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The Adjustable Fixation Device is indicated for soft tissue to bone fixation for:

• ACL/PCL repair / reconstruction
• ACL/PCL patellar bone-tendon-bone grafts
• Double-Tunnel ACL reconstruction
• Extracapsular repair: MCL, LCL, and posterior oblique ligament
• Illiotibial band tenodesis
• Patellar tendon repair
• VMO advancement
• Joint capsule closure

The Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button. The suspension loop is threaded through the titanium cortical button to form a graft suspension construction. The device facilitates repair through placement and retention of the soft tissue graft within bone.

The provided text is a 510(k) Summary for the ArthroCare Adjustable Fixation Device. It describes the device, its intended use, and non-clinical data establishing substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/algorithm performance.

Instead, it refers to:

• Bench testing: "Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading."
• Design Verification testing: "to demonstrate conformance to design and performance specifications."

The document explicitly states: "No clinical or animal data are included in this submission." This indicates that the regulatory submission primarily relies on non-clinical (bench) testing and comparison to predicate devices, rather than a study with human subjects, AI standalone performance, or MRMC studies.

Therefore, many of the requested categories for AI/algorithm-related studies cannot be filled from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

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

The document mentions "conformance to design and performance specifications" and that "All test results confirm that Adjustable Fixation Device is substantially equivalent to the predicate devices" and "meet their design, performance, and safety specifications." However, no specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or the exact reported performance values are provided in this summary. It only states that the device passes these unspecified criteria.

Regarding the study that proves the device meets the acceptance criteria:

Since this is a physical medical device (Adjustable Fixation Device for soft tissue to bone fixation), the "study" referred to is a series of non-clinical, bench-top tests, not a study of an AI algorithm's performance.

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

• Test Set Sample Size: Not specified for the bench testing.
• Data Provenance: The document only mentions "simulated human bone substrate" for comparative testing, indicating laboratory-based, non-clinical data. No country of origin for data is relevant or mentioned as it's not a human study.
• Retrospective or Prospective: Not applicable as this is bench testing on simulated materials.

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. Ground truth for mechanical bench testing is typically based on engineering standards, material properties, and standardized testing protocols, not expert human interpretation.

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

Not applicable, as this refers to adjudication for human-interpreted data (like radiology reads) which is not part of this submission. The "ground truth" for bench tests is determined by physical measurements and engineering analyses.

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. An MRMC study is for evaluating diagnostic image interpretation by humans, often with and without AI assistance. This submission is for a physical orthopedic fixation device and does not involve AI or human readers for diagnostic tasks.

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

No. This device is not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

The "ground truth" for the non-clinical bench testing would be engineering specifications, material science properties, and adherence to established biomechanical testing standards. For instance, a certain load (in Newtons) or number of cycles might be the "ground truth" performance requirement that the device must meet or exceed.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained for this device.

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

Not applicable, as there is no AI algorithm being trained.

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Intended Use: The Sinus Dilation System with Cannulated Instrument is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.
Indications for Use: The Sinus Dilation System with Cannulated Instrument is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.

The Sinus Dilation System with Cannulated Instrument consists of a disposable balloon which is mounted on a reusable cannulated delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic guidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to guide the device to the sinus ostium using endoscopic visualization. The instrument cannulation provides a working channel for suction, irrigation, etc.

The provided document K131709 describes a "Sinus Dilation System with Cannulated Instrument." The submission is a Special 510(k) notice for a modification to a previously cleared device (ENTrigue® Sinus Dilation System, K121351).

This type of device is classified as a Class I medical device (exempt from 510(k) requirements) under 21 C.F.R. § 874.4420, an "Ear, Nose, and Throat manual Surgical Instrument" with product code LRC. Due to its classification and the nature of the submission (Special 510(k) for a modification), the regulatory requirements for showing effectiveness through clinical studies involving human patients, as would be expected for AI/diagnosis devices, are not applicable here.

The "acceptance criteria" and "device performance" in this context refer to engineering and biocompatibility testing rather than diagnostic performance metrics like sensitivity, specificity, or AUC which are typical for AI/CADe devices.

