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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 Infinity-Looks are single use devices intended to be used for soft tissue approximation, including Achilles tendon repair in patients with acute rupture of the Achilles tendon.

The Infinity-Locks are non-absorbable, sterile, poly(ethylene terephthalate) sutures. They are prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Infinity-Locks differ from USP Sutures in being in the form of woven tapes and in exceeding all USP sizes.

The product comprises two sizes of textile implant based on the Neoligaments poly-tape design. The tapes have an integral loop at one end which are used to tie a cowhitch through one end of a ruptured tendon. The tapes have two tails which are then sutured through the separated end (using methods such as the Bunnell technique), thus drawing the two ends together in order to facilitate healing of the tear. One of the tails has a green stripe to aid identification and both taper into a cord to assist with passing through soft tissues.

This document is a 510(k) premarket notification for a medical device called "Infinity-Lock 3" and "Infinity-Lock 5" surgical sutures. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

The document does not describe a study involving an AI/Machine Learning device or a diagnostic device. It concerns a mechanical surgical suture. Therefore, many of the requested criteria (such as acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.

The "performance data" section in the document refers to mechanical testing of the sutures, not performance in a diagnostic or AI context.

Here's a breakdown of the relevant information provided in the document:

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

The document states: "Mechanical testing was performed on the modified device and original poly-tape in both knotted and unknotted conditions to determine the ultimate tensile strengths using an internal method, QT010, and following USP 39 NF33:2016 for non-absorbable surgical sutures, where applicable. The modified devices were found to be equivalent or superior in all cases."

While specific numerical acceptance criteria and performance values are not explicitly tabulated in this summary, the statement indicates that the new device met or exceeded the performance of the predicate device based on tensile strength tests. The standard followed, USP 39 NF33:2016, would contain the specific criteria.

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

• Sample Size: Not explicitly stated for the mechanical testing.
• Data Provenance: The testing was "internal" (Xiros Ltd.) as per method QT010.
• Retrospective or Prospective: This type of mechanical testing is typically a prospective validation of manufactured samples.

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

• Not applicable for this type of mechanical device. "Ground truth" for mechanical properties is established through standardized physical measurements and tests, not expert interpretation of diagnostic data.
• There was "Validation... undertaken by clinicians using cadaveric materials to demonstrate the suitability of the modified device for the intended use." This is about usability and fit-for-purpose, not diagnostic ground truth. The number and qualifications of these clinicians are not specified in this summary.

4. Adjudication method for the test set:

• Not applicable for this type of mechanical device. Mechanical tests have objective, measurable 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 is not an AI/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used:

• For mechanical properties: Objective physical measurements (ultimate tensile strength) against standards (USP 39 NF33:2016).
• For usability: Clinician assessment on cadaveric materials.

8. The sample size for the training set:

• Not applicable. This is a manufactured medical device, not an AI model requiring a "training set."

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

• Not applicable. See point 8.

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The Permaseal is indicated for soft tissue approximation of cardiac apical tissue during transcatheter valve replacement procedures.

The Permaseal device is composed of a delivery device and an implant that is deployed to facilitate access and closure. The deployment site is accessed via minimally invasive surgery or percutaneous surgery. The device is compatible with a 0.025" guide wire. The implant is designed to close punctures, incisions or ostomies in the cardiac apical tissue up to 30F, or 10mm in diameter.

The device features a handle designed to facilitate proper device placement and allow for singlehanded deployment of the implant. The handle contains a trigger that actuates the device and incorporates a mechanical safety. The handle functions as a tool to grip and position the device. It contains the actuating mechanism to control deployment of the anchor using a trigger mechanism.

The implant is composed of an array of eight polypropylene anchors connected by a 2-0 braided, coated polyester suture U.S.P, as seen in Figures 2 and 3. The suture was separately cleared to market through K021019.

The suture is threaded through the eyelets of the eight anchors in a circular pattern and terminates in a surgical knot. The excess suture provided is referred to as the loop limb. The opening that is formed in the center of the implant is referred to as the 'operative window.' The knot is tightened at the end of the procedure by advancing the knot pusher toward the implant. The knot pusher is shown in Figure 4. above. The knot pusher is affixed to the insertion tube by the knot pusher retainer and is removed from the tube before the implant is deployed.

