Search Results

HyperSuture All Blue Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture All Blue Extension Line cables are non-absorbable, sterile, surgical sutures, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture All Blue Extension Line cables are available in USP 2 and USP 5 and meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures.

HyperSuture All Blue Extension Line tapes are non-absorbable, sterile, surgical braids, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in 1.5mm tape (USP 2 equivalent) and 2.0mm tape (USP 5 equivalent).

Both HyperSuture All Blue Extension Line cables and tapes are available in blue, 36 inches in length, and with or without pre-attached needles.

The provided text is a 510(k) summary for the HyperSuture All Blue Extension Line. This document is a regulatory submission to the FDA for a medical device and describes its equivalence to a predicate device. It does not contain information related to software performance, clinical studies, or AI algorithm validation. The device in question is a surgical suture, not a software or AI-powered diagnostic tool.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) because these are concepts applicable to software or AI device validation, which is not what this document addresses.

The document focuses on establishing substantial equivalence to a predicate device based on material, manufacturing, and physical performance characteristics, primarily adhering to USP (United States Pharmacopeia) standards for surgical sutures.

Ask a specific question about this device

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

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

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

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

The document primarily focuses on:

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

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

Ask a specific question about this device

The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

The furnished document is an FDA 510(k) Premarket Notification for the medical device "Fix2Lock". This document is a clearance letter, not a study report for an AI/ML medical device. It pertains to a bone fixation screw and its substantial equivalence to predicate devices, not an AI-powered diagnostic or assistive technology.

Therefore, the document does not contain the information requested in the prompt regarding:

• Acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Types of ground truth.
• How ground truth for training data was established.

The document discusses non-clinical bench tests to verify the subject device's design specifications and compliance with various ASTM and ISO standards for materials, mechanical performance, sterilization, and packaging. This is for a physical implantable device, not a software algorithm.

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

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

Ask a specific question about this device

The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to tissue to tissue. Specific indications: Foot/ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament and Tendon Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Plantar Plate Repair

The Paratrooper™ Plantar Plate Repair System includes an all-suture soft tissue fixation device. The suture implant comes in one size and is provided attached to a needle.

The provided text describes the 510(k) premarket notification for the Paratrooper™ Plantar Plate Repair System. It is a medical device, specifically an all-suture soft tissue fixation device used for tissue-to-tissue and tissue-to-bone fixation. The information provided is primarily for regulatory clearance and does not detail a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or diagnostic accuracy study.

Therefore, many of the requested categories related to AI/ML or comparative effectiveness studies (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document. This document focuses on demonstrating substantial equivalence to predicate devices through performance testing, biocompatibility, and sterilization, rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any of the tests. The document only states that "All necessary testing has been performed on representative Paratrooper™ Plantar Plate Repair System components."
• Data Provenance: Not applicable in the context of clinical data. The testing mentioned appears to be bench testing on the device components themselves.

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

• Not applicable. This is not a study requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method 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:

• No. This is not an AI/ML device or a diagnostic device, so an MRMC comparative effectiveness study is not relevant.

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

• Not applicable. This is a hardware medical device.

7. The type of ground truth used:

• Not applicable in the conventional sense of ground truth for a diagnostic study. The "ground truth" for this device's performance would be the established engineering and biological standards for mechanical strength, biocompatibility, and sterility, which are verified through the specified tests.

8. The sample size for the training set:

• Not applicable.

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

• Not applicable.

Ask a specific question about this device

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

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

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

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

Acceptance Criteria and Reported Device Performance

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

Information Not Available in the Document:

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

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

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

Ask a specific question about this device