Here's an analysis based on the provided text, indicating what information is present and absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of units tested) for the bench tests (fatigue life, human factors, articulation/lock, cleaning/sterilization). It only states that "Bench testing was conducted."
• Data Provenance: The data is from "Bench testing," meaning it was conducted in a laboratory or manufacturing environment. There is no mention of country of origin for the data or whether it was retrospective or prospective, as this is laboratory testing, not clinical data from patients.

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

• This question is not applicable to this type of device and study. The "ground truth" for a mechanical device's performance (like articulating, locking, or fatigue life) is generally based on engineering specifications and validated testing protocols, not expert clinical interpretation of data. Human factors verification might involve users (physicians or other healthcare personnel), but their number or qualifications as "experts to establish ground truth" in the diagnostic sense is not relevant here and not specified.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers when establishing ground truth for diagnostic decisions. Since this is a submission for a mechanical device based on bench testing, such methods are not relevant or described.

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. This type of study is relevant to diagnostic devices, particularly AI-driven ones where human readers' performance is compared with and without AI assistance. This submission is for a mechanical surgical instrument.

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

• No, a standalone performance study was not done. This concept is only applicable to AI/algorithm-based diagnostic devices. The device in question is a physical surgical instrument; its performance is always "human-in-the-loop" as it is operated by a surgeon.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering specifications and validated test protocols. For example, a successful fatigue life test means the device withstood a specified number of cycles without failure, as per its design requirements. Successful cleaning and sterilization validation means it met established standards for those processes. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a physical surgical instrument modification. Training sets are relevant for machine learning algorithms.

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

• This question is not applicable for the same reason as point 8.

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The SpeedLock Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot

reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedLock Knotless Fixation System is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of soft tissue to bone.

The SpeedLock consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter, which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized. Both the anchor and inserter are designed for single use only.

The SpeedLock System also includes associated instruments for implanting the anchor into bone.

The design modifications include aligning the shape and size of the windows at the distal end of the anchor and adding a flat surface to the internal crossbar against which the anchor plug may rest once deployed. The modifications do not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the devices cleared indications for use.

The provided text is a 510(k) summary for the ArthroCare® Corporation SpeedLock® Knotless Fixation System. This document outlines a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might for a diagnostic AI algorithm.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission, as it concerns a physical bone fixation device, not a diagnostic AI or software.

However, I can extract information related to product performance and testing where available.

Acceptance Criteria and Device Performance (ArthroCare® Corporation SpeedLock® Knotless Fixation System)

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study referenced is a Design Verification testing program.

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

• Sample Size: Not specified quantitatively in the document. The testing involved "Insertion strength and pull-out strength testing."
• Data Provenance: The testing was conducted in a simulated bone substrate. This indicates a bench-top, in-vitro (non-human/animal) lab setting. The country of origin for the data is not specified but implicitly refers to the testing performed by ArthroCare Corporation.
• Retrospective/Prospective: Not applicable, as this was laboratory testing of a physical device.

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

• Not Applicable. This submission is for a physical medical device (bone anchor) and its performance in mechanical tests, not a diagnostic AI algorithm requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No. This is a hardware device; MRMC studies are relevant for software/AI interpretation where human readers are involved.

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

• Not Applicable. This is a hardware device; "standalone performance" generally refers to AI algorithm performance without human intervention. The testing described is of the physical device itself.

7. The type of ground truth used:

• For the mechanical tests (insertion strength, pull-out strength), the "ground truth" would be the measured mechanical properties against pre-defined engineering specifications or performance standards. The document refers to "design, performance, and safety specifications."

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device.

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

• Not Applicable. This is not an AI/machine learning device.

Summary of the Study:

The study involved Design Verification testing for the modified SpeedLock® Knotless Fixation System. This testing specifically included:

• Evaluation to demonstrate that the modifications did not alter the device's intended use or performance.
• Insertion strength testing in a simulated bone substrate.
• Pull-out strength testing in a simulated bone substrate.

The purpose of these tests was to demonstrate that the modified device continues to meet its pre-established design, performance, and safety specifications and that its mechanical properties remain substantially equivalent to its predicate device. The submission states that "All testing demonstrates that the modified SpeedLock Knotless Fixation System performs as intended and mechanical properties are substantially equivalent when used in accordance with its labeling." No clinical or animal data were included in this submission, indicating reliance solely on non-clinical, bench-top testing.