Upon release of the safety and actuation of the trigger, a spring-loaded pusher tube connected distally to 8 pusher pins is released, transmitting the force of the spring through the pusher pins to the anchors, simultaneously embedding the 8 anchors firmly into the tissue at the target site.

The anchors are deployed at a pre-determined depth with the sutures resting on the surface of the heart. Once deployed, the polyester suture and eight anchors create an 'operative window' in a pattern approximating that of a purse-string suture pattern. The anchors provide a secure attachment site for the suture that connects the multiple anchors together. The suture serves as a means to bring the incised tissue edges into apposition so as to close the puncture. Advancing the surgical knot in the suture with the knot pusher creates sufficient tension on the anchors to pull them and the tissue together so as to close punctures, incisions or otomies in the cardiac apical tissue up to 30F, or 10mm in diameter.

Below is a summary of the acceptance criteria and the studies that demonstrate the Permaseal device meets these criteria.

Acceptance Criteria and Reported Device Performance

Study Details: PERMASEAL Device

2. Sample Size and Data Provenance

• Test Set (Clinical Study - STASIS):
  • Sample Size: 34 patients were enrolled. 31 patients were included in the primary effectiveness analysis (1 roll-in and 2 protocol violations excluded).
  • Data Provenance: Prospective, multi-center, conducted at five clinical sites in Germany and the Netherlands.

3. Number of Experts and Qualifications (for Ground Truth)

• Clinical Study (STASIS): The document does not explicitly state the number or specific qualifications of experts used to establish "ground truth" for the clinical endpoints (e.g., diagnosis of pulsatile bleeding, assessment of AEs). However, it is implied that clinical trial investigators (most likely interventional cardiologists or cardiac surgeons) at the participating sites made these assessments based on standard clinical practice and the Valve Academic Research Consortium (VARC) 2 definitions for safety events. The study design is observational, and the endpoints are objective clinical outcomes.

4. Adjudication Method (for Test Set)

• The document does not explicitly mention a specific adjudication method (e.g., 2+1, 3+1). Clinical events and outcomes would typically be recorded by the study investigators at each site. For Serious Adverse Events (SAEs), causality assessment (relation to device or procedure) was performed, indicating a review by the study team or an independent committee. The two device-related SAEs were attributed to user error and a need for additional training, suggesting internal review of events.

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

• No, an MRMC comparative effectiveness study was not done. The STASIS study was designed to evaluate the Permaseal device's performance against a literature-derived performance goal (for the primary effectiveness endpoint) and observed clinical outcomes, rather than comparing human readers with and without AI assistance. The Permaseal is a physical medical device, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

• No, a standalone (algorithm only) study was not conducted. The Permaseal is a physical medical device for apical closure, not an algorithm or AI system. Its performance was evaluated in bench tests, animal studies, and a clinical study with human use.

7. Type of Ground Truth Used (for Test Set)

• Clinical Study (STASIS): The ground truth for the primary effectiveness endpoint was based on clinical observation and intervention (rate of pulsatile bleeding requiring significant surgical intervention). For safety endpoints, the ground truth was based on clinical diagnoses and outcomes data as defined by the Valve Academic Research Consortium (VARC) 2 definitions, including mortality, myocardial infarction, stroke, vascular complications, etc.
• Animal Studies: Ground truth was based on direct observation (e.g., survival, freedom from complications, pathological changes) and functional assessment in porcine models.
• Bench Studies: Ground truth was based on engineering specifications and measurements and functional performance tests.

8. Sample Size for the Training Set

• The document does not describe a "training set" in the context of an AI algorithm, as the Permaseal is a physical device. All described studies are for evaluating the device's safety and performance itself.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" for an AI algorithm. The studies described are for validation of the physical device.

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VENTRALIGHT™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

The ECHO 2.0™ Lap System is intended to be used to facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair.

The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh is a low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia renair.

