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The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture or size 3/0 TephaFLEX™ absorbable suture in repairs of the extremities such as those shown below:

Foot and Ankle
1 Hallux Valgus repairs
2 Medial or lateral instability repairs/reconstructions
3 Achilles tendon repairs/reconstructions
4 Midfoot reconstructions
5 Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist and Hand
1 Scapholunate ligament reconstructions
2 Ulnar and radial collateral ligament reconstructions
3 Lateral epicondylitis repair
4 Biceps tendon reattachment

The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm diameter specifically for use in ankle, foot, elbow, wrist and hand repairs and reconstructions. The Axya Bone Anchor is available as a system together with a drill bit, a delivery/extraction handle and a drill guide. These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. The Axya Model 3000 Titanium Bone Anchor is prethreaded with either non-absorbable suture or size 3/0 TephaFLEX™ suture material.

This document is a 510(k) summary for the Axya Medical, Inc. Model 3000 AxyaLoop™ Titanium Bone Anchor. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

This document does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) process for this type of device (a bone anchor) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring performance against specific, pre-defined quantitative acceptance criteria through a clinical study in the way a diagnostic device might.

Therefore, many of the requested items (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or not provided in this type of submission.

Here's a breakdown of what can be extracted or inferred:

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

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

• Not applicable / Not provided. This 510(k) summary does not describe a clinical study with a "test set" in the context of diagnostic or AI performance. The "testing" referred to is primarily bench testing for mechanical properties and material equivalence.

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

• Not applicable / Not provided. No clinical "test set" requiring expert ground truthing is described.

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:

• No. This is a hardware medical device (bone anchor), not an AI diagnostic or assistive device. MRMC studies are not relevant here.

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

• No. This is a hardware medical device.

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

• Not applicable / Not provided. For a bone anchor, the "ground truth" for its performance is typically established through biomechanical testing (e.g., tensile strength, pull-out force) and material science, demonstrating equivalence to established devices and safety of materials. Clinical outcomes for equivalence are usually based on the predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not applicable / Not provided. No "training set" in the AI sense is relevant for this device.

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

• Not applicable / Not provided.

Summary of the study/evidence provided in the 510(k) submission:

The submission relies on claims of substantial equivalence to predicate devices (Axya Medical, Inc. Model 3000 AxyaLoop™ Suture Anchor [K022207] and Depuy Mitek QUICKANCHOR Plus Bone Anchor [K041115]).

The evidence provided for this substantial equivalence primarily consists of:

• Material Equivalence: The device is made from materials (Titanium, non-absorbable sutures, TephaFLEX™ absorbable suture) with an "established history of use in medical applications."
• Design and Functionality Equivalence: The corkscrew-style thread and 2.0 mm diameter are presented as suitable for the specified anatomical areas, implying similar biomechanical function to predicates.
• Sterilization Process Equivalence: The sterilization process is stated to be "equivalent to the process used by the original suture manufacturers."
• Testing in accordance with FDA guidelines: While specific results are not provided here, the document states that "the devices produced by Axya have been tested in accordance with applicable FDA guidelines." This typically refers to bench testing for mechanical properties (e.g., pull-out strength) to demonstrate that the device performs equivalently to the predicate devices.
• Indications for Use Equivalence: The specified indications for use (foot, ankle, elbow, wrist, hand repairs) are similar to those for which predicate bone anchors are marketed.

In essence, the "study" proving the device meets criteria is a combination of material characterization, bench testing (mechanical performance), and a comparison of design and indications to already-approved predicate devices to establish substantial equivalence, rather than a clinical trial with acceptance criteria for patient outcomes or diagnostic performance.

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The Axya Suture Welding System is indicated for use in securing sutures in soft tissues and for securing ligatures of tubular structures wherever conventional sutures or surgical staples are appropriate. The System may be used in arthroscopic, laparoscopic and open surgical procedures.

The Suture Welding System described in this Notice is a fully disposable singlepatient-use hand-piece with an internal (battery) power supply/controller. This device is designed for use in securing a specific suture (Axya Medical Tufflex™ Polyester suture) with a weld rather than with a traditional knot. This reduces the bulk of the suture fastening point and eliminates the possibility of knot slippage. The single-patient-use device eliminates the need for repair and maintenance of suture welding devices with reusable power supply/control units.

The provided text describes the Axya™ Suture Welding System and Kit, a device designed to secure sutures with a weld rather than a traditional knot. The submission aims to establish substantial equivalence to predicate devices.

Here's an analysis of the provided text in the context of the requested information, while noting that some information is not explicitly present in the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalence to predicate devices and established standards.

