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The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:

• 1. Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
• 2. Foot Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy.
• 3. Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
• 4. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
• 5. Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
• 6. Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.

The CEPTRE® Knotted UHMWPE Suture PEEK Anchors are available as Screw Anchor (threaded) & Wedge Anchor (Tap in) which are preloaded with suture(s), tape(s) or suture-tape combinations on a disposable inserter assembly. The implant is supplied sterile and ready to use.

The provided document describes a 510(k) premarket notification for a medical device called the CEPTRE® Knotted UHMWPE Suture PEEK Anchor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set information, is not applicable or not provided in this specific type of regulatory document.

However, the document does contain information regarding acceptance criteria in the form of performance data and the study undertaken to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CEPTRE® Knotted UHMWPE Suture PEEK Anchor are based on demonstrating mechanical performance statistically equivalent to the predicate devices. The document reports that the device successfully met these criteria.

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

• Sample Size: The document does not specify the exact sample sizes used for the mechanical tests (pull-out strength, cyclical loading, drive-in torque) or for bacterial endotoxin and packaging tests. For regulatory submissions like 510(k), it is common to use statistically significant sample sizes, but the explicit numbers are often not included in the public summary.
• Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting. There is no information on country of origin for the data or whether it was retrospective or prospective, as these terms typically apply to clinical studies with human participants.

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

Not applicable. This device, being a mechanical implant, does not involve diagnostic interpretation or ground truth established by medical experts in the way a diagnostic imaging AI would. The "ground truth" for the performance tests is the objective measurement of mechanical properties and biological safety.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this involves objective mechanical and biological safety testing, not subjective 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

Not applicable. This is not an AI-powered diagnostic device, but a physical surgical implant. Therefore, MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.

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

Not applicable. This is a physical, non-AI medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

• Objective Mechanical Measurements: For pull-out strength, cyclical loading, and drive-in torque, the truth is the quantitative force, cycles, and torque measured according to established engineering and material science standards.
• Biological Safety Standards: For bacterial endotoxin, the truth is defined by the pyrogen limit specifications outlined in USP .
• Packaging Performance Standards: For packaging, the truth is established by the ability of the packaging to maintain sterility and product integrity under defined conditions.

These are all objective, measurable criteria, not subjective expert consensus or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not an AI model that requires a training set.

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

Not applicable. As this device does not use a training set, this information is not relevant.

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The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.

The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device with two PEEK non-absorbable polymer implants, preloaded with UHMWPE sutures. SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is preloaded with USP #3-0 UHMWPE suture whereas SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant XL is preloaded with USP #2-0 suture. The adjustable depth control knob is used to define the needle piercing length in the meniscus prior to deployment of the implant. These meniscal repair devices are available in various needle curvature.

The provided document, K230891, describes the SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and its substantial equivalence to a predicate device. However, the document does not contain acceptance criteria for the device's performance, nor does it detail a specific study proving the device meets said criteria with the requested level of detail for an AI/ML medical device.

The provided text focuses on the 510(k) submission for a physical medical implant (a suture and PEEK button for meniscus repair) and its comparison to a predicate device, rather than an AI/ML-driven device. As such, information regarding test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established for a training set (all typical for AI/ML device evaluations) are absent.

Here's an analysis based on the information that is available in the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "pull-out strength must be X N"). Instead, it states the conclusion of the test:

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

• Sample Size: Not specified for the pull-out strength, cyclical loading, bacterial endotoxin, or packaging tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The tests are non-clinical, likely bench testing.

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

Not applicable. The tests performed are non-clinical mechanical and biological compatibility tests, not evaluations that require expert interpretation of results to establish ground truth in the context of an AI/ML device.

4. Adjudication method for the test set

Not applicable. This concept is relevant for AI/ML performance ground truth establishment, not for the types of non-clinical tests 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 is not an AI/ML device. The study described compares the subject device's mechanical performance to a predicate device, not human reader performance with or without AI assistance.

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.

7. The type of ground truth used

For the non-clinical tests described:

• Mechanical Performance (Pull-out strength, Cyclical loading): The "ground truth" is measured physical properties and comparison to a predicate device's measured physical properties.
• Biological Compatibility (Bacterial Endotoxin): The "ground truth" is adherence to established pyrogen limit specifications (USP ).
• Packaging: The "ground truth" is the confirmation of sterile barrier integrity and product protection during simulated conditions.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL).

