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Anatomic Applications

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the Implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Comprehensive Convertible Glenoid Baseplate components are Intended for cementless applications with the addition of screw fixation.

Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive Convertible Glenoid Baseplate is round, truncated on the anterior and posterior sides. The baseplate features a medial boss through which a Central Screw is placed to hold the component in place. The back surface of the component is porous coated. There are two peripheral screw holes through the baseplate. Screws are available in both locking and non-locking styles. When used with a polyethylene liner, the construct is designed to articulate with a metallic humeral head attached to a humeral stem in a traditional, anatomic total shoulder configuration. Should revision to a reverse shoulder construct be desirable, the polyethylene liner can be removed without removal of the baseplate and replaced with a glenosphere component.

The provided text does not describe acceptance criteria for a device's performance in the context of an AI/ML-driven medical device, nor does it detail a study that proves a device meets such criteria.

Instead, this document is a 510(k) summary for a medical device called "Comprehensive® Convertible Glenoid," which is a shoulder joint prosthesis. The information presented is for the regulatory approval of this orthopedic implant.

Here's a breakdown of why this document doesn't contain the requested information about AI/ML device performance:

• Device Type: The device is a glenoid prosthesis, a physical implant for shoulder replacement surgery. It is not an AI/ML-driven device that analyzes data or images.
• Performance Data: The "Performance Data" section lists non-clinical tests typically performed on mechanical implants (e.g., range of motion, axial separation of tapers, shear load to failure, FEA stress simulation). These are engineering performance tests for mechanical integrity and function, not diagnostic or predictive performance metrics for an algorithm.
• Clinical Data: The document explicitly states, "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence." This means there was no clinical study conducted or required for this particular regulatory submission to assess device efficacy or safety in patients, let alone the performance of an AI.
• Ground Truth, Experts, Sample Sizes (for AI): Since this is not an AI/ML device, there are no mentions of test sets, training sets, data provenance, ground truth established by experts, or adjudication methods, which are all specific to the evaluation of AI/ML systems.
• MRMC Study: An MRMC comparative effectiveness study is used to assess the impact of an AI on human reader performance. This is irrelevant for a physical orthopedic implant.

In summary, the provided text does not contain the information requested about acceptance criteria and a study proving an AI/ML device meets those criteria. The document pertains to a traditional medical device (a shoulder prosthesis) and its regulatory submission based on mechanical and material performance testing, not AI/ML algorithm evaluation.

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Biomet Metal-On-Metal Total hip replacement components are intended for either cemented or uncemented use to replace the articulating portions of the hip during total hip arthroplasty.

Indications For Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-RinglocTM).
   (b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™).
5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The components of the M2a-Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

Metal-On-Metal Hip prosthesis components provide for total hip replacement with a direct metal to metal articulation. They consist of a series of metal femoral head prostheses (either monolithic or modular) that articulate with highly congruent mating acetabular components without the need for a ceramic or polyethylene liner.

This submission is intended to notify FDA that Biomet has included additional Contraindications to the labeling for Metal-On-Metal total hip prosthesis components to assure the safe and effective use of Biomet Metal-On-Metal components for the appropriate patient populations. These changes are incorporated into one IFU that will be applicable for all Metal-On-Metal components currently cleared by FDA.

The provided text is a 510(k) summary for a medical device. It explicitly states that no non-clinical or clinical testing was performed or included to support substantial equivalence. The submission is solely for updating the labeling (specifically, adding contraindications) for previously cleared metal-on-metal hip prosthesis components.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement cannot be extracted from this document, as no such studies were conducted for this particular 510(k) submission.

The document indicates:

• "Non-Clinical mechanical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."
• "Clinical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."

As a result, a table of acceptance criteria and reported device performance cannot be generated, nor can any details about studies, sample sizes, experts, or ground truth.

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The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

The provided document details a 510(k) premarket notification for the "Comprehensive® Reverse Shoulder - E1® Humeral Bearings." The focus of the submission is to demonstrate substantial equivalence to a predicate device, K080642, rather than to establish new safety and effectiveness through a comprehensive study meeting specific acceptance criteria as would be typical for an AI/ML device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and reader studies for a novel AI/ML device is not applicable to this document. This document pertains to a medical device (humeral bearings for shoulder replacement) that is evaluated based on material characteristics and mechanical performance, not an AI/ML algorithm.

