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The FIXIT®/ ComposiTCP™ threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.

FIXIT® / ComposiTCP™ Threaded Anchor System is composed of a bioabsorbable composite anchor (30% β-TCP/ 70%PLDL) pre-loaded on a disposable screwdriver and 2 sutures. Different variations of the product are available depending on the type of suture combination (2 flat sutures, or 1 round + 1 flat)

For each configuration, the implant is supplied sterile, ready to use.

The provided document is a 510(k) premarket notification for a medical device (FIXIT®/ComposiTCP™ Threaded Anchor System) and does not describe an AI/ML-based device. Therefore, the questions related to acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML models cannot be answered from this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for a suture anchor through non-clinical performance testing.

However, I can extract the acceptance criteria and reported device performance related to the mechanical properties as presented in the document:

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

The remaining questions cannot be answered from the provided text as they pertain to AI/ML device studies, which this document does not describe.

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The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.

The PULLUP® Adjustable Juxtacortical Fixation Device consists of an adjustable nonabsorbable braided loop and titanium button. The system is preloaded with traction threads. The PULLUP® Adjustable Juxtacortical Fixation Device is available in 2 versions: -PULLUP® for cortical tunnels having a diameter of 4.5 mm - PULLUP®XL for cortical tunnels having a diameter between 5 and 10 mm - The implant is supplied sterile, ready to use.

The provided document is a 510(k) premarket notification for a medical device called the PULLUP® Adjustable Juxtacortical Fixation Device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to establish safety and effectiveness from scratch.

Therefore, the document does not contain the detailed information on acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device, clinical trial, or diagnostic test. Instead, it demonstrates the device's performance through non-clinical performance testing to establish equivalence to predicate devices.

Here's an analysis based on the information available in the document, framed against your requested categories, with explanations for what is not present:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics in the way one would expect for an AI/ML device or a clinical outcome study. Instead, it makes a general statement about non-clinical performance testing:

The "non-clinical performance testing" would typically involve bench testing for mechanical properties (e.g., strength, fatigue, pull-out force) designed to show equivalence to the predicate devices. The specific metrics, thresholds, and results of these tests are not provided in this summary.

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

This information is not applicable and therefore not provided. The document states, "No clinical data has been presented." The performance testing mentioned is non-clinical (i.e., bench testing, not human patient data).

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)

This information is not applicable. Since no clinical data or human-interpreted data is referenced, there's no ground truth established by experts in this context.

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

This information is not applicable, as there is no human interpretation of data 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 information is not applicable. The device is a mechanical fixation device, not an AI/ML diagnostic or assistive tool.

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

This information is not applicable. The device is a mechanical fixation device; there is no algorithm involved.

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

For the non-clinical performance testing, the "ground truth" would be established by validated engineering test methods and relevant ASTM/ISO standards for mechanical testing of orthopedic implants. This often involves measuring parameters like tensile strength, cyclic loading, and pull-out strength, comparing the results of the new device against the known performance of the predicate devices under identical test conditions. Specific details are not disclosed in this summary.

8. The sample size for the training set

This information is not applicable. There is no AI/ML algorithm requiring a training set.

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

This information is not applicable. There is no AI/ML algorithm requiring a training set.

In summary: The provided 510(k) summary is for a physical medical device. It relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices (Arthrex TightRope RT and Biomet ToggleLoc System) in terms of safety and effectiveness. It explicitly states that "No clinical data has been presented." Therefore, the detailed information requested regarding AI/ML device studies, human readers, ground truth establishment by experts, and clinical trial specifics (like sample size, data provenance, adjudication) is not relevant or available in this document.

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BIOSORB Resorbable Bone Void Filler is a resorbable calclum salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable BoneVoid Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.

In addition, when used with appropriate opening osteotomy system devices, plates and screws, BIOSORB Resorbable Bone Void Filler Is Intended to be used as a bone void filler in tiblal osteotomies.

BIOSORB bone void filler (K021963 and K071155) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βΤCP) indicated for Bone Void Filling.

BIOSORB bone void filler presents a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. BIOSORB bone void filler implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues.

To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of BIOSORB RESORBABLE BONE VOID FILLER will comprise:

• 9 shapes: stick, granule, cube, block (6 shapes) o
• 3 material specifications: BIOSORB 30, BIOSORB 45 and BIOSORB 70 o
• 3 packaging: box, vial, syringe 0

The design modifications of the new NEOTIS set of wedges with respect to OTIS set of wedges include a sharper anterior area and a wider posterior area more fitting the natural tibia anatomy. 3 letters are printed to help the surgeon with the wedge orientation: A stands for Anterior, M stands for Medial and P for Posterior.

There are 50 NEOTIS parts instead of 10 OTIS parts, so that the range is increased.

