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The Ace Connex™ Pre-Sutured Fascia is intended for use as a component in soft tissue surgical procedures where constructs including those with allograft tissues are used for reconstruction, replacement, or augmentation of the hip labrum.

The Labrum Replacement and Augmentation Device, marketed as AceConnex™ Pre-Sutured Fascia subject device is a pre-assembled surgical construct comprised of allograft tissue and non-absorbable, synthetic suture. The allograft fascia lata tissue is terminally cleaned and disinfected using a proprietary process. The fascia lata tissue is pre-sutured with Force Fiber® ultra-high molecular weight polyethylene (UHMWPE) non-absorbable surgical suture cleared under K063778, and the device is terminally sterilized by low dose electron beam irradiation.

The device has a smooth side for articulating against the rotating cartilage surface and a sutured side which is secured against the bone and comes in three sizes to accommodate the needs of surgeons performing segmental (40-60mm and 60-100mm) and full circumferential (100-140mm) augmentations or reconstructions. Each device contains two adjustable sections where the device may be cut to provide adjustment options so that the device may be trimmed to fit the needs of patient and surgeon.

This document does not contain information about the acceptance criteria and study proving the device meets the acceptance criteria in the manner requested. The provided text is a 510(k) summary for the AceConnex™ Pre-Sutured Fascia, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in a tabular format.

Here's why the requested information cannot be extracted from this document:

1. Table of Acceptance Criteria and Reported Device Performance: While the document states that "the subject device passed all product performance tests" and lists some characteristics (e.g., "suture pullout strength greater than the estimated force on the labrum in a healthy hip during jogging"), it does not provide a formal table with quantitative acceptance criteria and corresponding quantitative device performance results.
2. Sample Size, Data Provenance, Expert Information, Adjudication Method, MRMC Study, Standalone Study, Ground Truth Type, Training Set Size, Training Set Ground Truth: None of these details, which are typical for clinical performance studies, are present in this 510(k) summary. This type of submission relies on demonstrating substantial equivalence through comparison to an already cleared predicate device, often supported by bench testing (product performance testing) rather than extensive clinical studies with human subjects and expert evaluations.

Based on the provided text, the following information can be extracted:

• Device Name: AceConnex™ Pre-Sutured Fascia
• Device Type: Pre-assembled surgical construct comprised of allograft tissue and non-absorbable, synthetic suture.
• Intended Use: As a component in soft tissue surgical procedures where constructs including those with allograft tissues are used for reconstruction, replacement, or augmentation of the hip labrum.

Regarding the "study that proves the device meets the acceptance criteria," the document mentions "Product Performance Testing," which included:

• Visual, physical, mechanical, and clinical properties assessment.
• Outcomes reported (without specific quantitative acceptance criteria or detailed study methodology):
  • Device integrity maintained during surgical preparation and application.
  • Device length was adjustable.
  • Device conformed to the acetabular rim.
  • Device was securable with knotted and knotless suture anchors.
  • Suture pullout strength greater than the estimated force on the labrum in a healthy hip during jogging.
  • Retains necessary tensile strength after two years frozen storage.
  • Similar physical properties of surgeon fascia allografts.
• Bacterial Endotoxin Testing: Resulted in less than 20 EU/Device, meeting bacterial endotoxin testing requirements (standards listed: USP chapter , ANSI/AAMI ST72:2011, FDA Guidance for Industry: Pyrogen and Endotoxins Testing).

In summary, the provided document does not contain the detailed clinical study information requested. It focuses on engineering and bench testing results to support substantial equivalence.

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The S-Core® Implant System (6.0 mm - 10.0 mm diameter) is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction,

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Hip: Capsular repair, acetabular labral repair, gluteus medius repair.

The S-Core® Implant System consists of screws and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for the size of device. These large and small bones may include the following:

