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The OSSIOfiber® Interference Screws, are indicated for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; Specifically:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion 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, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
• Knee: Repair/Reconstruction of the Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Patellar Tendon, Posterior Oblique Ligament, Iliotibial Band Tenodesis, MPFL
• 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

The OSSIOfiber® Interference Screw is an orthopedic implant made of poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The OSSIOfiber® Interference Screws are cannulated and fully threaded, available in diameters ranging from 6 to 12 mm and lengths from 23 to 28 mm. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the implantation site. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Interference Screw is supplied sterile, for single patient use only.

The OSSIOfiber® Interference Screw is designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentation such as ISO 9714 compatible instrumentations.

This document does not describe a study that uses AI or machine learning. It describes a medical device called the OSSIOfiber® Interference Screw and its clearance through the FDA 510(k) process. This process focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical (laboratory/mechanical) testing rather than clinical studies with human subjects or AI performance evaluations.

Therefore, many of the requested categories for AI/ML study acceptance criteria and performance data cannot be filled from the provided text.

Here's an analysis of what information can be extracted or inferred from the text related to the device's acceptance criteria and study, with explanations for the missing AI/ML specific data:

Device: OSSIOfiber® Interference Screw

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) clearance letter does not specify explicit numerical acceptance criteria in the typical format (e.g., "pull-out strength > X N"). Instead, it states that the device was found to be "at least as safe and effective" and demonstrated "at least equivalent performance" to the predicate devices. The performance is assessed comparatively.

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

• Sample Size: Not explicitly stated. The document mentions "Pull-out testing," "Torsional strength," and "driving torque testing" but does not provide the number of samples tested for each.
• Data Provenance: The studies are "non-clinical data" and "in-vitro degradation." This implies laboratory testing rather than human clinical data. The country of origin of the data is not specified, but the submitter is "Ossio Ltd." in Caesarea, Israel. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission, not gathered retrospectively from patient treatments.

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

Not applicable. This information is relevant for studies involving human interpretation (e.g., image analysis by radiologists). The described studies are non-clinical (mechanical and biocompatibility testing). Ground truth in this context would be defined by standard engineering and biocompatibility testing protocols, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described because the studies are non-clinical engineering tests.

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 clearance based on non-clinical performance and substantial equivalence, not an AI/ML diagnostic or assistive software. There is no AI component described.

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

Not applicable. This section is for AI/ML algorithms. No such algorithm is described.

7. The Type of Ground Truth Used

For mechanical testing (pull-out, torsional strength, driving torque): The "ground truth" is established by direct physical measurement according to validated test methods and engineering standards. The performance of the predicate device serves as the benchmark for comparison.

For biocompatibility: Ground truth is established by the results of ISO 10993 testing, which uses established biological endpoints and criteria.

8. The Sample Size for the Training Set

Not applicable. This is for AI/ML studies. No training set is mentioned as there is no AI/ML component.

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

Not applicable. This is for AI/ML studies.

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MILAGRO ADVANCE PEEK Interference Screws (7x23mm, 8x23mm, 9x23mm):

The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

• · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
• · Knee: Medial and lateral collateral ligament repair
• · Knee: Medial patellofemoral ligament reconstruction (femur fixation)
• · Shoulder: Proximal Biceps Tenodesis
• · Elbow: Distal Biceps Tenodesis

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle

MILAGRO ADVANCE PEEK Interference Screws (7x30mm, 8x30mm):

The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recorstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle

MILAGRO ADVANCE BR Interference Screws (7x23mm, 8x23mm, 9x23mm):

The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

• · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
• · Knee: Medial and lateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation)
• Shoulder: Proximal Biceps Tenodesis
• · Elbow: Distal Biceps Tenodesis

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle

MILAGRO ADVANCE BR Interference Screws (8x30mm, 7x30mm):

The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle

MILAGRO BR Interference Screws (7x15mm, 6x12mm, 5x12mm):

The DePuy Mitek MILAGRO BR Interference Screws designed to attach soft tissues to bone in orthopedic surgical procedures for the following indications:

· Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair

· Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair

· Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)

· Foot and Ankle: Lateral Stabilization. Medial Stabilization. Mid-Foot Reconstruction. Tendon Transfer in the Foot and Ankle

MILAGRO BR Interference Screws (5x23mm, 6x23mm, 6x30mm, 6x30mm):

The DePuy Mitek MILAGRO Interference Screw is indicated as follows:

• · Knee: (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures
• · Knee: Medial and lateral collateral ligament repair*
• · Shoulder: Proximal bicep tenodesis *
• Elbow: Distal bicep tenodesis*

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle

• These indications do not apply to 5x30mm Screws and 6x30mm Screws

The subject devices of this Special 510(k) are the MILAGRO Interference Screws and the Milagro ADVANCE Interference Screws. These interference screws are cannulated, threaded, tapered fasteners for use in interference fixation of soft tissue grafts and/or bone-tendon-bone grafts.

