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The PULLUP® BTB, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP devices are designed to be used as cortical fixation for ACL reconstruction.

The device is proposed in the following variants:

• -PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft.
• PULLUP® BTB: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft.
• -BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that must be mounted on the GraftTech® preparation station.
• -PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device.

Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm.

The implants are supplied sterile, individually packaged, ready to use.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the standard information requested for describing acceptance criteria and a study proving device performance for an AI algorithm is not applicable here.

Here's a breakdown of why the requested information cannot be provided from the given document:

• This is not an AI/Software as a Medical Device (SaMD) submission: The document describes PULLUP® BTB, PULLUP® CLIP, PULLUP® TEX CLIP adjustable fixation systems, and BT LOOP® for ligament reconstruction. These are physical implants, not AI algorithms.
• The document focuses on substantial equivalence to a predicate device: The purpose of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It doesn't typically involve new clinical studies with acceptance criteria in the way AI algorithm validation does.
• "Device performance" refers to mechanical and biological properties: In this context, "device performance" refers to the biocompatibility, biological, and mechanical properties of the physical implant, not the diagnostic or predictive performance of an algorithm.

Based on the provided text, I can extract the following relevant information regarding non-clinical performance:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

Explanation: The document states that "Non-clinical testing including biocompatibility, biological and mechanical performances were not impacted by the change. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices. The proposed device has been determined to be non-pyrogenic." This indicates that the new variants met the established non-clinical performance and safety profiles, thus fulfilling the acceptance criteria for these aspects.

The following requested information is NOT APPLICABLE or NOT AVAILABLE in the provided document, as it pertains to AI/algorithm validation, not to the premarket notification of a physical medical device:

• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, this document describes the substantial equivalence of a physical medical device (ligament fixation systems) through non-clinical testing, not the performance validation of an AI algorithm.

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Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.

TEVDEK® II NextStitch® and 'silky' II POLYDEK® NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.

Deknatel Polyester Surgical Sutures (i.e. Dacron®, Polydek, and Tevdek) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

The Deknatel® Polyester Surgical Suture is a non-absorbable surgical suture composed of twisted or braided Polyethylene Terephthalate fibers. Deknatel® Polyester Surgical Suture is available undyed (white) or dyed (green) and is offered in a variety of cut lengths, with or without needles, and with or without pledgets. Product labeling carries the following specific information on the suture: material (including color, number and length of sutures in the package); USP size (diameter, including any difference in diameter); the number, profile and size of any attached needles; and the number, size and density of pre-attached pledgets.

The Deknatel® Polyester Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) for tensile strength, diameter and needle attachment, except for suture size 7-0 which differs from USP in diameter only.

Deknatel® Polyester Surgical Suture is available in USP sizes 7-0 to 9 in the following configurations:

• . 'cottony' II: Uncoated (Not PTFE impregnated)
• "silky II" or Polydek®: Lightly coated (PTFE impregnated) .
• Tevdek® II: Heavily coated (more PTFE impregnated than "silky")) .

The Deknatel® Polyester Surgical Sutures are also available in the following productspecific configurations with or without needles, and with or without pledgets:

• Surgical Suture Tape as uncoated 'cottony' II in flat braid sizes of 1/8", 1mm, 2 mm, ● 3mm, 4mm and 5mm.
• . NextStitch® Cardiovascular Valve Suture is comprised of "silky" II POLYDEK and/or TEVDEK II polyester suture. NextStitch is a continuous chain of linked sutures designed to provide an alternative suturing technique for cardiovascular valve replacement procedures. NextStitch Sutures are available in USP Sizes 4-0, 3-0, 2-0 and 0 (metric sizes 1.5 through 3.5).
• Readi-Cut TEVDEK® II Bulk Non-Sterile Polyester Surgical Suture is bulk, non-● sterile Tevdek® II polyester suture available in USP Size 2.

This document is a 510(k) Premarket Notification for a surgical suture device (K192490) and primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not describe a study involving an AI/Machine Learning device. Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI device is not available in these provided pages.

However, I can extract information related to the device's performance criteria as established by the United States Pharmacopeia (USP) for surgical sutures, which serves as the "acceptance criteria" for this conventional medical 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 non-clinical testing (diameter, tensile strength, needle attachment). It generally states "all sizes" meet the requirements. It also does not provide details on data provenance (country of origin, retrospective/prospective) for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a surgical suture, and its performance is evaluated against established physical and chemical standards (USP, ISO) using laboratory testing, not by expert interpretation of data like in an AI study.

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

Not applicable. This device is a surgical suture, and its performance is evaluated against established physical and chemical standards using laboratory 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

Not applicable. This document pertains to a surgical suture, not an AI or imaging device involving human readers.

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

Not applicable. This device is a surgical suture.

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

The "ground truth" or reference standards for the device's performance are:

• United States Pharmacopeia (USP) Standards: Specifically, USP for diameter, USP for tensile strength, and USP for needle attachment. These are objective, published physical and mechanical test standards.
• ISO 10993-1: For biocompatibility.
• Ethylene Oxide (EO) Sterility Method, SAL 10-6: For sterility.

8. The sample size for the training set

Not applicable. This document describes a surgical suture, which is a physical device, not an AI device that requires a training set.

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

Not applicable. There is no training set for this type of medical device submission.

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The Siesta Medical, Inc. PRELUDE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.

The PRELUDE Tongue Suspension System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw and suture. The PRELUDE Tongue Suspension System consists of a pair of suture passers pre-loaded with size 2.0 braided polyester suture, a titanium bone screw that is pre-mounted on an inserter and size 1 monofilament polypropelyne suspension suture.

The Siesta Medical, Inc. PRELUDE Tongue Suspension System is a medical device designed for anterior tongue base suspension to treat mild or moderate obstructive sleep apnea (OSA) and/or snoring. The 510(k) submission (K101060) describes the device and the studies conducted to demonstrate its substantial equivalence to predicate devices, focusing on its performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the performance tests conducted but does not explicitly define "acceptance criteria" as quantifiable thresholds. Instead, it states that the performance compares favorably to predicate devices. The reported device performance is qualitative, indicating successful completion of the tests.

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

The provided 510(k) summary does not specify the sample sizes used for each of the in vitro mechanical tests. It only states that the tests were "conducted to evaluate the performance characteristics." The data provenance for these in vitro tests would typically be from laboratory testing performed by or for the manufacturer, Siesta Medical, Inc. The document does not specify country of origin for the data, but since the company is based in Los Gatos, CA, it's likely the testing was conducted in the USA or by labs commissioned by them. The study is an in-vitro performance evaluation, not a clinical study, so the terms "retrospective" or "prospective" do not directly apply in the same way they would to human subject research.

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 in vitro mechanical performance tests. They do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way an AI diagnostic or image analysis system would. The "ground truth" for these tests is based on objective physical measurements and engineering principles.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in clinical studies or expert review processes, typically for establishing consensus ground truth for subjective data (e.g., image interpretation). The mechanical tests performed for this device rely on objective measurements.

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 information is not applicable. The PRELUDE Tongue Suspension System is a physical medical device (an implantable system), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is entirely irrelevant to this device.

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

This information is not applicable. The device is an implantable physical system, not an algorithm or AI system.

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

For the in vitro mechanical tests, the "ground truth" is established through objective physical measurements using calibrated testing equipment and adherence to standard engineering test methodologies (e.g., tensile strength, torque, fixation strength). It is based on the inherent physical properties and performance limits of the materials and design, not on expert consensus, pathology, or clinical outcomes data in the traditional sense.

8. The sample size for the training set:

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and preclinical testing, rather than data-driven machine learning models.

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

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

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