Fixation of small bone fragments, such as apical fragments (patellar), minimally invasive reconstruction of fractures and joints, adjuvant for osteosynthesis in complex joint fractures, multifragment joint fractures, simple metaphyseal fractures fractures of the wrist, ankle, elbow, and shoulder, condylar fractures, osteochrondritis dissecans, osteochondral fixation, fractures, and fragments (talar, vault, femoral condyle), intra-articular fractures, ligament avulsion injuries, ligament fixation, other small fragments, cancellous bone fragments (talus) or fractures, areas where accurate screw placement is vital, metatarsal and phalangeal osteotomies, fractures of the tarsals, and other fractures of the foot, avulsion fractures of metatarsal V, tarso-metatarsal and metatarso-phalangeal arthrodesis, fractures of small joints, such as: ankle fractures, fractures of the fibula, malleolus, and calcaneus, distal tibia and pilon fractures, acetabular fractures, calcaneal and talar fractures, subtalar arthrodesis, ankle arthrodesis, other fractures of the pelvic ring, fractures of the femoral head and neck, supracondylar femoral fracture, slipped capital femoral epiphyses, an adjunct to DHIS in basilar neck fractures, intercondylar femur fractures, intracapsular fractures of the distal femur and proximal tibia, patellar fractures, tibial plateau fractures, small fragments of the hand wrist, fractures of the carpals and metacarpal arthrodesis, scaphoid fractures of the hand, phalangeal and interphalangeal fractures, fractures of the ulna and radius, radial head fractures of the olecranon and distal humerus, humeral head fractures, ligament fixation at the proximal humerus, glenoid fractures.

The S-Core® Implants are titanium screws that are threaded, headless, cannulated devices offered in diameters ranging from 4mm to 10mm. Each diameter size offers three length options; the shortest being 7mm for the 4mm diameter screw to the longest at 14mm for the 10mm diameter screw. Each screw body incorporates 0.8mm fenestrations on the screw head surface and in a helical pattern within the thread pitch. All screws are offered with the option of an hydroxyapatite (HA) coating. The system also includes stainless steel screw instruments for implantation.

The S-Core® Implant System may be used as a stand-alone screw for the fixation of fracture, fusion, and osteotomies. The S-Core Implant System may also be used with the S-Fibre Suture when used as a suture anchor for the attachment of soft tissue to bone.

The S-Fibre Suture is a non-absorbable, sterile, surgical suture composed of high molecular weight polyethylene (UHMWPE). It is available in white, size 3-0, meeting USP requirements except for oversize diameter. The S-Fibre Suture was originally cleared as the Force Fiber® Polyethylene Non-Absorbable Suture (K063778).

The S-Core® Implant suture anchor includes the S-Fibre Suture (prepackaged) with the titanium screw.

This document is an FDA 510(k) clearance letter for the S-Core® Implant System. It does not describe acceptance criteria for an AI/software device or a study proving an AI/software device meets acceptance criteria. The device is a physical bone fixation fastener (screws and suture anchors) and the testing described is mechanical and biocompatibility testing for this physical device.

Therefore, I cannot extract the information requested about acceptance criteria and a study proving an AI/software device meets the acceptance criteria from the provided text.

The closest relevant sections in the document are:

• Summary of Non-Clinical Performance Testing Bench Test: This section mentions mechanical testing (Torsional Properties, Insertion and Removal Torque, Pullout Strength, Fatigue testing) and bacterial endotoxin testing performed on the physical implant system. These are acceptance criteria for a physical medical device, not for an AI/software.
• Statement of Equivalence: This section states that the device is substantially equivalent to predicate devices based on indications for use and technological characteristics, and that "The submitted test data demonstrates that the proposed device is substantially equivalent to the predicates." This refers to the mechanical and biocompatibility testing mentioned, not an AI performance study.

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The Hercules® Syndesmosis Implant System is intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures and as an adjunct in external and intramedullary fixation systems. The Hercules® Syndesmosis Implant System is also intended to provide fixation during healing process after joint reconstruction in the midfoot and forefoot including correction of hallux valgus deformity.

The In2Bones Hercules® Syndesmosis Implant System is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two low profile titanium alloy buttons, designed to complement plate fixation or to allow use as a stand-alone device. This device is also packaged with various ancillary instruments to aid in insertion.

The provided text describes a 510(k) premarket notification for the "Hercules® Syndesmosis Implant System." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets clinical acceptance criteria.

Therefore, the information required to answer the prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, is not present in the provided text.

The document primarily focuses on:

• Regulatory Clearance: Announcing the FDA's determination of substantial equivalence for the Hercules® Syndesmosis Implant System (K220260) to previously cleared predicate devices.
• Device Description: A sterile, single-use system composed of UHMWPE suture and titanium alloy buttons, intended to stabilize syndesmotic trauma of the ankle.
• Indications for Use: Providing fixation during healing after syndesmotic trauma (e.g., Weber B and C ankle fractures) and as an adjunct in other fixation systems, as well as for fixation after joint reconstruction in the midfoot and forefoot.
• Basis for Substantial Equivalence: Similarities in indications, materials, and geometry to predicate devices (e.g., Arthrex Tightrope, Wright Medical Gravity Syndesmosis LP, Arthrosurface KISSLoc Suture System).
• Performance Testing (Bench Testing): Mentions "Cyclic displacement and load to failure bench testing (mechanical testing)" was performed and "The Hercules® Syndesmosis Implant System was validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization, ISO 11135 for ETO sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72." This refers to engineering/mechanical/biocompatibility testing, not clinical performance data or studies involving human subjects/readers.