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The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedFix Suture System is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

The provided text describes a 510(k) summary for the ArthroCare Corporation SpeedFix Suture System, not a study involving acceptance criteria and device performance in the context of AI or a reader study.

The document states that a "side-by-side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors." However, it does not provide details of the acceptance criteria, the specific test results, sample sizes, or the other information requested in the prompt (e.g., data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets).

Therefore, based only on the provided text, I cannot complete the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (SpeedFix Suture Implant cleared under K101437) rather than presenting a detailed performance study against defined acceptance criteria in the manner described by the prompt.

The document explicitly states: "The differences between the SpeedFix and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices." This indicates a reliance on the predicate device's established safety and effectiveness, supported by bench testing, rather than a de novo performance study against explicit internal acceptance criteria.

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The Titan Ti Suture Anchor System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:

• Shoulder· Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, 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/Tendon Repair, Bunionectomy;
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction,
• Elbow Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
• Hip: Capsular Repair, Acetabular Labral Repair

The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor

This document is a 510(k) summary for the ArthroCare Corporation Titan™ Ti Suture Anchor System. It describes a medical device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Based on the provided text, the device is a "Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)" and the submission is for a modification to an existing device, specifically the addition of polyethylene tubing to improve shaft design.

Crucially, this document does not describe a study to prove the device meets acceptance criteria. Instead, it is a regulatory submission for a medical device seeking clearance based on substantial equivalence to predicate devices. This type of submission generally does not include detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC comparative effectiveness specific to the current submission's modification. The FDA's clearance is based on the argument that the modification (the addition of polyethylene tubing) does not raise new questions regarding safety and effectiveness, implying that the performance characteristics of the device remain largely consistent with the predicate.

Therefore, I cannot provide the requested information from the given text as the information is not present. The document focuses on regulatory clearance, not on a detailed performance study as would be conducted for a new or significantly modified device requiring extensive clinical or analytical validation.

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The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to as the ArthroCare Spartan PEEK Suture Implant System.

The provided text describes a 510(k) submission for the ArthroCare Spartan PEEK Suture Implant System, which is a medical device for fixing soft tissue to bone. However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device evaluations.

The "study" mentioned in the document is a "bench performance testing" to demonstrate substantial equivalence to predicate devices, and it involves "ultimate strength and cyclic loading tests" in a simulated human bone substrate. This is a biomechanical engineering test, not a clinical study or an AI/ML performance evaluation.

Therefore, for aspects related to AI/ML device performance (like specific metrics, test sets, expert adjudication, MRMC studies, and training data information), the provided document does not contain the requested details.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

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

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

• Sample Size for Test Set: Not specified. The study involved "insertion of the anchors in a simulated human bone substrate," implying a number of implanted anchors and test cycles, but a specific count is not given.
• Data Provenance: Not applicable in the human data sense. The tests were performed in a "simulated human bone substrate," which suggests a lab-based, synthetic or cadaveric bone analog environment, not human patient data. This is a form of prospective bench testing.

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. Ground truth for a biomechanical bench test is typically established by the results of the physical tests (e.g., force at failure, cycles to failure) as measured by calibrated equipment, not by human experts.

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

• Not applicable. This concept is relevant for clinical studies or image interpretation, not for biomechanical bench testing.

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. This is not an AI/ML device, and no MRMC study was performed.

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

• Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the physical device's mechanical properties.

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

• The ground truth for this type of device (bone anchor) would be directly measured mechanical properties:
  • Ultimate Strength: The maximum force the anchor can withstand before failure or pullout.
  • Cyclic Loading Performance: The number of cycles the anchor can endure under specified loads without significant displacement or failure, simulating repetitive physiological stresses.
  • These are directly measured physical parameters, not derived from expert opinion or clinical outcomes in the traditional sense.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the AI/ML sense. "Training" for such a device would involve its design, manufacturing processes, and materials science.

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

• Not applicable for AI/ML training data. For the device itself, "ground truth" (i.e., meeting design specifications and material properties) would be established through material testing, engineering calculations, and quality control during manufacturing.

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The ArthroCare® Parallax® Contour® Vertebral Augmentation Device – enhanced when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax® Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

The ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced is used to disrupt cancellous bone and create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement) during kyphoplasty or vertebral augmentation procedures.

