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Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically:

• Sternotomy indications including the "rewiring" of osteomized sternums;
• Repair of long bone fractures due to trauma or reconstruction.

Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries for internal fixation of discontinued bone structures. The product are not to be used in conjunction with other bone fixation implants, like plates. The surgical sutures and tapes are made of UHMWPE (ultra-high molecular weight polyethylene), the needles are made in AISI300 steel series, according to the standard ASTM F899 and cerclage is assembled on an ABS loader, additional instruments may be used as well. Those materials are identical to those used in other cleared GMReis devices like the reference device cleared under K223114. It is provided in sterile condition sterilized by Ethylene Oxide.

Based on the provided FDA 510(k) clearance letter for the Stitch Cerclage - Suture System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is an FDA 510(k) clearance letter, which means the device has already been cleared. This letter summarizes the regulatory decision and mentions that studies were performed, but it does not contain the detailed study protocols, results, or data itself. Therefore, I will extract all available information and explicitly state when information is not present in this document.

Acceptance Criteria and Device Performance Study Summary

The acceptance criteria for this device are largely implied through the comparison to a predicate device and the successful completion of specified mechanical tests. The performance study focused on demonstrating substantial equivalence to the predicate device, particularly in mechanical properties relevant to its intended use as a bone fixation cerclage.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens, number of cycles for fatigue) used for the mechanical testing. It mentions "chemical composition, creep test, tension static and fatigue tests."
• Data Provenance: The studies were conducted by the manufacturer, GM Dos Reis Industria e Comercio Ltda, which is based in Campinas, Brazil. The data is based on mechanical testing, not clinical data, and therefore is not characterized as retrospective or prospective in the usual clinical sense. It's laboratory-based performance data.

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

• For this type of mechanical device clearance, "ground truth" is established through engineering standards, validated test methodologies, and comparison to the known performance of predicate devices.
• The document does not mention the use of human experts (like radiologists) for "ground truth" establishment as would be common for AI/imaging device clearances. The "experts" involved would be engineering and quality control personnel at the manufacturer and potentially external testing laboratories, ensuring compliance with test methodologies.

4. Adjudication Method for the Test Set

• Since this is a mechanical device performance study, no explicit "adjudication method" in the sense of clinician consensus on medical images is applicable or mentioned. The "adjudication" is inherent in the adherence to established mechanical testing protocols and statistical analysis of the results to demonstrate equivalence to the predicate.

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

• No MRMC study was done. This type of study is specifically relevant for imaging devices or AI algorithms where human readers' performance is being evaluated or augmented. The Stitch Cerclage Suture System is a physical medical device, not an imaging or AI diagnosis system.
• The document explicitly states: "No clinical data were included in this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. This concept pertains to AI algorithms. The Stitch Cerclage Suture System is a physical product and does not have an "algorithm-only" performance component.

7. Type of Ground Truth Used

• The "ground truth" for this device type is established through objective, quantifiable mechanical properties and material composition, compared against established industry standards (where available) or the performance of a legally marketed predicate device.
• Specifically, the study compared "chemical composition, creep test, tension static and fatigue tests" to information from a published article ("Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials", L. M. Hägerich, et al, Musculoskeletal Disorders (2022)) and to the predicate device.

8. Sample Size for the Training Set

• Not applicable / Not mentioned. This device is a physical product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal validation and verification activities, but this is distinct from training an AI model.

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

• Not applicable. As there is no AI "training set," there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is derived from engineering principles, relevant material standards (e.g., ASTM F899 for steel), and performance expectations set by the predicate device.

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Versalock Upper Limb Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.

Versalock Upper Limb Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates and screws are made from titanium alloy or pure titanium. The plates range in thickness from 1.4 to 3.5 mm, and the screws range in diameter from 2.0 to 3.5 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. Versalock Upper Limb Plating System are for single use and the devices are provided non-sterile. They must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

This document describes the Versalock Upper Limb Plating System, a medical device for internal bone fixation. However, it is a 510(k) Premarket Notification for a Class II medical device, specifically metallic bone fixation appliances and accessories. These types of devices generally rely on mechanical testing to demonstrate substantial equivalence rather than clinical studies involving human patients or AI performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria (such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable in this context. The acceptance criteria and "study" described herein are based on mechanical performance standards.

Here's an analysis of the provided information, focusing on what is available:

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

Explanation: The acceptance criteria for this device are defined by its ability to meet established mechanical testing standards (ASTM F382 for plates and ASTM F543 for screws) and demonstrate substantial equivalence to legally marketed predicate devices. The "reported device performance" is that it successfully met these criteria.

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

• Sample size: Not explicitly stated as a "test set" in the context of clinical or AI performance. For mechanical testing, the sample size would refer to the number of plates and screws tested per configuration. This information is typically detailed in the test reports, which are not included in this summary.
• Data provenance: Mechanical testing is conducted under controlled laboratory conditions, not on human data. The specific lab where the testing was performed is not mentioned, but the manufacturer is based in Brazil.

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

• Not Applicable. This device does not involve expert-established ground truth in the way an AI diagnostic device would. Its performance is assessed through objective mechanical properties.

4. Adjudication method for the test set

• Not Applicable. There is no "adjudication method" as understood in clinical studies with human observers. Mechanical testing results are compared against the accepted performance parameters of the ASTM standards and the predicate devices.

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 not an AI-assisted device, nor is it a diagnostic device that would involve human readers.