In summary, there is no information in this document about studies that prove the device meets acceptance criteria in a clinical or AI-assisted context, as the questions imply. The document pertains to the regulatory clearance process for a medical implant based on substantial equivalence, relying on mechanical and material testing, not diagnostic performance or human reader studies.

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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 Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and / or snoring.

The Encore System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone and hyoid bone suspension to the mandible bone using a bone screw and suspension lines. The Encore System consists of 1) an integrated suture passer pre-loaded with size #2-0 braided polyester suture, 2) three (3) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, 4) a threading tool, and 5) a drill bit. In addition, a #2 braided polyethelene suspension line is provided. All components are provided sterile.

This document is a 510(k) Pre-Market Notification from the FDA regarding the Siesta Medical Encore System. It's a regulatory clearance document and does not contain the detailed study results, acceptance criteria, or performance metrics typically found in a clinical study report.

Therefore, I cannot provide the requested information, which includes a table of acceptance criteria and reported device performance, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, details of MRMC studies (effect size), standalone performance, or ground truth establishment.

The document states:

• The device is the Encore™ System.
• Intended Use: Anterior advancement of the tongue base and hyoid suspension for the treatment of obstructive sleep apnea (OSA) and/or snoring.
• Change: The current submission (K201238) introduces a #2 braided polyethylene suspension line (vs. #2 braided polyester in the predicate K183310).
• Non-Clinical Testing: A "Suture Tensile Strength Test" was conducted.
• Conclusion of Testing: The results "confirmed that the strength of the #2 braided polyethylene suspension is similar to that of the existing #2 braided polyester suspension line."

This type of submission typically relies on demonstrating substantial equivalence to a predicate device, focusing on a specific change (in this case, the material of the suspension line) and ensuring that the new material does not negatively impact the device's fundamental function or safety. The "Suture Tensile Strength Test" is the evidence provided to support this claim, indicating that the new suspension line has comparable strength to the old one.

Without further documentation, it is impossible to fulfill the request for detailed study information.

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The In2Bones Hercules™ Suture Anchors are intended for use in the following applications:

1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.

2. Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.

3. Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair.

4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.

5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

The In2Bones Hercules™ Suture Anchor System is a bone implant device intended for the fixation of soft tissue to bone. This system consists of two anchor styles manufactured from ASTM F 2026 Poly Ether Ether Ketone (PEEK) - Fully threaded anchor and Knotless anchor - that are available in five sizes ranging from 2.0mm to 5.5mm and 4 sizes ranging from 2.5mm to 5.5mm respectively, for use in a range of fixation applications.

This document is a 510(k) summary for the Hercules™ Suture Anchor System. It details the device's indications for use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the mechanical performance tests in an easily digestible table format with reported performance. Instead, it states that "mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." This implies that the acceptance criteria are met if the device's performance is comparable to or better than previously cleared predicate devices, as assessed against the standards of ASTM F543-07.

To extract acceptance criteria and reported performance, we infer from what is mentioned:

Note: The document focuses on demonstrating substantial equivalence rather than defining specific acceptance criteria for a new, novel product. Therefore, the "reported device performance" is often a statement that the relevant standard was met, implying that the performance was acceptable relative to the predicate devices.

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of anchors) used for each mechanical test (Anchor Insertion Torque, Torque to Failure, Tensile Pullout, Cyclic Load, Post-Fatigue Pullout). It only mentions that "mechanical testing was done."
• Data Provenance: The studies were bench tests (non-clinical performance mechanical testing). This means the data is not from human subjects. The location where the tests were performed is not specified, but it would have been in a laboratory or testing facility. The data is prospective in the sense that these tests were conducted specifically for this submission, although they are based on established standards.

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

This section is not applicable as the studies are mechanical bench tests, not involving human interpretation or expert evaluation of data to establish a ground truth. The "ground truth" for these tests is defined by the physical properties and performance characteristics measured against industry standards (ASTM, ISO).