VENTRALIGHT™ ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis designed for the reconstruction of soft tissue deficiencies. The low profile mesh facilitates laparoscopic deployment and the pre-sized shapes offer ready-to-use benefits. VENTRALIGHT™ ST Mesh is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The uncoated fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating that separates the mesh from underlying tissue and visceral organ surfaces to minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

The VENTRALIGHT™ ST Mesh described above will be packaged pre-assembled to the ECHO 2.0TM Lap System. The ECHO 2.0™ Lap System is made of a deployment frame (pre-shaped nitinol wire encased in a thermoplastic coated nylon sleeve with a center hoisting loop) which is pre-attached to the VENTRALIGHT™ ST Mesh with connectors. Once inserted, the deployment frame facilitates laparoscopic deployment without the need of ancillary devices. Once initial mesh fixation is complete, the ECHO 2.0™ Lap System is completely removed from the body by cutting the center hoisting loop at the patient's skin level and pulling the deployment frame off the mesh and directly out of the abdominal cavity through a 10mm (or larger) trocar.

The provided text is a 510(k) Summary for a medical device (ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh). It outlines the device description, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

However, the document does not contain a table of acceptance criteria nor a detailed study description with specific numerical performance metrics, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study proving a device meets acceptance criteria. The performance data section lists the types of tests conducted, but not their results or specific acceptance thresholds.

Given the information provided, I cannot fulfill all parts of your request as the specific data regarding acceptance criteria and detailed study results are not present in this 510(k) summary. I can only describe the tests performed, not their outcomes or how they met specific acceptance criteria.

Here's a breakdown of what can be extracted from the text, and what is missing:

What can be extracted:

• Types of performance tests performed: Biocompatibility, Bench-top (simulated use, mesh integrity, ball burst, attachment strengths), Mechanical (nylon peel strength, hoisting loop attachment, crimp integrity), and Porcine Animal Model (simulated use, surgeon feedback).
• Absence of some types of studies: No electrical safety/EMC or software verification/validation were required as the device doesn't have such components. No clinical study was required.
• Intended Use & Indications for Use: The device is for reconstruction of soft tissue deficiencies (hernias), and the Lap System facilitates delivery of prostheses during laparoscopic hernia repair.

What is missing (and therefore cannot be provided in the table or detailed descriptions):

• Specific Acceptance Criteria: The document lists types of tests, but not the quantitative or qualitative criteria for success (e.g., "Ball Burst strength > X Newtons").
• Reported Device Performance: No actual results from the tests are provided, only that they were conducted "in support of the substantial equivalence determination."
• Sample Sizes: While tests were done, e.g., in a "porcine animal model," the number of animals or the number of samples for bench testing is not specified.
• Data Provenance: Not specified for bench tests. For biocompatibility, it states testing was conducted "in accordance with FDA Blue Book Memorandum #G95-1" and "leveraged from the primary predicate device." The animal model is porcine. The origin (country/institution) is not mentioned.
• Number of Experts/Qualifications for Ground Truth: Not applicable as specific ground truth data for performance metrics is not provided. Surgeon feedback was gathered for the porcine model, but details on "experts" or the number of surgeons are not given.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Explicitly states "No clinical study was required." This implies no MRMC study.
• Standalone Performance: While "Performance Testing - Bench" and "Performance Testing - Mechanical" describe tests on the device itself, the results establishing its standalone performance against defined acceptance criteria are not provided.
• Type of Ground Truth Used: For the porcine model, it's "surgeon feedback on product performance." For other tests, it would typically be defined metrics based on engineering specifications or ISO standards, but these are not detailed.
• Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/software device. The document explicitly states "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."
• Ground Truth for Training Set: Not applicable.

Based on the provided text, here is what can be inferred/extracted, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the tests (bench, mechanical, or animal model).
• Data Provenance:
  • Biocompatibility: "leveraged from the primary predicate device" and conducted "in accordance with FDA Blue Book Memorandum #G95-1" and ISO 10993-1.
  • Animal Model: Porcine animal model. Country of origin not specified. Retrospective/Prospective not specified, but typically prospective for animal studies.

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

• Not applicable/Not provided in detail. For the porcine model, "surveys which captured surgeon feedback on product performance" were used. The number or specific qualifications of these surgeons are not mentioned. For other tests, "ground truth" would be established by engineering specifications or compliance with standards, not expert consensus on performance data.

4. Adjudication method for the test set:

• Not applicable/Not provided.

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

• No. The document explicitly states: "No clinical study was required in support of the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh." This device is a physical surgical mesh and delivery system, not an AI or imaging device, so an MRMC study is not relevant.

