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The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.

The current Clavicle Fracture Fixation System accommodates fractures covering the mid-section and distal portions of the clavicle. As proposed in this 510(k) notification, the sponsor wishes to extend the product line by including a plate specifically designed for mid-shaft (i.e., non-distal) clavicle fractures. Because the proposed mid-shaft plate would not cover the distal aspect of the clavicle, its design will be slightly different. The proposed mid-shaft plate will be approximately 2/3 of the length of the current large size clavicle plate. Because the proposed mid-shaft plate will not engage the articular capsule of the clavicle, the distal screw holes of the current plate are eliminated.

The proposed mid-shaft plate will be available in one size only with an overall length of approximately 100mm. The thickness of the plate will be the same as the Suspension™ clavicle plates now on the market. Likewise, the width of the mid-shaft plate will be the same as the mid-shaft portion of the current plates. The screws used to secure the proposed mid-shaft plate to the clavicle are the same as those used for the current Suspension™ clavicle plates.

As with the current Suspension™ Clavicle Fracture Fixation plates, the proposed mid-shaft plate will be composed exclusively of 316L stainless steel. Implantable components are intended for re-sterilization, but are for single-use only.

A hex driver with a handle and a hex driver shaft for hand-tightening bone screws is supplied with the device. These accessories are intended for re-use and re-sterilization. Drill bits are required for creating pilot holes for bone screws. These drill bits are included supplied with the clavicle plates and are steam sterilized by the hospital center.

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

This 510(k) pertains to a device modification (a line extension) of an already cleared device, not a new device requiring extensive de novo performance studies. The core of the submission is to demonstrate that the modified device has not changed its performance characteristics and is substantially equivalent to its predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating this equivalence rather than establishing new performance benchmarks for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

Interpretation: The "acceptance criteria" here are essentially the established performance and safety profile of the predicate device (K102095). The new device (K113405) meets these criteria by demonstrating that it has not changed in material, performance characteristics (via a functional test), or safety profile from the predicate.

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

• Test Set Description: The "test set" in this context refers to the physical devices (the proposed mid-shaft clavicle plates) that were subjected to functional testing.
• Sample Size: The document does not specify the exact number (sample size) of mid-shaft clavicle plates used for the functional tests. It states "Functional test conducted in accordance with ASTM F382-99." ASTM F382-99, "Standard Specification for Metallic Bone Plates for Osteosynthesis," outlines testing methodologies and often includes recommendations for sample size for various tests (e.g., fatigue, static bending). Without the full test report, the specific sample size performed by the sponsor is unknown.
• Data Provenance: Not applicable in the traditional sense of patient data. The "data" comes from in vitro functional testing of the device itself. Therefore, there's no country of origin or retrospective/prospective distinction for patient data.

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

• Not Applicable: This is a mechanical device submission, not an AI/software device that relies on expert interpretation for ground truth. The "ground truth" for this device is its mechanical properties as measured by standardized engineering tests.

4. Adjudication Method for the Test Set

• Not Applicable: As above, this is a mechanical device, not an image-based or diagnostic AI/software device that would require adjudication of interpretations. The "test" results are objective measurements from mechanical testing.

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

• No: No MRMC study was done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. This submission is for a surgical implant, not a diagnostic tool.

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

• Yes (in concept, but for mechanical performance): The functional test performed according to ASTM F382-99 is a standalone performance test of the device's mechanical characteristics without human-in-the-loop performance influencing the device itself. The device's performance is objectively measured.

7. The Type of Ground Truth Used

• Engineering/Mechanical Performance Standards: The "ground truth" here is adherence to established engineering standards (ASTM F382-99) and demonstrating equivalent mechanical performance to a legally marketed predicate device. This is based on objective, quantifiable physical properties (e.g., strength, stiffness, fatigue resistance).

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/machine learning device. There is no "training set" in this context.

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

• Not Applicable: As there is no training set, this question is not relevant.

