Search Results

The Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: Shoulder: - · Bankart lesion repair - · SLAP lesion repair - · Acromio-clavicular separation repair - · Rotator cuff tear repair - · Capsular shift or capsulolabral reconstruction - · Biceps tenodesis - · Deltoid repair Foot and Ankle: - Hallux valgus repair - · Medial or lateral instability repair/reconstruction - · Achilles tendon repair/reconstruction - · Midfoot reconstruction - · Metatarsal ligament/tendon repair/reconstruction Elbow, Wrist and Hand: - Ulnar or radial collateral ligament reconstruction - · Lateral epicondylitis repair - · Biceps tendon reattachment - · Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) Knee: - · Extra-capsular repair - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - · Iliotibial band tenodesis - · Patellar realignment and tendon repair - Vastus medialis obliquus advancement Hip: (2.8-6.5mm anchors only) - · Capsular repair - · Acetabular labral repair

Javelot titanium anchors and sutures are preassembled onto an inserter, which enables insertion of the anchor into bone. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and the suture looped through the anchor. Javelot titanium suture anchors come in various configurations, including: with attached non-absorbable needle(s). In certain configurations, the Javelot titanium suture anchors are packaged with a drill, a drill guide and a drill guide handle. The anchors are offered in titanium material. The sutures are offered in non-absorbable USP braid Ultra High Molecular Weight Polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rods are offered in stainless steel material, the insertion handles are offered in polycarbonate (PC) material. The needles are offered in 302 stainless steel material, the drills are offered in 630 stainless steel material, the drill guides are offered in 304 stainless steel material, and the drill guide handles are offered in polyphenylsulfone (PPSU) material. Javelot titanium suture anchors are provided sterile, non-absorbable, for single use only.

The provided document is a 510(k) summary for a medical device (Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor), not a study report. Therefore, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a specific study designed to meet those criteria for an AI/software device.

The requested information regarding acceptance criteria and a study proving the device meets them, particularly points 2-9 which are specific to the evaluation of AI/software performance, are not applicable to this submission. This document describes a physical medical device (suture anchors) and its performance is evaluated through bench testing (mechanical, biocompatibility, sterilization, shelf-life, and MRI safety), not through AI/software performance metrics like sensitivity, specificity, or reader studies.

Here's a breakdown of what can be extracted from the provided text, recognizing that it doesn't align with the detailed AI/software performance study request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device, the "acceptance criteria" are implied by the standards and types of tests performed to demonstrate safety and effectiveness. The "reported device performance" refers to the successful completion of these tests in comparison to predicate devices, without specific numerical thresholds stated in this summary.

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

This information is not provided in the 510(k) summary. These details would typically be found in the full test reports, which are not included here. The tests are bench tests, not clinical studies on patient data.

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

Not applicable. This is a physical device, not an AI/software requiring expert adjudication for ground truth.

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

Not applicable, as this refers to expert review processes for AI/software data.

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

Not applicable. This is a physical device, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This does not involve an algorithm.

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

For mechanical tests, the "ground truth" would be the measured physical properties of the device under test conditions, evaluated against engineering specifications. For biocompatibility, it's compliance with established biological safety assessments. For sterilization, it's achieving a specified sterility assurance level. For MRI safety, it's adherence to defined safety limits for MR interaction. These are not types of ground truth relevant to AI performance.

8. The sample size for the training set

Not applicable. This is a physical device, no training data set is involved.

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

Not applicable. As there is no training set for a physical device.

In summary: The provided FDA 510(k) summary is for a physical medical device (suture anchors) and outlines the non-clinical bench testing conducted to demonstrate its substantial equivalence to predicate devices. The majority of the requested information pertains to the evaluation of AI/software performance, which is not relevant to this type of device submission.

Ask a specific question about this device

Smith & Nephew TWINFIX Ti Preloaded Suture Anchor with Needles, SL are intended for use only for the fixation of non-absorbable, synthetic, surgical suture material for the following indications.

Shoulder
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsulolabral reconstructions, Biceps tenodesis, and Deltoid Repairs

Foot and Ankle
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions

Elbow. Wrist and Hand
Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment

Knee
Extra-capsular repairs: Medial collateral ligament repair, Lateral ligament repair, Posterior oblique ligament, lliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement

The Smith & Nephew TWINFIX* Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL are designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique. TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL consists of a titanium alloy suture anchor and non-absorbable sutures with attached stainless steel needles. The non-absorbable sutures are offered either braided, silicone or PTFE impregnated, polyester (USP) or braided, uncoated, UHMW polyethylene and UHMW polyethylene with monofilament polypropylene or nylon co-braid. An insertion device is also offered which contains a stainless steel shaft with a ABS and polycarbonate handle. The TWINFIX Ti is designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique.

