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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 CITRELOCK® DUO is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The CITRELOCK® DUO is a two-piece design consisting of a cannulated, self-locking, CITRELOCK® implant made from CITREGEN® biomaterial coupled with an eyelet component made from PEEK. The CITRELOCK® DUO system consists of fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm.

The purpose of this Special 510(k) Device Modification is to advise the FDA of this line extension wherein an eyelet to accommodate suture was added to the previously 510(k) cleared CITRELOCK® "twist-ribbed", cannulated, self-locking bone anchor. The CITRELOCK® DUO device utilizes the same correspondingly sized and designed primary predicate, the CITRELOCK®, with the added PEEK eyelet at the tip of the device. These two components are sterile packaged together and mounted on a Cartridge that facilitates loading onto the Inserter instrument.

The CITRELOCK® DUO is made from CITREGEN® biomaterial, which is a resorbable, homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxyapatite (HA) and 40 wt.-% 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 phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.

The eyelet is made from polyether ether ketone (PEEK) conforming to ASTM F2026. Suture material is not provided with the device.

This is a 510(k) summary for a medical device modification, not a study evaluating AI performance. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance with respect to AI (e.g., human reader improvement with AI assistance, standalone algorithm performance, training set details) is not applicable or cannot be extracted from this document.

However, I can provide information based on the performance data presented for this specific medical device modification:

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

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The Citrespline™ and Citrelock™ ACL Implants are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The Citregen Tendon Interference Screw and CitreLock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist.

The subject devices are comprised of CITREGEN biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxyapatite (HA) and 40 wt.-% 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 phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.

The CITREGEN™ Tendon Interference Screw (TIS) and CITRELOCK™ Tendon Fixation Device are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm. There are two designs: 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock™) that is inserted into bone. Citregen TIS and Citrelock implants attach soft tissue to bone for surgical procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist. Select single use manual instruments are packaged together with an implant in a sterile "kit" configuration (Xpress Kit). There is an additional subset of sterile single use instruments to facilitate surgery (Prep Kit). Alternatively, there is a set of reusable instruments.

THE CITRESPLINE™ and CITRELOCK™ ACL Implants are bone anchor devices ranging in diameter from 7 to 12 mm in 1 mm increments, and lengths of 23, 28, and 33 mm. There are two designs for the system: 1) "twist-ribbed" cannulated, self-locking devices (CITRELOCK ACL) and 2) a "straight spline" style device (CITRESPLINE). Both designs have a cannula through the central axis for alignment into the surgically prepared site. Surgical placement is facilitated with a reusable set of instruments.

The provided text is a 510(k) summary for medical devices (Tendon Interference Screws and ACL Implants) and focuses on demonstrating substantial equivalence, specifically regarding a change in sterilization method (from EtO to gamma radiation). It is NOT an AI/ML device submission.

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/ML device's performance.
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test sets in an AI/ML context.
• Data provenance for AI/ML training/test sets.
• Number of experts or their qualifications for establishing ground truth in AI/ML.
• Adjudication methods for AI/ML ground truth.
• MRMC studies for AI/ML.
• Standalone AI/ML performance.
• Types of ground truth for AI/ML.
• Training set sample sizes for AI/ML.
• How ground truth for an AI/ML training set was established.

The document is entirely about physical medical devices and their material properties, biocompatibility, and sterility after a change in manufacturing process (sterilization method).

To answer your request, I would need a different document that details an AI/ML medical device submission.

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The Citregen Tendon Interference Screw and CitreLock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist.

The Acuitive Citrefix Knotless Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder foot ankle, knee, hand/wrist and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart 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, Mid-foot 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 Citrespline ACL and Citrelock ACL are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

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

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Reconstruction.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

This 510(k) notification advises FDA of minor changes to implant specifications, revisions and additions to the class 1 instruments, and an extension of shelf life to three years per the original validation plan presented in K200725.

The subject bone anchor devices are comprised of Citregen biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxyapatite (HA) and 40 wt.-% 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 phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites. The following paragraphs describe the subject devices.

The Citregen Tendon Interference Screw and Citrelock are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm. There are two designs; 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock) that is inserted into bone. Citregen Tendon Interference Screw and Citrelock implants attach soft tissue to bone for surgical procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist. The updates to the class 1 manual instruments include minor design modifications and new reusable instruments, single-use and sterile instruments that are packaged together with an implant in a "kit" configuration and new single-use and sterile instruments to facilitate surgery.

