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The X-FIX is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.

The AREX USA X-FIX is a single use, lightweight, low profile external fixation system designed to treat fractures dislocations of the digits of the hand. The device is designed to help restore proper digit alignment and range of motion while permitting mobilization and normal anatomical movement.

The provided text is a 510(k) premarket notification summary for the AREX USA X-FIX, an external PIP joint distraction device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria as might be seen for novel devices. Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.

Here's an analysis of the available information:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics against such criteria. The basis for clearance is substantial equivalence to a predicate device, the AREX USA Ligamentotaxor (K094043).

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

Not applicable. The submission relies on demonstrating substantial equivalence, not a clinical study with a "test set" in the traditional sense of evaluating device performance on patients. The "performance testing" mentioned likely refers to bench testing rather than clinical trials.

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. No ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No adjudication method is mentioned as there is no specific "test set" requiring 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

Not applicable. This device is a mechanical external fixation system, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies or AI-related effectiveness are irrelevant to this submission.

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

Not applicable. This device is a mechanical external fixation system, not an algorithm.

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

Not applicable. The submission focuses on substantial equivalence based on material properties, design, and intended use compared to a predicate device. "Ground truth" in a clinical study context is not relevant here.

8. The sample size for the training set

Not applicable. The document describes a medical device, not an AI model, so there is no training set mentioned or implied.

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

Not applicable. There is no training set.

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The Ligamentotaxor is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.

The Ligamentotaxor is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.

The provided text is related to a 510(k) premarket notification for a medical device called the AREX Ligamentotaxor (LTX). This document describes the device, its intended use, and a study conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria in terms of numerical thresholds for device performance (e.g., minimum accuracy, sensitivity, specificity, or specific ranges for clinical outcomes that define "success"). Instead, it focuses on demonstrating that the device's performance, particularly in terms of adverse events and clinical outcomes (pain, function, patient satisfaction), is similar to or compares favorably with predicate devices as reported in the literature.

Therefore, I cannot create a table of "acceptance criteria and reported device performance" as no explicit acceptance criteria are stated in the provided text. The study's purpose was to show substantial equivalence, not to meet a predefined numerical performance benchmark.

Here's a breakdown of the information that can be extracted from the document, organized according to your request, with an emphasis on what is present and what is not:

Acceptance Criteria and Study Details for AREX Ligamentotaxor (LTX)

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, the document does not provide specific numerical acceptance criteria for clinical performance. The "acceptance criteria" were implied by the regulatory standard of "substantial equivalence" to predicate devices, meaning the device should not raise new questions of safety and effectiveness and should offer similar clinical outcomes. Therefore, a table of explicit acceptance criteria and corresponding device performance cannot be generated from the given text.

The study aimed to demonstrate that:

• The fundamental scientific technology is substantially equivalent.
• Materials, design, and indications for use are similar to predicate devices.
• Distraction force testing was performed (results not detailed clinically).
• Clinical data showed outcomes for pain, function, and patient satisfaction were similar to those reported for predicate devices in the literature.
• Types and rates of adverse events compared favorably with those reported for predicate devices in the literature.
• All fractures healed.

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

• Sample Size: 83 cases.
• Data Provenance:
  • Country of Origin: Multicenter study conducted in 4 countries (specific countries not named).
  • Retrospective or Prospective: The description "was evaluated in a 10 site multicenter study" and details about patient follow-up (mean 15.2 months, ranging from 6 to 38 months) strongly suggest a prospective study, where data was collected following the device's application.

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

• The document does not specify the number of experts used to establish a "ground truth" in the diagnostic sense, nor their qualifications. The study was a clinical evaluation of a treatment device. Clinical outcomes (e.g., adverse events, range of motion, pain, DASH scores, patient satisfaction) were reported by the study sites/investigators, and fractures healing was also stated. It doesn't mention an independent panel of experts reviewing cases for a "ground truth" diagnosis.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method (e.g., 2+1, 3+1) for the clinical outcomes. The reporting appears to be based on direct clinical observation and patient self-reporting at the participating study sites.