The MILAGRO Interference Screws and MILAGRO ADVANCE Interference Screws are offered in varying sizing configurations. The devices are offered in absorbable Biocryl Rapide material which is a biocomposite material of 70% PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP or PEEK (Polyether ether ketone) material.

The devices are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

The provided document is a 510(k) Premarket Notification from the FDA for DePuy Mitek MILAGRO Interference Screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and detailed acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria and studies for an AI/SaMD. Specifically:

• No acceptance criteria table or device performance is reported in the context of an AI/SaMD. The document mentions "performance testing for insertion force" and "assessment of fixation strength" for the physical interference screws, which are not relevant to AI/SaMD performance.
• No sample size information for a test set for AI/SaMD is present.
• No data provenance for AI/SaMD is mentioned.
• No information regarding experts for ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or types of ground truth is available.
• No information about training set size or ground truth establishment for a training set for AI/SaMD is provided.

The document primarily focuses on:

• Device Identification: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw.
• Regulatory Information: Class II medical device, product codes MAI, MBI, regulated under 21 CFR 888.3030.
• Substantial Equivalence: Listing predicate devices (K103831, K143660, K123362, K161001). The primary reason for this 510(k) is a modification to the labeling to add additional foot and ankle indications, asserting that the "anchor design, materials, principal of operation, and intended use of the subject devices are identical to that of the predicate devices."
• Indications for Use: Detailed list of applications in knee, shoulder, elbow, foot, and ankle for various screw types and sizes.
• Non-clinical Testing: Briefly states "Verification activities were performed... included an assessment of fixation strength... as well as performance testing for insertion force," concluding that these tests demonstrated suitability for the additional indications.

In summary, the provided text does not describe an AI/software medical device or the specific types of studies (like MRMC or standalone performance evaluations) that would involve acceptance criteria for AI algorithms. It pertains to a physical orthopedic implant and its substantial equivalence to previously cleared devices.

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The Syntheface PEEK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less are also indicated for use in the following procedures: Knee -ACL Repair -PCL Repair -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Patellar realignment and tendon repair Vastus medialis obliquus advancement -Iliotibial band tenodesis Shoulder -Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repair Capsular shift or capsulolabral reconstruction -Acromioclavicular separation repair -Deltoid repair -Rotator cuff tear repair -Biceps tenodesis Foot and Ankle -Hallux valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repairs/reconstruction -Bunionectomy -Flexor Hullucis Longus (FLH) -Tendon Transfer Elbow, Wrist, and Hand -Biceps tendon reattachment -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Scapholunate ligament reconstruction -Tendon Transfer -Tendon Transfer -Carpometacarpal Joint Arthroplasty -Carpal Ligament Reconstruction

The Syntheface PEEK Screw Sheath is indicated for use in combination with Syntheface PEEK Interference Screw for fixation of soft tissue to bone during cruciate ligament reconstruction.

All Syntheface PEEK Interference Screws are non-absorbable. All interference screws are offered in a polyetheretherketone (PEEK) material. Syntheface PEEK Interference Screws are provided sterile, for single use only. The Syntheface PEEK Interference Screws are composed of 6 different configurations ranging from 6mm to 11mm in diameter and 25mm in length. The Syntheface PEEK Interference Screw can be used alone or be used in conjunction with the Syntheface PEEK Screw Sheath. The Syntheface PEEK Screw Sheath shall be used in conjunction with the Syntheface PEEK Interference Screw. All Syntheface PEEK Screw Sheaths are non-absorbable, and are intra-tunnel devices used to secure soft tissue grafts to bone during cruciate ligament reconstruction procedures. The Syntheface PEEK Screw Sheath is a polyetheretherketone (PEEK) material implant for use with Syntheface PEEK Interference Screw. Syntheface PEEK Screw Sheaths are provided sterile, for single use only.

The provided document is an FDA 510(k) Premarket Notification for the "Syntheface PEEK Interference Screw" and "Syntheface PEEK Screw Sheath." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo performance criteria against a specific clinical condition or a human reader. Therefore, the information regarding acceptance criteria, study design for proving device performance, sample sizes for test sets, expert involvement, and ground truth establishment (as typically requested for AI/diagnostic device studies) is not directly applicable or available in this document in the manner you specified.

