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JuggerKnot Soft Anchor OC are intended for use in soft tissue to bone fixation for the following indications: Knee MPFL Knee Patellar tendon repair Knee MCL Knee Quadriceps tendon repair Hip Acetabular labral repair Hip Proximal hamstring repair Hip Hip Labral reconstruction Foot and Ankle Achilles tendon repair Foot and Ankle Medial/lateral repair and reconstruction Foot and Ankle Plantar plate repair Foot and Ankle Mid- and forefoot repair Foot and Ankle Metatarsal ligament/tendon repair or reconstruction Shoulder Rotator Cuff Shoulder Shoulder Instability Shoulder Biceps Tenodesis Elbow Lateral epicondylitis repair Elbow Biceps tendon reattachment

The JuggerKnot Soft Anchor OC is identical to the previously cleared JuggerKnot Soft Anchor OC except for the presence of a bioceramics embedded in the anchor portion of the device. The JuggerKnot Soft Anchor OC is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester. Up to two nonabsorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black. The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The JuggerKnot Soft Anchor OC are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The provided text describes a medical device, the JuggerKnot Soft Anchor OC, and its clearance under a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to prove efficacy and safety from scratch.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria (especially in terms of diagnostic performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets) is not applicable in the context of this 510(k) submission.

The document focuses on non-clinical performance testing and substantial equivalence to a predicate device, as opposed to a diagnostic device for which such performance metrics would be relevant.

Here's a breakdown based on the information provided and what is implied by a 510(k) submission for this type of device:

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

   • Acceptance Criteria: For this device (a bone fixation fastener), acceptance criteria are primarily related to mechanical performance, biocompatibility, sterilization, and material properties, demonstrating it is as safe and effective as the predicate.
   • Reported Device Performance:
     • Mechanical Testing: "performed comparably to the predicate device in insertion, cyclic and pullout testing."
     • Sterilization: "sterilization adoption validation"
     • Biocompatibility: "biocompatibility testing per ISO10993- 1:2018"
     • Stability: "stability testing on the product packaging per ISO 11607-1:2006"
     • Usability Engineering: "usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015"
     • Endotoxin/Pyrogenicity: "Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP , USP and USP ."

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

   • Test Set (for mechanical and other non-clinical tests): Not explicitly stated numbers for each test, but standard engineering and biological testing samples would have been used.
   • Data Provenance: The tests were likely conducted in laboratories or facilities chosen by the manufacturer, Riverpoint Medical, LLC, which is based in Portland, Oregon, USA. The studies are prospective in the sense that they were conducted for the purpose of this submission.
   • Animal Study: "An animal study was performed to evaluate the biological safety and in vivo performance associated with the JuggerKnot Soft Anchor OC." No specific animal numbers are provided.

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 device is a medical implant (bone fixation fastener), not a diagnostic device requiring expert interpretation of images or other medical data for ground truth. Ground truth for this device relates to physical and biological properties.

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

   • This is not applicable for the reasons stated above. Adjudication methods are typically for diagnostic interpretations.

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 is an implantable fastener, not an AI-assisted diagnostic tool.

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 implant, not an algorithm.

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

   • For the non-clinical tests, the "ground truth" is based on established engineering standards, material science properties, and biological safety parameters. For the animal study, the "ground truth" would be the observed biological response to the implant in vivo.

8. The sample size for the training set:

   • This is not applicable. This is a physical device submission; there is no "training set" in the context of machine learning or AI.

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 Dunamis PunchTac Suture Anchors are intended to be used for reattachment of soft tissue to bone for the following indications:

• Shoulder Capsular stabilization Bankart repair Anterior shoulder instability repair SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
  Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/ reconstructions Achilles tendon repairs/ reconstructions Midfoot reconstructions Metatarsal ligament/ tendon repairs/ reconstructions Bunionectomy

Knee

Extra-capsular repairs: medial collateral ligament, lateral ligament, posterior oblique ligament

Patellar realignment and tendon repairs: vastus medialis obliquous advancement, Iliotibial band tenodesis

Hip

Hip capsule repair Acetabular labrum reattachment Abductor tendon repair (in anchors 4.5mm - 6.5mm)

The Dunamis PunchTac Suture Anchors is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components:

• Suture Anchor (threaded, push-in and knotless designs)
• . USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene Suture(s) or Suture Tape (provided in configurations with suture only)
• . Inserter Tool

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Dunamis LLC for their PunchTac Suture Anchors.

It primarily details:

• The FDA's determination of substantial equivalence for the Dunamis PunchTac Suture Anchors to legally marketed predicate devices.
• The regulatory classification and product codes for the device.
• The intended indications for use of the suture anchors.
• A brief description of the device components.
• The predicate devices used for comparison.
• Statements indicating that testing was performed (pull-out strength and insertion testing) and that the device met "pre-determined acceptance criteria identified in the Design Control Activities" and LAL testing requirements. However, it does not specify what those acceptance criteria were, what the reported performance was, or provide details about the study itself.

