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The X-Twist Biocomposite Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:

Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromo-Clavicular Separation Repair, Deltoid Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Meniscal Root Repair, Secondary or adjunct fixation for ACL/PCL reconstruction or repair, MPFL Repair/Reconstruction

Elbow: Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair

The X-Twist Biocomposite Suture Anchor consists of the implants (anchor and anchor tip) and the anchor driver assembly. The anchor and anchor tip are provided assembled to the driver and sterile. The X-Twist Biocomposite anchor is molded using a composite of beta-TCP (beta-tricalcium-phosphate) and PLGA (poly-lactic-co-glycolic acid). The anchor tip is molded using PEEK (polyetheretherketone). The anchor is fully threaded, double-helical, cannulated, and has inline fenestrations on each quarter-turn face. The anchor tip is retained on the driver via retention suture(s) or suture tape(s) that are passed through the driver cannulation, looped over the retention bridge within the tip, and returned out the proximal end of the driver handle and cleated. These devices are to be used with a drill, awl, and/or bone tap. The X-Twist Biocomposite Suture Anchors are provided sterile and in 4.75mm, 5.5mm, or 6.25mm diameters.

The X-Twist Biocomposite Suture Anchor, as described in this 510(k) summary, did not undergo a study to prove acceptance criteria in the traditional sense of a clinical or standalone performance study. Instead, the FDA determined substantial equivalence based on non-clinical testing and comparison to predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For the specific non-clinical test reported, here are the acceptance criteria and results:

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The Parcus Synd-EZ SS is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

The Parcus Synd-EZ SS is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

The Parcus Synd-EZ SS consists of two buttons with suture connecting them and are designed to be used for stabilizing the syndesmosis during healing. Building upon the technology of the Parcus Synd-EZ Ti, the Synd-EZ SS is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium, stainless steel and UHMWPE suture and is provided sterile.

The provided text is a 510(k) premarket notification summary for a medical device called "Parcus Synd-EZ SS." This document is a regulatory filing that demonstrates substantial equivalence to a predicate device, and as such, it does not contain acceptance criteria or detailed study information for new device performance.

The primary purpose of this 510(k) is a labeling change for MR conditional parameters, indicating that the design, materials, and manufacturing processes of the device itself have not changed since its previous clearance (K192964). Therefore, the document explicitly states: "No new testing was completed, apart from the testing required to support MR Conditional parameters that was provided in this submission."

Given this, I cannot extract the information you requested about acceptance criteria and proof of device performance for the medical functions of the Parcus Synd-EZ SS from this document. The document primarily focuses on the MR Conditional testing.

However, I can provide the available information regarding the MR Conditional testing:

Regarding MR Conditional Testing:

1. Table of Acceptance Criteria and Reported Device Performance (for MR Conditional Parameters):

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

• Sample Size: "worst-case device was selected for testing." The exact number of devices tested is not specified, but it implies a single representative device or a small number to characterize the "worst-case."
• Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by Parcus Medical, LLC (or a contracted lab) to comply with FDA guidance and ASTM standards. This would be prospective testing specifically for this submission.

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

• Not applicable for MR Conditional testing. MR Conditional testing relies on standardized physical measurements and engineering evaluations against defined limits, not expert clinical consensus on a "ground truth" derived from patient data.

4. Adjudication method for the test set:

• Not applicable. MR Conditional testing involves objective measurements rather than adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to MR Conditional testing of a physical implant.

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

• Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used:

• For MR Conditional testing, the "ground truth" is defined by the safety limits and thresholds established in regulatory guidance (FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment) and applicable ASTM standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

In summary, this document is a regulatory submission focused on demonstrating substantial equivalence and providing MR Conditional labeling. It does not provide detailed performance data or clinical study results for the device's primary indications, as those would have been covered in the original 510(k) clearances (K191783 and K192964) to which this device is substantially equivalent.

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The X-Twist PEEK Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:

Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.

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

The X-Twist PEEK Suture Anchor consists of an implantable anchor and anchor tip that are provided assembled to a driver. Retention suture(s) or suture tapes(s) are preloaded through the driver cannulation to secure the anchor tip onto the driver shaft. The anchor tip can be loaded with additional suture(s) or suture tapes(s) if needed for the intended surgical procedure. Clockwise rotation of the driver allows for advancement of the fully threaded anchor and anchor tip into the prepared bone socket to serve as the point of fixation for soft tissue repair.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: X-Twist PEEK Suture Anchor

Type of Study: Non-clinical (benchtop) testing and bacterial endotoxin testing. No clinical study was performed.

