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The Arthrex Mini Bio-Anchor is a bioabsorbable polylactide (PLDLA) screw intended to provide fixation of suture to bone in various surgeries such as foot. ankle, elbow, hand, and wrist. Specifically;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Foot: Hallux Valgus reconstruction
Ankle: Mid-foot reconstruction

The Arthrex Mini Bio-Anchor is manufactured using poly(L-lactide, co-D-L-lactide) or PLDLA. It is a threaded anchor with a suture evelet for inclusion of the Arthrex Fiberwire™or other appropriate suture. The Mini Bio-Anchor is available with a reusable guide for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone by using a uniquely sized single-use sterile drill.

This document is a 510(k) summary for the Arthrex Mini Bio-Anchor, a medical device. It's a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving acceptance criteria. Therefore, the information requested in the prompt, which pertains to studies demonstrating performance against acceptance criteria, training and test sets, expert involvement, and statistical analyses, is not present in this type of document.

The document provides:

• Device Description: The Arthrex Mini Bio-Anchor is a threaded, bioabsorbable (PLDLA) anchor for suture fixation to bone, available with a reusable guide and requiring a single-use drill for preparation.
• Intended Use/Indications for Use: Fixation of suture to bone in various surgeries (foot, ankle, elbow, hand, wrist), with specific examples like Biceps Tendon Reattachment in the elbow and Hallux Valgus reconstruction in the foot.
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to predicate devices based on having the same intended use and not raising new safety or effectiveness questions due to its material, which is well-characterized in predicate devices.

Missing Information:

The document does not contain any of the following, which would typically be found in a study report designed to prove a device meets acceptance criteria:

1. A table of acceptance criteria and reported device performance: This document does not define specific performance metrics or acceptance criteria for the device (e.g., tensile strength, pull-out force, biodegradation rate targets) nor does it report any test results against such criteria.
2. Sample size used for the test set and data provenance: No test sets or data are mentioned.
3. Number of experts used to establish ground truth and their qualifications: No experts are mentioned as establishing ground truth for performance testing.
4. Adjudication method for the test set: Not applicable as no test sets or adjudicated results are involved.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable as this is a physical medical implant, not an algorithm or AI.
7. Type of ground truth used: No performance testing results are presented, so no ground truth data is discussed.
8. Sample size for the training set: Not applicable as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.

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The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder (Bankart lesion repairs, SLAP lesion repairs, Acromio-clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Altoid repairs), Foot and Ankle (Hallux Valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions), Elbow, Wrist and Hand (Scapholunate ligament reconstructions, Ulnar or radial collateral ligament reconstructions, Tennis elbow repair, Biceps tendon reattachment), Knee (Extracapsular repairs and reattachments of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia, joint capsule closure to anterior proximal tibia; Extracapsular reconstruction, Iliotibial band tenodesis; Patellar realignment and tendon repairs), Bladder Neck Suspension (Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility).

The Pre-loaded Bio-Anchor is an injection molded Poly (L-lactic) acid suture anchoring device with an attached nonabsorbable braided polyester surure USP size #2. The device is circular in shape with three cylindrical ribs perpendicular to the long axis. The suture is passed through the eyelet of the anchor and attached to a wire by shrink tubing.

The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device (Pre-loaded Bio-Anchor Absorbable Suture Anchor). This type of document is a premarket notification to the FDA, demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device.

It is crucial to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence, not necessarily on presenting original clinical studies with acceptance criteria, sample sizes, and ground truth establishment in the way one might find for a novel, high-risk device requiring PMA (Premarket Approval).

Therefore, the information you've requested about specific acceptance criteria, detailed study designs, and performance metrics (like effect size for MRMC studies or standalone algorithm performance) is not typically found in a 510(k) summary like this one.

Instead, 510(k) submissions typically reference:

• Performance data from the predicate device: The new device is compared to a previously cleared device.
• Bench testing: To demonstrate physical and mechanical properties.
• Biocompatibility testing: To ensure safety when in contact with the body.
• Sterilization validation: To confirm the device can be consistently sterilized.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. It states: "Testing has been done to prove safety and effectiveness of the devices." The primary "performance" discussed is the demonstration of substantial equivalence to predicate devices in design, function, and intended use.

2. Sample sized 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 summary. Since the submission focuses on substantial equivalence and refers to "testing," it's likely referring to bench-top mechanical testing, biocompatibility testing, and sterilization validation, not large-scale clinical trials that would have clearly defined test sets in terms of 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)

This information is not applicable/not provided. The assessment for a suture anchor is generally based on mechanical properties and biological interactions, not interpretation of images or patient data that would require "ground truth" established by human experts in this context.

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

This information is not applicable/not provided. As explained above, the "test set" and ground truth establishment do not align with methods requiring adjudication by experts.

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

An MRMC study is not applicable to this type of device. This device is a physical implant (suture anchor), not an AI diagnostic tool or software.

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

This is not applicable as the device is a physical medical implant, not an algorithm or software.