Here's a breakdown of the acceptance criteria and study information for the BIOSORB Resorbable Bone Void Filler, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "cadaveric labs" but does not specify the number of cadavers or individual tests performed.
• Data Provenance: The cadaveric labs likely involved human cadavers. The country of origin is not specified, but the submitter is based in France. The study was prospective in the sense that new tests were conducted for this submission.

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

• Number of Experts: Not explicitly stated, however, the document refers to validation "by surgeons." This implies multiple surgeons were involved.
• Qualifications of Experts: "Surgeons" are the explicitly stated experts. No further details on their specific qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document only states that the enhanced anatomical fitting was "verified by surgeons." It doesn't detail how consensus was reached or how discrepancies (if any) were handled among the surgeons.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The study focused on verifying the anatomical fitting of the device through cadaveric labs, not on comparing human reader performance with and without AI.

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

• Standalone Performance: No, this is not applicable. The device is a physical bone void filler, not an AI algorithm. The performance evaluation involved physical assessment by surgeons in cadaveric labs.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the device's enhanced anatomical fitting was based on expert assessment/consensus by surgeons through cadaveric labs.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The development of the device design would involve engineering and material science principles, possibly with iterative design and testing, but not a "training set" in the context of machine learning.

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

• Ground Truth for Training Set: Not applicable, as this is not an AI/ML device. The design evolution of the BIOSORB Resorbable Bone Void Filler was likely informed by clinical experience with previous versions (K021963 and K071155) and anatomical considerations.

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LIGAFIX® / ComposiTCP® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (beta-TCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX / ComposiTCP range of products consists of resorbable cannulated screws available in several models designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. LIGAFIX / ComposiTCP interference bone screw is made of a ceramic (beta-TCP) / polymer (Poly Lactic Acid -PLA) composite. LIGAFIX / ComposiTCP interference screw is available in several sizes and in two beta-TCP/ PLA ratios 60/40 (LIGAFIX 60/ ComposiTCP 60) and 30/70 (LIGAFIX 30/ ComposiTCP 30). LIGAFIX / ComposiTCP interference bone screws are supplied sterile and individually packaged in double heat sealed pouches. The purpose of this 510(k) was to address modifications to the head of certain screw configurations, along with modifications to the cannula to allow use with 1.1mm guide wire. The subject system offers screws in diameters ranging from 7 mm to 12 mm with lengths ranging from 20 mm to 35 mm.

This is a medical device 510(k) submission for a resorbable interference screw, not an AI/ML device. Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) are not applicable.

Here's an analysis based on the provided text, focusing on the available information for a traditional medical device:

Acceptance Criteria and Device Performance for LIGAFIX Interference Screw

The device, LIGAFIX Interference Screw, is a traditional medical device and not an AI/ML algorithm. Therefore, the acceptance criteria and study data are presented in terms of mechanical and biocompatibility performance rather than metrics typically associated with AI/ML (e.g., AUC, sensitivity, specificity, F1-score).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. For mechanical and biocompatibility testing of traditional medical devices, sample sizes are typically determined by regulatory standards (e.g., ISO, ASTM) and statistical considerations for material property testing, rather than a clinical "test set" in the AI/ML sense. The text mentions "mechanical tests and dimensional analysis," which would involve testing a specific number of manufactured units.
• Data Provenance: Not specified, but generally, such testing is conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility. The manufacturer is "SCIENCE FOR BIOMATERIALS" located in France.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/ML (e.g., expert consensus on image labels) is not relevant here. Device performance is assessed through objective physical and chemical tests based on established standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML device, there's no "adjudication method" in the sense of resolving discrepancies between expert opinions on a dataset. Performance is determined by compliance with engineering specifications and regulatory standards.

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

• Not Applicable. MRMC studies are specific to evaluating the diagnostic performance of imaging devices or AI algorithms involving human readers. This device is an implantable screw.

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

• Partially Applicable (in a different context). The "standalone performance" of the device refers to its physical and biological performance (biocompatibility, mechanical strength) as an implantable object, independent of a human-in-the-loop diagnostic process. The text states: "Mechanical tests and dimensional analysis confirmed that LIGAFIX / ComposiTCP screws are biocompatible and presents the requisite strength to provide sustained fixation of the graft." This represents the device's inherent performance characteristics.

7. The Type of Ground Truth Used

• For physical and chemical properties: Objective Measurement/Standard Compliance. Ground truth is established by physical measurements (e.g., dimensions, load-to-failure), chemical analysis for material composition, and biological assays for biocompatibility, all compared against pre-defined engineering specifications and relevant regulatory standards (e.g., ISO standards for medical devices, ASTM standards for materials testing).
• For substantial equivalence: Comparison against the characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/ML device that learns from data.

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

• Not Applicable. There is no "training set" for this type of medical device.

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LIGAFIX 30 is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (30% β-TCP) and Poly Lactic Acid (70% PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX 30° resorbable cannulated screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX 30® interference screws are made of a ceramic (30% ß-TCP) / polymer (70% Poly Lactic Acid -PLA) composite.

