceptance Criteria and Reported Device Performance (Based on available information):

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not applicable in the context of mechanical testing. The tests simulate biomechanical conditions in a laboratory setting.

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

• This information is not applicable as the device is a physical implant, not an AI/software device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

• This information is not applicable. Mechanical testing results are based on direct measurements and material science principles, not expert adjudication.

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. This is not applicable to a physical medical device. The document explicitly states: "Clinical studies were not conducted for the subject devices."

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

• No. This is not applicable to a physical medical device.

7. The type of ground truth used

• This information is not applicable. For mechanical testing, the "ground truth" is derived from established engineering standards and physical laws, not clinical outcomes or expert consensus in the medical imaging sense.

8. The sample size for the training set

• Not Applicable. There is no training set for a physical device.

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

• Not Applicable. There is no training set for a physical device.

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The TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot.

The TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.

TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium. The small screws are indicated to be used as an aid in fracture fixations, non-unions and osteotomies of small bones and small bone fragments; the large screws are indicated to be used in fracture fixations, non-unions and osteotomies of large bones and large bone fragments. The TriMed Compression Screws are designed to provide additional constraint of movement of a fractured/osteotomized bone and non-unions and are intended only as an aid to fix the fracture/osteotomy in place during the healing process.

Based on the provided FDA 510(k) Clearance Letter for TriMed® Compression Screws (K243943), here's an analysis of the acceptance criteria and the study proving the device meets them.

It's important to note that this document is for a physical medical device (compression screws), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the typical criteria for AI/ML-based devices (such as ground truth establishment by experts, adjudication, MRMC studies, standalone algorithm performance, training/test set sample sizes for AI, etc.) are not applicable here.

The "study" in this context refers to mechanical testing to demonstrate the device's performance and substantial equivalence to predicate devices, rather than clinical studies with human subjects or AI model validation.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for bone fixation fasteners like the TriMed® Compression Screws are primarily related to their mechanical properties, material biocompatibility, and intended use as compared to "predicate" devices already on the market. The core concept for a 510(k) clearance is "substantial equivalence."

Table of Acceptance Criteria and Reported Device Performance

The submission implies successful completion of these tests, leading to the substantial equivalence determination. |
| Material Compatibility | The materials used (medical grade stainless steel and titanium) must be biocompatible and suitable for long-term implantation in the human body. | "TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium."

The use of "medical grade" materials and comparison to predicate devices (some using stainless steel and titanium, others titanium only) implies conformance to established material safety standards. |
| Design and Principles of Operation | The device's design features, principles of operation, and manufacturing processes should be substantially equivalent to legally marketed predicate devices, ensuring similar safety and effectiveness profiles. | "TriMed Compression Screws are substantially equivalent to the predicate devices in terms of design features, principles of operation, manufacturing, packaging, and labeling."

The document specifically discusses the introduction of additional materials (stainless steel) and new screw diameters/lengths, asserting that these differences are "minor and do not raise different questions concerning safety or effectiveness." |
| Intended Use / Indications for Use | The stated indications for use for the device must align with historical use of similar devices and be supported by the device's design and performance. | TriMed® Compression Screws are indicated for "fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot" (Small Screws) and "large bones and large bone fragments" (Large Screws). This aligns with the use of predicate bone fixation fasteners. |
| Predetermined Change Control Plan (PCCP) | The PCCP outlines pre-approved modifications and the testing required to ensure continued safety and effectiveness without requiring new 510(k)s. This demonstrates a proactive approach to managing changes. | The PCCP details planned modifications (new materials, screw head designs, headed screw line extension) and specifies the test methods and validation activities (e.g., ASTM F543-17, FDA guidance, IEC 62366-1) that will be performed for each change. |

Study Details (as applicable to a physical medical device)

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of human data. For mechanical testing, this refers to the number of components or devices tested. ASTM F543-17 would specify the required number of samples for each mechanical test (e.g., torsional strength, bending strength, fatigue).
• Data Provenance: The document focuses on performance testing (mechanical studies) rather than clinical data from patients. The testing was conducted "in accordance with ASTM F543-17, FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, and/or in comparison to compression screws cleared under predicates K050681 and K093676." This implies the data is generated from laboratory testing of the manufactured devices. No country of origin for data (like patient data) is relevant here, as it's product engineering test data. It's prospective data generation from in vitro testing.