Here's an analysis of the provided text regarding the Smith & Nephew TWINFIX Ti 3.5 Suture Anchor's acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

Study Details

The provided text does not describe a study involving AI or software performance, but rather a traditional medical device 510(k) submission for a physical surgical anchor. Therefore, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth types related to AI) are not applicable.

Here's what can be extracted from the provided document:

1. Sample size used for the test set and the data provenance: Not applicable. The document refers to "Mechanical test data" but does not specify sample sizes or data provenance in terms of origin or retrospective/prospective nature. This generally refers to bench testing performed in a laboratory setting.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a mechanical device, ground truth is established through physical measurements against defined engineering specifications.

3. Adjudication method for the test set: Not applicable.

4. 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-enabled device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used: For a mechanical device, the ground truth is established by engineering specifications and validated testing methods (e.g., ASTM standards or internal protocols) for physical properties like insertion force, pull-out strength, fatigue, etc.

7. The sample size for the training set: Not applicable. There is no AI training set for this physical device.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications:

Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis

Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

Hip
Acetabular labral repair

In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:

Knee
ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction

The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoop™ , a Button or a coreless Sleeve structure, and a passing suture. A ZipLoop™ is constructed from ultra high molecular weight polyethylene (UHMWPE) or polyester. It is passed through the Sleeve or Button, thus creating a soft tissue fixation device that bunches or locks against the bone when deployed.

The Biomet Sleeve and Button Soft Tissue Devices received 510(k) clearance (K071704) based on substantial equivalence to legally marketed predicate devices, rather than through a study demonstrating direct achievement of specific performance acceptance criteria for a novel device. Therefore, the information provided in the document does not include a detailed table of acceptance criteria and reported device performance in the way typically seen for a new technology requiring such validation.

Instead, the submission relied on non-clinical testing and comparison to predicates.

Here's a breakdown based on the provided text:

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

This information is not explicitly available in the provided 510(k) summary. The submission states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This is a general statement rather than a detailed report of specific performance metrics against defined acceptance criteria. Without a specific new performance claim, the FDA typically assesses substantial equivalence based on materials, design, and intended use being similar enough to established predicates.

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

• Sample Size for Test Set: Not applicable/not specified. Clinical testing was not provided as a basis for substantial equivalence. The non-clinical testing details are not provided.
• Data Provenance: Not applicable, as no clinical studies were performed. The non-clinical testing details (e.g., in vitro, cadaveric) are not specified, nor is the country of origin.

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

Not applicable, as no clinical studies requiring expert ground truth establishment for a test set were conducted.

4. Adjudication method for the test set

Not applicable, as no clinical studies requiring adjudication were conducted.

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 fixation device, not an AI-assisted diagnostic or imaging tool.

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

Not applicable for clinical studies for this submission. For the non-clinical testing, the "ground truth" would implicitly be relevant engineering standards, biomechanical properties, and the established performance of the predicate devices.

8. The sample size for the training set

Not applicable, as no machine learning algorithm was involved.

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

Not applicable, as no machine learning algorithm was involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria, in this context, is the non-clinical testing mentioned in the 510(k) summary. The nature of a 510(k) clearance for this type of device (soft tissue fixation) primarily relies on demonstrating that the new device is substantially equivalent to existing legally marketed predicate devices.

The document states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

This indicates that Biomet performed tests (likely mechanical, biomechanical, and material characterization tests) to ensure the physical properties and performance characteristics of the Sleeve and Button Soft Tissue Devices were comparable to the predicate devices. The "acceptance criteria" were therefore implicitly that the new device's performance would fall within ranges deemed acceptable and safe, consistent with the performance of the chosen predicate devices, for the stated indications for use.

The predicates listed are:

• Multitak SS Suture System™ (K973015) - Bonutti Research
• BioRaptor™ (K053344) - Smith & Nephew
• Cruciate Ligament Button (PolySuture Button) (K813581) - Biomet Sports Medicine

The "study" was a set of non-clinical tests designed to show that the new device's materials, design, sizing, and ability to perform soft tissue to bone fixation did not raise new questions of safety or effectiveness when compared to these existing devices. The specifics of these tests (e.g., pull-out strength, fatigue testing, material biocompatibility) are not detailed in this summary but would have been part of the full 510(k) submission.

In essence, for a 510(k) based on substantial equivalence and non-clinical data alone for a device like this, the "acceptance criteria" are that the device performs functionally within its intended use and is comparable enough to predicates that it doesn't require a new PMA.

Ask a specific question about this device