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The Acu-Sinch Repair System is intended to be used in conjunction with a clavicle plate of the Congruent Bone Plate System to provide fixation during the healing of clavicle fractures.

The Acu-Sinch Repair System also may be used as a stand-alone system for treatment of acromioclavicular and/or coracoclavicular ligament disruption.

The Acumed Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Acumed's Locking Clavicle Plating System is designed to provide fixation during fractures, fusions, or osteotomies of the clavicle.

The Acu-Sinch Repair System consists of several components (Suture Anchor, Clavicle Fracture Plate, Acu-Sinch plate, Suture Retainer, Screws, and Suture) which can be combined to create various device constructs to treat the indications listed above. The Suture Anchor can be used for fixation of suture to bone in the anatomic locations listed above.

The acceptance criteria and study proving the device meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact "sample sizes" in terms of number of devices or iterations for the preclinical testing. The testing described is preclinical (laboratory-based mechanical testing), not a clinical study involving human or animal subjects, so data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the typical sense. The testing was performed on the device components themselves.

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

This information is not applicable as the "ground truth" for the preclinical mechanical tests is based on the physical properties and performance of the device components compared to established predicate devices, rather than expert interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable as the preclinical tests involve objective mechanical measurements and comparison to predicate devices, not expert adjudication of clinical outcomes or images.

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

No, an MRMC comparative effectiveness study was not done. The study conducted was preclinical mechanical testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a surgical repair system, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the preclinical testing was established by the performance of legally marketed predicate devices. The acceptance criterion for the Acu-Sinch Repair System was that its mechanical performance (load to failure, fatigue, pull-out strength, and general engineering analysis) was "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is a medical device subject to preclinical mechanical testing, not an algorithm that requires training data.

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

This question is not applicable for the reasons stated above.

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The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.

The predicate Congruent Bone Plate System (K012655) consists of bone plates and screws which provide fixation for fractures, fusions, and osteotomies of the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula. The purpose of this 510(k) is to modify two components of the Congruent Bone Plate System and to add one component to this predicate system. These modifications are intended to allow the operating surgeon to better accommodate various patient anatomies when treating distal and midshaft fractures of the radius. All components are made of titanium alloy conforming to ASTM F136.

The provided text describes a 510(k) summary for the Acumed Congruent Bone Plate System. This is a medical device for bone fixation, and the summary details its indications for use, device description, and preclinical testing.

However, the information required to answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" is not present in the provided text. The document refers to preclinical testing (static and dynamic 4-point bend testing in accordance with ASTM F382) to demonstrate substantial equivalence to a predicate device. This type of testing evaluates the mechanical properties of the device, not its "performance" in the context of diagnostic accuracy, human reader improvement, or ground truth establishment, which are typical metrics for AI/ML-based medical devices or diagnostic tools.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions related to sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these concepts are not applicable to the type of device and testing described in this 510(k) summary.

In summary, the provided document does not contain the requested information regarding acceptance criteria and studies related to diagnostic/AI performance.

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The I.T.S. Olecranonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal ulna (olecranon) in the elbow. Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of the proximal ulna (olecranon).

The I.T.S. Olecranonplate with Angular Stability is a low-profile universal left and right titanium 8, 10, and 12 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 3.5mm Cortical screws of various lengths are self-tapping and are interchangeable in use to lock the plate to the dorsal shaft of the ulna. The Olecranonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) Summary of Safety and Effectiveness for a medical device called "Olecranonplate with Angular Stability." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices.

Specifically, the text includes:

• Device Description: The I.T.S. Olecranonplate with Angular Stability is a low-profile universal titanium plate with various length cancellous self-tapping and head locking stabilization screws, and cortical screws. It is made from CP titanium and 6-4 alloyed titanium.
• Intended Use/Indications for Use: Fixation of complex intra- and extra-articular fractures, osteotomies, nonunions, malunions, and various types of simple and complex fractures of the proximal ulna (olecranon).
• Basis of Substantial Equivalence: It is substantially equivalent to Acumed Olecranon Plate, Synthes Curved Reconstruction Plate, and Zimmer Zuelzer Hook Plate for fracture of the Olecranon.
• Summary of Safety and Effectiveness: States that the device is "shown to be safe and effective for use in fracture fixation of the proximal ulna (olecranon) in the elbow," but does not provide details of any study or acceptance criteria used to demonstrate this.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study's methodology as this information is not present in the given text.

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The HALLU® -PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:
-Hallux rigidus
-Severe hallux valgus (IM angle > 20° and HV angle > 40°)
-Deformity from rheumatoid arthritis
-Failed previous surgical procedure
-Traumatic arthritis
-Neuromuscular instability.

The HALLU® -PLATES are available in two different designs :

• the HALLU®-C PLATE -
• the HALLU®-S PLATE -
  The HALLU®-C PLATE and the HALLU® -S PLATE are low profile Titanium plates dedicated to first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation (10° valgus and 10°dorsiflexion). Their fixation is provided by Titanium SNAP-OFF® screws available in a two diameters: 3.0 and 2.7 mm. They exist in different colors for size identification. The bone contact surface is sand blasted in order to maximize plate stability. The range of HALLU -C PLATE and HALLUS S PLATE include 6 sizes ( 31eft/3right) for optimal anatomic fit. Moreover, the HALLU®-S PLATE has an anatomical design providing optimal bone coverage.

The provided text describes a medical device, the HALLU®-PLATES, and its regulatory clearance based on substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies (e.g., sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable.

However, I can extract the information related to the device's testing and the standards it met.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Applicable Information:

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

• Sample Size: Not explicitly stated as this was a physical device test, not a data-driven software evaluation. The document mentions "Test 1" and "Test 2," implying multiple samples of the plate were tested for bending and fatigue.
• Data Provenance: The tests were conducted to comply with French Standard ISO 9585 and ASTM Standard F-382-99. This implies the tests were performed in a controlled laboratory setting, likely in the country of origin of the sponsor (France) or a qualified testing facility. The study type is experimental/bench testing, not retrospective or prospective human data.

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

• This question is not applicable as the "ground truth" for a physical device test like this is defined by established engineering standards (ISO 9585 and ASTM F-382-99) and the physical properties of the materials and design, not by expert human interpretation.

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

• This question is not applicable for a physical device test. The compliance is determined by measurements against predefined standard thresholds.

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, a MRMC comparative effectiveness study was not done. This is a physical bone plate, not an AI or imaging device that would involve human readers.

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

• Yes, a standalone test was done. The device's performance (bending strength, stiffness, fatigue strength) was evaluated independently against established physical standards. This is analogous to a "standalone" test for a physical product.

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

• The ground truth was based on established engineering standards for bone plates: French Standard ISO 9585 and ASTM Standard F-382-99.

8. The sample size for the training set:

• Not applicable. This device underwent physical bench testing, not a machine learning training process.

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

• Not applicable. As above, there was no training set for a machine learning model.

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