4. Adjudication Method for the Test Set

This section is not applicable as the studies are mechanical bench tests. Adjudication methods (like 2+1, 3+1) are typically used for studies involving multiple human readers assessing medical images or patient data where disagreements may arise.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers, and the provided information pertains to the mechanical performance of a medical device (suture anchors), not an AI algorithm for diagnostic purposes.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. The device is a physical medical implant (suture anchor system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance tests is based on established engineering standards and specifications (e.g., ASTM F543-07, ANSI/AAMI ST72, ISO 11135, ISO 11137-2, ISO 10993-1, ISO 11607-1). The device's performance is compared against these objective, quantifiable standards and against the performance of predicate devices as measured under these standards.

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As stated above, there is no training set for a physical medical device.

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

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

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

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

Acceptance Criteria and Reported Device Performance

• Suture diameter
• Tensile strength
• Needle attachment | "Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter."
  "Force Fiber Suture - Black is tested in accordance with USP - non-absorbable surgical sutures for suture diameter, tensile strength and needle attachment, and meet the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003." |
  | Material Biocompatibility (ISO 10993-1:2018) | Evaluation through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. This implies meeting the safety requirements for medical devices in contact with the body. | "All materials used in the fabrication of the Force Fiber Suture - Black were evaluated through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." |
  | MRI Safety | "MR Safe" designation, meaning it poses no known hazards in MR environments. | "Force Fiber Suture - Black is tested to demonstrate it is "MR Safe" and poses no known hazards in MR environments." |
  | Substantial Equivalence | No differences in technological characteristics and performance characteristics compared to predicate devices, and the difference (addition of black dye) does not raise new questions of safety or efficacy, making it as safe and effective as currently marketed predicate devices. This is the primary "acceptance criterion" for a 510(k) pathway. | "Force Fiber Suture – Black is substantially equivalent to its predicate Force Fiber Suture devices because there are no differences in technological characteristics and performance characteristics between the proposed and predicate devices. The proposed sutures have the same fundamental design and intended use as the predicate devices. The difference between Force Fiber Suture - Black and its predicate Force Fiber Suture devices is the addition of black dye... This difference does not raise new questions of safety or efficacy. Therefore, Force Fiber Suture - Black is as safe and effective as its currently marketed predicate devices." |

Information Not Available in the Document:

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

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

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

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The FIXIT®/ ComposiTCP™ threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.

FIXIT® / ComposiTCP™ Threaded Anchor System is composed of a bioabsorbable composite anchor (30% β-TCP/ 70%PLDL) pre-loaded on a disposable screwdriver and 2 sutures. Different variations of the product are available depending on the type of suture combination (2 flat sutures, or 1 round + 1 flat)

For each configuration, the implant is supplied sterile, ready to use.

The provided document is a 510(k) premarket notification for a medical device (FIXIT®/ComposiTCP™ Threaded Anchor System) and does not describe an AI/ML-based device. Therefore, the questions related to acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML models cannot be answered from this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for a suture anchor through non-clinical performance testing.

However, I can extract the acceptance criteria and reported device performance related to the mechanical properties as presented in the document:

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

The remaining questions cannot be answered from the provided text as they pertain to AI/ML device studies, which this document does not describe.

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The SuperBall Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.

The SuperBall Meniscal Repair System is a suture retention device comprised of two nonabsorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. More specifically, the device consists of suture bundles, a mesh stitch, actuator suture, pulling suture, and SuperBall securing element. The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene. The system allows for repair procedures in the lateral and medial meniscus, located within the outer 2/3 region of the meniscal zone (i.e., medial and posterior). The structure of the SuperBall is a self-locking structure enabling the SuperBall securing element to remain in its collapsed position. The SuperBall remains secure as the braided component (Mesh) is collapsed from within by pulling the Actuator Suture. The SuperBall System is provided sterile for single use only.

The provided text is a 510(k) summary for the Arcuro Medical Ltd.'s SuperBall Meniscal Repair System, which is a medical device. This document describes the device, its intended use, and various tests performed to demonstrate its substantial equivalence to a predicate device.

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

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

The document doesn't explicitly state "acceptance criteria" as a list with pass/fail thresholds. Instead, it describes performance tests and states that the device "demonstrated compliance," "performs as intended," or "confirm that the SuperBall has appropriate strength."

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

• Sample Size for Test Set: Not explicitly stated for most bench tests. For the usability study, "A total of eight surgeons evaluated the usability of the device, with six surgeons evaluating use of the final finished configuration of the device."
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. All studies described are bench tests or usability evaluations, not clinical trials on human subjects.

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 question does not directly apply as the studies are primarily bench testing and a usability evaluation. There is no "ground truth" in the sense of a medical diagnosis being established by experts against which the device's diagnostic performance is compared.