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

• Not Applicable (N/A). This is a physical medical device, not an AI/SaMD. "Ground truth" is established by engineering standards (e.g., ASTM F543-17) and direct comparison to the physical properties of predicate devices. The "experts" would be the engineers and scientists conducting the mechanical tests and comparing the results to the specified performance criteria, but their number and specific qualifications for "ground truth" establishment are not detailed in the context of expert consensus on an image or clinical finding.

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

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical/imaging studies, typically for AI models. For mechanical testing, the results are quantitative and objective, measured against predefined standards.

4. 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 (N/A). MRMC studies are specific to evaluating the clinical performance of diagnostic or AI-assisted devices with human readers interpreting cases. This device is a surgical implant.

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

• Not Applicable (N/A). This criterion is for AI algorithms. The "standalone performance" of these screws refers to their mechanical integrity without human interaction, which is assessed through the mechanical testing mentioned.

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

• Engineering Standards and Predicate Device Performance Data. For a physical implant, "ground truth" for clearance is based on adherence to recognized mechanical engineering standards (e.g., ASTM F543-17) and demonstrating that the device performs equivalently or better than, and poses no new safety concerns compared to, the already cleared predicate devices.

7. The sample size for the training set:

• Not Applicable (N/A). This question is for AI/ML models. There is no "training set" in the context of clearing a physical medical device. The "training" for the device would be its design and manufacturing process, optimized through engineering principles.

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

• Not Applicable (N/A). As there's no training set for an AI model, this question is irrelevant here. The design and manufacturing of the screws are based on established biomechanical principles and material science.

In summary, the 510(k) clearance for the TriMed® Compression Screws relies on demonstrating substantial equivalence to predicate devices through a combination of engineering design comparisons, material characterization, and rigorous mechanical performance testing according to well-established standards. The typical criteria for AI/ML devices do not apply to this type of traditional medical device.

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The following are osteosynthesis configurations that may be applicable to the TriMed Fusion Cups and Screws:

1. Arthrodesis of joints in the midfoot
2. Arthrodesis of the wrist and hand

The TriMed Fusion Cup System is used as an aid to the treatment of certain types of small bone arthrodesis. Fusion cups are manufactured from implantable medical grade polyetheretherketone (PEEK) and allow biaxial locking of screws. The cups are designed to be used with TriMed 2.4mm compression screws made of Ti6Al-4V ELI. Variation in implant size, diameter, and shape are intended to allow the implants to accommodate differences in patient size and sites of application. This special 510(k) is submitted to allow market release of additional sizes of fusion cups and compression screws.

The provided FDA 510(k) clearance letter describes the TriMed Fusion Cup System, a device used for osteosynthesis in small bone arthrodesis, specifically in the midfoot, wrist, and hand. The document provides information on the device description, intended use, and a summary of non-clinical tests.

However, the letter does not contain explicit acceptance criteria in the format of specific numerical thresholds or performance metrics that are typically expected in a comprehensive study report. Instead, it refers to successful verification testing and meeting performance requirements defined in FDA Guidance documents.

Here's an attempt to extract and infer the information based on the provided text, while acknowledging the limitations of what is explicitly stated:

Acceptance Criteria and Device Performance Study

The document indicates that the device's performance was evaluated through non-clinical testing. The "acceptance criteria" are implied by the statement that the "new Fusion Cup designs successfully passed verification testing following the same protocol executed on the original device" and that "new screws successfully met performance requirements defined within the FDA Guidance, 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway.'"

Since specific numerical acceptance criteria and reported performance values are not provided in the clearance letter, the table below will reflect the general statements made.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the test set. It refers to "verification testing" and "performance testing" but does not provide numbers of devices or test conditions.

• Sample Size: Not specified.
• Data Provenance: The tests are explicitly described as "Non-Clinical," indicating laboratory-based testing rather than human clinical data. The country of origin for the data is not specified, but the submission is for FDA clearance in the United States. It's a prospective evaluation for the updated device sizes.

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

This section is not applicable as the clearance letter focuses on a mechanical device (implants) and its non-clinical performance. The "ground truth" for such devices typically relies on engineering specifications and validated test methods, not expert human interpretation in the way it would for AI-powered diagnostic devices. Therefore, there's no mention of experts establishing ground truth in this context.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations (e.g., in medical image analysis), which is not relevant to the non-clinical mechanical testing described here.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure the effect size of AI on their performance. The TriMed Fusion Cup System is a mechanical implant, not a diagnostic tool requiring human interpretation.

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

This question is not applicable. The TriMed Fusion Cup System is a physical medical device (implants and screws), not a software algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.