1. Table of Acceptance Criteria and Reported Device Performance

4. Adjudication Method for the Test Set

• Not applicable. As this is non-clinical benchtop and laboratory testing, there is no adjudication method involving human interpretation to establish ground truth for a test set. The results are quantitative measurements against predefined criteria.

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

• No. An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices."

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

• Not applicable. This device is a physical medical implant (suture anchor), not an algorithm or AI-powered system, so the concept of "standalone performance" in the context of AI does not apply. The performance evaluated is the physical and biological characteristics of the device itself.

7. Type of Ground Truth Used

• Benchtop Testing: Engineering performance metrics (e.g., force, torque, elongation) compared against established design specifications and predicate device performance.
• Bacterial Endotoxin Testing: Quantitative measurement of endotoxin levels against a regulatory standard (USP and ).

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms. While the device's design might have involved iterative testing and refinement, this is not documented as a formal "training set" in the context of this submission. The "training" in a broad sense would be the development process and previous predicate device data.

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

• Not applicable. As no formal "training set" (in the AI/ML sense) was used, this question is not relevant. The "ground truth" for the device's development would likely be established through biomechanical principles, material science, and the performance characteristics of previously cleared predicate devices.

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The Parcus Actiflip is used for fixation of bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repari (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.

The Parcus ActiFlip device consists of a titanium implantable button that is mounted onto an inserter shaft that allows for placement and deployment of the button. ActiFlip is available in three (3) configurations, with or without UHMWPE suture – Naked (without suture), CINCH, WHIP.

The provided text is a 510(k) summary for the Parcus ActiFlip device. It outlines the device's indications for use, its characteristics, and how its substantial equivalence to predicate devices was established. However, it explicitly states that "Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices" and that "Performance was established based on acceptance criteria with the rationale that the new specific indications...do not introduce a worst-case for mechanical performance of the subject device."

This type of submission for a medical device (a 510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance through a clinical trial with specific performance metrics and acceptance criteria for algorithm-based diagnostic or prognostic devices.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-driven diagnostic devices. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance: No such table or performance metrics are provided. The "performance" mentioned refers to mechanical performance, not diagnostic accuracy.
2. Sample size used for the test set and data provenance: No test dataset details are given.
3. Number of experts used to establish ground truth and qualifications: Not applicable as there's no clinical data or ground truth establishment for a diagnostic study.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was performed or is mentioned.
6. Standalone (algorithm-only) performance: Not applicable as this is a physical implant, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there's no algorithm training mentioned.
9. How ground truth for the training set was established: Not applicable.

The document describes a physical medical device (a fixation fastener), not an AI/ML-driven diagnostic or image analysis tool. The "performance" mentioned is mechanical validation (implicitly, by showing it's not a 'worst-case' scenario compared to predicates), not the type of performance evaluation relevant to AI diagnostics.

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The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair

The Parcus Titanium Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.

The provided text pertains to the 510(k) premarket notification for the "Parcus Titanium Interference Screws." This is a medical device for orthopedic fixation, specifically for ligaments and tendons. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than a study evaluating the performance of a diagnostic AI device against acceptance criteria. Therefore, most of the requested information regarding AI device-specific acceptance criteria and studies (such as MRMC studies, human-in-the-loop performance, expert qualifications for ground truth, sample sizes for training/test sets concerning AI, etc.) is not applicable to this document.

However, I can extract information related to the device's performance testing where described, as it serves a similar purpose to acceptance criteria demonstration for physical medical devices.

Here's an analysis based on the closest applicable information in the provided text:

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

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

• Sample Size: The document mentions that pull-out strength and insertion torque were measured for the smallest (7mm), largest (12mm), and an intermediate size of the Parcus Titanium Interference Screws. The exact number of samples for each size is not specified in this document.
• Data Provenance: The performance data for pull-out strength and insertion torque is referenced as being included with the submission of K083619 (the predicate device). This suggests the performance data was likely generated through in-vitro mechanical testing. The country of origin for this data is not specified.

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

N/A - This medical device is a physical fixation screw, not an AI diagnostic device. Ground truth as typically understood for AI studies (e.g., expert consensus on image interpretation) is not applicable here. The "ground truth" for this device's performance would be the direct measurements of mechanical properties.

4. Adjudication method for the test set

N/A - As above, adjudication methods for expert disagreement on ground truth are not applicable to the mechanical testing of a physical medical device.