Here's an analysis of the provided text regarding the ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced, focusing on the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on a Special 510(k) submission, which means the device is a modification of an already cleared predicate device (K100479). For such submissions, the primary focus is to demonstrate that the changes do not significantly affect safety or efficacy and that the modified device performs comparably to the predicate. Therefore, the "acceptance criteria" here are largely related to maintaining the performance and characteristics of the predicate device.

Note on "Acceptance Criteria": In a 510(k) for a modified device, the "acceptance criteria" are not typically expressed as specific quantitative thresholds like "90% sensitivity" or "tensile strength > X N." Instead, the key criterion is demonstrating substantial equivalence to the predicate device, primarily through comparative testing that shows the modified device performs similarly or meets the same functional requirements.

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

The document does not specify sample sizes for the functional performance testing (test set). It only states that "Functional performance testing of the device included torque, insertion and withdrawal, flexure, device attachment/deployment/ removal, and mechanical displacement of bone have been completed."

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. Given the nature of mechanical performance testing for a medical device submitted to the FDA in the US, it is highly likely that this testing was conducted in a controlled laboratory environment in the US (prospective testing for this submission).

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

This type of information is not applicable to this specific submission. The "ground truth" for mechanical functional testing is typically established by engineering standards, validated test methods, and direct measurement against known physical properties or the performance of the predicate device, not by expert medical opinion in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

This is not applicable to the type of testing described. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints where differing opinions need to be resolved. The testing mentioned (torque, insertion, etc.) is objective mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No, an MRMC comparative effectiveness study was not done for this submission. MRMC studies are typically used to evaluate the impact of a diagnostic device (often image-based) on reader performance. This device is a surgical tool, and its evaluation focuses on mechanical performance and safety, not on improving human reader interpretation.

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

Not applicable. This device is a manual surgical instrument, not an algorithm or an AI system. Therefore, standalone performance (in the context of AI) is not relevant.

7. The Type of Ground Truth Used

For the functional performance testing, the "ground truth" would be established by:

• Engineering specifications and standards: The device must meet predefined mechanical strength, flexibility, and operational parameters.
• Performance of the Predicate Device: The modified device's performance is compared directly to the known and cleared performance characteristics of its predicate. The goal is to demonstrate that the new device performs within the acceptable range or equivalently to the predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical tool and does not involve AI or machine learning algorithms that would require a "training set."

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

Not applicable, as there is no training set for this device.

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The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to as the ArthroCare Spartan PEEK Suture Implant System.

The provided text is a 510(k) summary for the ArthroCare Corporation Spartan™ PEEK Suture Implant System, outlining its substantial equivalence to a predicate device. It does not describe a study involving AI, human readers, or a test set with ground truth established by experts.

Therefore, many of the requested categories related to acceptance criteria, AI performance, expert adjudication, and ground truth establishment cannot be extracted from this document as they are not present.

However, I can provide the available information regarding the device's performance based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Bench performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant in accordance with FDA Guidance Document Testing for Bone Anchors." It does not provide specific numerical acceptance thresholds or detailed numerical results for the ultimate strength or cyclic loading tests beyond confirming they were performed and supported substantial equivalence.

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

Not applicable. The study described is a bench performance test for a medical device (suture implant), not a study involving a test set of data with human subjects or images.

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 was a physical bench performance test, not a study requiring expert-established ground truth for a test set.

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

Not applicable. This was a physical bench performance test.

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. This document does not mention any MRMC study or AI assistance.

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

No. This document does not mention any algorithm or AI performance.

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

The "ground truth" equivalent for this device's performance evaluation was its mechanical behavior (ultimate strength and cyclic loading) in a simulated human bone substrate, compared against the predicate device. This is based on physical testing standards and comparisons.

8. The sample size for the training set

Not applicable. This was a physical bench performance test, not a machine learning study.

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

Not applicable. This was a physical bench performance test, not a machine learning study.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was a series of bench performance tests. These tests involved:

• Insertion of anchors in a simulated human bone substrate.
• Ultimate strength testing.
• Cyclic loading tests.

The purpose of these tests was to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant to its predicate device (Arthrocare 5.5mm Spartan PEEK Suture Implant System, K102262) in accordance with the "FDA Guidance Document Testing for Bone Anchors." The summary concludes that "The performance testing and device comparison demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use."