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The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures. For lateral clavicle fractures, the Suspension™ Clavicle Fracture Fixation System may also be used with the Suspension™ Acromioclavicular (AC) Repair System.

The subject device consists of the following implantable components:

1. Three sizes of clavicle fracture plate for each shoulder (i.e. small, medium, and large; each with Left & Right configurations)
2. Eight 2.7mm lengths of non-locking & locking bone screws
3. Eight 3.5mm lengths of non-locking & locking bone screws
   Implantable components are included in a carrier case and must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but are for singleuse only. All implantable components are composed of stainless steel.
   The optionally accompanying Suspension™ Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor with pre-threaded suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. Implantable portions of the device are: USP size 5 braided polyethylene suture, coracoid anchor, clavicle set screw, clavicle sleeve extension washer, clavicle sleeve.

The provided text describes a 510(k) summary for the Suspension™ Clavicle Fracture Fixation System, a medical device, and not an AI/ML-based diagnostic or prognostic device. Therefore, the traditional "acceptance criteria" and "study" questions related to AI/ML device performance (e.g., sensitivity, specificity, human-in-the-loop studies, ground truth establishment by experts) are not applicable in this context.

Instead, the "acceptance criteria" for a medical device like this, under a 510(k) pathway, revolve around substantial equivalence to a predicate device. This is demonstrated primarily through performance testing, safety testing (biocompatibility, sterility), and engineering analysis to show that the device meets its intended use and does not raise new questions of safety or effectiveness.

Here's how to reframe the information based on the provided text, focusing on the substantial equivalence criteria for this mechanical device:

Device Acceptance Criteria and Supporting Study

Device Name: Suspension™ Clavicle Fracture Fixation System
Premarket Notification Number: K112923
Predicate Device: Smith & Nephew (K061352) and K102095 (previous version of the subject device) for components.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: Multiple cadaver shoulders and simulated bone.
• Sample Size: Not explicitly stated as a number of samples or cases. The document uses phrases like "multiple cadaver shoulders" and "in all instances" for simulated bone testing, suggesting sufficient samples were tested to draw conclusions.
• Data Provenance: The cadaver and simulated bone testing was conducted specifically for this submission to support the device's performance. The location of the test facility is not explicitly mentioned, but it's part of a US FDA 510(k) submission. It is a prospective set of tests conducted for regulatory submission.

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

Not Applicable (N/A). This is a mechanical device, not an AI/ML diagnostic. The "ground truth" is established by physical measurement of mechanical properties (yield load, stiffness, ultimate load) using an Instron™ device and observation of failure modes, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set

Not Applicable (N/A). As this is mechanical testing, there is no human "adjudication" in the sense of consensus reading or clinical judgment. The results are quantitative measurements from the Instron™ device.

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

Not Applicable (N/A). This type of study is relevant for diagnostic performance, typically for image-based AI/ML systems where human reader performance is being evaluated with and without AI assistance. This device is an orthopedic implant.

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

Not Applicable (N/A). This question applies to AI/ML algorithms. The device is a physical implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through biomechanical testing data obtained from:

• Measurements using an Instron™ device (for yield load, stiffness, ultimate load).
• Observation of failure modes during testing.
• Engineering analysis for specific concerns like fretting/corrosion.
• Reference to previously established biocompatibility and sterility validation data from predicate devices/prior submissions.

8. The Sample Size for the Training Set

Not Applicable (N/A). There is no "training set" in the context of a physical medical device like an orthopedic implant. Training sets are relevant for AI/ML models.

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

Not Applicable (N/A). As there is no training set, this question is not applicable.

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The Suspension™ Acromioclavicular (AC) Repair System can be used for adult patients. The AC Repair System is indicated for securing suture to bone for acromioclavicular separations and coracoclavicular displacement.

The Suspension" Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor, pre-threaded suture and other attachment accessories that eliminate the need for tying a knot in the suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. The suture is a USP size 5, co-braided, white/blue polypropylene, non-absorbable suture.

