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The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.

The Anchora Su2ura® Approximation Device is a sterile single use device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue. The device is a 5mm single-use endoscopic suturing device loaded with threaded anchors. It is designed to deploy up to 19 anchors by a trigger action of the handle of the delivery system. After deployment, each anchor is anchored within the tissue in which it was deployed. After deployment of 2 or more anchors, the suture that passes between the anchors can be tightened to pull the anchors toward each other and approximate the tissue. The delivery system consists of a plastic handle and a 36-cm stainless steel shaft. The handle includes a Trigger, a Knob, and a Toggle Button. A Cap can be added at the distal edge of the Shaft to advance extracorporeal suture knots. The anchors can be deployed in single-stitch or running- stitch configuration. The device deploys the anchors through a needle with an outer diameter of 2.1 mm, available in two lengths: 5 mm and 9 mm protrusion. The Anchor is advanced outside of the needle by a Pushrod. Each anchor, made of stainless steel, is threaded with an off-the-shelf UHMWPE suture manufactured by Teleflex Medical. The device provides the anchors already threaded on this suture. The device is sterile packaged and designed for single use only. The device is manufactured from medical grade materials (mainly plastics and stainless steels).

The Su2ura Approximation Device is a sterile, single-use endoscopic suturing device with the following acceptance criteria and reported performances:

1. Acceptance Criteria and Device Performance

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

• Biocompatibility: Not explicitly stated as a test set with a specific sample size of biological samples, but rather a set of material characterization studies (extractables and leachables) and toxicological risk assessments. The input does not provide information on the number of samples for these tests.
• Human Factors: 18 representative users. The provenance of the users (e.g., country of origin, whether they were clinicians or laypersons, etc.) is not specified. The study appears to be prospective.
• Pre-Clinical Performance (Animal Study): 8 pigs (5 for test items, 3 for control items). The provenance of the data is a GLP animal study. It is a prospective study.
• Mechanical Performance, MRI Safety, Packaging Integrity: These involved various bench tests. The sample sizes for each specific test (e.g., number of devices tested for tensile strength or deployment reliability) are not explicitly stated in the provided text. The data provenance is from laboratory/bench testing.

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

• Biocompatibility: No explicit external experts are mentioned for establishing ground truth. Compliance was based on ISO standards.
• Human Factors: The "representative users" assessed usability. It's not stated whether these were "experts" in the sense of clinicians or if their feedback constituted a "ground truth" to be adjudicated. Their feedback was used to confirm usability.
• Pre-Clinical Performance (Animal Study): Not explicitly stated how many experts were involved in evaluating the histopathological data, but it would typically involve veterinary pathologists. Their specific qualifications are not detailed.
• Mechanical Performance, MRI Safety, Packaging Integrity: Ground truth for these studies relies on recognized ASTM and USP standards and internal engineering measurements. No external "experts" were mentioned for ground truth establishment beyond standard scientific and engineering practices.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (like 2+1 or 3+1) for the various studies conducted as part of the regulatory submission.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical tool, and its effectiveness is not assessed through human reader interpretation of images, but rather through direct use in surgery, performance in bench tests, and pre-clinical animal studies. Clinical testing was expressly stated as "not required to demonstrate substantial equivalence."

6. Standalone Performance Study

The studies described (bench testing, animal study, human factors) are essentially "standalone" in the sense that they evaluate the device itself. However, the term "standalone performance" often refers to the algorithm-only performance of AI devices without human-in-the-loop. This device is a mechanical surgical tool, not an AI or imaging diagnostic device, so this concept does not directly apply.

7. Type of Ground Truth Used

• Biocompatibility: Compliance with ISO 10993 standards (e.g., acceptable levels of extractables/leachables, lack of toxicological risk).
• Human Factors: User feedback and observed usability were used to confirm clarity of training and IFU, and the overall usability of the device. This is a form of self-reported or observed performance against predetermined usability goals.
• Pre-Clinical Performance (Animal Study): Histopathological data (from tissue analysis) and clinical monitoring of animals provided the ground truth for safety and performance (e.g., successful closure, similar long-term safety profile to controls).
• Mechanical Performance, MRI Safety, Packaging Integrity: These rely on objective measurements and adherence to established industry standards (ASTM, USP) and predefined product specifications.

8. Sample Size for the Training Set

This question is not applicable. The Su2ura® Approximation Device is a mechanical surgical device, not a machine learning or AI model, so there is no "training set" in the context of algorithm development.

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

This question is not applicable, as there is no training set for this type of device.

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Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.

Force Fiber Suture - Black is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE) dyed black using D&C Black #4 not to exceed 1.0% by weight. It is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter.

