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The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:

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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

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

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The Arthrex Bio-Corkscrew Suture Anchor is a 5.5 x 15mm fully threading anchor configured with suture or with suture and needles.

This K043337 submission for the Arthrex Bio-Corkscrew Suture Anchor is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device). For devices cleared via 510(k), especially for general orthopedic fixation devices like suture anchors, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through comparison to a predicate device's performance, rather than through a rigorous, AI-specific performance study with pre-defined acceptance criteria and ground truth validation. This clearance relies on the established safety and effectiveness of the predicate.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in a 510(k) submission for this type of device, as it does not involve an AI/ML algorithm or a new performance claim that requires such a study design.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (General to 510(k) process):

• Same Intended Use: The new device must have the same intended use as a legally marketed predicate device.
• Same Technological Characteristics: The new device must have the same technological characteristics as the predicate, OR different technological characteristics must not raise new questions of safety and effectiveness.
• No New Questions of Safety and Effectiveness: Any differences in technological characteristics must be demonstrated to be as safe and effective as the predicate.

Reported Device Performance (as per the 510(k) Summary):

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

• Not applicable: This 510(k) submission does not describe a clinical study with a "test set" in the context of an AI/ML algorithm or a performance study requiring such a sample size. The substantial equivalence relies on comparison to a predicate device and potentially non-clinical bench testing (but details of such testing are not provided in the summary).

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

• Not applicable: No "ground truth" was established for a test set in the context of an AI/ML or diagnostic performance study as described in the provided document.

4. Adjudication Method for the Test Set

• Not applicable: There was no test set requiring adjudication in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: An MRMC comparative effectiveness study was not done, as this is a medical device for physical fixation, not an image analysis or diagnostic AI tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable: This device is a physical suture anchor, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable: No "ground truth" data of the type requested (expert consensus, pathology, outcomes data) was used in this 510(k) submission for the purpose of validating an AI/ML model or a new diagnostic claim. The "ground truth" for substantial equivalence is effectively the performance and safety profile of the predicate device.

8. The Sample Size for the Training Set

• Not applicable: This submission does not involve a "training set" for an AI/ML model.

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

• Not applicable: This submission does not involve an AI/ML model or a training set requiring ground truth establishment.

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The Stryker BioZip Suture Anchor is a soft tissue anchor that will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:

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

Knee: Extra Capsular Repairs Medial Collateral Ligament Lateral Collateral Ligament Posterior Oblique Ligament Illiotibial Band Tenodesis Patellar Tendon Repair. '

Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Biceps Tendon Reattachment.

Foot and Ankle: Medial Instability Repair/Reconstruction Lateral Instability Repair/Reconstruction Achilles Tendon Repair/Reconstruction Midfoot Reconstruction Hallux Valgus Reconstruction.

Pelvis: Bladder Neck Suspension Procedures.

The Stryker BioZip Suture Anchor is intended for single-use only.

The Stryker BioZip Suture Anchor consists of a Poly L-lactic acid (PLLA) screw-in type suture anchor pre-threaded with two non-absorbable USP braided polyester sutures (one white and one green, needles attached) preloaded on a disposable inserter. The anchor is a bio-absorbable screw with eyelets to receive the sutures and a hex shaped cannulation down its center to accept the inserter's hex shaped tip mates with the anchors hex shaped cannulated core. By rotating the inserter the anchor is screwed into the bone. Once in place the ends of the suture are used to secure soft tissue to the bone.

The Stryker BioZip Suture Anchor will be provided sterile for single-use (ASTM 4169). The device will be sterilized by Ethylene Oxide (EN550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per ISO-10993 and G95-1.

The provided text describes the Stryker BioZip Suture Anchor, a medical device for securing soft tissue to bone. However, it does not contain details about acceptance criteria, device performance metrics, or a study report that would typically include such information for a new device's clearance.

Instead, this document is a 510(k) Summary of Safety and Effectiveness for the Stryker BioZip Suture Anchor, submitted to the FDA. The primary purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing the new device's technological characteristics and intended use to those of the predicate.

Here's what can be extracted from the document, though it won't directly answer all your questions about acceptance criteria and a detailed performance study:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Implied by Substantial Equivalence): The implicit acceptance criterion for a 510(k) submission is "substantially equivalent performance" to the predicate device in terms of intended use, safety, and efficacy. Specific quantitative acceptance criteria (e.g., maximum pull-out strength, degradation rate) are not explicitly stated in this summary for the product's performance but would have been part of the testing supporting the substantial equivalence claim.
• Reported Device Performance:
  • Intended Use: Securing soft tissue to bone using suture in reconstructive surgery.
  • Material: Poly L-lactic acid (PLLA) for the anchor, with non-absorbable USP braided polyester sutures.
  • Sterility: Provided sterile for single-use (ASTM 4169), sterilized by Ethylene Oxide (EN550) to a sterility assurance level (SAL) of 10^-6.
  • Biocompatibility: Biocompatible per ISO-10993 and G95-1.
  • Comparison to Predicate: "The subject device was shown to have substantially equivalent performance when compared to the predicate device." (Predicate: Arthrex 5.0 mm Bio-Corkscrew Suture Anchor, K990987).

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

• Not specified. The document does not provide details on specific sample sizes for performance testing. Data provenance (country of origin, retrospective/prospective) is also not mentioned. This type of detail would typically be found in the full test report, not the 510(k) summary.

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

• Not applicable/Not specified. This type of information is usually relevant for studies involving human interpretation (e.g., imaging studies). For a mechanical device like a suture anchor, "ground truth" would be established through engineering and materials testing, not expert consensus on interpretations. The document does not mention any expert panels for ground truth determination.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. As "ground truth" is not established by human review for this type of device, an adjudication method like 2+1 or 3+1 is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study is typically for evaluating diagnostic or imaging systems where human readers interpret data. This is a surgical implant, so an MRMC study is not relevant.

6. If a Standalone Performance Study (Algorithm Only) Was Done:

• Not applicable. This is a physical medical device, not an algorithm. Performance studies would involve mechanical and biological testing. The summary states "The subject device was shown to have substantially equivalent performance when compared to the predicate device," which implies standalone performance testing was conducted and compared, but specifics are absent in this summary.

7. The Type of Ground Truth Used:

• For this device, "ground truth" would be established through:
  • Engineering and Mechanical Testing: Such as pull-out strength, torque performance, fatigue testing, degradation characteristics, etc.
  • Biocompatibility Testing: In vitro and in vivo tests to ensure the material is safe for implantation.
  • Sterility Testing: Validation of the sterilization process.
• However, the summary document does not explicitly detail the specific ground truth metrics or methodologies used, only stating that it proved substantial equivalence to the predicate.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, no training set for an algorithm.

In summary: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a performance study with explicit acceptance criteria and results. While it confirms that studies were conducted to prove biocompatibility, sterility, and performance to establish substantial equivalence, it does not include the detailed quantitative data you've requested.

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