7. The Type of Ground Truth Used

For the described non-clinical tests, the "ground truth" would be established by:

• Engineering Specifications: The design parameters and material properties that the device is intended to meet.
• Predicate Device Performance: The original device's performance under similar test protocols, serving as a benchmark.
• FDA Guidance Document Standards: The specific performance criteria outlined in documents like "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway" and ASTM standards (e.g., ASTM F543). These documents provide standardized methods and expected performance ranges for such devices.

8. The Sample Size for the Training Set

This question is not applicable. The concept of a "training set" refers to data used to train machine learning models. The TriMed Fusion Cup System is a mechanical device, not an AI/ML product, so there is no training set in this context.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated in point 8.

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The TriMed Sidewinder and Cluster Plates are indicated for fractures, non-unions & osteotomies of the distal fibula.

The TriMed Straight Plates and Ankle Hook Plates are indicated for fractures, non-unions & osteotomies of the distal fibula and distal tibia.

The TriMed Medial Malleolar Sleds and 4.0 Cannulated Compression Screws are indicated for fractures, non-unions & osteotomies of the Medial Malleolus of the distal tibia.

TriMed Ankle Fixation System (AFS) is a comprehensive ankle fracture fixation system intended to aid the treatment of certain types of fractures, malunions, and non-union of the tibia and fibula. The system is designed to constraint movement between bone surfaces and is intended only as an aid to fix the fracture in place during the healing process.

The system implants consist of plates, screws and wire form devices and supporting instrumentation. The implants vary in designs, and sizes to accommodate patient size, anatomy and fracture type. The implants manufactured from 316L medical grade stainless steel per ASTM F138 or F139.

Here's a breakdown of the acceptance criteria and study information for the TriMed Ankle Fixation System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA's letter (K243999) on the TriMed Ankle Fixation System indicates that the device's performance was evaluated against established standards and guidance documents. The acceptance criteria are implicitly defined by these standards, with the reported performance being that the device met or exceeded them.

Regarding the Predetermined Change Control Plan (PCCP) specifically for combining the Medial Malleolar Sled and Washer:

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for the mechanical testing mentioned (ASTM F543-17, FDA Guidance, ASTM F382). These standards typically define sample size requirements. The data provenance is implied to be from TriMed, Inc.'s internal testing, as it's a premarket notification for their device. No specific country of origin for the data is mentioned, but the submitter is based in Santa Clarita, California, USA. The studies are retrospective in the sense that they were conducted to support the 510(k) submission for an existing device or a planned modification.

3. Number of Experts and Qualifications for Ground Truth

This document describes pre-market device clearance based on mechanical testing and equivalence to predicate devices, not on diagnostic performance where expert ground truth establishment would be relevant. Therefore, there are no experts referenced for establishing ground truth as this is primarily a hardware/material performance evaluation.

4. Adjudication Method for Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation (e.g., image-based diagnostics) to establish a consensus ground truth. This submission focuses on the mechanical and material properties of a surgical implant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for evaluating the impact of AI systems on human readers' diagnostic performance. This document concerns a physical medical device (ankle fixation system) and its mechanical performance, not an AI or diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No. This is not an algorithm or software device.

7. Type of Ground Truth Used

The "ground truth" for the TriMed Ankle Fixation System's mechanical performance is defined by the standards and guidance documents (e.g., ASTM F543-17, ASTM F382) that specify acceptable mechanical properties and testing methodologies. The device's performance is then compared to these established benchmarks and to predicate devices rather than clinical outcomes or pathology reports in the context of this 510(k) summary. For the Predetermined Change Control Plan, the ground truth for performance verification will be the results of the specified static bend and endurance bend testing.

8. Sample Size for the Training Set

Not applicable. There is no AI/machine learning component involved that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or implied.

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The following fracture configurations may be applicable for treatment using TriMed Elbow and Forearm System:

1. Fractures, malunions and non-unions of the radius and ulna amenable to plate and/or screw fixation where the size, shape and location of the fractured bone are appropriate for the specific implant(s) used.

2. Fractures and osteotomies of the olecranon.

The TriMed® Elbow and Forearm System, comprising of bone plates, wire forms and screws, are intended to be used as an aid to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of plate and/or screw, wire form, tension band, or pin fixation. The TriMed Elbow and Forearm System plates, wire forms and screws are designed to provide additional constraint of movement of a fractured fused or osteotomized bone and are intended only as an aid to fix the fracture in place during the healing process.

