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CoNextions TR Tendon Repair System is indicated for the repair of severed Tendons in adults (22 years of age or older). The product is intended for the following indications:

• Digital Flexor Tendons
• Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8)

The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.

The information regarding the acceptance criteria and study details for the CoNextions TR Tendon Repair System is extracted from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:

  • Initially, 90 participants were screened and randomized: 40 to the CoNextions TR group and 50 to the Suture group.
  • After exclusions (8 participants under 22, 1 participant with unrelated injury), 81 participants remained.
  • For the 12-week follow-up: 72 participants (88.9% of 81).
  • For the 24-week follow-up: 70 participants (86.4% of 81).
  • Specific numbers for CoNextions TR group and Suture group are:
    • Rupture (12 weeks): 33 CoNextions TR, 45 Suture (for specific analysis 1/34 CoNextions TR, 5/47 Suture)
    • Surgical site infection: 34 CoNextions TR, 47 Suture
    • Strickland Score (12 weeks): 27 CoNextions TR, 41 Suture
    • Strickland Score (24 weeks): 30 CoNextions TR, 42 Suture
    • Secondary Effectiveness (24 weeks): N=32-33 for CoNextions TR, N=40-42 for Suture.

• Data Provenance: Prospective, multi-site clinical evaluation. The country of origin is not explicitly stated, but the FDA submission implies a US-based study or one adhering to US regulatory standards.

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

• Number of Experts: 5
• Qualifications of Experts: Fellowship-trained hand surgeons.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for establishing ground truth, such as a 2+1 or 3+1 consensus. The study was a clinical evaluation conducted by the involved surgeons and clinical staff, with outcomes assessed and recorded per protocol. Participants and therapists performing the majority of outcome assessments were blinded for the first 12 weeks.

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 was not an MRMC study and does not involve AI assistance. The study compares a novel medical device (CoNextions TR Tendon Repair System) to a standard-of-care suture repair method for tendon lacerations.

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

This was not a standalone (algorithm only) study. It was a clinical study comparing a medical device with a human-in-the-loop (surgical implantation) to another surgical method.

7. The Type of Ground Truth Used

The ground truth was established through direct clinical outcomes and measurements from human patients, including:

• Physical examinations for re-rupture and surgical site infection.
• Objective measurements like goniometry for Strickland's Scores (mobility).
• Patient-reported outcomes (VAS Pain Scores, DASH Questionnaire Scores).
• Strength measurements (Grip Strength, Tip Pinch Strength).

8. The Sample Size for the Training Set

The document describes a clinical evaluation for the device and provides a summary of benchtop and animal testing. It does not mention a "training set" in the context of an algorithm or AI. The term "training set" is not applicable here as this is a device performance study, not an AI/ML study.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned in the document.

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The SPEEDTRAP suture construct is indicated for use in soft tissue approximation in orthopedic procedures.

The SPEEDTRAP graft preparation system consists of a suture construct provided on a disposable delivery device. The SPEEDTRAP Graft Preparation system is offered in long and short configurations with white (undyed) and green/white (undyed) color options, including single and multi-pack (Qty. 4) offerings.

This document is a 510(k) summary for the SPEEDTRAP Graft Preparation System, a medical device for soft tissue approximation. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study demonstrating the device meets those criteria, as typically found in an AI/software medical device submission.

However, it does describe the types of tests performed to establish equivalence.

Here's an analysis based on the provided text, highlighting the absence of the requested information for AI/software devices and interpreting the available data in the context of a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of acceptance criteria with corresponding performance data in the way one would expect for an AI/software medical device. Instead, it states that "Performance data equivalence was established using non-clinical testing, including suture diameter and suture tensile strength testing." It also mentions "bacterial endotoxin testing."

While not explicitly called "acceptance criteria," the regulatory standards and testing performed for substantial equivalence imply certain thresholds must have been met for these non-clinical tests.

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

• Test Set Sample Size: Not specified. The document states "non-clinical testing" was performed, but the number of sutures or tests conducted for diameter, tensile strength, or endotoxin is not provided.
• Data Provenance: Not applicable in the context of human data. These are non-clinical (laboratory/bench) tests on the physical device itself.

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

Not applicable. Ground truth, in the context of AI/software devices, refers to expert labeling or pathology. For this physical medical device, "ground truth" would be established by standardized measurement techniques and laboratory protocols for the non-clinical tests. No human experts are mentioned for establishing ground truth for these device performance metrics.

4. Adjudication Method for the Test Set:

Not applicable. This concept is for human expert review of cases, typically for AI/software validation. The performance tests described (suture diameter, tensile strength, bacterial endotoxin) are objective laboratory measurements, not subjective expert assessments requiring adjudication.

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 relevant for evaluating the impact of AI on human reader performance, usually in diagnostic imaging. The SPEEDTRAP Graft Preparation System is a physical surgical suture system, not an AI/software diagnostic tool.