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

• Yes, various "standalone" performance tests were conducted on the device components and the assembled system. These include:
  • Biocompatibility Testing
  • Bench-Top Simulated Use
  • Mesh Integrity (following simulated use)
  • Ball Burst
  • Connector to Mesh Attachment Strength
  • Connector to Deployment Frame Attachment Strength
  • Nylon Peel Strength
  • Center Hoisting Loop to Deployment Frame Attachment Strength
  • Crimp Integrity
• However, the results of these tests meeting specific acceptance criteria are not detailed in this summary.

7. The type of ground truth used:

• For the performance testing, the ground truth would be based on engineering specifications, material properties, and compliance with recognized standards (e.g., ISO for biocompatibility).
• For the porcine animal model, "surgeon feedback on product performance" acted as a form of experiential ground truth.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not an AI/software device that would require a "training set." The document explicitly states: "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."

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

• Not applicable.

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The LARIAT® III Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

The LARIAT® III Suture Delivery Device is a one-piece, single-use suture delivery and deployment device with a pre-tied size "0" polyester suture loop that is pre-loaded on a retractable Delivery Snare on the distal end of the device. The pre-tied suture loop is held onto the Delivery Snare and allows for multiple opening and closings of the suture loop without release. Upon tightening of the suture loop, the suture is released from the Delivery Snare. An accessory lumen within the LARIAT III device is designed for aspiration and flushing. The LARIAT III device is compatible with access site diameters of 4.3mm and larger. The suture is itself a cleared medical device as a part of K021019.

The provided document is a 510(k) premarket notification for the LARIAT® III Suture Delivery Device. It details the device's characteristics, intended use, and claims of substantial equivalence to a predicate device (LARIAT II Suture Delivery Device). This type of submission relies on comparisons to already-cleared devices and bench testing rather than clinical study data for device performance metrics related to diagnostic accuracy or clinical outcomes often seen with AI/ML devices. Therefore, a direct application of typical "acceptance criteria" for AI/ML performance metrics and detailed clinical study information is not present in this document.

However, I can extract the information that is available regarding the device's performance through bench testing in support of its substantial equivalence claims.

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

The document does not explicitly state numerical "acceptance criteria" with thresholds for each test, but rather lists the types of bench tests performed to confirm the device performs "according to the stated intended use." The reported device performance is broadly stated as successful completion of these tests.

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

The document specifies "bench testing" was conducted. This typically refers to laboratory-based tests on physical devices or components, not clinical data. Therefore, details like "country of origin of the data" or "retrospective or prospective" do not apply. The sample size for each specific bench test is not provided in this summary.

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

Not applicable. Bench testing of a mechanical device does not typically involve human experts establishing ground truth in the way it would for an AI diagnostic device. The "ground truth" for these tests would be derived from engineering specifications and widely accepted physical/material science principles.

4. Adjudication method for the test set

Not applicable, as this refers to a method used to resolve discrepancies among human experts during ground truth establishment for clinical/diagnostic performance, which is not relevant for this type of bench 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 device is a surgical tool, not an AI/ML diagnostic or assistive 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

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

7. The type of ground truth used

For bench testing, the "ground truth" is typically defined by accepted engineering specifications, material properties, and functionality requirements rather than expert consensus, pathology, or outcomes data. For example, a "suture tensile strength test" would have a specified minimum tensile strength (ground truth) that the suture must meet.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model that requires a training set.

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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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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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The LARIAT Loop Applicator facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

The LARIAT Loop Applicator is a one piece, single-use suture delivery and deployment device with a pre-tied polyester suture loop that is pre-loaded on the device. A central lumen within the LARIAT Loop Applicator is designed for aspiration and stabilization of tissue during the delivery of the LARIAT Suture Loop.

The provided 510(k) notification describes a medical device, the LARIAT Loop Applicator, and its intended use. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets particular acceptance criteria in the manner typically associated with studies for AI/ML devices or diagnostic tools.

Instead, this 510(k) focuses on demonstrating substantial equivalence to predicate devices, primarily through in-vitro testing and assessment of biocompatibility. The information provided is characteristic of a medical device submission that relies on established safety and effectiveness profiles of already cleared devices and materials.

Given this, I cannot fully complete all sections of your request as they are not explicitly addressed in the provided text. I will fill in what is available and indicate where information is missing.