The provided document does not contain information regarding acceptance criteria and a study proving a device meets these criteria. It is a 510(k) clearance letter and summary for a medical device (TriMed Elbow and Forearm System).

Here's what the document does provide:

• Device Name: TriMed Elbow and Forearm System
• Intended Use/Indications for Use: Treatment of certain types of fractures and osteotomies of the radius, ulna, and olecranon using plate and/or screw fixation, wire form, tension band, or pin fixation.
• Predicate Devices: K060041 TriMed Bone Plates and K010545 Tension Band Wire.
• Technological Comparison: The new device is stated to be substantially equivalent to predicate devices in material (316L Stainless Steel), design features, principles of operation, manufacturing, and labeling.
• Non-Clinical Tests: Static and dynamic four-point bending tests were conducted per ASTM F382-17, following FDA Guidance Document recommendations for "Orthopedic Non-Spinal Metallic Bone Screws and Washers."
• Clinical Studies: None were conducted for the subject devices.
• Predetermined Change Control Plan (PCCP): Details a future modification to combine the Olecranon Sled and Washer into a single device, with plans for biocompatibility, sterilization, and mechanical performance testing (static bend and endurance bend).

Therefore, I cannot answer the requested questions as the information is not present in the provided text. The document focuses on demonstrating substantial equivalence to existing devices based on material, design, and non-clinical mechanical testing, rather than establishing and meeting specific performance acceptance criteria through the type of study outlined in your request (e.g., studies involving human perception, AI performance, or expert ground truth).

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Specific indications for use of the subject devices in Wrist Fixation System are as follows: TriMed Volar Plates and Radial Peg Plates:

Fractures, non-unions or osteotomies of the distal radius.

TriMed Ulnar Peg Plates:

Fractures, non-unions and osteotomies of the distal end of the ulna.

TriMed Pin Plates:

1. Fractures of the radial column of the wrist.

2. Fractures of the dorsal ulnar cortex of the distal radius.

TriMed Wire Forms, Shear Plates and Hook Plates

Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.

TriMed Radial Osteotomy System is indicated for osteotomies of the distal radius.

TriMed Welded Wire Forms in Wrist Fixation System 3 is indicated for Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.

TriMed Volar Bearing Plates and Volar Fixed Angle Plates consist of anatomically shaped plates used for fractures, non-unions or osteotomies of the distal radius. Volar Bearing Plates utilize distal bearings to allow peg angulation. Volar Fixed Angle Plates have pre-defined peg-hole trajectories. TriMed Fixed Angle and Bearing Plates are compatible with 2.3mm locking pegs and 2.3mm nonlocking cortical bone screws distally and 3.2mm screws proximally.

TriMed Wrist Hook Plates are anatomically shaped plates used for fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. TriMed Wrist Hook Plates are compatible with 2.3mm screws and locking pegs.

TriMed Pin Plates are anatomically shaped plates used for the treatment of the radial column of the wrist and fractures of the dorsal ulnar cortex of the distal radius. TriMed Pin Plates are compatible with 1.1mm k-wires and 2.3mm screws.

TriMed Radial Peg Plates are anatomically shaped for the radial column used for fractures, nonunions or osteotomies of the distal radius. TriMed Radial Peg Plates are compatible with 2.3mm screws and locking pegs. TriMed Ulnar Peg Plates are semi-tubular straight plates used for fractures, non-unions and osteotomies of the distal end of the ulna. TriMed Unar Peg Plates are compatible with 2.3mm screws and locking pegs.

TriMed Shear Plates are anatomically shaped plates used for fragments of the distal radius. TriMed Shear Plates are compatible with 2.3mm screws.

TriMed Wire Forms are contoured to be used for fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. TriMed Wire Forms are used with washers or wireform plates and 2.3mm threaded pegs and 2.3mm screws. TriMed Welded Wireforms have a welded washer that accept 2.3mm screws.

TriMed Radial Osteotomy Plates are used to perform osteotomies of the distal radius. TriMed Radial Osteotomy Plates have pre-defined peg-hole trajectories. TriMed Radial Osteotomy Plates are compatible with 2.3mm locking pegs and 2.3mm non-locking cortical bone screws distally and 3.2mm screws proximally.

All implants are made from 316L Stainless Steel per ASTM F138/139 and are supplied non-sterile.

The provided text describes a 510(k) premarket notification for the TriMed Wrist Fixation System and related devices. It does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is for a traditional medical device (implants and screws) and explicitly states: "Clinical studies were not conducted for the subject devices."

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets those criteria from this document.

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