However, I can extract information about the non-clinical tests conducted, which serve a similar purpose of demonstrating performance for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device, not an AI/ML algorithm, the "acceptance criteria" are implied by demonstrating equivalence to a legally marketed predicate device through non-clinical testing. The "reported device performance" refers to the results of these non-clinical tests. Specific numerical acceptance criteria are not explicitly stated as they would be for an AI/ML diagnostic's sensitivity/specificity. Instead, the performance demonstrated that the new device "performed within the intended use" and did not raise new safety or efficacy issues when compared to the predicate.

2. Sample size used for the test set and the data provenance

• Sample size: Not explicitly stated for specific tests, but generally refers to a sufficient number of test articles/specimens to perform the mechanical tests listed (e.g., multiple specimens for tensile strength, impact strength, pull-out, lever-out, and torque-out tests).
• Data provenance: Not explicitly stated, but these are material and mechanical property tests typically conducted in a laboratory setting by the manufacturer (Biomet Manufacturing Corp.) or a qualified testing facility. The data would be prospective to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. For this type of mechanical device, "ground truth" is established by adherence to recognized ASTM standards for material and mechanical properties, not by expert consensus on clinical findings. The evaluation is based on scientific and engineering principles.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are for clinical evaluations or subjective assessments, not for objective mechanical property testing against standards.

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

• Not applicable. This is a physical medical device, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.

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

• Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

• Non-clinical/Mechanical Performance and Material Standards: The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ASTM D-638 for tensile testing, ASTM F-648 for IZOD impact strength) and the comparative performance against the predicate device.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set."

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

• Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" or ground truth for one.

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Indications for the HipLOC™ Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.

The HipLOC™ Compression Hip Screw is designed as an internal fixation device to provide alignment and strong stabilization for fractures of the proximal femur.

The provided text is a 510(k) summary for the HipLOC™ Compression Hip Screw, an internal fracture fixation device. The document states that no clinical testing was performed as a basis for substantial equivalence. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document focuses on demonstrating substantial equivalence to predicate devices (Biomet® Compression Hip Screw System, K781389; DHS® System, Synthes, K981757) based on technological characteristics and non-clinical laboratory testing.

Specifically, the following sections cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance results from a clinical study are provided.
2. Sample size used for the test set and the data provenance: No test set from a clinical study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth from a clinical study is mentioned.
4. Adjudication method for the test set: Not applicable as there is no clinical test set.
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: Not applicable as this is not an AI/imaging device and no clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
7. The type of ground truth used: Not applicable as there is no clinical study with ground truth.
8. The sample size for the training set: Not applicable as there is no training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable as there is no training set for an algorithm.

The document explicitly states under "Non-Clinical Testing": "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." And under "Clinical Testing": "None provided as a basis for substantial equivalence."

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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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The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated.

1. Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants.
2. Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty.
3. Sternotomy indications include the "re-wiring" of sternums following osteotomy.
4. Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.

The Biomet® Cable System is available in either titanium or stainless steel, consisting of a flexible, multi-strand, medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or a medical grade stainless steel (316LVM, ASTM F-138) cable. The systems are available in both single and double styles. The cable is locked into place via a pre-loaded crimp. Instruments for the Biomet® Cable System include a Cable Tensioner, a Cable Crimper, and a Cable Cutter. The titanium system is compatible with other medical grade implants made of titanium and the stainless steel system is compatible with other stainless steel implants, whenever "wiring" may help secure the attachment of other implants.

This submission for the Biomet® Cable System (K071271) explicitly states that no clinical testing was performed as a basis for substantial equivalence. Therefore, there is no study to prove the device meets acceptance criteria based on human clinical data.

Instead, the submission relies on non-clinical laboratory testing and substantial equivalence to predicate devices. This means that the "acceptance criteria" are implied by the performance of the predicate devices and the non-clinical testing demonstrates that the Biomet® Cable System performs comparably to those predicates in a lab setting.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No clinical test set was used. The "test set" was entirely non-clinical laboratory testing. The submission does not specify the sample size or details of the non-clinical tests performed.

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

Not applicable. No clinical test set or human-established ground truth was used in this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

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

Not applicable. This is a medical device for bone fixation, not an AI or imaging diagnostic device. No MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was effectively:

• The established performance and safety profiles of the cited predicate devices (Medtronic/Sofamor Danek Atlas™ Cable System, K920201, K925812, K030816; Songer Spinal Cable System, K922952).
• The results of non-clinical laboratory testing which "indicated that the device was functional within its intended use."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Correction of functional neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
   Cemented and Uncemented Applications

Biomet Manufacturing Corp. is modifying the manufacturing process of ultrahigh molecular weight polyethylene (UHMWPE) used in the fabrication of polyethylene acetabular mgh molecular naglio partiles. The modified manufacturing process results in a higher cross-linked polyethylene. The highly cross-linked UHMWPE is infused with medical grade Vitamin E.