• Usability Study: "A total of eight surgeons" evaluated the device. Their specific qualifications (e.g., years of experience, specialty beyond "surgeon") are not detailed.

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

Not applicable. The described studies are bench tests and a usability evaluation, not studies requiring adjudication of diagnostic outcomes.

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

Not applicable. This device is a surgical repair system, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted.

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

Not applicable. This device is a physical surgical tool, not an algorithm.

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

Not applicable. As noted in point 3, the studies are focused on the physical and functional performance of the device (bench tests) and its ease of use by surgeons (usability study), not diagnostic accuracy against a ground truth.

8. The sample size for the training set

Not applicable. This document is about a manufactured medical device, not an AI algorithm that requires a training set.

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

Not applicable. As noted in point 8, there is no AI algorithm training set.

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The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair

FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material.

The implant is available in 2 different configurations:

• · FIXIT®Knotless: supplied in a holder,
• FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures.
  The implant is supplied sterile, ready to use.

The provided text describes a medical device submission (K170868) for the FIXIT® Threaded Anchor System. This device is a suture anchor, and the submission aims to demonstrate its substantial equivalence to a predicate device, the Arthrex Bio-Composite Corkscrew (K082810).

It is crucial to understand that this document describes a non-AI/ML medical device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth used," "sample size for the training set," and "how the ground truth for the training set was established" do not apply in the context of an AI/ML device validation study.

Instead, the acceptance criteria for this type of device (traditional medical device) are outlined by regulatory bodies such as the FDA. For a Class II medical device like the FIXIT® Threaded Anchor System, the primary acceptance criteria for market clearance via a 510(k) pathway revolve around demonstrating substantial equivalence to a legally marketed predicate device. This is achieved through comparisons of:

• Intended Use: Must be the same or very similar to the predicate.
• Technological Characteristics: Must be similar to the predicate.
• Performance Data: Non-clinical testing (e.g., mechanical, biocompatibility) must show that the new device performs as safely and effectively as the predicate, and any differences in technological characteristics do not raise new questions of safety or effectiveness.

Here's a breakdown based on the provided text, adapted for the context of a traditional 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)

This information is not provided in the document as it pertains to AI/ML validation studies. For this traditional device, non-clinical tests typically involve:

• Mechanical testing: A certain number of samples (e.g., a statistically significant number of anchors) would be tested for properties like pull-out strength or fixation strength. The specific sample sizes are not detailed in this summary.
• Biocompatibility testing: This is typically performed under ISO standards (e.g., ISO 10993) using standardized biological models (e.g., cell cultures, animal models) with a defined number of replicates, but the specifics are not in this summary.
• Bacterial Endotoxin Testing: This involves testing samples of the final sterile device using established methods like the Limulus Amebocyte Lysate (LAL) assay, with specific sample numbers.

The data provenance is inherent to laboratory testing rather than clinical data sets. The testing would have been conducted by the manufacturer or contracted labs following established protocols.

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 concept is not applicable to this type of traditional device submission. "Ground truth" established by experts is relevant for AI/ML diagnostic or interpretative devices. For the FIXIT® Threaded Anchor System, the "ground truth" for performance is established by objective, quantifiable physical and chemical tests (e.g., measuring force, observing cell reaction, detecting endotoxins) against industry standards or predicate device performance.

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

This is not applicable for a traditional medical device like a suture anchor. Adjudication methods are typically employed in clinical trials or AI/ML evaluations to resolve disagreements among human readers or experts on ground truth.

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. MRMC studies are specific to evaluating diagnostic devices, especially those involving human interpretation, often in the context of AI assistance. The FIXIT® Threaded Anchor System is a surgical implant, not a diagnostic tool, and involves no "human readers" or "AI assistance" in its intended function.

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

This is not applicable. This refers to AI/ML algorithm performance without human intervention. The FIXIT® Threaded Anchor System is a physical implant; there is no algorithm involved.

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

The "ground truth" for this device's performance is based on objective measurements and adherence to established standards in non-clinical testing:

• Biocompatibility: Adherence to ISO 10993 series standards, using established biological models and endpoints.
• Mechanical Performance: Quantifiable physical measurements (e.g., pull-out strength, torque, fatigue life) compared against engineering specifications, predicate device performance, or relevant biomechanical literature. The "ground truth" here is the physical measurement itself.
• Bacterial Endotoxin: Quantitative measurement of endotoxin levels, compared against specified regulatory limits.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm requiring a training set.

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

This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.

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