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CITREPORE™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CITREPORE is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. CITREPORE is intended to be used for filling bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, CITREPORE resorbs and is replaced with bone during the healing process.

CITREPORE™ is a synthetic, highly porous, resorbable bone void filler fabricated from a polymer bioceramic composite comprised of 60 wt.-% polymer and 40 wt.-% ASTM F1538 4555 Bioactive Glass. The polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. Bioactive Glass is a biologically compatible synthetic material consisting of silicates, sodium oxides, and phosphates. The constituent materials (citrate, Ca, P, O, H, Si) exist naturally in normal bone.

CITREPORE is provided to the end user in a variety of shapes and sizes that facilitates new bone formation across the graft site and throughout the interconnected porous structure. CITREPORE is pliable and sponge-like and can be cut to fit the bony defect using traditional instruments that are available in the OR at the time of surgery. At the time of surgery, CITREPORE can be infused with autologous blood, bone marrow aspirate, and/or other fluids. As body fluids penetrate the device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites. Upon implantation, the Bioactive Glass component of CITREPORE undergoes a surface modification that provides for direct bonding to surrounding bone via an apatite layer (i.e., bioactive). CITREPORE is single use and provided sterile.

MATERIALS: POC (poly-octamethylene-citrate) and ASTM F1538 4555 Bioactive Glass.

The provided text is a 510(k) premarket notification for a medical device called "Citrepore™", a resorbable bone void filler. It details the device's characteristics, intended use, and a comparison to a predicate device, along with performance data. However, this document does not describe a study involving an AI/Software as a Medical Device (SaMD) and therefore does not contain the specific information requested in the prompt regarding acceptance criteria and performance of such a device, human readers, or expert adjudication for ground truth of a test set.

The performance data section describes typical testing for a physical medical device (like biocompatibility, osteoconductivity in an animal model, porosity, etc.), not the AI/SaMD related metrics such as sensitivity, specificity, or reader study outcomes.

Therefore, I cannot extract the information required to populate the table or answer the specific questions about an AI/SaMD study, as this document pertains to a physical bone void filler device.

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The Acuitive CITREFIX™ Knotless Suture Anchor is intended for fixation of suture to bone in the shoulder foot/ankle, knee, hand/wrist and elbow in 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, Achiles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction. Metatarsal Ligament Repair/Tendon Repair

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

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

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

The CITREFIX Knotless Suture Anchor is comprised primarily of Acuitive Technologies' proprietary CITREGEN, citrate-based polymer / bioceramic composite material. An integral eyelet made of PEEK conforming to ASTM F2026 facilitates passage of the suture through the tip of the anchor. The CITREFIX device is offered in diameters between 2.9 and 5.5 mm and lengths ranging between 12.5 and 24.0 mm. The CITREFIX Knotless Suture Anchor is implanted with reusable instruments, which include size specific drill and awl options for preparing the bone and an insertion instrument for placement of the CITREFIX device. Suture is not provided with the CITREFIX device.

The CITREFIX Knotless Suture Anchor is made from CITREGEN biomaterial, a homogeneous biocomposite of 60 % unsintered hydroxyapatite (HA) and 40 % polyester. CITREGEN's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer occurs through hydrolysis of ester bonds located between the monomers and at crosslink sites.

This document is a 510(k) summary for a medical device (The Acuitive Citrefix™ Knotless Suture Anchor). It does not present a study proving the device meets acceptance criteria in the way you've described (e.g., in the context of an AI/ML medical device with accuracy metrics).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for a physical medical implant. The "acceptance criteria" here are largely related to functional performance and safety testing compared to established standards and the predicate device, rather than diagnostic performance metrics like sensitivity or specificity.

Therefore, I cannot populate the table and answer all questions as requested because the provided input does not contain information about:

• Diagnostic performance metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets in the context of diagnostic accuracy studies
• Data provenance (country of origin, retrospective/prospective) related to patient data for diagnostic evaluation
• Number of experts, qualifications, or adjudication methods for ground truth in diagnostic studies
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Training set information (size, ground truth establishment)

However, I can extract the information relevant to the performance testing described for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

• Pull-out strength at Time-Zero
• Pull-out strength after soaking in 37°C PBS
• Pull-out strength after 5,000 cycles of simulated physiological loading | Bench testing was performed for pull-out strength on the worst-case (2.9mm diameter) and intermediate size (4.5mm) subject CITREFIX devices, and a same-size predicate Arthrex PushLock device.

Results: "demonstrating substantial equivalence of the predicate and subject devices." (Specific numerical values for pull-out strength are not provided in this summary.) |
| Material/Biocompatibility:

• Biocompatibility per ISO 10993-1
• Elemental analysis per ASTM F2902
• Extractables & Leachables (E&L) testing
• Toxicological risk assessment | - Biocompatibility demonstrated by ISO 10993 testing for a permanent implant, including toxicological risk assessment through the lifecycle of the device.
• Biocompatibility studies performed with CITREGEN devices at various stages of life cycle through 90% demonstrated biocompatibility per ISO 10993-6.
• E&L testing performed, with biocompatibility and toxicological risk assessments concluding that CITREGEN material devices are safe for long-term implantation. |
  | Sterility & Shelf-Life:
• Sterility testing (including EO residuals)
• Bacterial endotoxin testing
• Packaging and shelf life testing (real and accelerated time aging) | - Meets set endotoxin limits (

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