The provided text is a 510(k) Summary for a medical device (100 kGy E-Poly™ Acetabular Liners- Additional Profiles). It describes the device, its intended use, and claims substantial equivalence to a predicate device.

However, the provided document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria in the way a typical clinical performance study would.

Instead, it states:

• "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
• "Clinical Testing: None provided as a basis for substantial equivalence."

This means the submission relies on non-clinical (i.e., lab-based, not involving human patients) testing to demonstrate that the modified manufacturing process for the UHMWPE used in the acetabular liners results in a product that is substantially equivalent to the previously cleared predicate device (K050327 - E-Poly™ (Vitamin E) Acetabular Liners). Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot populate the table and answer the questions as requested because the document explicitly states that no clinical performance study was conducted or provided. The "acceptance criteria" here relate to the non-clinical tests demonstrating substantial equivalence, not clinical performance metrics.

If you are looking for a document that does include details on clinical studies, acceptance criteria, and ground truth establishment for a device's performance, this particular submission is not it, as it relies on non-clinical data for substantial equivalence.

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The Titanium Repicci II(® Unicondylar Femoral Knee Components and CoCr Repicci II(8) Unicondylar Knee are indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

These devices are single-use implants intended for implantation with bone cement.

The Titanium Repicci II® Unicondylar Femoral Knee Components are medial or lateral unicondylar knee replacement implants available in six sizes. Each size is anatomical in nature and is available in two configurations - one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM).

The CoCr Repicci II® Unicondylar Knee (K020264) is available in five sizes. Each size is anatomical in nature and is available in two configurations – one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM),

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Important Note: The provided document is a 510(k) summary for a knee implant, which in many cases, especially for predicate devices, relies heavily on substantial equivalence to already approved devices rather than new clinical trials demonstrating performance against specific clinical acceptance criteria. The information you're asking for (e.g., acceptance criteria, test set details, expert qualifications, HRMC studies) is typically found in the clinical study reports for devices that require extensive new clinical evidence, often for novel devices or those with higher risk classifications.

Based on the provided text, the device is being cleared based on substantial equivalence, meaning it's demonstrated to be as safe and effective as a legally marketed predicate device. This often involves non-clinical testing (e.g., mechanical, materials) and comparison of design and indications for use, rather than extensive human clinical trials with performance metrics.

Analysis of Acceptance Criteria and Study for K063515

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" for the device's performance in the clinical sense are not explicitly stated in terms of specific sensitivity, specificity, accuracy, or similar clinical metrics. Instead, the "acceptance criteria" are implied by demonstrating that the new device is as safe and effective as its predicates.

The "study that proves the device meets the acceptance criteria" largely relies on non-clinical testing and comparison to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of a human clinical test set. The evaluation primarily involved non-clinical laboratory testing.
• Data Provenance: Not applicable for clinical data. The non-clinical testing would have been performed in a laboratory setting, likely at Biomet or a contracted facility.

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

• This information is not provided because the submission did not involve a clinical study requiring expert ground truth for a test set in the way a diagnostic AI device would. The "ground truth" for non-clinical testing would be measured physical properties and performance against established engineering standards or predicate device benchmarks.

4. Adjudication Method for the Test Set

• Not applicable as there was no human clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical Testing: None provided as a basis for substantial equivalence."
• Therefore, there is no effect size reported for human readers with or without AI assistance.

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

• Not applicable. This device is a physical knee implant, not a software algorithm.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" would be established engineering specifications, material properties (e.g., tensile strength, fatigue life), and performance metrics (e.g., wear testing, load bearing capacity) as defined by relevant ISO or ASTM standards, and comparative data from the predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish "ground truth" for the new device itself in a clinical context.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable, as there was no training set in the context of machine learning.

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The 23 mm Single Peg Patella Components intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   The device is indicated for cemented application only.

The 23 mm Single-Peg Patella Component has the following features: (1) 23 mm diameter with a 1″ true dome shape with grooves on the underside; (2) single-peg design; (3) made with ArCom® polyethylene. The 23 mm Single-Peg Patellae are intended for inset into the host patella only using bone cement

This 510(k) submission (K061340) for the 23 mm Single-Peg Patella Component does not include any clinical study data or acceptance criteria related to device performance in a clinical setting.