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

• No, an MRMC comparative effectiveness study was not done. The study described is a clinical evaluation of the device's performance in treating patients, comparing its outcomes against literature-reported outcomes of predicate devices (not a direct head-to-head comparison with human readers or another device in the same patient group). There is no mention of "human readers" or "AI assistance."

6. Standalone Performance Study

• Yes, a standalone clinical performance study was done. The described multicenter study evaluated the AREX Ligamentotaxor (LTX) on its own, without human-in-the-loop assistance, to assess its clinical safety and effectiveness in the treatment of PIP joint fractures and dislocations. The results were then compared to literature for predicate devices.

7. Type of Ground Truth Used

• The "ground truth" in this context refers to the clinical outcomes and observations recorded during the study. It includes:
  • Clinical Outcomes: Flexion/extension range of motion, finger/thumb mobility, pain (VAS 10-point scale), quick DASH scores, job status, patient satisfaction.
  • Adverse Events: Documented occurrences like residual pain, secondary subluxations, superficial infections, clinodactyly, stiff/painful fingers, swan neck deformations, premature removal.
  • Healing: Report that "all fractures healed."
  • These are based on direct clinical assessment by healthcare professionals and patient-reported outcomes.

8. Sample Size for the Training Set

• The document does not refer to a "training set." This term is typically used in the context of machine learning or AI development. The study described is a clinical trial/evaluation of a physical medical device.

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

• As there is no mention of a "training set" or AI in this document, this question is not applicable.

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The AREX SCRU2 headless compression screw is intended for fixation of intra-articular and extra-articular fractures of the upper and lower extremities, as well as non-unions of small bones and bone fragments, arthrodesis of small joints, bunionectomies and osteotomies. Examples include scaphoid and other carpal bones, metacarpais, tarsals, metatarsals, patella, ulmar styloid, capitellum, radial head and radial styloid.

The AREX SCRU 2 Headless Compression Screws are cannulated, self drilling, self tapping, dual-pitch threaded devices which can be countersunk into the bone. The screw is available in titanium alloy with and OD of 2 5 or 3 mm and lengths from 10mm up to 45 mm, in increments of 5 mm. The screws are supplied non-sterile.

The provided text is a 510(k) Premarket Notification summary for the AREX SCRU 2 Headless Compression Screw. This document is for a medical device (a screw for bone fixation), not a software or AI-driven diagnostic device.

Therefore, the specific questions related to acceptance criteria for a study proving device performance, sample sizes for test and training sets, expert review, MRMC studies, standalone performance, and ground truth establishment are not applicable to this type of submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving novel performance through extensive clinical studies with specified acceptance criteria as would be required for a new diagnostic technology or a high-risk device.

Here's how the provided information relates to the request, focusing on the concept of "acceptance" in the context of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (for 510(k) submission): The primary "acceptance criteria" here is demonstrating substantial equivalence to legally marketed predicate devices. This is achieved by comparing the device's design, materials, and intended use to those of the predicates.
• Reported Device Performance: The document states that the "design, materials and indications for use demonstrate that the AREX SCRU 2 headless compression screws are substantially equivalent to the predicate devices, and safe and effective for use, when used in accordance with the supplied instructions for use."
  • No specific quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity) are provided, as these are typically not required for substantial equivalence claims for this type of device.

2. Sample size used for the test set and the data provenance: Not applicable. There was no "test set" in the context of clinical performance data in this 510(k) submission. The evaluation is based on a comparison to predicate devices, not on a new clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is not relevant for a substantial equivalence claim for a bone screw.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 passive implant, 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 device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. There is no "training set" for an AI model, as this is not an AI device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a medical device (a bone screw) demonstrating substantial equivalence to already approved devices. It does not involve performance studies in the way one would analyze a diagnostic tool or an AI-driven device, and therefore most of the requested information regarding study design and performance metrics is not present. The "study" in this context is the comparison of the device's characteristics to those of predicate devices.

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