Instead, the document details non-clinical bench tests performed to demonstrate that the subject device performs as well as the predicate device. The acceptance criteria for these tests would generally be based on comparison to the predicate device's performance or established engineering standards for similar medical devices.

Here's an attempt to extract and present the relevant information within the framework you provided, acknowledging the limitations for an equivalence submission:

Acceptance Criteria and Device Performance Study (Based on 510(k) Equivalence)

This 510(k) submission establishes substantial equivalence to legally marketed predicate devices, not de novo clinical effectiveness. Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating that the new device is as safe and effective as the predicate through non-clinical bench testing and material compliance.

1. Table of Acceptance Criteria and Reported Device Performance

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

For non-clinical bench testing, the "test set" typically refers to the number of devices or material samples subjected to the tests. The document states that "Non-clinical bench tests were conducted in support of the substantial equivalence determination," but it does not specify the sample sizes used for each mechanical test (screw-in, pullout, fatigue) or for the biocompatibility, endotoxin, sterilization, or shelf-life tests.

Data Provenance: All data appears to be retrospective from internal lab testing performed by the manufacturer, Suzhou Endophix Co., Ltd., based in China.

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

This question is not applicable to this type of 510(k) submission. "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms that interpret medical images or data. For an orthopedic implant seeking substantial equivalence, the "ground truth" is typically defined by engineering specifications, material standards, and benchmark performance of the predicate device, rather than expert consensus on clinical cases. The tests are designed to meet these engineering and material "truths."

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving multiple readers evaluating patient cases, often to establish a consensus "ground truth" for ambiguous findings. Since this submission relies on non-clinical bench testing, no such adjudication method was employed.

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. An MRMC study is relevant for diagnostic devices, particularly AI-powered ones, to assess their impact on human reader performance. The Syntheface PEEK Interference Screw and Screw Sheath are orthopedic implants, not diagnostic tools, and do not involve human readers or AI assistance in their function.

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

Not applicable. This question pertains to the performance of an AI algorithm in isolation. The devices in this submission are physical orthopedic implants, not algorithms.

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

As mentioned in point 3, the concept of "ground truth" as typically defined for diagnostic or AI studies (e.g., expert consensus, pathology, outcomes data) does not directly apply here. Instead, for this orthopedic implant, the "ground truth" for its performance is established through:

• Material Standards: Adherence to established ASTM and ISO standards for PEEK and biocompatibility.
• Engineering Specifications: Meeting predefined dimensional tolerances and mechanical property requirements.
• Predicate Device Performance: Demonstrating comparable mechanical performance (screw-in, pullout, fatigue) to the legally marketed predicate devices through bench testing.

8. The sample size for the training set

Not applicable. The concept of a "training set" belongs to machine learning and AI algorithms. These devices are physical implants, and their development did not involve a training set.

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

Not applicable, as there is no "training set" for these physical orthopedic implants.

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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 OneFix Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, BLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The OneFix Biocomposite Small Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot. ankle, knee, hand, wrist, elbow, shoulder, and hip. 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, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral repair

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In con junction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue.

The OneFix Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

The OneFix Cannula System is introduction of instrumentation through a portal for surgical procedure.

The OneFix Biocomposite Anchors consist of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 96 model codes over 4 families. The anchors widths range from 3.0mm through 6.5mm and lengths of 11.9mm through 16.8mm.

The OneFix Biocomposite Small Anchors consist of cannulated anchors with an eyelet. They are preloaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 9 model codes corresponding to variations of sutures with anchor dimensions (11.9mm x 2.4mm x 3.0mm).

The OneFix All Suture Anchors consist of one "fixed suture" and 2 or 3 non-absorbable sutures. The non-absorbable suture is manufactured from UHMWPE and PET fibers. The OneFix All Suture Anchor is implanted using its self-punching option and are pre-loaded on a handled insertion device. They come in 14 various model codes.

The OneFix Biocomposite Interference Screws are inserted into the bone tissue and the external thread is screw shaped and the inside of the screw is start shaped. The screws are manufactured from PLGA copolymer and ß-TCP. There are 36 model codes with outside diameter ranging from 7-12mm and 20-35mm lengths.

The OneFix Cannula Systems is intended to puncture through tissue to make a pathway for surgical instruments during surgery. It consists of a cannula and a trocar made of polycarbonate. There are 3 types of this product: threaded, smooth and all smooth and comes in 72 model codes with inside diameter of 4.3mm through 8.1mm and lengths of 84mm through 130mm.

All implant components are provided sterile and are designated as single use. The system also includes the reusable surgical instruments required for implantation.

