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Biomet Sports Medicine™ Anchors and ZipLoop™ Constructs are intended for use In soft Intended DSC. District oper of it the shoulder, foot / ankle, elbow, knee, hand / wrist, and hip. The Biomet suture anchor devices have similar indications for use with one Indication for Use statement for nonresorbable anchor devices and another for resorbable anchor devices. ZipLoop™ Constructs may be (esoraged separately (one Indication for Use Statement covers a ZipLoop™ Construct packaged separately) or preloaded on suture anchors In place of sutures (an Indication for Use statement for non-resorbable anchor device with ZipLoop™ Construct and another for a resorbable anchor device with a ZipLoop™ Construct). Specific indications for use are as follows:

Anchor devices without ZipLoop Constructs:
Device Name: Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK Anchors
Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK and Hitch™ PEEK Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific Indications are as follows:
Shoulder: Acromio-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle: Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs
Elbow: Blceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee: ACL/PCL (only for ALLthread™ Titanlum and ALLthread™ PEEK anchors), Illiotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Reallgnment / Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx, Ulnar/Radial Collateral Ligament Reconstruction Acconstraction) Tenash Titanium and ALLthread™ PEEK), Volar Plate Reconstruction
Hip: Labral

Device Name: ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors
ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hltch™ L-15 Suture Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot and ankle, elbow, knee, hand and wrist, and hip. Specific indications as follows:
Shoulder: Acromio-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle: Achilles Tendon Repair / Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot / Forefoot Reconstruction / Repairs
Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral / Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee: ACL/PCL (only for ALLthread™ L-15), Illiotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment / Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb) (not Including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not including Hitch™ L-15), Ulnar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15}, Volar Plate Reconstruction (not Including Hitch™ L-15)
Hip: Labral

ZipLoop™ Constructs packaged separately:
Device Name: Full, Bowtie and Half Zip-Loop™ Constructs
Full, Bowtle and Half ZipLoop™ Constructs are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, knee, and hip.
When a ZipLoop™ Construct is packaged separately, the specific Indications for use are as follows:
Shoulder: Acromio-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle: Achilles Tendon Repair / Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs / Reconstruction, Midfoot/Forefoot Reconstruction / Repairs
Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral / Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee: ACL/PCL (only for 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Illiotiblal Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment / Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Ulnar/Radial Collateral Ligament Reconstruction (only for 2-0 or larger UHMWPE Full and Bowtie ZipLoop™ Construct), Volar Plate Reconstruction
Hip: Labral
When a ZipLoop™ Construct Is packaged with a Blomet Sports Medicine™ internal fixation device, please refer to the package insert included with the surgeon's choice of internal fixation device for specific indications.

Anchor devices packaged with ZlpLoop™ Constructs:
Device Name: Ti-Screw, ALLthread™ Titanlum, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs
Ti-Screw, ALLthread™ Titanlum, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs are Indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:
Shoulder: Acromio-Clavlcular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Blceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle: Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs
Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee: ACL/PCL (only for ALLthread™ Titanium and ALLthread™ PEEK anchors in conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Illiotiblai Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment / Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Ulnar/Radial Collateral Ligament Reconstruction (only for Tl-Screw, ALLthread™ Titanium and ALLthread™ PEEK In conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct); Volar Plate Reconstruction
Hip: Labral

Device Name: ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors with ZipLoop Constructs
ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors with ZipLoop Constructs are indicated for soft tissue reattachment procedures in the shoulder, foot and ankle, elbow, knee, hand and wrist, and hip. Specific indications as follows:
Shoulder: Acromio-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle: Achilles Tendon Repair / Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot / Forefoot Reconstruction / Repairs
Elbow: Bloeps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral / Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee: ACL/PCL (only for ALLthread™ L-15 in conjunction with 2-0 or larger UHMWPE Full or Bowtle ZipLoop™ Construct), Illiotiblal Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb) (not including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not Including Hitch™ L-15), Uinar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15 In conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Volar Plate Reconstruction (not including Hitch™ L-15)
Hip: Labral

The Blomet Sports Medicine™ suture anchor devices (Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK, ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15) Suture Anchors are internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation due to injury or degenerative disease. The devices are available preloaded with suture and / or a ZipLoop™ Construct.
The Biomet Sports Medicine™ ZipLoop™ Constructs provide a flexible, adjustable means of soft tissue The blomer in a manner that does not require the surgeon to the a knot in sutures. The ZipLoop™ Constructs are available in three configurations and two strand materials.

The information provided is a 510(k) Summary for Biomet Sports Medicine™ Anchor devices and ZipLoop™ Constructs. This document primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel device.

Therefore, many of the requested categories related to acceptance criteria, clinical study design, and performance metrics are not applicable or not provided in this type of submission.

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 provided in the document. The 510(k) Summary states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use." However, specific acceptance criteria (e.g., tensile strength, pull-out force thresholds) and the quantitative results (reported device performance) from this non-clinical testing are not detailed. The submission relies on demonstrating that the technological characteristics (material, design, sizing) are "similar or identical" to predicate devices.

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

• Sample Size for Test Set: Not provided. The document mentions "Non-clinical laboratory testing" but does not specify the sample size for these tests.
• Data Provenance: The nature of the non-clinical tests suggests laboratory testing. Country of origin is not specified, and it is inherently retrospective in the sense that the testing would have been completed prior to this submission. It is not prospective clinical 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. Since this is a non-clinical submission demonstrating substantial equivalence to predicate devices, there isn't a "ground truth" establishment in the context of expert review of data like in image-based diagnostic AI. The "ground truth" in this context would be the performance characteristics of the predicate devices themselves, and the non-clinical tests would aim to show the new devices perform comparably.

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

• Not applicable. As above, no expert adjudication process is described for this type of 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

• No. This document is for medical devices (suture anchors and constructs), not for AI/diagnostic software, so an MRMC comparative effectiveness study is not relevant and was not conducted.

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

• Not applicable. This pertains to medical hardware, not an algorithm.

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

• Not explicitly defined in the context of expert review. For non-clinical performance testing of mechanical devices, the "ground truth" refers to established engineering standards, material specifications, and the known performance of the predicate devices. The study aimed to show the new devices meet functional requirements comparable to these benchmarks.

8. The sample size for the training set

• Not applicable. This submission is for mechanical medical devices, not an AI algorithm. There is no concept of a "training set" in this context.

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

• Not applicable. As there is no training set mentioned, this question is not relevant.

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