Search Results

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.

Ask a specific question about this device

The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

The proposed device, WEGO-STAINLESS STEEL, is monofilament, non-absorbable surgical suture composed of stainless steel. WEGO-STAINLESS STEEL is undyed and uncoated. The proposed device is composed of suture and needle. The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes. WEGO-STAINLESS STEEL complies with the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.

The provided document is a 510(k) summary for the "WEGO-STAINLESS STEEL" surgical suture, in which the manufacturer asserts substantial equivalence to a predicate device (Surgical Stainless Steel Suture K170767). The document describes non-clinical tests conducted to support this claim, but it does not describe an AI/ML powered device, nor does it detail acceptance criteria related to AI/ML performance, or comparative effectiveness studies of AI vs. human readers.

Therefore, the requested information regarding AI/ML acceptance criteria, study details, expert involvement, and MRMC studies cannot be extracted from this document, as it is outside the scope of a traditional medical device (surgical suture) 510(k) submission.

However, I can provide the available information regarding the non-clinical tests performed to demonstrate substantial equivalence for the surgical suture:

Acceptance Criteria and Device Performance (for Non-Clinical Tests of Surgical Suture)

The acceptance criteria for the "WEGO-STAINLESS STEEL" surgical suture were based on compliance with established international and pharmacopeial standards. The reported device performance indicates that the proposed device met these standards.

The subsequent questions are related to AI/ML device studies and are not applicable to this document, as it concerns a conventional surgical suture.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes non-clinical tests on a physical device, not an AI/ML model.
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. Ground truth for AI/ML is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No clinical study was included, and this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
The DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
The DePuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.

The DePuy Synthes Porous Polyethylene Implants consist of porous/smooth implant sheets with or without titanium.
The DePuy Synthes Titanium Wire is a nonabsorbable, monofilament, sterile surgical wire composed of commercially pure titanium wire is available in a length of 500mm with different gauge sizes, and is available with or without a permanently attached stainless steel needle.
The DePuy Synthes Titanium Wire with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm, and has a permanently attached stainless steel needle.

The provided text describes the 510(k) premarket notification for the DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio, focusing on their MR Conditional labeling. It primarily details non-clinical performance testing rather than a clinical study evaluating diagnostic accuracy or algorithmic performance with human readers.

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

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion: The non-clinical performance data demonstrated that the subject devices, when exposed to the MR environment under specific MR conditions of use, did not raise new questions of safety or efficacy.

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

The document does not detail a "test set" in the context of clinical or algorithmic performance. The testing described is non-clinical performance testing on the devices themselves to assess their safety in an MR environment. Therefore, information about human data provenance, sample size of a test set, etc., is not applicable to this type of study.

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

Not Applicable. As this is non-clinical performance testing for MR safety, there is no "test set" that requires expert ground truth establishment in the traditional sense of medical image analysis or diagnosis. The "ground truth" here is the physical interaction of the device with the MR environment as measured by standardized tests.

4. Adjudication Method for the Test Set

Not Applicable. There is no "test set" requiring adjudication by experts. The performance is measured against established engineering standards for MR safety.

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 describes non-clinical performance testing for MR safety of physical implants and wires. It does not involve any AI, human readers, or a comparative effectiveness study.

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

No. The document describes non-clinical performance testing of physical medical devices, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on established engineering and safety standards (ASTM standards) for assessing the behavior of medical devices in a Magnetic Resonance (MR) environment. This includes:

• ASTM F2052-14 for magnetically induced displacement force.
• ASTM F2213-06 for magnetically induced torque.
• ASTM F2182-11a for radio frequency (RF) heating.
• ASTM F2119-07 for image artifacts.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/algorithm study involving a training set. The descriptions are for non-clinical performance testing of physical devices.

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

Not Applicable. As there is no training set for an algorithm, there is no ground truth established in this context.

Ask a specific question about this device

The Thorecon Rigid Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.

The Thorecon Rigid Fixation System may be implanted via an open or minimally invasive approach. Where additional stability is desired, devices can be used with traditional monofilament wire or Sternal Cable of similar material. The Thorecon Rigid Fixation System includes plates (some with integrated cable subassemblies) manufactured from 316L stainless steel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainless steel (ASTM F1314). Non-implantable needles, used to guide the cable around the sternum, are manufactured from 420 or Custom 470 stainless steel. Thorecon devices are all single-use. The plates, complete with the necessary screws and instruments (torque driver and tensioner/cutter) required for completion of the surgery, are provided sterile in a disposable kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system.