Here's the breakdown based on the provided text:

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)

• Sample Size: Not specified for in-vitro testing.
• Data Provenance: Not specified, but generally, in-vitro testing for 510(k) submissions would be conducted in a controlled lab setting, likely within the US where the applicant is located.
• Retrospective/Prospective: Neither. The testing mentioned is in-vitro performance and biocompatibility testing, not clinical data collection.

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 applicator, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for its performance would be its mechanical functionality (e.g., suture delivery, knot tying) and material safety, evaluated through engineering and biocompatibility testing.

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

Not applicable. This type of adjudication method is relevant for studies involving human interpretation or clinical endpoints, not for the in-vitro performance and biocompatibility testing described.

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

Not applicable. This device is a surgical tool, not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and AI improvement effect sizes are not relevant to this submission.

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

Not applicable. The device is a physical surgical applicator, not an algorithm.

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

The "ground truth" implicitly used for this device involves:

• Engineering specifications and functional requirements for safe suture delivery and deployment.
• Biocompatibility standards and established safety profiles for the materials used and similar predicate devices.
• The effectiveness of the predicate devices in their intended uses.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

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The ThRevo™ Suture Anchor with Disposable Driver is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

The ThRevo™ Suture Anchor with Disposable Driver consists of a titanium suture anchor with a self-tapping cutting tip. The design requires no predrilling and can be inserted by hand into the bone with the accompanying disposable driver. The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in design, performance specifications, function and intended use to the Super Revo® Suture Anchor. The design of the implant has not been modified.

The only modification to the currently marketed device is the ThRevo™ Suture Anchor with Disposable Driver is preloaded with three (3) nonabsorbable USP size # 2 braided polyester sutures (green, white and green/white striped) instead of two (2) nonabsorbable, USP size # 2 braided polyester sutures (green and white). The surgical technique has been slightly modified to for account for the addition of the third suture.

The implant design has not been modified in any way. The titanium suture anchor implant of the ThRevo™ Suture Anchor with Disposable Driver is the same as for the Super Revo® Suture Anchor (510(k) # K003984). Both are provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. Also, both the ThRevoTM Suture Anchor with Disposable Driver and Super Revo® Suture Anchor are supplied sterile and single use.

This modification does not affect the device's intended use, fundamental scientific technology or performance specifications.

This is a 510(k) premarket notification for a medical device called the ThRevo™ Suture Anchor with Disposable Driver. It is primarily a declaration of substantial equivalence to a previously marketed device, the Super Revo® Suture Anchor, rather than a study proving the device meets acceptance criteria.

Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" are not applicable to this type of submission. However, I can extract the relevant information provided:

Here's a breakdown of the available information:

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

The document does not provide specific numerical acceptance criteria or performance metrics in a table format. The core of this 510(k) is to demonstrate substantial equivalence. It states:

• Acceptance Criteria Implied: The new device (ThRevo™ Suture Anchor with Disposable Driver) must be substantially equivalent to the predicate device (Super Revo® Suture Anchor) in design, performance specifications, function, and intended use, and not raise new issues regarding safety and effectiveness.
• Reported Device Performance: The document explicitly states: "The design of the implant has not been modified." and "The implant design has not been modified in any way. The titanium suture anchor implant of the ThRevo™ Suture Anchor with Disposable Driver is the same as for the Super Revo® Suture Anchor". The only modification is the addition of a third suture.

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 specified. The document refers to "Testing has been conducted to assure that providing the suture anchor with the additional strand of nonabsorbable USP #2 polyester suture does not raise any new issues regarding safety and effectiveness." However, the details of this testing (sample size, methodology) are not provided in this summary.
• Data Provenance: Not specified.

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/Not specified. This is not a study involving expert assessment of a test set for ground truth establishment.

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

• Not applicable/Not specified.

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

• No. This is a submission for a physical medical device (suture anchor), not an AI-assisted diagnostic tool.

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

• No. Not applicable, as this is not an algorithm.

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

• Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning model.

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

• Not applicable.

Summary of the Study (or justification for substantial equivalence):

The "study" presented here is a Special 510(k) Summary aiming to demonstrate "substantial equivalence" of the ThRevo™ Suture Anchor with Disposable Driver to a legally marketed predicate device, the Super Revo® Suture Anchor (510(k) # K003984).