The submission explicitly states under "Clinical Testing": "None provided as a basis for substantial equivalence." This means there was no study performed to evaluate the device's performance against specific acceptance criteria in humans.

Instead, the substantial equivalence was based on non-clinical testing and comparison to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text, while also highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No clinical test set data was provided. Non-clinical testing would have involved specific sample sizes for mechanical tests, but these details are not present in the summary.

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

Not applicable. No clinical test set and thus no ground truth established by experts in this context.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a medical implant, not an AI software, and no clinical comparative effectiveness study was conducted for this 510(k) submission.

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

Not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in a clinical sense. For non-clinical testing, the "ground truth" would be established by engineering specifications, material standards, and biomechanical principles, evaluated through laboratory testing.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an algorithm or machine learning.

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

Not applicable.

Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:

The 510(k) submission for the 23 mm Single-Peg Patella Component relies entirely on non-clinical laboratory testing and substantial equivalence to predicate devices to demonstrate safety and effectiveness.

• Non-Clinical Testing: The summary broadly states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This type of testing would typically include mechanical, fatigue, wear, and possibly material characterization tests to ensure the device's physical properties and performance meet design specifications and relevant industry standards. However, specific details about the tests performed, the acceptance criteria for those tests, or the results are not provided in this 510(k) summary.
• Substantial Equivalence: The primary "proof" of meeting acceptance criteria for market clearance is its "substantial equivalence" to three legally marketed predicate devices: Vanquard™ Patella (K040770), Ultra High Molecular Weight Components Knees (K921182), and AGC Revision Knee Prosthesis (K912245). The applicant argues that the "technological characteristics (material, design, sizing, and indications)" are "similar or identical" to these predicates. The FDA concurred with this assessment, allowing the device to be marketed.

In essence, the device was deemed to meet acceptance criteria not through a clinical study demonstrating its performance in patients, but by showing it is functionally similar to already approved devices and performs acceptably in laboratory tests.

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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only.

The Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove product line is a two piece system intended for use with additional tibial products to replace the patellofemorotibial joint space. The system is composed of one type of femoral and two types of patellae. The system can be used with any commercially available Biomet® Tibial Tray, Vanguard™ CR, CR-L, or AS bearing, or augment.

The femoral component is cruciate retaining (CR) in both left and right configurations. The femoral implants are available in both Interlok® and porous finish. The sizes of femoral implants range from: 55 - 80mm.

Two different all-polyethylene patellae designs will function with the new femoral components a round, modified dome and a medially offset patella. Both designs have 3-pegs, concentric grooves, and cement pockets for cement fixation.

The provided document is a 510(k) summary for the Biomet Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove knee replacement system. It details the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data.

Here's why and what information is missing:

• Non-Clinical Testing: The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This generally refers to bench testing (e.g., mechanical strength, wear resistance) rather than clinical performance measured against acceptance criteria. The specific acceptance criteria for these non-clinical tests and the detailed results are not provided in this summary.
• Clinical Testing: Crucially, the document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence." This means no human studies were conducted or provided to the FDA to demonstrate the device's clinical performance.

Therefore, I cannot provide the requested table or detailed information on studies that prove the device meets acceptance criteria because such information is not present in the provided text.

Based on the available text, here's what can be inferred or stated about the lack of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document mentions non-clinical testing for "functional within its intended use," but no specific performance metrics or acceptance criteria are detailed.
2. Sample Size used for the test set and the data provenance: This information is not provided as no clinical test set was used for substantial equivalence. For non-clinical tests, details of the sample size are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as no clinical test set was used.
4. Adjudication method for the test set: This information is not applicable as no clinical test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not done. The document states "Clinical Testing: None provided as a basis for substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This question is not applicable as the device is a medical implant (knee prosthesis), not an algorithm or AI.
7. The type of ground truth used: This information is not applicable as no clinical studies are mentioned. For non-clinical (bench) testing, "ground truth" would typically refer to engineering standards or material properties, but these details are not provided.
8. The sample size for the training set: This information is not applicable as no clinical studies or AI/algorithm development (which would require a training set) are described.
9. How the ground truth for the training set was established: This information is not applicable for the same reasons as above.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" to existing legally marketed devices primarily through technological characteristics (material, design, sizing, indications) and non-clinical bench testing. It explicitly states that no clinical testing was provided as a basis for this equivalence.

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