The provided text is a 510(k) Premarket Notification for the Thorecon™ Rigid Fixation System. It describes a medical device related to bone fixation, specifically for the sternum. The document focuses on regulatory approval and substantial equivalence to a predicate device, supported by non-clinical (mechanical and MR safety) testing.

Therefore, the information requested about acceptance criteria, study design for AI/human reader performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, and MRMC studies is not present in this document. This document concerns a physical medical device (implants, screws, etc.) and its mechanical and material properties, not an AI or software-as-a-medical-device (SaMD) product.

The document states:

• Purpose of Submission: To obtain clearance of modifications to the Thorecon Rigid Fixation System, including the addition of MR Conditional Safety Labeling.
• Discussion of Supporting Non-Clinical Testing: "The following nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable."
  • Mechanical Performance (Worst-Case Construct Assessment, Assessment of previously completed testing, Cerclage Dynamic Tension Testing)
  • MR Safety Evaluation following standards (ASTM F2052-15, ASTM F2213-17, ASTM F2182-11a, ASTM F2119-07)

Since the request is specifically about a study that proves a device meets acceptance criteria, and the provided text is about a physical medical device (Thorecon™ Rigid Fixation System) rather than a software or AI device, it's important to clarify that the "device" in question here is the implantable hardware.

Here's an interpretation of the acceptance criteria and the study based on the provided document, in the context of a physical medical device, while acknowledging that the original prompt's questions are generally geared towards AI/SaMD.

Acceptance Criteria and Device Performance (for a Physical Medical Device)

The document does not explicitly list quantitative acceptance criteria in a table format with reported performance for individual tests. Instead, it states that all identified nonclinical tests "passed acceptance criteria established by the predicate device where applicable." This indicates a qualitative statement of compliance rather than specific numerical values.

1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, this exact table cannot be constructed with specific numerical values as they are not provided.

2. Sample Size Used for the Test Set and the Data Provenance
For a physical device's mechanical and MR safety testing:

• Sample Size: Not explicitly stated as "sample size" in the context of human data. For mechanical and MR safety testing of physical devices, samples would refer to the number of device units tested. This specific number is not provided in the summary.
• Data Provenance: This is not applicable in the context of human data or geographical origin for mechanical and MR safety testing of a physical device. These tests are laboratory-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for mechanical and MR safety testing of a physical medical device is established by physical measurements and compliance with engineering standards, not by expert human interpretation.

4. Adjudication Method for the Test Set
Not applicable. This applies to subjective human interpretations for ground truth, not objective physical 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 is for AI-assisted image interpretation or similar cognitive tasks, not for a physical implantable device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for AI algorithms, not a physical implantable device.

7. The Type of Ground Truth Used

• For Mechanical Performance: Engineering specifications, material properties, and comparative performance against the predicate device.
• For MR Safety Evaluation: Compliance with established ASTM standards (F2052-15, F2213-17, F2182-11a, F2119-07) and FDA guidance for MR conditional labeling.

8. The Sample Size for the Training Set
Not applicable. This terminology refers to machine learning models. For a physical device, there isn't a "training set" in the AI sense. Design and manufacturing processes are iteratively refined based on engineering principles and test results.

9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is for AI models. Principles of engineering and materials science guide the design and manufacturing of the device.

Summary in relation to the document:

The provided document, a 510(k) Premarket Notification, is for a physical medical device (Thorecon™ Rigid Fixation System) which aids in sternal fixation. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing for mechanical performance and MR compatibility. The document states that these tests were conducted and "passed acceptance criteria established by the predicate device where applicable" and complied with relevant ASTM standards and FDA guidance for MR safety, leading to the "MR Conditional" designation.

The questions in the prompt are largely tailored for Artificial Intelligence (AI) or Software as a Medical Device (SaMD) products, which typically involve performance evaluation based on human-interpreted data, often medical images. The nature of the Thorecon™ Rigid Fixation System and the testing described in this 510(k) summary (mechanical and MR safety) does not involve AI or human data interpretation studies of the kind implied by the questions.

Ask a specific question about this device

The Thorecon Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.

The Thorecon Fixation System may be implanted via an open or minimally invasive approach. Where additional stability is desired, devices can be used with traditional monofilament wire or Pioneer Sternal Cable of similar material.

The Thorecon Fixation System includes plates (some with integrated cable subassemblies) manufactured from 316L stainless steel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainless steel (ASTM F1314). Non-implantable needles, used to guide the cable around the sternum are manufactured from 420 or Custom 470 stainless steel.