The document does not provide specific methodologies, number of samples tested, or detailed quantitative results for these bench tests, but states they were completed and supported the substantial equivalence claim.

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The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs: reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedFix Suture Implant is a bone anchor that facilitates the attachment of tissue to bone. The SpeedFix Suture System consists of an implant and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.

The following device-specific instrumentation is part of this submission:

SpeedLock Drill, Bone Drill
Bone Hole Locator
SpeedLock Drill Guide, Drill Guide

Here's an analysis of the provided text regarding the SpeedFix Suture System (K101437), focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a substantial equivalence determination, not a study setting specific numeric acceptance criteria for performance such as accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are based on demonstrating that the SpeedFix Suture System is as safe and effective as the predicate device (Opus® SpeedLock® Knotless Fixation Device K090615).

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

• Sample Size: The document does not specify a numerical sample size (e.g., number of anchors, number of tests). It only states "in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing."
• Data Provenance: The testing was "in vitro," meaning it was conducted in a laboratory setting, not with human or animal subjects. The data is thus retrospective in the sense that it evaluates the device's characteristics, but it's not clinical data. The country of origin for the data is not specified, but the manufacturer is ArthroCare Corporation in Sunnyvale, CA, USA, so it's likely U.S.-based or from a facility associated with the U.S. company.

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

Not applicable. This was a bench test (in vitro mechanical testing) comparing a new device to a predicate device based on FDA guidance for bone anchors. It did not involve expert review or establishment of "ground truth" in the diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. There was no expert review or adjudication process, as the "test set" was mechanical testing of the device itself.

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 device is a surgical implant (suture system/bone anchor), not a diagnostic or AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

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

Not applicable. This is a medical device (implantable hardware), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the in vitro bench testing, the "ground truth" can be considered the objective mechanical properties and performance characteristics (e.g., pull-out strength, fatigue resistance) measured according to established engineering and material science standards outlined in the "US FDA Guidance Document for Testing Bone Anchors." The "truth" is whether the new device's performance falls within an acceptable range compared to that of the predicate device, demonstrating equivalent safety and effectiveness based on these measurable physical properties.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, this device does not involve a training set.

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The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fully-threaded, corkscrew shape anchor available in a 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile. Associated Class I instruments for installation and removal of the implant are available separately. Together, the Spartan suture anchor and instrumentation will be known as the ArthroCare Spartan PEEK Suture Implant System.

The provided text describes a submission for a medical device (ArthroCare Spartan PEEK Suture Implant) seeking substantial equivalence to predicate devices, rather than a study proving performance against defined acceptance criteria (e.g., diagnostic accuracy metrics like sensitivity or specificity). Thus, many of the requested items (e.g., details on training/test sets, expert adjudication, MRMC studies) are not applicable to this type of submission.

However, the text does outline the type of assessment conducted and the criteria used to establish substantial equivalence.

Here's an attempt to answer the questions based on the provided document, noting where specific information is not present or applicable:

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

For a substantial equivalence claim for a bone fixation fastener, the "acceptance criteria" are generally that the new device performs comparably to the predicate device in relevant mechanical tests, demonstrating similar safety and effectiveness.

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

• Sample Size: Not specified in the document. The text mentions "bench performance testing" and "in vitro testing" involving "insertion of the anchors" in a "simulated human bone substrate," implying a laboratory-based study. The number of anchors tested, or repetitions performed, is not provided.
• Data Provenance: Not specified, but given it's "bench performance testing" and "in vitro testing," it's not applicable in terms of country of origin or retrospective/prospective human data. It is a laboratory study.

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 device is a bone fixation fastener. The "ground truth" here is established through objective mechanical testing, not expert interpretation of diagnostic images or clinical outcomes.

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

Not applicable. This is a mechanical engineering bench test, not a diagnostic study requiring expert 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 a medical device (bone fixation fastener), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (bone fixation fastener), not an algorithm. The testing described is "standalone" in the sense that it's the device itself being tested mechanically.

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

The "ground truth" for this type of device is established by objective physical measurements from controlled mechanical testing (ultimate strength, cyclic loading performance) against established standards or predicate device performance.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set." The product development likely involved iterative design and testing, but not in the context of machine learning.

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

Not applicable, as there is no "training set" in the context of an AI algorithm.

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