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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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