Thorecon Fixation System devices are all single-use. The plates, complete with the necessary screws and instruments (screw driver and tensioner/cutter) required for completion of the surgery are provided sterile in a kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system.

Here is an analysis of the acceptance criteria and supporting study for the Thorecon™ Fixation System, based on the provided text:

Preamble: The provided document is a 510(k) summary for a medical device (Thorecon™ Fixation System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel effectiveness. Therefore, the "study" referenced in the context of this document primarily refers to non-clinical testing performed to show that the new device performs at least as safely and effectively as existing, legally marketed devices. It is not an effectiveness study in the typical sense of a clinical trial demonstrating a new treatment's efficacy.

Acceptance Criteria and Reported Device Performance

• Screw Push-Out of Plate Force Test
• Bone Screw Pull-Out Test per ASTM F543
• Static Tension Testing
• Dynamic Tension Testing |
  | Packaging, Sterility & Shelf Life | Validation completed per standards:
• ISO 11607 (Packaging)
• ASTM D4169 (Shipping Containers)
• ISO 11137-2 (Sterilization Dose)
• ASTM F1980 (Accelerated Aging)
• ISO 17665-1 (Moist Heat Sterilization) |
  | Biocompatibility | Evaluation completed per ISO 10993 (Parts 1, 5, 10, and 11). |
  | Pyrogenicity | Evaluated using Limulus amebocyte lysate (LAL) assay, ensuring endotoxin level meets the requirement of maximum endotoxin limit for implantable medical devices [20 EU per device]. |

Additional Information on the "Study" (Non-Clinical Testing)

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

   • The document does not specify numerical sample sizes for the individual mechanical, packaging, sterility, shelf life, biocompatibility, or pyrogenicity tests. It only states that these tests were performed and "passed acceptance criteria."
   • The data provenance is internal, originating from testing conducted by or for A&E Medical Corporation to support their 510(k) submission. No specific country of origin for the data is mentioned, but the company is based in the USA. The tests are non-clinical (laboratory/bench) studies, not patient data (retrospective or prospective).

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

   • This question is not applicable in the context of this 510(k) submission. "Ground truth" and "experts" are terms typically used in studies involving subjective assessments (e.g., image interpretation, clinical diagnosis) where human judgment needs to be standardized or measured against a gold standard. For engineering and materials testing (mechanical performance, sterility, etc.), the "ground truth" is defined by established scientific principles, validated testing methodologies, and international standards (e.g., ISO, ASTM), rather than expert consensus on subjective observations.

3. Adjudication Method for the Test Set:

   • This is not applicable as the "test set" consists of non-clinical, objective measurements against pre-defined performance standards or predicate device performance, not subjective appraisals requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers (e.g., radiologists) interpreting medical images or clinical data, often with and without AI assistance, to assess diagnostic performance. The Thorecon™ Fixation System is a surgical implant; its performance is evaluated through biomechanical and materials testing, not through diagnostic interpretation.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

   • This question is not applicable as the Thorecon™ Fixation System is a physical medical device (surgical implant), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

6. The Type of Ground Truth Used:

   • The "ground truth" for the non-clinical tests mentioned (mechanical, packaging, sterility, biocompatibility, pyrogenicity) is based on established industry standards (e.g., ASTM, ISO), regulatory requirements (e.g., FDA guidelines), and performance data from predicate devices. For example, for mechanical tests, the ground truth is a specific force or displacement value that the device must withstand or perform to a certain degree. For pyrogenicity, it's a defined endotoxin limit. For biocompatibility, it's compliance with established biological safety profiles.

7. The Sample Size for the Training Set:

   • This question is not applicable. "Training set" refers to data used to train machine learning models. The Thorecon™ Fixation System is a physical medical device, not an AI software, and therefore does not have a "training set" in this context. The manufacturing process and design are based on engineering principles and material science, not machine learning.

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

   • This question is not applicable for the same reason as point 7.

Ask a specific question about this device

MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.

MERISTEEL™ Stainless steel suture is a monofilament, non-absorbable sterile surgical suture composed of stainless steel. This suture is available undyed and uncoated. MERISTEEL™ suture is available in a range of gauge sizes and lengths, and attached to standard stainless steel needles of various types and sizes. Stainless steel suture complies with the requirements of the United States Pharmacopoeia for Non Absorbable Surgical suture and European Pharmacopoeia for Sterile Non-Absorbable surgical strands

This looks like a 510(k) summary for a medical device (MERISTEEL™ Stainless Steel Surgical Suture). However, the document does not contain acceptance criteria for an AI/ML-driven device or study details proving those criteria are met.