The provided document is a 510(k) summary for medical devices, specifically orthopedic bone fixation appliances. It does not contain information about acceptance criteria for a study, nor does it describe a study that proves a device meets acceptance criteria in the way typically associated with AI/ML-driven devices (e.g., performance metrics like sensitivity, specificity, or reader studies).

This document is for a traditional medical device (anchors, screws, and cannulas) used in orthopedic surgery. The "study" referenced here is the comparison to predicate devices to demonstrate substantial equivalence, which is a regulatory pathway for market clearance for certain types of medical devices.

Therefore, many of the requested categories in your prompt are not applicable to the content of this FDA 510(k) summary for a physical orthopedic device.

Here's an explanation based on the provided text and why certain sections of your request cannot be fulfilled:

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

• Not applicable / Not provided. This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on setting and meeting specific performance acceptance criteria from a clinical trial or algorithm test for a new technology like AI/ML. The "performance" described is in terms of material properties, design features, and intended use being similar to predicates.

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

• Not applicable / Not provided. There is no "test set" in the context of an AI/ML algorithm or clinical study described. The "test" in a 510(k) often refers to bench testing (e.g., mechanical strength) which is not detailed in this summary.

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 / Not provided. No ground truth establishment for a diagnostic or prognostic task is mentioned.

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

• Not applicable / Not provided.

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 / Not provided. This device is a physical surgical implant/tool, not an AI-based diagnostic or assistive device.

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

• Not applicable / Not provided. The device is not an algorithm.

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

• Not applicable / Not provided.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not an AI/ML device.

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

• Not applicable / Not provided. There is no "training set."

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" in a 510(k) context for a traditional device largely revolve around demonstrating substantial equivalence to predicate devices. This is achieved by comparing technological characteristics, intended use, and materials.

The "study" or evidence provided to meet this "acceptance criteria" (substantial equivalence) is a qualitative comparison of the new device (OneFix product line) to several predicate devices.

Comparison of Technological Characteristics (as described in the document):

The document explicitly states:
"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The OneFix Biocomposite/All Suture Anchors and Interference Screws and Cannula Systems and the predicate devices share the following characteristics:

• Materials of construction
• Manufacturing processes
• Sizes offered
• Product design for shape and macrostructures
• Sterilization methods"

Predicate Devices Used for Comparison:

The devices for which substantial equivalence is claimed are:

• Fixone Biocomposite Anchors; K192484
• Fixone Biocomposite Small Anchors; K192032
• Fixone All Suture Anchors; K192709
• Fixone Interference Screws; K193497
• JOINIX Cannula System; K162070

In conclusion, this document demonstrates that the OneFix product line is substantially equivalent to already cleared predicate devices based on a comparison of their intended use, technological characteristics (materials, manufacturing, size, design, sterilization), and performance (implied to be similar because of the equivalence in characteristics and materials). No specific quantitative performance metrics or studies in the context of AI/ML are presented.

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The Auxilock Titanium Interference Screw is in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Auxein Brand Auxilock titanium Interference screw is cannulated, tapered fastener for use in Interference fixation of ligaments and tendons in patients requiring ligament or tendon-repair.

The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7 to 12 mm in diameter and 20 to 35 mm in length.

Each variant of Auxilock Titanium Interference Screw are sold both in non-sterile and sterile (EO & Gamma Sterile) conditions.

Non-sterile version of Auxilock Titanium Interference Screw have to be sterilized before use.

The provided document is a 510(k) Premarket Notification for a medical device called "Auxilock Titanium Interference Screw." It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML powered device.

Therefore, the requested information about acceptance criteria, study design for AI/ML performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not present in this document.

This document pertains to a traditional orthopedic implant, a titanium screw used for ligament and tendon fixation, whose acceptance is based on:

1. Substantial Equivalence: Comparing its characteristics (indications for use, material, performance standards, sterilization, dimensions) to an already legally marketed predicate device (Parcus Titanium Interference Screw - K083619).
2. Mechanical Testing: Demonstrating performance through pull-out strength, torsional strength, screw-in and screw-out, and pull-out based fatigue tests.
3. Material Compliance: Adhering to relevant ASTM material standards (ASTM F 136 and ASTM F 899-12).
4. Biocompatibility: Testing as per EN ISO 10993-1.
5. Sterilization and Endotoxins: LAL testing for bacterial endotoxins and packaging/shelf-life studies (EN ISO 11607-1:2009).