This document is a 510(k) summary for a medical device called "Force Fiber® Suture - Black." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study where specific performance criteria are measured against acceptance criteria. Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the general acceptance criteria and what is reported about the device's performance based on the provided text.

Acceptance Criteria and Reported Device Performance

Information Not Available in the Document:

Because this document is a 510(k) summary demonstrating substantial equivalence for a surgical suture, not a clinical study report for an AI/imaging device, the following information is not provided:

2. Sample size used for the test set and the data provenance: Not applicable in this context. The testing mentioned refers to material properties and biocompatibility, not performance against a specific "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI algorithms (e.g., diagnostic accuracy) is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 suture, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For material properties, the "ground truth" would be established by validated testing methods and specifications (e.g., USP standards), not expert consensus on medical images or outcomes.
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a medical device (surgical suture) and demonstrates its compliance with established regulatory standards (USP, ISO) and substantial equivalence to existing predicate devices. It does not involve AI or imaging diagnostics, and therefore, many of the requested data points related to those types of studies are not relevant or present.

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The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

The ExpressBraid Graft Manipulation device consists of a stainless steel, straight needle attached to a strand of MaxBraid suture. The two ends of the strand of suture are crimped into the needle. The suture may be all white or blue/white MaxBraid suture. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polyethylene (UHMWPE) fibers and a blue and white co-braid configuration consisting of Deklene II, Polypropylene suture braided into 100% UHMWPE fibers. The suture is provided uncoated. The colorant used in the blue and white co-braid consists of [phthalocyaninato (-2)] cooper <0.5% by weight per 21 CFR Sec. 74.3045.

This document describes the ExpressBraid Graft Manipulation device, a non-absorbable surgical suture. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria in a clinical context with AI.

However, based on the provided text, we can extract details related to the performance testing conducted to support substantial equivalence. It's important to note that this is not a study assessing AI performance or human reader improvement.

Here's an analysis of the provided text in relation to your request, with the understanding that the "device" in this context is the ExpressBraid Graft Manipulation suture:

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

The document doesn't explicitly present a table of acceptance criteria with corresponding performance data in the typical sense for an AI device. Instead, it states that the device was tested against USP (United States Pharmacopeia) standards for non-absorbable surgical sutures and also compared to a predicate device.

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

The document does not specify the sample size for the performance testing (tensile strength, diameter, needle attachment, or comparative testing).
The data provenance is from laboratory testing performed by the manufacturer, Biomet Manufacturing Corp., as part of their 510(k) submission. No information on country of origin of the data or whether it's retrospective or prospective is given, as it's mechanical and biocompatibility testing, not clinical 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 to the type of device and testing described. The "ground truth" for mechanical and biocompatibility testing is established by adherence to recognized standards (USP, ISO 10993-1) and direct measurement, not by expert consensus on clinical findings.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses or image interpretations, not for direct mechanical or chemical property 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, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant to AI-assisted diagnostic tools, not to a surgical suture. The document describes comparative performance between two sutures (the subject device and a predicate) in terms of mechanical properties.

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

This question is not applicable. This device is a physical surgical suture, not a software algorithm.

7. The type of ground truth used

The "ground truth" used for this device's performance assessment relies on:

• Established standards: United States Pharmacopeia (USP) requirements for surgical sutures and ISO 10993-1 for biocompatibility.
• Direct measurement and comparison: Mechanical and chemical properties were measured and compared to the predicate device.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. As there is no training set for an AI model, there is no ground truth established for one.

In summary: The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a surgical suture based on its mechanical properties and biocompatibility as compared to predicate devices and recognized standards. It does not contain information related to AI performance, clinical trials with human readers, or expert-based ground truth establishment as would be relevant for an AI/ML medical device.

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The MedShape, Inc., Porous Morphix® Suture Anchor with Force Fibere is intended for fixation of suture to bone in the shoulder, footlankle, knee, hand/wrist and elbow in the following procedures:

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

The proposed Porous Morphix® Suture Anchor with Force Fiber® Suture is a line extension to our Morphix® product family and is substantially equivalent to the Morphix® Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, in which the features and intended uses are the same. In addition, the technological characteristics of the Morphix® and the Porous Morphix® Suture Anchor are equivalent. Differences between the Porous Morphix® Suture Anchor and the MedShape predicate Morphix® Suture Anchor include an extruded porous layer on the top surface of the device and a change in the preferred suture supplier (suture supplier CP Medical, previously cleared under K041894, was switched to suture supplier Teleflex Medical, previously cleared under K033654). This porous surface is derived directly from the implant body and is not a sintered coating.