The provided document describes a traditional medical device (surgical sutures) and outlines tests conducted to demonstrate equivalence to a predicate device, such as:

• **Diameter USP **
• **Tensile strength USP **
• **Needle attachment USP **
• Suture Length
• Biocompatibility as per ISO 10993-1

These are performance standards for the physical properties and biological safety of the suture material, not criteria related to AI/ML performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document is about a conventional medical device submission.

Ask a specific question about this device

Stainless Steel Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

Stainless Steel Suture is a sterile monofilament or multifilament, non-absorbable sterile surgical suture composed of 316L stainless steel. The suture is also available coated with polyethylene. Stainless Steel Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes. Stainless Steel Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for Sterile Non-Absorbable Strands and the United States Pharmacopoeia (USP) for Non Absorbable Surgical Sutures. The European Pharmacopoeia recognizes units of measure Metric and Ph. Eur. sizes as equivalent which is reflected on the labeling.

Stainless Steel Suture elicits a minimal acute inflammatory reaction in tissue and is not absorbed. Implantation studies in animals show that no significant change in the retention of tensile strength of the suture occurs during the lifetime of the implantation.

The provided text describes a 510(k) premarket notification for a medical device called "Stainless Steel Suture" by Ethicon Incorporated. This is not a study proving device performance against acceptance criteria in the manner typically seen for new, innovative devices with novel performance characteristics or AI components. Instead, it's a submission to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, and ground truth types related to performance metrics) are not applicable in this context because the FDA cleared this device based on its substantial equivalence to an existing device, rather than novel performance data from a clinical or algorithm-based study.

The primary "acceptance criteria" here relate to demonstrating that the new device is as safe and effective as the predicate device, with a focus on updated labeling for MRI safety. The "study" isn't a complex clinical trial or AI algorithm validation, but rather a series of bench and design verification tests and a comparison to the predicate.

Here's the information extracted and adapted to the prompt, with explanations for why certain fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as this was a substantial equivalence submission based on bench testing of the product, not a clinical study with patient data. The tests would have used appropriate numbers of suture samples per the relevant ASTM and USP standards.
• Data Provenance: The data provenance is from bench/design verification activities performed by Ethicon Inc., in compliance with design control requirements. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission on the device to verify compliance with standards and MRI safety guidelines. Country of origin not specified, but likely where Ethicon's primary R&D/manufacturing takes place (e.g., USA given the submitter's address).

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

• Not Applicable. For a device like a stainless steel suture cleared via substantial equivalence, ground truth as typically defined for AI or diagnostic studies (i.e., expert consensus on clinical findings, pathology confirmation) is not relevant. The "ground truth" for the bench tests would be the established scientific/engineering principles and the specifications within the referenced ASTM and USP standards. The "experts" involved are the testing personnel and engineers who conducted and validated the bench tests according to recognized industry standards.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1 consensus) are typically used in clinical studies or AI algorithm validation to resolve discrepancies among human readers or between AI and human reads. This submission is based on objective bench testing against pre-defined engineering and safety standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study involving human readers or AI assistance was conducted or is relevant for its clearance.

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

• Not Applicable. This device is a physical surgical implant, not an algorithm or software. No standalone algorithm performance testing was performed.

7. The Type of Ground Truth Used

• Engineering Standards and Specifications: The "ground truth" for this device's performance is compliance with established and recognized engineering and medical device standards, specifically:
  • United States Pharmacopoeia (USP) monographs for sutures ( Needle Attachment, Tensile Strength, Diameter).
  • ASTM Standards for MRI Safety (F2503, F2052, F2119, F2182, F2213).
  • AAMI/ANSI/ISO 10993-7 for EO residual testing.
  • ANSI/AAMI ST72:2011 and USP , for Bacterial Endotoxin Testing (BET).
  • European Pharmacopoeia (Ph. Eur.) for Sterile Non-Absorbable Strands.
  • The "ground truth" also stems from the long history of safe and effective use of the predicate device (Surgical Stainless Steel Suture, K946173) which the proposed device is substantially equivalent to.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device, so there is no training set.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

Ask a specific question about this device

The modified E-PACK™ procedure kits are provided with the same indication statements for each component of the kit, identical to the labeling provided with the individually marketed device.

Ethicon, Inc. E-PACK™s are considered convenience kits because two or more separate types of Ethicon finished devices are packaged together for the convenience of the user. Ethicon, Inc. certifies that all components within the E-PACK™ procedural kit are legally marketed devices manufactured by or for Ethicon, Inc. The classification of the kit is based on the highest classification of the devices that are provided in the kit. Ethicon, Inc. E-PACK™ Procedure Kits highest device classification is Class II.

