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The Riverpoint Medical HS Fiber® sutures are indicated for injury and/or reconstruction of soft tissue, excluding the ones listed in contraindications, where soft tissue ligation or approximation is required. The Riverpoint Medical HS Fiber® sutures are also indicated for conditions where allograft tissues are required to be fixated, such as ACL tears.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

This FDA 510(k) clearance letter pertains to a surgical suture, the HS Fiber® Suture, and not an AI/ML powered device. Therefore, the request to describe acceptance criteria and a study proving device performance in the context of AI/ML (e.g., test set, ground truth, expert consensus, MRMC study, training set) cannot be fulfilled based on the provided document.

The document states: "The updates being proposed are limited to the labeling, no additional performance testing or biological evaluation was required." This indicates that no new performance studies (of any kind, let alone AI/ML specific ones) were conducted for this particular 510(k) submission (K252201). The device is deemed substantially equivalent to a previously cleared predicate device (K231163) based on the technological identity and minor labeling changes.

Therefore, I cannot provide the requested information for an AI/ML device from this document.

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HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surqical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for a medical device called "HS Fiber Sutures." This document is not about an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and studies for AI/ML device performance.

The questions are specifically about:

• Table of acceptance criteria and reported device performance (for an AI/ML model)
• Sample size and data provenance for a test set (for an AI/ML model)
• Number and qualifications of experts for ground truth (for an AI/ML model)
• Adjudication method for a test set (for an AI/ML model)
• MRMC comparative effectiveness study (for an AI/ML model)
• Standalone performance (for an AI/ML model)
• Type of ground truth (for an AI/ML model)
• Sample size for training set (for an AI/ML model)
• Ground truth establishment for training set (for an AI/ML model)

Instead, this document describes a traditional medical device (surgical sutures) and demonstrates its substantial equivalence to a predicate device. The performance data mentioned for the HS Fiber Sutures relates to:

• USP performance requirements for needle attachment and tensile strength.
• Biocompatibility (per ISO 10993-1:2018).
• Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments.

The conclusion is that the HS Fiber Suture (K231163) is substantially equivalent to the predicate device (K190817), primarily due to identical intended use, materials, manufacturing processes (sterilization), and meeting established physical performance standards for sutures. There are no mentions of AI, machine learning, algorithms, or any studies involving human readers or expert consensus for image interpretation.

Therefore, I cannot extract the requested information from this document.

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HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for:

• · Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
• · Repair of long bone fracture due to trauma or reconstruction.

The Riverpoint Medical HS Fiber® Cerclage sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

Here's a breakdown of the acceptance criteria and study information for the Riverpoint Medical HS Fiber® Cerclage, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample sizes used for each specific test set. It broadly mentions tests performed, but not the number of units or samples involved in, for example, the tensile strength or fatigue strength testing.

Regarding data provenance, the study appears to be non-clinical, laboratory-based testing conducted by the manufacturer, Riverpoint Medical, LLC. No information is given about the country of origin of the data beyond the manufacturer's location in Portland, Oregon, USA. The studies are retrospective in the sense that they are conducted on manufactured devices as part of the submission process, not on a prospective cohort of patients.

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

This information is not applicable as the studies described are non-clinical, mechanical, and material characteristic tests, not studies requiring expert interpretation of medical images or patient data to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not done. The device is a physical medical device (suture) and not an AI/software-based medical device that would involve human readers or AI assistance.

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

A standalone performance study was not done. Again, this is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical performance studies were:

• Established standards and specifications: United States Pharmacopeia (USP) requirements for sutures (primarily for needle attachment and tensile strength), and various ISO and EN standards for sterilization, biocompatibility, packaging, and usability.
• Predicate device performance: Comparative testing was conducted against a predicate device (Arthrex FiberTape Cerclage - K170206) to demonstrate comparable performance in areas like tensile strength, fatigue strength, creep, and wear debris.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" for this type of physical medical device. The device is manufactured based on design specifications and then tested against these specifications and regulatory standards.

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

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

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HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

This submission is for a medical device (HS Fiber surgical suture) and not an AI/ML powered device, therefore most of the requested information cannot be extracted from the text. The document describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.

However, based on the provided text, here is the information related to the acceptance criteria and performance data for the device:

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

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

The document does not specify the exact sample sizes used for the testing. It generally states that the device "meets requirements" and "is tested," but doesn't provide specific numbers of units tested. The provenance of the data is not mentioned (e.g., country of origin, retrospective/prospective).