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

The concept of "ground truth" as typically applied in AI/diagnostic studies is not directly applicable here. For a mechanical device like a suture anchor, "ground truth" would be related to material properties meeting specifications, biomechanical performance (e.g., pull-out strength), and biocompatibility, which are verified through engineering and biological testing, not clinical "outcomes data" in the same sense as a drug or complex diagnostic. The basis for safety and effectiveness is largely demonstrated through comparison to predicates and testing of physical properties.

8. The sample size for the training set

This information is not applicable/not provided. Training sets are relevant for AI algorithms, which this device is not.

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

This information is not applicable/not provided. Training sets and ground truth establishment methods are primarily for AI/machine learning models.

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The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.

Shoulder:

1. Bankart lesion repairs
2. SLAP lesion repairs
3. Acromio-clavicular separation repairs
4. Rotator cuff tear repairs
5. Capsular shift or capsulolabral reconstructions
6. Biceps tenodesis
7. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
2. Medial or lateral instability repairs/reconstructions
3. Achilles tendon repairs/reconstructions
4. Midfoot reconstructions

Elbow, Wrist and Hand:

1. Scapholunate ligament reconstructions
2. Ulnar or radial collateral ligament reconstructions
3. Tennis elbow repair
4. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs and reattachments of:
   a. medial collateral ligament
   b. lateral collateral ligament
   c. posterior oblique ligament or joint capsule to tibia
   d. joint capsule closure to anterior proximal tibia
2. Extracapsular reconstruction, iliotibial band tenodesis
3. Patellar realignment and tendon repairs

The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.

The material used for this device is:

Anchor - Poly (L-lactic) acid (PLLA)

The provided text is a 510(k) Summary of Safety and Effectiveness for the Linvatec Bio-Anchor™ Absorbable Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a performance study with quantitative results.

Therefore, many of the requested categories regarding acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies cannot be answered directly from the provided document. The document describes the device, its intended use, and its similarities and dissimilarities to predicate devices. It refers to a "chart of similarities and dissimilarities" to demonstrate substantial equivalence, which is a qualitative comparison rather than a formal performance study with acceptance criteria.

Below is an attempt to address your request based only on the information provided in the input, with many fields explicitly marked as "Not provided in the document."

Acceptance Criteria and Device Performance

Since this is a 510(k) submission primarily focused on substantial equivalence, specific numeric acceptance criteria for performance are not explicitly stated in the provided text. The "performance" demonstrated is typically compliance with mechanical and material properties similar to the predicate device. The table below represents a qualitative comparison used for substantial equivalence rather than quantitative acceptance criteria.

Study Details

1. Sample size used for the test set and the data provenance: Not provided in the document. The document describes a comparison to predicate devices for substantial equivalence, not a performance study with a defined test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment for a clinical test set is not described as part of this 510(k) submission.
3. Adjudication method for the test set: Not applicable/Not provided.
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 document is for a medical device (suture anchor), not an AI-assisted diagnostic or therapeutic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used: Not applicable/Not provided. The basis for approval is substantial equivalence to a legally marketed predicate device, primarily based on design, materials, and intended use, rather than a clinical performance study with "ground truth" as typically understood in diagnostic device evaluation.
7. The sample size for the training set: Not applicable/Not provided. This is a medical device, not an AI model requiring a training set.
8. How the ground truth for the training set was established: Not applicable/Not provided.

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Bladder Neck Suspension
The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.
The material used for this device is:
Anchor - Poly (L-lactic) acid (PLLA)
The Bio-Anchor Absorbable Suture Anchor is available in sizes ranging from 2.5mm to 5.2mm diameter.

The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device (Bio-Anchor Absorbable Suture Anchor) submitted to the FDA in 1997. This type of document is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not a study designed to prove the device meets specific acceptance criteria based on performance data.

Therefore, the document does not contain the acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone algorithm performance, or details on how ground truth was established for training and test sets as typically found in a clinical study report.

Here's why this information is missing and an explanation based on the document type:

This 510(k) submission focuses on demonstrating substantial equivalence to existing, legally marketed devices. It does this by:

• Describing the device: Its material (PLLA), shape, and mechanism of action.
• Stating its intended use: Bladder neck suspension for female urinary incontinence due to urethral hypermobility.
• Identifying predicate devices: Linvatec Revo/Mini Revo, Mitek GII Anchor and Absorbable Anchor, Zimmer Statak Device, Zimmer Resorbable Soft Tissue Attachment Device, and Vesica Medical, Inc. Bone Anchor System.
• Comparing the new device to predicates: A table highlights similarities and dissimilarities in materials, intended use, sterilization, and sizes. The key similarity emphasized is the material (PLLA) with the Zimmer Resorbable device and the intended use with several predicates.

The FDA's review and approval (as indicated by the letter in Section 4 and 5) signify that they found the device substantially equivalent to predicates and thus determined it to be safe and effective for its stated intended use, based on the information provided and comparisons to established devices. It does not imply that a new clinical study with specific acceptance criteria was performed or reported in this document.

If such a study were conducted, its results would typically be included as part of the submission, detailing methods, endpoints, statistical analyses, and performance metrics. However, for a 510(k) requiring substantial equivalence, extensive comparative performance data against specific acceptance criteria is often not required if equivalence can be demonstrated through other means (e.g., material, design, and intended use similarity to predicate devices).

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