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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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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

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 Cayenne Medical, Inc. SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Cayenne Medical, Inc. SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff repairs
• Biceps tenodesis

Foot and Ankle

• Hallux valgus repairs
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Mid and forefoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
• Bunionectomy

Elbow

• Ulnar or radial collateral ligament reconstruction
• Lateral epicondylitis repair
• Biceps tendon repair

Hand and Wrist

• Collateral ligament repair
• Scapholunate ligament reconstruction
• Volar plate reconstruction
• Tendon transfers in phalanx

Hip

• Acetabular labral repair

Knee

• Extra-capsular repairs
• Medial collateral ligament
• Lateral collateral ligament
• Posterior oblique ligament
• Patellar realignment and tendon repairs
• Illiotibial band tenodesis
• VMO advancement
• Joint capsule closure

The SureLock™ All-Suture Anchor is a sterile (using ethylene oxide sterilization method), manually operated, single procedure all suture anchor device for reattachment of soft tissue to bone. The all-suture anchor is preloaded with floating suture and loaded on a disposable inserter. SureLock™ All-Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.

The SureLock™ All-Suture Anchor is offered in two different sizes, 1.4mm and 2.2mm. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures.

The 1.4mm anchor is formed by passing one end of a length of suture perpendicularly back through itself in alternating directions a number of times. This results in a construct resembling a ladder. The four suture tails are cut and trimmed. A floating suture is passed through the loops in the anchor to form the anchor construct.

The 2.2mm anchor is formed by passing the end of a first length of suture through the core of a second length. Then, one end of the second length is passed through the core of the first length, creating a loop with four suture tails. The loop is twisted alternately a number of times with the floating sutures weaved through each twist to form the anchor construct.

The 1.4mm anchor is pre-loaded with one floating suture and the 2.2mm size is preloaded with two floating sutures.

The disposable inserter has a working shaft length of 22,2 cm with an outer shaft diameter of 2.0 mm for the 1.4mm SureLock anchor and 2.4mm for the 2.2mm SureLock anchor. The inserter shaft is made out of surgical grade stainless steel and the handle and knob are made out of ABS plastic. The inserter pushes the suture anchor construct into a hole drilled in the bone. The knob on the inserter handle is rotated to apply tension on the floating suture(s) to expand and deploy the anchor in the bone tunnel. The floating suture limbs are then released from the inserter and the inserter is removed.

The Cayenne Medical, Inc. SureLock™ All-Suture Anchor is a medical device designed to reattach soft tissue to bone in orthopedic surgical procedures. The device comes in two sizes, 1.4mm and 2.2mm, and is pre-loaded with non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a dedicated table format. However, it indicates that the key performance metric for proving substantial equivalence to predicate devices is ultimate pull-out strength.

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

• Sample Size: The document does not explicitly state the numerical sample size used for the mechanical testing (pull-out strength). It mentions testing "both predicate and subject devices for the range of the subject device indications using three bone block densities." This implies multiple tests across different densities, but the exact number of samples per device or density is not provided.
• Data Provenance: Not specified, but likely from laboratory testing conducted by Cayenne Medical, Inc. The data is retrospective in the sense that it's reported after the testing was performed for the 510(k) submission. There is no information regarding country of origin for the data.

3. Number of Experts and their Qualifications for Ground Truth:

Not applicable. This device is not an AI/ML medical device, and therefore, a ground truth established by human experts for image interpretation or diagnosis is not relevant for this type of mechanical device. The "ground truth" here is the objective measurement of pull-out strength in a laboratory setting.

4. Adjudication Method for the Test Set:

Not applicable, as this is laboratory mechanical testing against a predicate device, not involving human interpretation or consensus. The comparison is based on quantitative measurements.

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

Not applicable. This is not an AI/ML medical device requiring human-in-the-loop performance evaluation or MRMC studies.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an AI/ML general purpose medical device.

7. Type of Ground Truth Used:

The ground truth for the performance claim (comparable pull-out strength) is derived from mechanical testing data (objective measurements of ultimate pull-out strength) rather than expert consensus, pathology, or outcomes data. The comparison is made against a legally marketed predicate device.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML medical device. There is no "training set" in the context of device development for a mechanical suture anchor.