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

N/A - This is not an AI-assisted diagnostic device.

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

N/A - This is not an AI algorithm.

7. The type of ground truth used

For the mechanical performance testing (pull-out strength, insertion torque), the ground truth is the direct physical measurement of these properties, likely using laboratory equipment. For pyrogenicity, the ground truth is established through LAL testing laboratory results. For substantial equivalence, the "ground truth" is the physical and functional characteristics of the device itself compared to a legally marketed predicate device.

8. The sample size for the training set

N/A - This is not an AI device, so there is no "training set."

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

N/A - As above, no training set for an AI model.

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The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The GFS BTB devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The Parcus ATLAS is indicated for adjunct fixation of the 1st and 2nd metacarpals in CMC arthroplasty.

The Parcus Actiflip Naked, Actiflip Cinch, and Actiflip Whip are used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, pectoralis repair (minor), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

The Parcus Synd-EZ Ti are intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ Ti are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

The Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6AI4V ELI, and may also include an UHMWPE polyblend suture component. Each device is provided sterile.

This document is a 510(k) Premarket Notification from Parcus Medical, LLC for several orthopedic fixation devices. It is a submission to the FDA for market clearance, asserting substantial equivalence to previously cleared predicate devices. The primary focus of the performance data in this submission is related to MR Conditional safety, as the devices themselves are largely unchanged from their predicates.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that "worst-case devices were selected for testing" for the MR environment evaluation. It does not provide a specific number for the sample size.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It implies the testing was conducted by or for Parcus Medical, LLC, which is based in Sarasota, Florida, USA. The testing was likely prospective for the specific purpose of this submission (determining MR Conditional status).

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

This type of information is not applicable to this submission. The "ground truth" here is based on objective physical measurements of the devices' interaction with an MR environment and chemical testing (LAL), not on expert subjective interpretation or clinical outcomes. The evaluation against standards like the "FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards" serves as the "ground truth" criteria.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective physical and chemical testing against established standards, not on expert consensus or adjudication of subjective data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms, not for the safety assessment of orthopedic implants.

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

No, a standalone algorithm performance study was not done. This submission is for medical devices (implants), not for an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this submission is based on:

• Physical measurements and compliance with established standards: For MR Conditional safety, this refers to measurements of magnetic force, torque, and heating in MR environments, assessed against the "FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards."
• Chemical testing results: For LAL (Limulus Amebocyte Lysate) testing, the ground truth is the measured endotoxin level against a defined acceptable limit.
• Predicate device characteristics: For biocompatibility, packaging, shelf-life, and sterilization, the "ground truth" is that these aspects remain unchanged and were previously deemed acceptable based on predicate devices.

8. The Sample Size for the Training Set

This is not applicable. This submission is for medical devices (implants) and does not involve an AI algorithm that requires a training set.

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

This is not applicable for the reason stated above.

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The Parcus Miti Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

The Parcus V-lox™ Titanium Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Hip: Acetabular Labral Repair

The Parcus Miti and V-lox Titanium Suture Anchors are a family of threaded, tapered fasteners for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136). It comes preloaded with either one, two, or three strands of sutures between 3-0 and #2 in size or suture tape between 1.4mm and 2.0mm wide. The suture and suture tape is available either with or without attached needles, and is provided sterile and attached to a driver. The Miti Suture Anchor is available in diameters of 2.0mm, 2.5mm and the V-lox Titanium Suture Anchor is available in diameters of 4.5mm, 5.0mm, 5.5mm and 6.5mm.

The provided text describes a 510(k) premarket notification for Parcus V-lox Titanium Suture Anchors and Parcus Miti Suture Anchors. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically associated with a new AI/software device. Instead, this document is a regulatory submission demonstrating substantial equivalence to previously cleared devices.

Here's an analysis of why the requested information cannot be fully provided based on the input:

• Type of Device: The devices are physical implants (suture anchors), not an AI or software device. The "performance data" section focuses on MR (Magnetic Resonance) compatibility, which is a safety evaluation for implanted medical devices, not an evaluation of diagnostic or treatment efficacy based on AI algorithms.
• Regulatory Pathway: A 510(k) submission primarily aims to demonstrate "substantial equivalence" to a predicate device, meaning it is as safe and effective as a device already on the market. This often involves comparing device specifications, materials, and intended use, and sometimes includes performance testing for specific safety attributes (like MR compatibility here), rather than clinical efficacy studies against acceptance criteria for a new mode of action.