The provided text describes a 510(k) submission for a medical device, the Porous Morphix® Suture Anchor with Force Fiber® Suture. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically associated with AI/ML device performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MedShape, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture - now referred to as Morphix®, K091202) based on:

• Same Intended Uses: The new device has the same indications for use as the predicate.
• Equivalent Technological Characteristics: Analysis of non-clinical test results (monotonic and post cyclic suture fixation strength in Sawbone® bone analogue [pull-to-failure], dimensional verification, and material safety data [both bio and MRI compatibility]) supports this equivalence.
• Minor Differences: The differences are an extruded porous layer on the top surface of the device and a change in suture supplier. These differences were determined not to raise questions concerning safety and effectiveness.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These points are relevant to AI/ML device validation, which is a different regulatory pathway and type of study than what is presented in this 510(k) summary for a physical medical device (suture anchor).

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The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

The Mesh Introducer Needle is a combination of a Bone Access Assembly (Single Step Instrument) and a Mesh Assembly. The Bone Access Assembly comprises a cannula (acting as a working channel), a dilator-reamer, and a K-wire. The Mesh Assembly comprises a fabric-made mesh (pouch) through which the bone cement is introduced into the treatment site, mounted on a small diameter injection cannula, provided with a blunt edge stylet.

The provided text is a 510(k) summary for the "Mesh Fenestrated Introducer Needle." This document is part of the FDA regulatory process for medical devices and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving performance against acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found within the provided text. The document describes the device's intended use and design, and states that its characteristics are substantially equivalent to predicate devices, but it does not include a performance study with acceptance criteria.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: This type of information is typically found in a detailed performance study report. The 510(k) summary provided here does not contain such a table or specific performance results.
2. Sample sizes used for the test set and the data provenance: No performance study details are provided, so no sample sizes or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This relates to a performance study with a test set, which is not included in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Again, this refers to a performance study that is not detailed in the provided text.
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 type of study is specifically relevant to AI/diagnostic imaging devices. The device described (Mesh Introducer Needle) is a surgical instrument and not an AI-powered diagnostic device, so an MRMC study would not be applicable, and thus is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Similar to point 5, this is relevant to AI/algorithm-based devices, which this is not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no performance study is detailed, no ground truth methodology is described.
8. The sample size for the training set: This is relevant for machine learning models, which are not part of this device.
9. How the ground truth for the training set was established: Again, this is relevant to machine learning models, which are not part of this device.

The 510(k) process for a device like the Mesh Introducer Needle primarily relies on demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) through comparisons of intended use, design, materials, and technological characteristics, as well as bench testing or sometimes limited clinical studies to ensure aspects like biocompatibility, sterility, and mechanical integrity. The provided text only covers the "substantial equivalence" argument, not a performance study against specific acceptance criteria.

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The Stryker Intraline Anchor is a soft tissue anchor which will be used for tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. The anchor is intended for use in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift/Capsulolabral Reconstruction. Foot and 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, Illiotibial Band Tenodesis. Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Pelvis: Bladder Neck Suspension Procedures. The Stryker Soft Eyelet RC Anchor is intended for single-use only.

Each configuration of the Stryker Intraline Anchor Family is a screw-in anchor that is pre-threaded with nonabsorbable USP braided ultra high molecular weight polyethylene (UHMWPE) suture (K033654, K040472 and K063778) and pre-assembled on a disposable inserter. The Stryker PEEK Intraline Anchor will be manufactured from PEEK-OPTIMA® (polyetheretherketone). The Stryker Titanium Intraline Anchor will be manufactured from titanium alloy Ti 6Al 4V EL1. The Stryker Intraline Anchor Family will be validated to a SAL of 10th using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7.

The provided document is a 510(k) Summary for the Stryker Intraline Anchor, a medical device for tissue fixation to bone. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific performance acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study specifics is not available in this document.

However, I can extract what is implied and stated regarding equivalence and the basis for approval.

Here's a breakdown of the requested information based on the provided text:

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

Based on the document, direct quantitative acceptance criteria and reported device performance are not explicitly stated in a table format. The approval is based on "substantial equivalence" to a predicate device. The general acceptance criteria are implied to be that the device performs equivalently to the predicate and meets relevant safety and performance standards.

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 available in the provided 510(k) summary. The document does not describe a specific clinical or performance test set with a sample size. The approval is based on equivalence to an already approved device.

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 available. No specific "test set" and thus no experts for establishing ground truth are detailed in this regulatory summary.

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

This information is not available. No specific test set or adjudication method is described.

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 is not applicable. The device is an orthopedic surgical anchor, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This is not applicable. The device is a surgical implant, not an algorithm.

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

This information is not available. As no specific study with a "test set" and a defined ground truth is presented, this cannot be determined from the document. The "ground truth" for regulatory approval in this context is the safety and effectiveness of the predicate device to which the new device is compared.