6. If a Standalone Performance Study (Algorithm Only) was done:

No, a standalone (algorithm only) performance study was not done. This is specific to AI/software devices operating without human intervention. The SPEEDTRAP system is a manually implanted surgical device.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be the objective, measured values obtained through standardized laboratory testing methods. For instance, for suture diameter, the ground truth would be the measurement obtained using a calibrated micrometer; for tensile strength, it would be the force at break measured by a tensile testing machine according to a standard. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device.

In summary: The provided document is a 510(k) summary for a physical medical device (suture system). It details regulatory information and establishes substantial equivalence based on material, design, and non-clinical performance (suture diameter, tensile strength, bacterial endotoxin). The questions provided are primarily geared towards the validation of Artificial Intelligence/Software as a Medical Device (AI/SaMD), and thus, most of them are not directly applicable to the content presented in this document.

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The Compressyn™ Band is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

The Compressyn™ Band System consists of a stainless steel coupler preloaded with a polyester fiber band. It is a cerclage fixation device that is placed around or through the sternum and locked in place to provide stabilized fixation.

The acceptance criteria and study proving the device meets them are summarized below based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states, "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate devices." Specific numerical acceptance criteria and the Compressyn™ Band's performance against them are not provided, only that the outcome met the substantial equivalence criteria.

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

The document does not specify the sample size for the test set (number of devices tested) or the data provenance (country of origin, retrospective/prospective). It only mentions that "All necessary verification and validation testing has been performed."

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

N/A. This is a medical device (cerclage bone fixation) testing, not an AI or diagnostic imaging study that would require expert-established ground truth. The testing involves mechanical and performance characteristics.

4. Adjudication Method for the Test Set

N/A. The testing described is performance-based (mechanical tests) typically without human adjudication in the context of diagnostic agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

N/A. This is a medical device (cerclage bone fixation) testing, not an AI or diagnostic imaging study that would involve human readers.

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

N/A. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" or reference for comparison appears to be the performance characteristics of the predicate devices. The study aimed to demonstrate "substantial equivalence" of the Compressyn™ Band's mechanical and physical performance to these predicate devices. The specific physical properties or failure points of the predicate devices would form the benchmark for comparison.

8. The Sample Size for the Training Set

N/A. This is not an AI/machine learning study, so there is no concept of a "training set."

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

N/A. As there is no training set for an AI model, this question is not applicable.

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The Coalescent Surgical U-CLIP™ and accessories is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular procedures.

The Coalescent Surgical U-CLIP™ device is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip (optionally containing suture) and connected to needles via flexible members (optionally including various types of suture). This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Coalescent Surgical U-CLIP™ and Accessories:

Acceptance Criteria and Device Performance

Study Details

It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA for market clearance, not a detailed scientific study publication. As such, specific methodological details often found in a peer-reviewed research paper are condensed or omitted.

1. Sample Size used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated in the provided summary. The text mentions "in vitro and in vivo data," implying animal or human testing, but no specific numbers for the test subjects or samples are given.
   • Data Provenance: Not explicitly stated. The nature of in vitro and in vivo studies suggests laboratory and potentially animal testing, but the country of origin or whether it was retrospective/prospective is not specified.

2. Number of Experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable/Not mentioned. The "ground truth" here is less about expert consensus on interpretations (as in imaging studies) and more about objective functional performance measurements against established specifications and predicate device performance. The testing would likely be performed by engineers and technicians according to documented protocols.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of data (e.g., images) requires consensus. Here, the "ground truth" is based on objective measurements and comparisons.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance (e.g., radiologists interpreting images) with and without AI assistance. The U-CLIP is a surgical device, not an AI interpretation tool.

5. Standalone (Algorithm Only) Performance:

   • No, a standalone algorithm-only performance study was not done. The U-CLIP is a physical medical device, not an algorithm. The assessment is of its physical and functional properties.

6. Type of Ground Truth Used:

   • The ground truth for the performance claims appears to be:
     • Objective Functional Measurements: Data derived from in vitro (laboratory) and in vivo (live organism) testing.
     • Comparison to Predicate Device Performance: The functional characteristics and safety profile of the U-CLIP were compared against already legally marketed predicate devices (other U-CLIP models and Ethicon sutures).
     • Compliance with Standards: Adherence to internal specifications, external standards (not explicitly named but implied by "external standard requirements"), and USP suture testing requirements.

7. Sample Size for the Training Set:

   • Not applicable/Not mentioned. The U-CLIP is a manufactured device; there isn't a "training set" in the machine learning sense. Its design involved engineering, material science, and prior iterations (as indicated by the predicate devices).

8. How the Ground Truth for the Training Set was Established:

   • Not applicable/Not mentioned. As there is no "training set" in the AI sense, this question is not relevant. The "ground truth" for its development would be based on design specifications, material properties, biomechanical principles, and the performance characteristics of its predecessors.

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