The use of the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button provides the orthopaedic surgeon a means of accurate fixation in ligament reconstructive surgery of soft tissue to bone fixation. The fixation device allows for arthroscopic ligament reconstruction approaches.

Here's a breakdown of the acceptance criteria and study information for the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button, based on the provided FDA 510(k) summary.

Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria in the vein of a novel AI/software device. Therefore, the information provided will reflect the nature of a medical device clearance process for a predicate-based device, emphasizing non-clinical performance and material equivalence.

Acceptance Criteria and Device Performance

The acceptance criteria for this device are primarily demonstrated through non-clinical performance testing and material equivalence to predicate devices. The "performance data" acceptance criteria are implicitly tied to demonstrating comparable or superior mechanical properties and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each individual non-clinical test (e.g., number of specimens for pull-out strength or cyclic loading, number of animals for biocompatibility studies).

The data provenance is from non-clinical laboratory testing conducted by the manufacturer, Healthium Medtech Limited, likely in India, as that is the submitter's location. The studies are retrospective in the sense that they are conducted on manufactured devices as part of the clearance process, but they are not clinical studies.

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

This information is not applicable in the context of this 510(k) submission. For non-clinical performance and biocompatibility testing of a medical device like this button and suture system, "ground truth" is established by adherence to recognized ASTM/ISO standards for mechanical testing and biocompatibility. There isn't an "expert" panel establishing a diagnostic ground truth as there would be for an AI/software device interpreting medical images.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication typically refers to the process of resolving discrepancies among expert interpretations in clinical studies, particularly for diagnostic devices. For mechanical and biocompatibility testing, results are quantitative and compared against predefined specifications from relevant standards or predicate device performance. Deviation from these specifications would lead to failure, not "adjudication."

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those involving human interpretation of medical images, to assess reader performance with and without AI assistance. The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is a surgical implant, not a diagnostic imaging device or an AI-assisted interpretation tool.

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

No, a standalone performance evaluation in the context of a "human-in-the-loop" scenario is not applicable. This device is a physical surgical implant. The concept of "standalone" typically applies to AI algorithms that can perform a task without human intervention or interpretation (e.g., an AI that directly diagnoses an illness from an image).

7. The Type of Ground Truth Used

For this device, the "ground truth" is predominantly based on:

• Established industry standards: ASTM/ISO standards for mechanical testing (e.g., tensile strength, fatigue) and biocompatibility (ISO 10993 series).
• Performance of legally marketed predicate devices: The "Conmed Linvatec XO Button™" and "RIGIDLOOP™ Cortical Fixation System" set the precedent for acceptable performance and safety profiles.
• Material properties data: Scientific literature and material specifications for UHMWPE and Titanium.

8. The Sample Size for the Training Set

This is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical implant; there is no AI model involved in its function that would require a training set.

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

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

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T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button are to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. This device is employed in Knee ligament repair and reconstructive procedures, specifically for ACL/PCL repair and reconstruction.

The T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button is a permanently implantable Polyether Ether Ketone (PEEK) cortical tibial suspension fixation device which provides the orthopaedic surgeon a means of accurate fixation in ligament reconstructive surgeries and repair. The fixation device allows for endoscopic or open ligament reconstruction approaches. The Closed button is preloaded with UHMWPE adjustable loop and in Open Button the UHMWPE adjustable loop is non preloaded.

This is a 510(k) premarket notification for a medical device called the T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button and the T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button. This document does not describe a study involving AI or human readers. Instead, it focuses on demonstrating the substantial equivalence of the new device to existing predicate devices through non-clinical performance testing and material comparisons.

Therefore, many of the requested sections related to AI performance, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable to this type of device submission.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study proving it meets them:

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: Not explicitly stated in the document. The document refers to "bench testing" and "studies" but does not quantify the number of devices tested for mechanical or biocompatibility assessments.
• Data Provenance: The studies are non-clinical (bench testing, in vitro, and in vivo animal studies for biocompatibility). India (Healthium Medtech Limited is based in Bangalore, India) is the location of the manufacturer and presumably where these tests were conducted or commissioned. The data is prospective, generated specifically for this submission.

