(61 days)
The Javelot PK-S suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart lesion repair -SLAP lesion repair -Acromioclavicular separation repair -Rotator cuff tear repair -Capsular shift or capsulolabral reconstruction -Biceps tenodesis -Deltoid repair Foot/Ankle: -Hallux Valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repair/reconstruction Elbow: -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Biceps tendon reattachment 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
The Javelot PK-S suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair Foot/Ankle: - -Hallux Valgus reconstruction - -Medial stabilization - -Lateral stabilization - -Achilles tendon repair - -Mid-foot reconstruction - -Metatarsal ligament/ tendon repair - -Bunionectorny Elbow: - -Ulnar/ radial collateral ligament reconstruction -Biceps tendon reattachment - -Lateral epicondylitis repair Hand/Wrist: - -Scapholunate ligament reconstruction - -Ulnar/Radial collateral ligament reconstruction Knee: - -Medial collateral ligament repair - -Lateral collateral ligament repair - -Posterior oblique ligament repair - -Iliotibial band tenodesis - -Patellar tendon repairs - -Anterior cruciate ligament repair (4.75-5.5mm anchors only) - -Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5mm anchors only) -Quadriceps tendon repair (4.75 mm anchors only) -Meniscal root repair (4.75 mm anchors only) Hip: -Capsular Repair -Acetabular labral repair - -Proximal hamstring repair (4.75-5.5mm anchors only) - -Gluteus Medius Repair (4.75-5.5mm anchors only)
The Javelot PK-P suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: - -Rotator cuff repair -Bankart repair -SLAP lesion repair -Biceps tenodesis -Acromioclavicular 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 Hip: -Capsular repair -Acetabular labral repair
The Javelot PK-P suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: - Shoulder: -Bankart repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair - Foot/ Ankle: -Hallux Valgus reconstruction -Medial stabilization -Lateral stabilization -Achilles Tendon Repair -Mid-foot reconstruction -Metatarsal ligament repair/ tendon repair -Digital tendon transfers (2.5mm anchor only) -Bunionectomy (2.9-4.5mm anchors only) Elbow: -Ulnar or radial collateral ligament reconstructions -Biceps tendon reattachment - -Lateral epicondylitis repair (2.9-4.5mm anchors only) Hand/ Wrist: -Scapholunate ligament reconstruction -Ulnar collateral ligament reconstruction (2.9-4.5mm anchors only) -Radial collateral ligament reconstruction (2.9-4.5mm anchors only) -Carpal ligament reconstruction (2.5mm anchors only) -Repair/Reconstruction of collateral ligaments (2.5mm anchors only) -Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits (2.5mm anchors only) -Digital tendon transfers (2.5mm anchors only) Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair -Iliotibial band tenodesis -Patellar tendon repairs Hip: (2.9-4.5mm anchors only) -Acetabular labral repair -Capsular repair
The Javelot PK-L suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: - Shoulder: - -Bankart lesion repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff tear repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair - -Anterior shoulder instability (3.7mm anchors only) Foot/ Ankle: - -Hallux Valgus repair - -Medial or lateral instability repair - -Midfoot reconstruction - -Metatarsal ligament/tendon repair/reconstruction - -Achilles tendon repair/reconstruction - -Bunionectomy (3.7mm anchors only) Elbow: - -Ulnar or radial collateral ligament reconstruction -Biceps tendon reattachment -Lateral epicondylitis repair (3.7mm anchors only) - Hand/Wrist: - -Scapholunate ligament reconstruction - -Ulnar collateral ligament reconstruction - -Radial collateral ligament reconstruction Knee: - -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair - -Iliotibial band tenodesis - -Patellar tendon repair Hip: (3.7mm anchors only) -Hip capsule repair Acetabular labrum reattachment/ reconstruction
All Javelot PEEK suture anchors are preassembled onto an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The anchors are offered in a polyetheretherketone (PEEK) material with a screw-in, push-in (with or without lock-in) design. The sutures are offered in non-absorbable USP braid ultrahigh molecular weight polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rod is offered in stainless steel material, the insertion handle is offered in acrylonitrile butadiene Styrene copolymers (ABS) material. Javelot PEEK suture anchors come in various configurations, including: with attached nonabsorbable suture(s). Javelot PEEK suture anchors are non-absorbable, provided sterile, for single use only.
This is a 510(k) premarket notification for multiple suture anchors. The document focuses on establishing substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. It does not describe a clinical study of the device or an AI/human-in-the-loop study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in the format usually seen for clinical studies or AI product validations. Instead, it states that "Non-clinical bench tests were conducted in support of the substantial equivalence determination" and that the "testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device."
The types of mechanical tests performed are listed, with the implication that the new devices met the performance characteristics expected for substantial equivalence:
| Parameter | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Insertion Testing | Performance comparable to predicate devices | Conducted; passed (implied by conclusion of substantial equivalence) |
| Pullout Testing | Performance comparable to predicate devices | Conducted; passed (implied by conclusion of substantial equivalence) |
| Component Interconnection Testing | Performance comparable to predicate devices | Conducted; passed (implied by conclusion of substantial equivalence) |
| Fatigue Testing | Performance comparable to predicate devices | Conducted; passed (implied by conclusion of substantial equivalence) |
| Biocompatibility | In accordance with ISO 10993-1: 2018 | Evaluated and deemed compliant |
| Bacterial Endotoxin | To meet endotoxin limit specifications | Determined using LAL testing to meet specifications |
| Sterilization | SAL of 10^-6 (validated according to ISO 11135:2014) | Validated to a SAL of 10^-6 |
| Shelf-life | 5 Years (evaluated by accelerated aging test) | Evaluated to be 5 years |
| MRI Safety | MR safe (per ASTM F2503) | Labeled MR safe |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical bench tests. It does not specify sample sizes for these tests, nor does it refer to "test sets" in the context of human data or AI validation. Therefore, provenance information like country of origin or retrospective/prospective is not applicable.
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 information is not applicable as the document describes non-clinical bench testing, not a clinical study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical bench testing, not a clinical study 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
No such study was conducted or described in this document. This is a medical device (suture anchor) and not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable since the device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical bench tests, "ground truth" would be established by standardized testing methods and measurement against predefined performance metrics (e.g., pullout strength, fatigue limits) according to relevant ASTM and ISO standards. This is not comparable to ground truth in a clinical or AI study.
8. The sample size for the training set
This is not applicable as the document describes a physical medical device, not an AI system.
9. How the ground truth for the training set was established
This is not applicable as the document describes a physical medical device, not an AI system.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.