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

• Not Applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this medical device is adherence to established mechanical performance standards (ASTM F382 and F543) and factual data demonstrating substantial equivalence in material, design, and performance to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model.

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

• Not Applicable.

In summary: The provided document is an FDA 510(k) clearance for a bone plating system. The "study" proving the device meets acceptance criteria is a series of mechanical tests conducted according to ASTM standards (F382 for plates, F543 for screws), which confirmed the device is mechanically equivalent to its predicate devices. The acceptance criteria are essentially defined by these standards and the equivalence to existing cleared devices. Information relevant to AI/clinical performance metrics (like expert reviews, reader studies, ground truth establishment for AI) is not relevant to this type of device submission.

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Quick - Radius Disposable Set is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate and screw systems is suited for treatment of fractures in osteopenic bone.

Quick - Radius Disposable Set are plate and instruments kit, for osteosynthesis procedures of the distal radius, in sterile condition, single use and disposable instruments after use. This sterile set must be used with 2.4mm screws, also sterile and individually packaged. The surgeon selects the best combination of plate size, left or right and screw designs and quantities, as needed. Single use and sterile templates are available, individually packed, for determining the size of the plate to be used. Also, as an option, individually packed plates, instruments only kit, and instruments with plates and screws kit, are available in sterile condition.

The plates and screws are produced with Titanium Alloy, according with standard ASTM F136, and the instruments are made of Stainless Steel, according with standard ASTM F899.

The provided text describes a 510(k) submission for a medical device, the "Quick - Radius Disposable Set." The document primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel device or an AI/algorithm-based diagnostic tool.

Therefore, the information required to populate the fields related to acceptance criteria, specific performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/algorithm-based device is not present in the provided text.

The document states:

• "The proposed device is a line extension to the predicate device with new presentation forms." (Page 3, Section VI)
• "The proposed and predicate devices have the same basic design, intended use and biocompatibility profile." (Page 3, Section VI)
• "Difference between the proposed device and the predicate includes addition of a presentation form in a sterile condition." (Page 3, Section VI)
• "The subject Quick - Radius Disposable Set components possess the same technological characteristics as the predicate devices. These include: performance, shape and dimensions, material and manufacturing, sizes, biocompatibility and device usage." (Page 3, Section VII)
• "The EO sterilization has been validated to a sterility assurance level (SAL) of 10-6, according to ISO 11135" (Page 3, Section VII)
• "Any differences between the proposed device and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness." (Page 3, Section VI and Page 4, Section VIII)

In conclusion, this submission is for a physical medical device (bone plates and screws set) seeking 510(k) clearance based on substantial equivalence to predicate devices, mainly through demonstrating equivalent design, materials, and a validated sterilization process. It does not involve software, AI, or diagnostic claims that would necessitate the types of performance studies and acceptance criteria typically associated with those technologies.

Therefore, I cannot fill in the requested table and answer the specific questions about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm, as the provided text does not contain such information. The "performance data" section in the document (Section VII) refers to the performance of the physical components (e.g., mechanical performance, biocompatibility) rather than diagnostic accuracy metrics.

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The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hip: Capsular repair, acetabular labral repair.

The Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately.

Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices".

The Suture Anchors - GM Reis is composed of two different groups of anchors:

• HTA – Headless Titanium Anchor.
  • Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm
• -ZIP Anchor.
  • Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm.

This document is a 510(k) Premarket Notification from the FDA regarding "Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors." It details the device, its intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria for an AI/algorithmic device.

The document discusses non-clinical performance data for the suture anchors themselves (insertion torque, pullout strength, MRI compatibility) to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-driven diagnostic or therapeutic tool.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about a study proving an AI/algorithmic device meets acceptance criteria, which is not what this FDA document is about.

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Cut Screw - Percutaneous Compression Screw are single use devices indicated for fixing and stabilizing the bones of the mid foot, metatarsal and phalanges of the foot using an appropriate relation bone-screw size.

The Cut Screw - Percutaneous Compression Screw for bone synthesis, with a hole in the center in order to allow the passage of the guide wire, thus facilitating its placement, as the surgeon is able to verify the positioning of the screw through the radiological image of the guide wire before its placement. In addition, the Cut Screw -Percutaneous Compression Screw, provides anatomical reduction, stable fixation, and preservation of blood supply by using a percutaneous incision. The screws have a hexagonal connection for a wrench. They are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, it could be provided in sterile condition sterilized by Ethylene Oxide or non-sterile condition to end user and must be cleaned, and steam sterilized before use.

The provided document is a 510(k) Premarket Notification for a medical device called "Cut Screw - Percutaneous Compression Screw." This document focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device) rather than clinical performance (e.g., diagnostic accuracy of an AI/ML algorithm). Therefore, the information requested in your prompt, which pertains to the acceptance criteria and study design for proving the performance of a device, particularly for AI/ML-based medical devices, is not present in this document.

Specifically, the document states:

• "No clinical data were included in this submission." (page 5)
• The performance data provided is limited to non-clinical mechanical testing (Torsional Properties, Driving Torque, Axial Pullout Strength per ASTM F543) to demonstrate safety and efficacy in terms of mechanical properties. (page 5 & 6)

Therefore, I cannot provide answers to the questions regarding acceptance criteria, study types (MRMC, standalone), ground truth, sample sizes for test/training sets, or expert qualifications as these are not relevant to this type of device submission as described in the provided text.

The document's purpose is to show similarity in design, materials, and mechanical performance to an already approved device, rather than proving a new diagnostic or therapeutic capability through clinical studies.

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