Key "Proof" points:

• Device Description (E): The titanium suture anchor implant itself has not been modified from the predicate device.
• Modification: The only change is the addition of a third non-absorbable USP size #2 braided polyester suture.
• Intended Use (F): The intended use (rotator cuff repairs in the shoulder) remains the same.
• Substantial Equivalence (G): "The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in intended use, scientific technology and design to the Super Revo® Suture Anchor. Testing has been conducted to assure that providing the suture anchor with the additional strand of nonabsorbable USP #2 polyester suture does not raise any new issues regarding safety and effectiveness."
• Suture Safety: The additional suture material (Polydek) is from TeleFlex Medical, which is approved for commercial distribution under 510(k) number K021019. The other two sutures are from Surgical Specialties and approved under NDA 80-950.

In essence, the "study" for this 510(k) filing relies on the established safety and effectiveness of the predicate device and the materials used, asserting that the minor modification (addition of a suture) does not alter the fundamental safety or performance profile. No detailed clinical or performance study data is provided in this summary.

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The Stryker Mini-Mender Meniscal Repair System is intended for use in arthroscopic suture fixation techniques of meniscal tears.
The Stryker Mini-Mender Meniscal Repair System is intended for single-use only.

The Stryker Mini-Mender Meniscal Repair System consists of a set of disposable pre-curved Cannulas and double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture. The needles-suture are pre-assembled to a pair of disposable Introducers (needle-suture passers).

This document is a 510(k) summary report for the Stryker Mini-Mender Meniscal Repair System, which is a medical device and not a software algorithm or AI device. Therefore, many of the requested categories related to acceptance criteria and study design for software performance (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable.

Here's an analysis based on the provided text, focusing on the device's regulatory pathway and the criteria for its marketing clearance:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device and adherence to relevant standards and guidance documents. The device performance is assessed in terms of its ability to meet these equivalence criteria and comply with safety and efficacy guidelines for surgical sutures and instruments.

Details Regarding Study/Evaluation (For a non-AI/software device)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   For a physical medical device like this, there isn't a "test set" in the sense of a dataset for an algorithm. Rather, the device undergoes specific engineering, material, and biological testing to ensure it meets the required standards. The document doesn't specify sample sizes for these tests (e.g., how many sutures were tested for tensile strength, how many devices for sterility, etc.), but it implicitly states these tests were conducted to demonstrate compliance with standards like USP, ISO-10993, EN 552, and ASTM 4169. Data provenance is not specified but would typically be from in-house or contracted laboratory testing in the country of manufacture or testing.

2. 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 (N/A). The "ground truth" for this device is established by adherence to recognized medical device standards and regulations, rather than expert interpretation of a clinical dataset. Compliance is assessed by regulatory bodies (FDA) and manufacturers through established testing protocols.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   N/A. Adjudication methods are relevant for clinical trials or diagnostic performance studies involving human interpretation. For this physical device, compliance is based on meeting pre-defined physical, chemical, and biological specifications.

4. 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:
   N/A. This is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   N/A. This device is a physical surgical tool, not an algorithm. Its performance is inherent in its design, materials, and manufacturing, and it is used by a human surgeon.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for this device's clearance is established through compliance with recognized standards and regulations. Specifically:

   • Predicate device's safety and efficacy: The Linvatec SharpShooter Meniscal Repair System serves as a basis for determining substantial equivalence, implying its established safe and effective use.
   • USP Section XXV - Nonabsorbable Surgical Sutures: A pharmacopeial standard detailing requirements for surgical sutures.
   • ISO-10993 (Biocompatibility): International standard for biological evaluation of medical devices.
   • EN 552 (Sterilization): European standard related to sterilization of medical devices.
   • ASTM 4169 (Sterility packaging): Standard for sterility assurance and packaging.
   • Class II Special Controls Guidance Document: Surgical Sutures: FDA guidance document outlining specific controls for this device type.
   • Clinical acceptance of meniscal repair with suture: The submission explicitly states suture repair is the "Gold Standard" and "has been well published in professional journals."

7. The sample size for the training set:
   N/A. This is a physical device, not an AI model. There is no "training set" in this context.

8. How the ground truth for the training set was established:
   N/A. As there is no training set, this question is not applicable.

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