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 is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device that would require expert-established ground truth for a test set.

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

This is not applicable as the submission is for a physical medical device (suture). Testing involved adherence to established physical and biological standards, not image or data 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 as the submission is for a physical medical device (suture) and not an AI/ML powered device.

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

This is not applicable as the submission is for a physical medical device (suture).

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

The "ground truth" for the device's performance is based on established, objective, and quantitative performance standards set by:

• United States Pharmacopeia (USP) standards for physical properties like tensile strength and needle attachment.
• ISO 10993-1:2018 (Biological Evaluation of Medical Devices) for biocompatibility.
• FDA Guidance "Pyrogens and Endotoxins Testing: Questions and Answers" for endotoxin levels.

8. The sample size for the training set

This is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device that requires a training set. The device is manufactured according to specifications and tested for compliance.

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

This is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device.

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HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

The provided document is a 510(k) summary for the Riverpoint Medical HS Fiber Suture, a non-absorbable surgical suture. It details the device, its intended use, and comparative performance data against a predicate device to establish substantial equivalence for FDA clearance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the HS Fiber Sutures meet requirements established by the United States Pharmacopeia (USP) for needle attachment and tensile strength. However, specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, or specific detachment forces for needle attachment) and the reported device performance values against these criteria are not explicitly provided in this summary. Instead, it makes a general statement of compliance.

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

The document does not specify the sample size used for the performance tests (e.g., for needle attachment or tensile strength).
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, given that it's a 510(k) submission to the FDA, the testing would have been conducted to international and U.S. standards. The tests are prospective in nature, as they are performed to demonstrate product quality and compliance for regulatory submission.

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

This type of information is not applicable to this submission, as the device is a surgical suture, not a diagnostic or AI-driven decision support system that requires expert consensus for ground truth. The "ground truth" here is objective physical and biological properties measured according to established standards (USP/ISO).

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where human interpretation or assessment is involved, often in diagnostic imaging or clinical endpoints. This is not applicable to the performance testing described for a surgical suture, which involves objective, standardized laboratory measurements.

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

An MRMC study is not applicable to this device. This type of study is used to assess the change in human reader performance (e.g., radiologists, pathologists) when aided by an AI algorithm, compared to reading without AI. The HS Fiber Suture is a surgical implant, not an diagnostic or AI-assisted device.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study of an algorithm is not applicable to this device. The HS Fiber Suture is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the HS Fiber Suture is based on objective, standardized measurements of physical and biological properties. This includes:

• USP Performance Requirements: For metrics like tensile strength and needle attachment.
• ISO 10993-1:2009: For biological evaluation (biocompatibility).
• FDA Guidance on Pyrogens and Endotoxins Testing: For endotoxin quantification.

These are established scientific and regulatory standards that define acceptable performance for such devices.

8. Sample Size for the Training Set

This concept is not applicable to this device. "Training set" refers to data used to train machine learning algorithms. The HS Fiber Suture is a physical medical device, not an AI model.

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

As noted above, the concept of a "training set" and its associated ground truth is not applicable to this device. The "ground truth" for demonstrating the safety and effectiveness of the suture is established through adherence to recognized manufacturing quality standards and performance specifications, as defined by organizations like USP and ISO.

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RiverBond, RiverSilk, RiverPro, and RiverLon non-absorbable sutures are intended to be used for soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

HS Fiber non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

Riverpoint Medical non-absorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. They are composed of the applicable suture material and a standard medical grade suture needle as applicable (sutures can be provided without needles as well).

The provided text describes a 510(k) summary for Riverpoint Medical's non-absorbable surgical sutures. It outlines the device description, intended use, and states that the sutures are designed to meet specific safety and effectiveness criteria. However, it does not contain a study report with specific acceptance criteria or performance data in the format requested.

The document states:
"Riverpoint Medical non-absorbable sutures have been designed to meet the requirements for diameter, tensile strength, and needle attachment strength as specified within USP 32. Testing is performed on each lot of product to verify that USP requirements have been met prior to release."

This sentence indicates the acceptance criteria are based on USP 32 standards for these parameters. However, the document does not provide a table with these specific USP 32 requirements or the reported device performance against them. It also does not include information about sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance studies, training sets, or how ground truth for training was established.

Therefore, I cannot populate the table or provide the detailed study information as requested. The document confirms that testing is performed to verify compliance with USP 32, but it does not present the results of such testing or the study design in a way that allows for the extraction of the requested metrics.

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