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

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

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The Cayenne Medical, Inc. Quattro® GL Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Hip

• Hip capsule repair
• Acetabular labrum reattachment

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff repairs
• Biceps tenodesis

Elbow, Wrist, and Hand

• Biceps tendon reattachment
• Ulnar or radial collateral ligament reconstruction
• Lateral epicondylitis repair

Knee

• Extra-capsular repairs
• Medial collateral ligament
• Lateral collateral ligament
• Posterior oblique ligament
• Patellar realignment and tendon repairs
• Vastus medials obliquous advancement
• Illiotibial band tenodesis

Foot and Ankle

• Hallux valgus repairs
• Medial or Lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Midfoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
• Bunionectomy

This traditional 501(k) premarket notification is to expand the indications for use for Cayenne Medical Quattro GL Suture Anchor. The Quattro GL (LabraLink) Suture Anchor was cleared per premarket notification K112960. Cayenne seeks to expand the existing indications for use for the subject device to include the indications listed above.

The Quattro® GL Suture Anchor is a sterile, manually operated, single procedure suture anchor. The anchor has two suture eyelets allowing for one or two sutures to be loaded through the eyelets. The suture anchor is mounted on an inserter. The Quattro GL Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures. The Quattro GL Suture Anchor is only offered in one size, 2.9mm with four suture color options. The anchors are offered in two configurations, single loaded or double loaded sutures. Suture(s) used on the anchor are size # 2 non-absorbable surgical sutures. The Quattro GL inserter has a working length of 25.8 cm with an outer shaft diameter of 3.2 mm. Since the market clearance of this device, the length of the Suture Anchor was decreased from 15mm to 11.4mm. The technological characteristics of the Quattro GL Suture Anchor have not changed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Quattro® GL Suture Anchor:

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

The provided 510(k) summary does not explicitly state specific acceptance criteria in a quantitative or qualitative manner that would be typically found for performance metrics like sensitivity, specificity, accuracy, etc., for a diagnostic device.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on:

Key takeaway: The primary "acceptance criterion" for this 510(k) appears to be demonstrating that the device is substantially equivalent to legally marketed predicate devices, particularly in terms of its mechanical properties and that the expanded indications for use do not introduce new safety or effectiveness concerns. The specific numerical values for "pull-out strength" that define "comparable" are not provided in this summary.

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

The document mentions "Non-clinical testing data submitted, referenced, or relied upon" including "Mechanical testing (pull-out strength)."

• Sample Size: The specific sample size used for the pull-out strength testing is not specified in the provided summary.
• Data Provenance: The document does not provide details on the country of origin of the data or whether the testing was retrospective or prospective. Given it's mechanical testing of physical anchors, it's inherently prospective in nature for a new batch of tested devices.

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 section is not applicable to the provided document. The Quattro® GL Suture Anchor is a medical device (suture anchor) for surgical reattachment, not a diagnostic device that requires expert interpretation for establishing ground truth on a test set (e.g., for image analysis). The "ground truth" for this device lies in its physical and mechanical properties (e.g., strength, biocompatibility), which are evaluated through non-clinical laboratory testing.

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

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 (two readers agree, third is tie-breaker) are used in diagnostic studies to resolve discrepancies in expert interpretation of medical images or data. The testing described for the suture anchor is mechanical in nature and does not involve human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The Quattro® GL Suture Anchor is a surgical implant, not an AI-powered diagnostic tool or system designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

This section is not applicable. The device is a physical surgical implant. There is no algorithm or AI component to this device that would have standalone performance.

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

For the mechanical testing (pull-out strength), the "ground truth" would be the objective, empirically measured physical properties of the suture anchors under controlled laboratory conditions, typically using standardized testing methods (e.g., ASTM standards) on a material testing machine. This is not "expert consensus" or "pathology" in the diagnostic sense, but rather a direct measurement of physical performance.

8. The sample size for the training set

This section is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set" of data.

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

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

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The Cayenne Medical, Inc. LabraLink™ Suture Anchor is intended for the reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.