The Citrefix is a suture anchor offered in diameters between 2.9 and 5.5 mm and lengths ranging between 12.5 and 24.0 mm, and includes an integral eyelet made of PEEK that facilitates passage of suture through the tip of the anchor. The Citrefix is implanted with reusable instruments that include size specific drills and awls for preparing the bone, and an insertion instrument for placement of the Citrefix device. Suture is not provided with the Citrefix device.

The Citrespline ACL and Citrelock ACL are bone anchor devices ranging in diameter from 7 to 12 mm in 1 mm increments, and lengths of 23, 28, and 33 mm. There are two designs for the system: 1) "twist-ribbed" cannulated, self-locking devices (Citrelock ACL) and 2) a "straight spline" style device (Citrespline ACL). Both designs have a cannula through the central axis for alignment into the surgically prepared site. Surgical placement is facilitated with a reusable set of instruments.

This document (K220833) is a 510(k) premarket notification for medical devices, specifically bone fixation appliances and fasteners. It details the device's indications for use and compares it to previously cleared predicate devices. The document concerns minor changes to existing devices and additions to instrument kits, and therefore does not contain acceptance criteria for performance studies of the device itself (e.g., a software algorithm or diagnostic tool).

Instead, the performance data section (G. Performance Data on page 9) focuses on the validation of manufacturing processes and materials for the devices and their accompanying instruments. This type of validation ensures that the device and its accessories are safe, sterile, biocompatible, and maintain their properties over their shelf life, which are the relevant "acceptance criteria" and "proof" for this class of device given the nature of the submission (minor modifications to existing devices).

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance in the context of, for example, a diagnostic algorithm's sensitivity or specificity, because this submission package does not describe such a study for these devices. The "performance data" here refers to manufacturing and material characteristics.

Here's a breakdown of the requested information based on the provided text, indicating where the information is not applicable (N/A) for this specific type of device submission:

Acceptance Criteria and Study for K220833

This 510(k) submission (K220833) pertains to minor changes and additions to existing bone fixation devices (Citregen™ Tendon Interference Screw, Citrelock™, Citrefix™, Citrespline™ ACL, and Citrelock™ ACL) and their associated instruments. The "studies" conducted for this submission relate to the validation of manufacturing processes, material properties, and instrument sterility/shelf life, rather than performance metrics of a diagnostic or treatment algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of a "test set" for a performance study. The validation studies for biocompatibility, sterility, shelf life, and packaging integrity would have involved sample sizes appropriate for those specific tests (e.g., multiple units for sterility validation, packaging strength tests). These are typically determined by statistical sampling plans for manufacturing quality control and regulatory compliance.
• Data Provenance: The studies are described as internal validation and verification activities, likely conducted at the manufacturer's facilities (Acuitive Technologies, Inc., Allendale, NJ, USA) or by contract labs. The document does not specify country of origin for data in the sense of clinical cases, nor does it refer to retrospective or prospective patient data.

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

• N/A. This submission does not involve a diagnostic or interpretive device requiring expert ground truth establishment from medical images or clinical observations. The "ground truth" here refers to the verified physical and material properties, and manufacturing process compliance with standards.

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

• N/A. Adjudication methods are typically relevant for clinical studies where subjective assessments (e.g., image interpretation) need to be resolved. The studies described are objective engineering and laboratory validations.

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:

• N/A. This device is a physical implant and surgical instrumentation, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.

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

• N/A. This device is a physical implant and surgical instrumentation, not an algorithm.

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

• The "ground truth" for the acceptance criteria outlined is based on established international and national standards for medical device manufacturing, biocompatibility, sterilization, packaging, and shelf life (e.g., ISO 10993-1, AAMI ST79, ISO 11607-1, ASTM F1980, etc.). Compliance with these standards constitutes the "ground truth" for the safety and effectiveness aspects addressed by this 510(k).

8. The sample size for the training set:

• N/A. This submission does not involve machine learning or AI, and therefore no "training set" in that context. The "training" in the context of device manufacturing would refer to personnel training, not data for an algorithm.

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

• N/A. As there is no training set for an algorithm, this question is not applicable.

In summary, the provided document is a regulatory submission for physical medical devices and their minor modifications, focusing on manufacturing, material, and process validations required for substantial equivalence, rather than performance data for a diagnostic or AI-driven system.

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The Citrespline™ and Citrelock™ ACL Implants are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The CITRESPLINE™ and CITRELOCK™ ACL Implants are soft tissue fixation devices ranging in diameter from 7 to 12 mm in 1 mm increments, and lengths of 23, 28, and 33 mm. There are two designs for the system: 1) a "twist-ribbed" cannulated, self-locking device (trade names CITRELOCK ACL and CITRELOCK) and 2) a "straight spline" style device (trade name CITRESPLINE). Both designs include a cannula through the central axis to allow for alignment into the surgically prepared site. Like the predicate devices, surgical placement of the implants in bone is facilitated with a reusable set of instruments. The CITRESPLINE and CITRELOCK ACL Implants are intended to attach soft tissue to bone for procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist.