8. The sample size for the training set

This information is not applicable. The device is a physical surgical 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. As above, this is not relevant for this type of device.

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The Stryker PEEK TwinLoop Tac is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs:

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

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

Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Hand/Wrist: Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers.

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

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

Pelvis: Bladder Neck Suspension for Female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Stryker PEEK TwinLoop Tac is intended for single-use only.

The Stryker PEEK TwinLoop Tac is a push-in type implant with two USP#1 high strength suture eyelets pre-threaded with USP#2 non-absorbable braided surgical sutures and pre-assembled on a disposable inserter. The Stryker PEEK TwinLoop Tac will be manufactured from PEEK-OPTIMA® LT3 (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc. The sutures will be USP braided ultra high molecular weight polyethylene (UHMWPE) suture (K033654, K040472 and K063778). The Stryker PEEK TwinLoop Tac will be validated to a SAL of 10th using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7.1995.

The provided text is a 510(k) summary for the Stryker PEEK TwinLoop Tac, a PEEK Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about a clinical study or performance testing against specific acceptance criteria for the device itself.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document states that the technological and material differences between the Stryker PEEK TwinLoop Tac and the predicate devices "do not affect the safety and efficacy of the product." This statement, along with the device's classification as a Class II orthopedic device, strongly suggests that the FDA's clearance was based on substantial equivalence to existing devices rather than a de novo clinical trial with specific performance criteria.

However, based on the information provided, I can address some of the other points:

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable. The provided document is a 510(k) summary that establishes substantial equivalence. It does not contain acceptance criteria for specific device performance metrics or the results of a study demonstrating the device meets those criteria. The clearance is based on the device being similar enough to already-marketed devices such that no new questions of safety or effectiveness are raised.

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

• Not Applicable. This document does not describe a clinical performance study with a test set. Substantial equivalence claims for devices like this are often supported by bench testing (mechanical properties, sterilization, biocompatibility) rather than large-scale human clinical trials. The document mentions "The Stryker PEEK TwinLoop Tac will be validated to a SAL of 10-6 using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7.1995." This relates to validation of the sterilization process and biocompatibility, not clinical efficacy or performance in a patient test set.

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

• Not Applicable. No clinical test set or ground truth establishment by experts is described in this 510(k) summary.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable. No clinical test set or adjudication method is described.

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 PEEK suture anchor, a physical implant, not an AI-driven diagnostic or assistive device. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• Not Applicable. As mentioned above, this is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Not Applicable. No clinical "ground truth" (in the sense of a diagnostic or predictive AI system) is discussed for this device. The "truth" for this type of device is its physical and material properties, and its ability to perform its intended mechanical function, as implied by its substantial equivalence to predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. There is no mention of a "training set" as this is not an AI or machine learning device.

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

• Not Applicable. No training set or associated ground truth establishment is mentioned.

Summary regarding acceptance criteria and study:

The 510(k) summary indicates that the device's substantial equivalence is based on its material composition (PEEK-OPTIMA® LT3), intended use, safety, and efficacy being comparable to the predicate devices (Arthrex PEEK SutureTak and Arthrex Bio-Corkscrew FT). The document does not describe a specific study with defined acceptance criteria for the Stryker PEEK TwinLoop Tac's performance. Instead, it relies on the established safety and efficacy of the predicate devices and demonstrates that the new device does not introduce new questions of safety or efficacy.

The document mentions adherence to various voluntary safety and performance standards (e.g., ISO 10993-1, EN 550, EN 556-1, EN 11607-1, EN 11607-2, EN 980, EN 1041, and EN ISO 14971) and validation of sterilization. These standards and tests are general and not presented as specific acceptance criteria with quantifiable performance results in this summary.

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The Super Revo® Herculine™ Suture Anchor is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

The Super Revo® Herculine™ Suture Anchor is a titanium suture anchor implant pre-threaded with undyed (white) and colored (white with blue stripe), nonabsorbable, braided, ultra-high molecular weight, polyethylene suture. It is provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. The Super Revo® Herculine™ Suture Anchor is supplied sterile and single use.

The modification described in this Special 510(K) is to supply the Super Revo® suture anchor with the ultra-high molecular weight polyethylene suture.

The provided text is a 510(k) summary for a medical device (Super Revo® Herculine™ Suture Anchor) and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document states that the modification to the device (the type of suture used) "does not raise any new issues regarding safety and effectiveness" and that "Testing has been conducted to assure that providing the suture anchor with the ultra-high molecular weight, braided, polyethylene suture does not raise any new issues regarding safety and effectiveness." However, it does not provide details about what tests were conducted, their acceptance criteria, or the results.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of your specific questions. The document mainly focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

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