The LabraLink™ Suture Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair. The anchor has two suture eyelets allowing for one or two sutures to be loaded through the eyelets. The suture anchor is mounted on an inserter. The LabraLink Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.

The LabraLink Suture Anchor is offered in one size, 2.9 x 15 mm with four suture color options. The anchors are offered in two configurations, single loaded or double loaded sutures. Suture(s) used on the anchor are size # 2 non-absorbable surgical sutures. The LabraLink inserter has a working length of 25.8 cm with an outer shaft diameter of 3.2 mm.

Mechanical testing was performed on the LabraLink Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was significantly higher than the predicate device.

The provided text is a 510(k) summary for the LabraLink™ Suture Anchor, a medical device. It does not describe acceptance criteria for a study, nor does it present results from a clinical study to prove the device meets such criteria. Instead, it details the device's technical specifications, intended use, and substantial equivalence to previously marketed predicate devices, which is the basis for its FDA clearance.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on regulatory clearance based on substantial equivalence, primarily through mechanical testing comparisons with predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics against human expert ground truth.

If you have a different document that describes such a study, please provide it.

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The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is intended for use for approximation of soft tissue such as the repair of meniscal tear infuries

The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is a sterile single use device for the approximation of soft tissue such as the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with Size 2/0 Force Fiber Ultra High Molecular Weight (UHMW) Non Absorbable Polyethylene suture (K040472), inclusive of a pre-tied knot. The distal end of the device will be offered in various angular configurations to enable access to areas of the meniscal anatomy, and to allow for user preference.

The provided text is a 510(k) summary for the Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture. It describes the device, its intended use, and states that performance testing was conducted. However, it does not provide specific details about the acceptance criteria, the study design, or the results of the performance testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• If a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document only states that:

• Performance testing was conducted to verify that the Meniscal Repair Device with High Strength Suture is safe and effective and performs as intended. (Under "PERFORMANCE DATA")
• All components...are comprised of materials which are evaluated in accordance with ISO Standard 10993-1. (Under "MATERIALS")

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and materials, rather than providing detailed performance study results that would typically be associated with software or AI-driven diagnostic devices. For mechanical devices like this meniscal repair device, performance testing usually involves bench testing for mechanical properties (e.g., tensile strength, knot security) and biocompatibility testing, rather than studies involving human readers or expert consensus on diagnostic outcomes.

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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 Arthrotek® Maxfire™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The Arthrotek® Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of 2-0 Maxbraid™ ultra-high molecular weight polyethylene/polypropylene suture (Teleflex Medical, K040472) covered with two nonresorbable polyester or polyethylene sleeves. The anchors are pre-loaded on to an insertion instrument. The inserter allows for single entry into the joint. Once in the joint, the inserter will pierce the meniscus at the desired location. A pusher within the handle of the inserter allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the free ends of suture are gently pulled by the surgeon, drawing the loops into a flat, donut-shaped ring. This anchor sits on the backside of the meniscus. The suture is covered with either a polyester or polyethylene sleeve in order to control the size of the knot thus ensuring that the anchor does not become too small and pull through the meniscal tissue. By tensioning the suture, a sliding knot allows the meniscal tear to be compressed.

This document is a 510(k) summary for the Arthrotek® Maxfire™ Meniscal Repair Device. It details the device's description, intended use, and claims of substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence." However, it does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the non-clinical data).

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

This information is not provided in the document. The testing was non-clinical laboratory testing, not human-read clinical studies.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. The testing was non-clinical laboratory testing, not human-read clinical studies requiring adjudication.

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

No MRMC study was done. The document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone Performance Study:

A standalone study was done in the sense that non-clinical laboratory testing was performed on the device itself. However, this was not an "algorithm only without human-in-the loop performance" study as the device is a physical medical device, not an AI algorithm. The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

7. Type of Ground Truth Used:

The ground truth for the non-clinical testing would have been established through a set of predefined performance specifications and engineering standards for medical devices of this type (suture anchors). The results of the non-clinical laboratory tests would then be compared against these established functional and performance requirements to determine if the device was "functional within its intended use."

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device and therefore does not have a "training set" in the context of an AI algorithm.

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

This information is not applicable, as the device is a physical medical device and does not utilize a training set.

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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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