Summary of Acceptance Criteria and Reported Device Performance (based on the provided document for a non-AI/ML device):

Other requested information (not available for an AI/ML device in this document):

• Sample sizes used for the test set and the data provenance: Not applicable to this type of device. The mechanical tests used samples of the smallest diameter screw (7mm).
• Number of experts used to establish the ground truth...: Not applicable. Ground truth for an orthopedic screw is based on engineering specifications, material science, and mechanical testing results, not expert interpretation of AI outputs.
• Adjudication method...: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For this device, the "ground truth" is established through physical and mechanical property testing against defined engineering standards and comparison to a predicate device's established performance.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair

The Parcus Titanium Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.

The provided text pertains to the 510(k) premarket notification for the "Parcus Titanium Interference Screws." This is a medical device for orthopedic fixation, specifically for ligaments and tendons. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than a study evaluating the performance of a diagnostic AI device against acceptance criteria. Therefore, most of the requested information regarding AI device-specific acceptance criteria and studies (such as MRMC studies, human-in-the-loop performance, expert qualifications for ground truth, sample sizes for training/test sets concerning AI, etc.) is not applicable to this document.

However, I can extract information related to the device's performance testing where described, as it serves a similar purpose to acceptance criteria demonstration for physical medical devices.

Here's an analysis based on the closest applicable information in the provided text:

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

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

• Sample Size: The document mentions that pull-out strength and insertion torque were measured for the smallest (7mm), largest (12mm), and an intermediate size of the Parcus Titanium Interference Screws. The exact number of samples for each size is not specified in this document.
• Data Provenance: The performance data for pull-out strength and insertion torque is referenced as being included with the submission of K083619 (the predicate device). This suggests the performance data was likely generated through in-vitro mechanical testing. The country of origin for this data is not specified.

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

N/A - This medical device is a physical fixation screw, not an AI diagnostic device. Ground truth as typically understood for AI studies (e.g., expert consensus on image interpretation) is not applicable here. The "ground truth" for this device's performance would be the direct measurements of mechanical properties.

4. Adjudication method for the test set

N/A - As above, adjudication methods for expert disagreement on ground truth are not applicable to the mechanical testing of a physical medical device.

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 is not an AI-assisted diagnostic device.

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

N/A - This is not an AI algorithm.

7. The type of ground truth used

For the mechanical performance testing (pull-out strength, insertion torque), the ground truth is the direct physical measurement of these properties, likely using laboratory equipment. For pyrogenicity, the ground truth is established through LAL testing laboratory results. For substantial equivalence, the "ground truth" is the physical and functional characteristics of the device itself compared to a legally marketed predicate device.

8. The sample size for the training set

N/A - This is not an AI device, so there is no "training set."

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

N/A - As above, no training set for an AI model.

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Fixone Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery. This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 6 models. It provide non-sterile (user must sterilization before use).

The provided text describes a medical device called "Fixone Biocomposite Interference Screw" and outlines its clearance process with the FDA. It includes a 510(k) summary focusing on bench testing and biocompatibility.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

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

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

The document primarily details bench testing for mechanical, physical, and biocompatibility properties. It does not mention a clinical test set or human subject data.

• Sample Size (for bench tests): The "Tensile strength" test mentions an "average strength of 10 stands," indicating a sample size of at least 10 for that specific test. Other tests, such as those related to "Extractable color" and "Residue after evaporation," refer to "a quantity of suture, equivalent to not less than 250mg" and standard protocols, but specific sample counts for each bench test are generally not provided.
• Data Provenance: The bench tests were conducted by AJU Pharm Co., Ltd. in Korea (per the applicant information). These are laboratory tests, not clinical data from patients. They are inherently retrospective in the sense that they are conducted on manufactured devices in a controlled environment.

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. This device approval is based on bench testing and biocompatibility assessments, not on studies requiring human experts to establish "ground truth" for diagnostic or clinical performance. The "ground truth" for the tests performed are the defined standards and specifications (e.g., ASTM, ISO standards, quantified limits for chemical properties).

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

Not applicable. As noted above, this is not a diagnostic or clinical performance study that would involve expert adjudication of results. The results are quantitative measurements against predefined criteria.

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 (an interference screw for ACL/PCL reconstruction) and not an AI-powered diagnostic or assistive tool.

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 (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established by:

• Industry Standards: ASTM F2502, ASTM F1839-08, various ISO 10993 series for biocompatibility.
• Pharmacopoeial Standards: USP (for external surface).
• Defined Quantitative Limits: Specific values for pH difference, potassium permanganate consumption, residue after evaporation, maximum absorbance, and tensile strength (e.g., "not less than 100N").
• Comparison to Predicate Device: The fixation strength (push-out test) directly compares the subject device to the predicate device under the same conditions. This implies the predicate device's established performance serves as a comparative ground truth.

8. The sample size for the training set

Not applicable. This is not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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