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The LARGE UNI-CLIP® STAPLE is indicated for fixation of bone fractures or for bone reconstruction.

Examples include:

• Arthrodesis in hand or foot surgery
• Fractures management in the foot or hand
• Mono or Bi-cortical osteotomies in the foot or hand
• Distal or proximal metatarsal or metacarpal osteotomies
• Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

The size and number of staple(s) used should be adapted to the specific indication.

The LARGE UNI-CLIP® STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs.

The surgeon can obtain a true compression, adjustable and controlled with many choice of size.

The LARGE UNI-CLIP® STAPLE is made from 316L Stainless Steel that conforms to ISO 5832-1 and ASTM F138 & F139 standards.

Here's a breakdown of the acceptance criteria and study information for the LARGE UNI-CLIP® STAPLE based on the provided 510(k) summary:

This device is not an AI/ML device, so many of the requested fields regarding AI/ML specific studies (like MRMC, standalone performance, training set details) are not applicable. The device is a bone fixation staple and the submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria (e.g., minimum tensile strength, maximum deformation). Instead, it relies on a comparative assessment of mechanical properties to the predicate device.

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

• Sample Size: Not explicitly stated. The document mentions "Mechanical tests have been carried out," implying a set of samples were tested, but the exact number isn't provided.
• Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer (Newdeal SAS). The document does not indicate country of origin for the data or if it was retrospective/prospective in a clinical context. Given it's mechanical testing of a device, it is typically laboratory-generated.

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

This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is derived from instrumentation and engineering standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for objective mechanical testing.

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 evaluating human performance (e.g., radiologists reading images) with and without AI assistance, which is not applicable to a bone staple.

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

No, a standalone algorithm performance study was not done. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used was objective mechanical measurements (e.g., load-to-failure, stiffness, deformation) obtained through laboratory testing, compared against the predicate device.

8. The Sample Size for the Training Set

This is not applicable. There is no AI/ML algorithm involved, so no training set was used.

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

This is not applicable as there is no training set for an AI/ML algorithm.

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The "new" uni-clip® staple is indicated for fixation of bone fracture or for bone reconstraucion, including:

• Arthrodesis in hand or foot surgery .
• Mono or Bi-cortical osteotomies in the foot or hand ●
• Fracture management in the foot or hand ●
• Distal or proximal metatarsal or metacarpal osteotomies .
• Fixation of osteotomies for Hallux Valgus treatment such as . scarf, chevron, etc.

The UNI-CLIP® STAPLE is designed so that, by widening the "chamond", mosseon can obtain a true compression, adjustable and controlled, with many choices of size.

The provided text describes a 510(k) submission for the "UNI-CLIP® STAPLE," a bone fixation staple. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving specific performance criteria through a clinical study with detailed metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested details regarding acceptance criteria and study particulars cannot be found in this document.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This information is not provided. The study mentioned is about comparing mechanical properties to predicate devices, not a clinical test set with patient data.

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

• Not applicable as no clinical test set with ground truth established by experts is described.

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

• Not applicable as no clinical test set with expert adjudication is described.

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 is not an AI/diagnostic device. No MRMC study or AI assistance is mentioned.

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

• Not applicable as this is a medical device (bone staple), not a diagnostic algorithm.

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

• For the mechanical performance comparison, the "ground truth" or reference was the performance of the predicate device (UNI-CLIP® STAPLE (K991482)) based on its stated resistance to torsion, torque of divergence, and strength of compression. This is a technical/engineering "ground truth" rather than clinical.

8. The sample size for the training set:

• Not applicable as this is a bone staple, not a machine learning model.

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

• Not applicable.

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The UNI-CLIP® STAPLE is implanted for fixation of bone fractures or for bone reconstructions.

The UNI-CLIP® STAPLE is indicated for:

• Mono or bi-cortical osteotomies in the forefoot
• Distal or proximal metatarsal osteotomies
• Fusion of the first metatarsophalongeal joint and the interphalangeal joint
• Fixation of the osteotomies for hallux valgus treatment (such as, Scarf, Chevron)
• Akyn type Osteotomy
• Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
• Arthrodesis and osteotomy fixation in the Midfoot and Hindfoot

The UNI-CLIP® STAPLE is designed so that, by widening the "diamond", mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled, with many choices of size.

The provided text describes a medical device submission (K991482) for the UNI-CLIP® STAPLE, but it does not contain information related to acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications that would be found in a clinical or analytical performance study a for AI/ML device.

The document is a 510(k) summary for a traditional medical device (a bone fixation staple) and focuses on demonstrating substantial equivalence to a predicate device based on mechanical properties and intended use. The "Summary of Studies" section only mentions:

• "Torque of divergence and strenght of compression the UNI-CLIP® STAPLE was studied and found to have a resistance to torsion in compliance with the selected standard."

This is a very general statement about a mechanical test and does not provide the detailed information requested for an acceptance criteria table or a study description as typically applied to AI/ML device evaluations.

Therefore, I cannot populate the table or answer the specific questions provided in the prompt based on the given text. The information required (e.g., acceptance criteria, reported performance values, sample sizes for test/training, ground truth methods, expert qualifications, adjudication, MRMC studies) is completely absent in this document.

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