The modified package will consist of individual finished devices, with or without their original primary package, that are placed into a plastic sleeve organizer that is subsequently placed into a blister tray with a Tyvek lid.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the E-PACK™ Procedure Kit. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

It's important to note that this document pertains to a procedure kit consisting of pre-packaged existing medical devices (sutures, clips, etc.) and its packaging design and sterilization, not an AI/ML-driven medical device or a diagnostic device whose performance is measured via metrics like accuracy, sensitivity, or specificity.

Therefore, most of the requested information regarding acceptance criteria and study designs relevant to AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

However, I can extract the information that is relevant to the device described:

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

The document describes performance testing related to product integrity and manufacturing processes, not diagnostic performance. The "acceptance criteria" here relate to meeting existing standards for medical device components and packaging.

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

The document does not specify exact sample sizes for each test (e.g., number of kits tested for stability or transit). It states that testing was "performed," and the results "provide reasonable assurance." The data provenance is internal design verification testing performed by Ethicon, Inc.

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

This is not applicable. The product is a pre-packaged kit of existing devices, and the "testing" relates to physical characteristics, sterility, and packaging integrity, not diagnostic or clinical accuracy requiring expert interpretation of ground truth.

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

Not applicable.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an algorithm.

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

The "ground truth" here is defined by compliance with established international standards (e.g., ISO 10993-7 for biocompatibility, ISO 11607-1 for packaging, ISO 14971 for risk management) and the confirmed performance of the individual components within the kit, which were already legally marketed and had their own established safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

Ask a specific question about this device

Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.

This document is a 510(k) premarket notification for surgical sutures, not an AI/ML device. Therefore, the requested information (acceptance criteria and study details for an AI-powered device) is not present in the provided text.

The document describes traditional medical devices (surgical sutures) and asserts their substantial equivalence to predicate devices based on:

• Intended use
• Material
• Design
• Performance (Diameter, Needle attachment, and Tensile strength)
• Sterilization method
• Biocompatibility evaluation

The performance testing summarized indicates that the sutures meet the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Non-absorbable Sutures. It also mentions biocompatibility evaluation, rabbit pyrogen and LAL testing, and compliance with ASTM F138-13 for steel sutures.

Ask a specific question about this device

"DemeSTEEL" is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.

Demetech's DemeSTEEL is a Monofilament and/or Multifilament Non-absorbable surgical suture composed of 316L Stainless Steel and supplied with and without needles affixed to the sutures. Demetech's DemeSTEEL Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures. DemeSTEEL Stainless Steel sutures are composed of 316L stainless steel conforming to the FDA recognized ASTM Standard F138 Grade 2 "Stainless steel bar and wire for surgical implants".

This document describes the Demetech Non-Absorbable Stainless Steel Surgical Suture (DemeSTEEL) and its equivalency to predicate devices, primarily through non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document leverages the United States Pharmacopeia (USP) standards as its primary acceptance criteria. The device is reported to meet or exceed these standards.

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

The document does not explicitly state the specific sample sizes for each non-clinical test. It generally states that "Non-clinical testing was conducted on the device to prove conformance to the requirements of USP standards." The data provenance is laboratory testing conducted by Demetech, likely in the US, given the company's address and the FDA submission. The data is prospective, generated specifically for this submission.

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

Not applicable. This is a medical device submission primarily based on objective physical and chemical testing against established standards (USP, ASTM). There were no experts involved in establishing a "ground truth" in the way it is typically understood for interpretative tasks (e.g., medical image analysis). The "ground truth" here is adherence to specified material and performance parameters.

4. Adjudication Method for the Test Set:

Not applicable. No adjudications were performed as this primarily involves objective measurements of physical and chemical properties against predefined standards.

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 a submission for a surgical suture, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study was conducted or is relevant.

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

Not applicable. This is a physical medical device (suture), not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" used is defined by:

• Established Industry Standards: United States Pharmacopeia (USP) for non-absorbable surgical sutures, including specific sections for diameter, tensile strength, needle attachment, suture length, and sterility.
• Material Specifications: ASTM Standard F138 Grade 2 for 316L stainless steel.
• Biocompatibility Standards: Implicitly, common standards for biocompatibility testing for implantable devices, with the 316L material having an "established history of use."

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable. As noted above, there is no "training set." The performance of the suture is assessed against predefined, universally accepted physical and chemical standards.

Ask a specific question about this device