The CITRESPLINE and CITRELOCK ACL Implants are made from CITREGEN biomaterial, which is a homogeneous biocomposite comprised of 60 wt. -% unsintered hydroxyapatite (HA) and 40 wt.-% polyester. CTREGEN'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 phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.

The provided text is a 510(k) premarket notification letter and supporting documentation for two medical devices, the Citrespline™ and Citrelock™ ACL Implants. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance through a clinical study with acceptance criteria in the manner typical for AI/ML device submissions.

Therefore, many of the requested details, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training and testing, are not applicable to this document. This document describes the mechanical testing and material properties of the implant devices, not an AI/ML algorithm.

However, I can extract information related to the performance data and "acceptance criteria" as presented within the context of mechanical and material testing for these implant devices, and present it in a similar structured format.

Here's the closest interpretation of your request based on the provided text:

Description of Acceptance Criteria and Device Performance (for Implant Devices)

The device in question, the Citrespline™ and Citrelock™ ACL Implants, are soft tissue fixation devices intended for surgical reattachment of ligaments and tendons. The documentation focuses on demonstrating their substantial equivalence to a legally marketed predicate device (K200725) through material composition, technological characteristics, and mechanical performance testing, specifically "pull-out" strength.

The "acceptance criteria" are implied by the phrase "possess similar or significantly higher pull out strengths relative to the primary predicate devices." The study described is a benchtop mechanical testing study, not a clinical study involving human subjects or an AI/ML algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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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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The Citregen Tendon Interference Screw (TIS) and Citrelock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-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, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The Citregen TIS and Citrelock are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm to be used with reusable instruments. There are two designs for the system: 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock™) that is inserted into bone. The Citregen TIS and Citrelock system is intended to attach soft tissue to bone for procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist.

The Citregen TIS and Citrelock are made from Citregen biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxvapatite (HA) and 40 wt.-% 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 phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.

The provided text focuses on the 510(k) premarket notification for the Citregen Tendon Interference Screw and Citrelock. This document primarily addresses the substantial equivalence of this medical device to a predicate device, rather than providing detailed acceptance criteria and study results in the context of an AI/ML powered medical device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment cannot be extracted from the provided text as it pertains to a traditional medical device (a physical screw) and not an AI/ML algorithm.

Here's what can be extracted based on the nature of the submission:

• Device Type: The device is a traditional medical implant (tendon interference screw).
• Study Purpose: The studies were conducted to demonstrate substantial equivalence to a predicate device, primarily focusing on safety and performance characteristics relevant to an orthopedic implant.

Here's a breakdown of what could be extracted related to performance data, even though it's not in the context of AI/ML acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance: This type of table is not present for acceptance criteria in the AI/ML sense. However, the document states that "performance characteristics... were established via comprehensive studies" and that results of these studies "demonstrated that the Citregen TIS performance was substantially equivalently to the predicate device."

   • Acceptance Criteria (Implied for a physical implant): Substantial equivalence to the predicate device in terms of "imaging, histological, histomorphometry, and biomechanical data."
   • Reported Device Performance: "The Citregen TIS performance was substantially equivalently to the predicate device."

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

   • Test Set (for in-vivo animal studies): Ovine (sheep) model of ACL reconstruction.
   • Sample Size: Not explicitly stated as a number, but mentioned as a "GLP functional ovine model."
   • Data Provenance: Not specified, but likely from a laboratory conducting GLP (Good Laboratory Practice) studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an orthopedic implant's performance in animal models would typically be established through pathological examination, imaging analysis, and biomechanical testing by specialized researchers/veterinarians, not "experts" in the AI/ML sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to this type of device and study.

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 device is not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

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

   • Ground Truth: Based on "imaging, histological, histomorphometry, and biomechanical data" from the ovine model, evaluated at 0, 3, 6, 12, and 24 months.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Text:

The provided document describes a traditional medical device (Citregen Tendon Interference Screw and Citrelock) and its 510(k) submission to the FDA, demonstrating substantial equivalence to a predicate device. The performance data presented refers to bench testing, biocompatibility tests, and animal studies (GLP ovine model) to assess the device's physical and biological performance over time, not the performance of an AI/ML algorithm. Therefore, the questions tailored for AI/ML device evaluations are largely not addressable from this document.

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