Given this context, I will address the requested points as much as possible, clarifying where the information is not present due to the nature of the submission.

Acceptance Criteria and Device Performance

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

The document does not provide a table of acceptance criteria for diagnostic performance or treatment efficacy. The only performance data presented relates to MR compatibility.

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

The document mentions "worst-case devices were selected for testing" for MR compatibility. However, it does not specify the exact sample size (number of devices tested) for the MR evaluation. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) as this was a laboratory-based physical test on the device itself, not a clinical data study.

• 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 point is not applicable. The MR compatibility testing is a physical measurement of the device's interaction with an MR environment, not a diagnostic or clinical assessment requiring expert consensus or ground truth in the medical sense.

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

This point is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for physical performance testing like MR compatibility.

• 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 point is not applicable. The device is a physical medical implant (suture anchor), not an AI or software system that would involve human readers or AI assistance.

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

This point is not applicable. The device is a physical medical implant, not an algorithm.

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

For the MR compatibility testing, the "ground truth" would be the scientifically established physical limits and behaviors for MR safety as defined by FDA guidance and ASTM standards. It's a technical standard, not a medical "ground truth" derived from patient data.

• 8. The sample size for the training set

This point is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

This point is not applicable. There is no training set.

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The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, lliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle Lateral Stabilization. Medial Stabilization. Midfoot Reconstruction. Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Hip Acetabular Labral Repair

The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are tapered fasteners with an eyelet at the distal tip and circumferential barbs used to secure the implant in bone and provide suture fixation without the need for knot tying. After passing through the target tissue, sutures are passed through the distal eyelet of the anchor, it is pounded into place which secures both the anchor and the suture in place. This is the same design and insertion technique as the predicate Knotless PEEK CF Push-In Suture Anchors. The predicate device was originally provided in 3.5mm and 4.5mm diameters and this 510(k) will expand that size range to include 2.8mm and 5.5mm options. The Knotless PEEK Push-In Suture Anchor is made from polyetheretherketone (PEEK) and the Knotless PEEK CF Push-In Suture Anchors are made from carbon fiber polyetheretherketone (PEEK CF). The Parcus predicate device is comprised of carbon fiber polyetheretherketone (PEEK CF). The Parcus reference devices consist of devices comprised of either PEEK or PEEK CF. The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are provided sterile with a single use suture passer and either with or without a single use inserter.

This document describes the Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors. The provided text is a 510(k) summary for a medical device and, as such, does not contain information about acceptance criteria or a detailed study proving the device meets those criteria in the context of diagnostic performance or AI model evaluation.

The "Summary Performance Data" section briefly mentions that the device was evaluated for "strength and elongation under cycle loading and ultimate failure conditions" and that "Results were compared with test data for the predicate device and demonstrated substantial equivalency." This indicates mechanical testing was performed to demonstrate that the new device performs comparably to an existing, legally marketed device (the predicate).

However, the document does not provide specific numerical acceptance criteria for these mechanical tests, nor does it detail the specific results. It also does not involve any AI, image analysis, or human reader performance evaluation, and therefore, many of the requested points are not applicable.

Below is an attempt to address the request based only on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the mechanical performance tests. The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from internal testing conducted by Parcus Medical, LLC. The testing is for a new device attempting to prove substantial equivalence to a predicate, so it is a prospective evaluation of the new device's performance against existing data or concurrent testing of the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device performance study, not a study requiring expert interpretation of diagnostic data.

4. Adjudication method for the test set
Not applicable. This is a mechanical device performance study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to a physical medical device (suture anchors) and does not involve AI, image analysis, or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical device.

7. The type of ground truth used
For the mechanical tests, the "ground truth" (or reference) was the performance data of the predicate device (Parcus Knotless PEEK CF Suture Anchors, K113730) for "strength and elongation under cycle loading and ultimate failure conditions." For biocompatibility, the ground truth was based on the known materials and manufacturing processes of the predicate and reference devices. For pyrogenicity, it was an endotoxin limit specification.

8. The sample size for the training set
Not applicable. This document describes the testing of a physical medical device and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established
Not applicable. This document describes the testing of a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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The Parcus AcTiFlip is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

The Parcus AcTiFlip and GFS Ultimate Hip devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture and are provided sterile.

This FDA 510(k) summary provides limited information regarding the acceptance criteria and study data for the Parcus Medical AcTiFlip and GFS Ultimate Hip devices.