Therefore, I cannot provide the requested information from this document.

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The Smith & Nephew MICRORAPTOR Suture Anchor is intended for the reattachment of soft tissue to the following indications:

Hip
Acetabular labrum repair/reconstruction

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Biceps tenodesis

The Smith & Nephew MICRORAPTOR Suture Anchor consists of an anchor on a flexible and/or straight inserter, flexible and/or straight drill, and curved and/or straight insertion accessory instruments. The implant will be offered in an absorbable material (REGENESORB), single loaded #1 ULTRABRAID suture with multiple suture color offerings. This device is provided sterile, for single use only.

This document is a 510(k) Pre-Market Notification for a medical device called the "MICRORAPTOR REGENESORB Suture Anchor". It describes the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices, rather than a clinical study evaluating the performance of an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and comparative effectiveness studies for an AI device is not applicable to this document.

This document describes the following for the MICRORAPTOR REGENESORB Suture Anchor:

1. Acceptance Criteria and Reported Device Performance (Summary):

The performance of the MICRORAPTOR REGENESORB Suture Anchor was evaluated against performance specifications derived from its predicate devices.

Study Description (Summary per the provided text):

The submission refers to "Performance data" to demonstrate that the MICRORAPTOR REGENESORB Suture Anchor met the specified criteria. These appear to be benchtop or laboratory tests, not clinical studies involving human subjects or AI algorithms.

• Bacterial Endotoxin Testing: Was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011.
• Insertion Strength Testing: Performance data demonstrates the device met specifications based on the predicate Pivot NANOTACK Suture Anchor, 1.4mm (K131769).
• Cyclic Loading Testing: Performance data demonstrates the device met specifications based on the predicate OSTEORAPTOR Suture Anchor (K082215).

Given that this document describes a traditional medical device (suture anchor) and not an AI/ML powered device, the following points are not applicable and are therefore marked as "N/A":

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (This is for an AI/ML powered device, not a suture anchor)
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): N/A
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (The "ground truth" here is the performance of specified predicate devices and standard endotoxin limits for a physical device)
8. The sample size for the training set: N/A
9. How the ground truth for the training set was established: N/A

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The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: Hip: Hip capsule repair - Acetabular labrum reattachment/reconstruction Shoulder: Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator Cuff repairs Biceps Tenodesis Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy Knee: Extra-capsular repairs - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Iliotibial band tenodesis Elbow, Wrist, and Hand: Lateral epicondylitis repair Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions

Subject of this Traditional 510(k) premarket notification is an addition to the indications for use for the Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K082215, and K093428, respectively, and have identical indications for use. Smith & Nephew, Inc. seeks to expand the existing indications for use for the subject devices to include acetabular labrum reconstruction.

The provided document is a 510(k) summary for Smith & Nephew suture anchors, seeking to expand their indications for use. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a new study with performance metrics.

Therefore, many of the requested sections related to acceptance criteria, device performance from a test set, expert involvement, and ground truth are not explicitly available in the provided text. The submission relies on the prior clearances and the inherent characteristics of the device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it states that "Smith & Nephew is relying on the mechanical testing (insertion strength, pull-out strength, and suture sliding) provided for the predicate devices as a measure of substantial equivalence." This implies that the acceptance criteria for these mechanical properties were met in the original clearances of the predicate devices, and because there have been no changes to the design or materials, they are still considered met.

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

Not applicable. This submission doesn't describe a new study with a "test set" for performance evaluation in the context of diagnostic accuracy or a similar measurable outcome. The "test set" implicitly refers to the mechanical testing performed for the original clearances of the predicate devices. The document does not provide details on the sample sizes or data provenance (country of origin, retrospective/prospective nature) of these original mechanical tests.

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

Not applicable. There is no mention of experts establishing a "ground truth" for a test set in this 510(k) submission. The evaluation is based on mechanical properties and substantial equivalence to previously cleared devices.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described for a test set in this submission.

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 medical device for surgical procedures (suture anchors), not an AI-assisted diagnostic tool. An MRMC study is irrelevant to this submission.

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.

7. The Type of Ground Truth Used

The "ground truth" for this type of device (suture anchors) is established through mechanical testing (e.g., measuring forces required for insertion, pull-out, and suture sliding) against engineering specifications and industry standards, and ultimately, through clinical outcomes data from the use of the device and its predicates. The submission references reliance on "mechanical testing" for the predicate devices and "published articles supporting the additional indication," suggesting that the clinical effectiveness and safety of such devices are established in the medical literature.

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. This is not an AI/machine learning device.

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