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SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

SB Anchor is used for connecting with Healing abutment or Cover Cap on the top of the SB Anchor to fix the SMARTbuilder that is predicated 510(K), K120951, K130840. The SB Anchor has the same material, indication for use, technological characteristics and similar design as the predicate device, Height in the SMARTbuilder System. The SB Anchor is designed for use with NT Fixture connection (K081078) and TS SA Fixture connection (K121995).

This document is a 510(k) premarket notification for a dental device called "SB Anchor." It asserts substantial equivalence to a predicate device, the "SMARTbuilder System." The document does not describe a study involving an AI/CADe device or its performance criteria/results.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device conformance for an AI-based system. The provided text is a regulatory submission for a conventional medical device (an endosseous dental implant abutment).

Specifically, the document states:

• "No clinical studies are submitted" (Page 5, Section 8). This explicitly indicates that no clinical performance data for the device, including any related to AI or a study demonstrating its meeting of acceptance criteria, is present.
• The entire document revolves around demonstrating substantial equivalence to a predicate device based on material, indication for use, and technological characteristics of a physical implant component, not a software algorithm.

Based on the provided text, the following information is not available:

1. A table of acceptance criteria and the reported device performance: Not applicable as this is not an AI/CADe device and no performance study is described.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: No.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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This device, Polymer OBL SB Series and Cinch Series Anchor/Suture Combination is intended for use only for the fixation of non-absorbable synthetic sutures for the following indications.

The Polymer Cinch SB Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Shoulder:

• Bankhart Repair
• SLAP Lesion Repair
• Acromio-clavicular separation
• Rotator Cuff Repair
• Capsule and Capsulolabral Reconstruction
• Biceps Tenodesis
• Deltoid Repair

Hand, Wrist, Elbow:

• Scapholunate ligament reconstruction
• Ulnar Collateral Ligament Reconstruction
• Lateral Collateral Ligament Reconstruction
• Biceps Tendon Reattachment
• Elbow Medial/Lateral Repair of Tendons in the Elbow

Foot:

• Hallux Valgus Reconstruction
• Mid and Forefoot Reconstruction

Knee:

• medial collateral ligament
• lateral collateral ligament
• posterior oblique ligament
• Joint capsule closure
• Illiotibial band tendonesis
• VMO Advancement

Urinary: Bladder Neck Suspension

The Polymer OBL SB Anchor is a simple modified polyacetal cylinder designed to be pushed through a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. Each anchor is preloaded with suture and includes an insertion device.. These components are packaged together sterile in double mylar/tyvek pouches or formed trays. The device is single use. The device can be used for open and arthroscopic procedures.

The anchor is a modified cylinder made of polyacetal. From the end, the anchor is round with two grooves milled 180° apart. From the side, the anchor is a parallelogram with a hole through it. The anchors will be referred to by the diameter and the overall length, for example 2x8 means the diameter is 2.0 mm and the length is 8 mm. Refer to the drawing on page 12 for the dimensions "C" and "A".

The largest anticipated size of the anchor is 3 mm in diameter and 15 mm in length (3x15). The smallest anticipated size of the anchor is 2 mm in diameter and 8 mm in length (2x8). The purpose of the hole through the device is to hold suture. The smooth longitudinal grooves on each side of the device allow the suture to pass into the bone hole without pinching the suture. The ends of the device are designed to initiate rotation of the device as it is pushed and subsequently pulled into place. The ends are tapered at angles that range from 30° to 60°. The anchor is symmetric, allowing it to be inserted with regard to which end enters first. The shape of the device distributes the load over a large bone surface reducing the risk of bone breakage or pullout.

The Insertion Device is a manual surgical instrument comprised of a handle, sleeve, and piston. The handle is constructed from polypropylene and serves the functions of holding all pieces together and to interface between the surgeon's hand and the device. The sleeve houses the piston and the Anchor. The sleeve keeps the Anchor and piston in-line to allow the piston to push the Anchor into the implantation site.

The Suture is Braided Polyester Suture from Surgical Specialties (See Appendix 3 for Approval Letters. N80950). The largest anticipated diameter of the suture USP #2. The smallest anticipated diameter of suture is USP #2-0. The suture is preloaded in the anchor eyelet.

Materials
Anchor: Polyacetal Inserter: Piston and Sleeve: Stainless Steel, Handle: Polypropylene Suture: Braided Polyester from Surgical Specialties, See Appendix 3.

Use
To implant the Anchor, the surgeon must first create an implantation site in bone. OBL supplies accessory drills and awls to prepare these sites.

Once the implantation site is prepared, the surgeon simply aligns the Anchor to the hole, pushes the handle toward the bone, retracts, and disconnects the Suture from the Inserter. The Suture will be retained by the Anchor. Pulling back on the Suture further engages the Anchor into the walls of the hole. The surgeon is then left with an Anchor in the bone and Suture to attach to the soft tissue.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the requested information about AI/ML specific acceptance criteria, study designs, and performance metrics (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable.

The document describes the device, its intended use, a comparison to predicate devices, and performance data related to its physical characteristics.

Here’s the available information presented in a format that aligns with the requested table, as much as possible for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not applicable for this type of device submission):

The following points are specific to AI/ML device evaluations and are not present in this 510(k) submission for a non-AI surgical anchor:

• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
• Standalone (algorithm only) performance
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data)
• Sample size for the training set
• How the ground truth for the training set was established

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