Here's an analysis based on the provided text, highlighting where information is available and where it's missing for your specific requests:

Summary of Acceptance Criteria and Device Performance (Limited Information):

Detailed Responses to Specific Questions:

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

   • See the table above. The document primarily states that the devices demonstrate "substantial equivalency" to predicate devices for mechanical properties (strength and elongation) and meet endotoxin specifications. Specific numerical acceptance criteria for strength and elongation are not
     provided in this summary, nor are the precise numerical results of the testing.

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: The document states that "testing was conducted on the worst case configurations," but does not specify the sample size (N) for these tests.
   • Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. It describes laboratory testing, not clinical studies.

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

   • This is not applicable as the summary describes mechanical and biocompatibility laboratory testing of a medical device (fixation fasteners), not a diagnostic or AI-driven device requiring expert-established ground truth.

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

   • This is not applicable for mechanical and biocompatibility testing. Adjudication methods are typically used in clinical studies or studies involving human assessment of data.

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

   • This is not applicable. The device (fixation fasteners) is not an AI/diagnostic 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:

   • This is not applicable. The device is a physical medical implant, not an algorithm.

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

   • For the mechanical tests, the "ground truth" (or more accurately, the reference standard for comparison) was the performance of the predicate device. The testing aimed to show that the new device's performance was "substantially equivalent" to this established predicate.
   • For pyrogenicity, the "ground truth" was established based on endotoxin limit specifications, which are regulatory standards.

8. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is not an AI/machine learning device. The testing described is for physical properties and biocompatibility.

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

   • This is not applicable for the reasons stated above.

In summary, the provided FDA 510(k) letter and summary focus on demonstrating substantial equivalence of a physical medical device (bone/soft tissue fixation fasteners) to already cleared predicate devices through mechanical testing and biocompatibility assessments. It does not involve AI, diagnostic algorithms, or human interpretation studies.

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The Parcus Synd-EZ SS is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

The Parcus Synd-EZ SS is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

The Parcus Synd-EZ SS consists of two buttons with suture connecting them and are designed to be used for stabilizing the syndesmosis during healing. Building upon the technology of the Parcus Synd-EZ Ti, the Synd-EZ SS is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium, stainless steel and UHMWPE suture and is provided sterile.

The provided text describes the Parcus Synd-EZ SS, a medical device intended for fracture repair and syndesmotic fixation. However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/algorithm performance.

Here's what can be extracted and what is missing:

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

The document provides a general statement about performance testing but does not offer a table of specific acceptance criteria or quantitative performance metrics.

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 available in the provided text. The document mentions "Devices were assembled to test blocks," implying laboratory testing, but does not specify the sample size or any data provenance related to human subjects or clinical data.

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 information is not available in the provided text. The device described is a physical implant, not an AI or diagnostic tool that would typically involve expert-established ground truth for performance evaluation in the way you've framed the question. The "testing" referred to is mechanical.

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

This information is not available in the provided text. Adjudication methods are typically used in clinical trials or studies involving expert interpretation, which is not described here for this mechanical device.

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 available in the provided text. The device is a surgical implant and does not involve AI assistance for human readers. Therefore, an MRMC study related to AI effectiveness is not relevant to this device.

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

This information is not available in the provided text. The device is a physical implant and does not involve an algorithm.

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

The "ground truth" for this device's performance would be established through mechanical test standards and material properties. The document states that "Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions." This implies engineering and biomechanical testing, where the "ground truth" is defined by established engineering principles and benchmarks for such implants. It's not clinical "ground truth" in the sense of diagnosis or pathology.

8. The sample size for the training set

This information is not available in the provided text. The document describes a physical medical device, not an AI/machine learning model that would have a "training set."

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

This information is not available in the provided text. This question is not applicable as there is no mention of a training set or AI model.

Summary of what the document does indicate about performance:

• Type of Study: Laboratory performance testing ("side by side with the predicate device").
• Parameters Evaluated: Strength and elongation under cyclic loading and ultimate failure conditions.
• Conclusion: The device "demonstrated substantial equivalency" to the predicate device (Parcus Synd-EZ Ti, K191783).
• Other Testing: LAL (Limulus Amebocyte Lysate) testing for pyrogenicity and a biocompatibility assessment in alignment with ISO 10993-1 were also conducted.

This document focuses on the regulatory clearance for a physical medical device based on substantial equivalence to a predicate device, primarily through mechanical testing and biocompatibility assessments. It does not pertain to the evaluation of AI systems or diagnostic performance as implied by many of your questions.

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