LIGAFIX 30° interference screws are supplied sterile and individually packaged in double heat sealed pouches.

This document is a 510(k) summary for the LIGAFIX® Resorbable Interference Screw. It describes the device and its intended use, and states that substantial equivalence is based on similar fundamental scientific technology, operating principle, and intended use as a previously cleared predicate device (K050407), with modifications limited to additional screw sizes and a slightly modified head design.

Therefore, the submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission for substantial equivalence based on modifications to an already cleared device, not a performance study.

Thus, I cannot answer the questions as the requested information is not present in the provided text.

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LIGAFIX® is indicated for use in anterior cruciate ligament reconstruction to provide interference fixation of grafts.
LIGAFIX® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (β-ΤCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX® is a resorbable cannulated screw designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. LIGAFIX® interference bone screw is made of a 30% ceramic (ß-TCP) / 70% polymer (Poly Lactic Acid -PLA)(6v composite. LIGAFIX® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches. LIGAFIX® screws present a socket which accepts a screwdriver of triangular cross-section that inserts deep into the core of the screw, to produce improved torque distribution.

The provided text is a 510(k) Premarket Notification for the LIGAFIX® Interference screw. This type of FDA submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies with complex acceptance criteria typically seen for new drug applications or high-risk devices.

Therefore, the study described here is primarily a comparative study to a predicate device rather than a standalone clinical trial with defined acceptance criteria for efficacy. The "acceptance criteria" for this submission are fundamentally the demonstration of substantial equivalence.

Here's an analysis based on the provided document:

Description of the Study and Acceptance Criteria

The submission for the LIGAFIX® Resorbable Interference Screw (K050407) is a 510(k) premarket notification. The primary "study" involved demonstrating that the device is substantially equivalent to legally marketed predicate devices, specifically the BioLok® Screw (K002070) and BIOSORB® Resorbable Void Filler (K021963).

The "acceptance criteria" for this type of submission are met when the FDA determines that the new device has the same intended use, technological characteristics, and performs similarly to the predicate device, or if it has different technological characteristics, that they do not raise new questions of safety and effectiveness.

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

For a 510(k), explicit, quantitative acceptance criteria for a new clinical outcome are generally not presented in the same way as a full clinical trial. Instead, the "acceptance criteria" are implied by demonstrating equivalence in key performance areas to the predicate device. The "reported device performance" is essentially the evidence provided to satisfy this equivalence.

• Indicated for "anterior cruciate ligament reconstruction to provide interference fixation of grafts" (same as predicate, implied). |
  | Material Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of... material..."
• LIGAFIX®: 30% ceramic (ß-TCP) / 70% polymer (Poly Lactic Acid -PLA) (6v composite)
• Predicate Material: Not explicitly detailed for BioLok® in this summary, but equivalence asserted. |
  | Design Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of... design..."
• LIGAFIX®: Resorbable cannulated screw, socket accepts triangular screwdriver. Design features are presented as comparable to predicate. |
  | Function/Performance Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of... function."
• Biological, mechanical and biocompatibility tests have been performed.
• Results confirmed that LIGAFIX® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft.
• LIGAFIX® screws strength retention profiles are compatible with the healing process. (These findings directly support functional equivalence to the predicate). |
  | Safety (no new safety questions) | "highly biocompatible" and "requisite strength" (implied no new safety concerns compared to predicate due to materials and mechanical properties). |

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

The summary does not describe a clinical trial with a "test set" of patients in the typical sense. The "performance data" mentioned are "Biological, mechanical and biocompatibility tests have been performed." These are typically bench tests and potentially in vitro or in vivo (animal) studies, not patient studies with a defined sample size.

• Sample Size for Test Set: Not applicable in the context of a human clinical test set. The sample sizes would refer to the number of screws or biological samples tested in laboratory/animal studies, which are not specified.
• Data Provenance: Not applicable for a clinical test set. The tests were performed by the manufacturer or a contracted lab. The submitter is from France ("Sciences et Bio Matériaux, ZI du Monge, F 65100 LOURDES - FRANCE"). These would be internal R&D test results.

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. This is a medical device 510(k) submission based on bench testing and material characterization, not a study requiring expert clinical assessment for ground truth.

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

Not applicable. There was no clinical test set 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

Not applicable. This is not an AI-enabled diagnostic device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" here is established through objective scientific and engineering metrics from materials science, biomechanics, and biocompatibility testing, compared to established standards and the characteristics of the predicate device.

• Biocompatibility: Likely evaluated against ISO 10993 standards using in vitro and in vivo (animal) tests.
• Mechanical Strength: Measured through biomechanical testing (e.g., torque, pull-out strength, degradation profiles) using engineering standards.
• Material Composition: Verified through analytical chemistry techniques.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

Not applicable. There is no training set for this device.

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