The provided text describes a 510(k) summary for the "Suspension™ Acromioclavicular (AC) Repair System." This document is a premarket notification to the FDA for medical devices, asserting substantial equivalence to existing legally marketed devices. It focuses on demonstrating that the new device is as safe and effective as its predicates.

The information provided does not describe a study involving acceptance criteria for device performance based on statistical metrics like accuracy, sensitivity, or specificity, nor does it involve human readers, ground truth established by experts, or MRMC comparative effectiveness studies.

Instead, the "Performance" section outlines non-clinical testing for mechanical properties to demonstrate substantial equivalence. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's the breakdown of the information that is available or can be inferred:

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

The document states: "The device has been subjected to non-clinical testing including Driving Torque, Pull-Out Strength, Lock Screw Torque, Anchor Torque, and Suture Testing." It also mentions: "The axial pull test data was compared and analyzed."

However, specific numerical acceptance criteria (e.g., "Pull-Out Strength > X N") and the reported numerical performance data for these tests are not provided in the summary. The summary concludes that the device "perform[s] in a manner equivalent to the predicate devices," implying that the performance met unstated acceptance criteria derived from the predicate devices.

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

The document does not specify the sample sizes for the "non-clinical testing" (Driving Torque, Pull-Out Strength, etc.). The data provenance is not explicitly mentioned but implies laboratory testing of the device itself. This is not patient data.

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

Not applicable. No ground truth based on expert medical opinion was established for these mechanical performance tests.

4. Adjudication method for the test set

Not applicable. No human adjudication was involved for these mechanical performance tests.

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 a 510(k) summary for a physical medical device (AC Repair System), not an AI diagnostic tool.

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

Not applicable. This is a 510(k) summary for a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be the direct measurement of the physical properties (e.g., force, torque) of the device components, compared against established engineering and material science standards, and performance characteristics of predicate devices. There is no expert consensus, pathology, or outcomes data used as ground truth for these specific tests.

8. The sample size for the training set

Not applicable. This is not a machine learning model.

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

Not applicable. This is not a machine learning model.

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The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.

The Suspension™ Clavicle Fracture Fixation System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from 316L Stainless Steel.

The device consists of the following implantable components (some or all of which may be used based on the nature of the injury):

• 1. Three (3) Sizes of Clavicle Fracture Plate for Each Shoulder (i.e. small, medium, and large; each with Left & Right).
• 2. Eight (8) Lengths each of 2.7mm Non-Locking & Locking Bone Screws.
• 3. Eight (8) Lengths each of 3.5mm Non-Locking & Locking Bone Screws.

Implantable components are included in a surgical tray that must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but these components are for single use only.

The implants are used with instrumentation including:

• Hex Driver .
  • o Handle and a 2.5mm hex driver for hand tightening bone screws
• Assorted Drill bits .
  • o To create pilot holes for bone screws. The drill bits are compatible with most AO connections.
• Drill Guide Assemblies .

Here's an analysis of the provided 510(k) summary regarding the Suspension™ Clavicle Fracture Fixation System, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing (e.g., mechanical tests like torsional strength, bending, screw driving torque) and a predicate device comparison analysis. These types of tests typically do not involve human subject data or "test sets" in the sense of clinical trials. The sample sizes for these mechanical tests are not specified in the summary, but would refer to the number of devices or components tested. The data provenance is internal to the manufacturer's testing facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The evaluations were based on engineering and material science principles, and comparison to a predicate device, not on expert consensus of clinical data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as there was no clinical test set requiring ground truth adjudication by experts.

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. This device is a physical orthopedic implant, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical mechanical tests, the "ground truth" is defined by established engineering standards and comparative performance against the legally marketed predicate device. For the predicate comparison, the ground truth is the established safety and effectiveness profile of the predicate device (Smith & Nephew Peri-Loc locking bone plates, locking and non-locking bone screws for the upper extremity - K061352).

8. The Sample Size for the Training Set
This information is not applicable. This is a physical orthopedic implant, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.

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