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 is a physical medical device. "Ground truth" in this context refers to the validated methods and resulting measurements from mechanical and biological tests, not expert interpretation of data. These tests would be conducted by qualified laboratory personnel and validated against international standards.

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

• Not Applicable. As above, this is not an interpretive diagnostic device. Test results are quantitative measurements against predetermined specifications and international standards.

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 physical implant for orthopedic surgery, not an AI-powered diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• For mechanical performance (Pull-Out, Cyclic Loading): Quantitative measurements of force, displacement, and cycles against predefined specifications and industry standards. The "ground truth" is that the device must withstand certain loads and cycles without failure, demonstrating "equipotent" performance to predicate devices.
• For biocompatibility: Adherence to international standards (e.g., ISO 10993) for biological evaluation of medical devices, using in vitro and in vivo (animal) models to assess toxicity, sensitization, pyrogenicity, and tissue reaction. The "ground truth" is the observation of "non-sensitizer," "non-reactive," "non-pyrogenic," "non-cytotoxic," and "minimal or no reaction" based on established biological endpoints.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not Applicable. As above, no training set for an AI model. For the device itself, the "ground truth" for its design and manufacturing is established through engineering specifications, material standards, and compliance with quality management systems.

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The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures:

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

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

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

4. Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty).

5. Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction.

6. Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon Repair.

The STATIV® Knotted UHMWPE Suture Anchor is a fixation device intended to provide secure fixation of soft tissue to bone and is available in self-tap/self-punching variant also. It consists of a soft Suture Anchor with attached non-absorbable suture(s) to an inserter with handle. The Anchor are available in various sizes, preloaded with suture, tape or suture-tape combinations. This device is provided sterile, for single use only.

The provided text is a 510(k) Summary for the STATIV® Knotted UHMWPE Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance data.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the subject device. Instead, it states:

• "The pull-out strength and displacement under cyclic loading of STATIV® Knotted UHMWPE Suture Anchor and Predicate device. The results were reviewed and side by side comparisons were done with the identified predicate device and it demonstrated that there were no significant differences between the STATIV® Knotted UHMWPE Suture Anchor and the predicate device."
• "During the bench testing of subject device, it was observed that the changes in dimensions are not leading to any kind of new risks with the performance of subject device, and the acceptance criteria was met in each of the performance tests as per defined guidelines and applicable standards." (Emphasis added)

While it indicates that acceptance criteria were met, the specific numerical values for these criteria and the measured performance of the STATIV® Knotted UHMWPE Suture Anchor are not detailed in this summary. It only broadly mentions "Pull out Strength" and "Cyclical Loading" as performance data.

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 "bench testing" and "literature study."

• For the direct performance testing of the subject device (Pull out Strength and Cyclic Loading), the sample size is not specified.
• The provenance of this data (e.g., conducted by Healthium Medtech Limited in India) is not explicitly stated, although the manufacturer is based in Bangalore, India.
• The nature of the study (retrospective or prospective) is also not specified, but given it's bench testing for a new device, it would typically be considered prospective.

For "SE Analysis 1: Anchor Material," a "literature study" is referenced: "The influence of suture material on the strength of horizontal mattress suture configuration for meniscus repair." Reference 1 points to https://pubmed.ncbi.nlm.nih.gov/23340094/. The details of this secondary study's sample size and provenance would be found in the linked publication, but are not present in this FDA document.

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 device is a physical suture anchor, and the evaluation involves bench testing of mechanical properties, not interpretation of data by experts for ground truth establishment in the way it would be for a diagnostic AI device.

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

This section is not applicable as the evaluation relies on physical bench testing rather than subjective 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 is not applicable. The device is a surgical implant (suture anchor), not an AI-assisted diagnostic tool for human readers.

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 (suture anchor), not an algorithm. Performance testing was done on the physical device itself.

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

For the bench performance data (pull-out strength and cyclic loading), the "ground truth" would be established by standardized mechanical testing procedures and measurements using calibrated equipment, as per "defined guidelines and applicable standards." These are objective, quantitative measurements, not expert consensus or pathology in the context of diagnostic devices.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This is not applicable. As stated above, the device is not an AI model.

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