Study Details:

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

   • In vitro studies: The specific sample size for the in vitro studies (e.g., number of welds tested for knot strength) is not provided.
   • In vivo studies: The specific number of animals (New Zealand rabbits) used for the in vivo testing is not provided, though it mentions "bowel tissue of the New Zealand rabbit."
   • Data Provenance: The document does not specify the country of origin of the data. The studies appear to be conducted by or for Axya Medical, Inc.
   • Retrospective or Prospective: Both in vitro and in vivo studies described appear to be prospective in nature, designed specifically to test the device's performance.

2. 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):

   • The document mentions "investigators" for the animal study ("The investigators concluded that there was no significant difference..."). However, the number and specific qualifications of these experts are not provided. For in vitro studies, it's implied that standard laboratory practices and personnel were involved in performing tests against USP requirements.

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

   • The document does not describe any formal adjudication method like 2+1 or 3+1 for establishing ground truth from multiple experts. The conclusion from the animal study appears to be a consensus of the "investigators."

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a surgical tool, not an AI or imaging diagnostic tool that would typically involve human "readers" or AI assistance in interpretation. The comparison is between a device-secured suture and a manually-knotted suture in terms of physical performance and biological response.

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

   • This question is not applicable as the device is a physical surgical tool and not an algorithm. Performance is assessed directly through physical and biological testing of the device's output (welded sutures).

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

   • In vitro: Ground truth for suture strength was established by USP (United States Pharmacopeia) requirements for suture materials.
   • In vivo: Ground truth for safety/efficacy in the animal model was established through histopathologic evaluation (pathology) for adverse changes and likely observed functionality/healing, with conclusions drawn by "investigators."

7. The sample size for the training set:

   • This concept is not applicable to this type of medical device. The Axya Suture Welding System is a mechanical/thermal device, not an AI-based system that requires a "training set."

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

   • This question is not applicable for the reasons stated above (not an AI device).

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Tufflex™ Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Tufflex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Tufflex™ sutures are braided for optimal handling properties.

The provided text describes the 510(k) submission for the Tufflex™ polyester suture, which is a medical device. The information primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with detailed performance metrics like those for diagnostic AI devices.

Instead of "acceptance criteria," the document refers to compliance with USP requirements and equivalence to predicate materials for specific physical properties of the suture.

Here's an analysis based on the provided text, structured to answer your questions where applicable. Please note that many of your specific questions are designed for AI/diagnostic device studies and are not directly addressed by this type of 510(k) for a physical medical product like a suture.

1. Table of Acceptance Criteria and Reported Device Performance

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

The text does not specify the exact sample sizes used for testing suture diameter or knot tensile strength. It only states that "summaries of studies were conducted to evaluate the suture diameter and knot tensile strength as specified in the FDA Guidance Document."

• Data Provenance: Not explicitly stated, but typical for physical medical device testing, it would likely be laboratory-generated data from manufacturing lots. There is no mention of country of origin of data, nor whether it was retrospective or prospective in the clinical sense (as it's a materials test, not a patient outcome study).

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

This question is not applicable to this type of device. "Ground truth" in the context of a physical medical device like a suture refers to established physical standards (USP requirements). No human experts are used to "establish" this ground truth in the way described for AI/diagnostic devices. The testing is objective against published standards.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous "result" that requires adjudication by experts, as the testing is against defined physical parameters.

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

No. This type of study is for evaluating observer performance with diagnostic or AI-assisted interpretation, which is not relevant for a surgical suture.

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

Not applicable. This is not an AI or algorithm-based device. The "performance" is based on the physical properties of the suture itself.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Tufflex™ polyester suture's performance against the "acceptance criteria" (USP requirements) is objective physical standards and specifications for surgical sutures. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

Summary of the Study and Acceptance Criteria:

The "study" cited in the 510(k) submission for the Tufflex™ polyester suture was a series of tests performed to demonstrate that the device complies with the United States Pharmacopeia (USP) requirements and is equivalent to predicate devices for key physical properties.

• Acceptance Criteria: Compliance with USP requirements for suture diameter and knot tensile strength, and equivalence to the sterilization process of predicate devices. These criteria are established by regulatory guidance ("Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" - June 23, 2003) and industry standards (USP).
• Study That Proves Meets Criteria: The manufacturer "conducted summaries of studies" to evaluate these properties. The data from these studies "demonstrate that the Tufflex™ polyester suture satisfied the USP requirements and was equivalent to the predicate materials."

In essence, for this type of medical device, "acceptance criteria" are met by demonstrating adherence to established material specifications and manufacturing equivalency, rather than through clinical performance studies involving patient outcomes or expert interpretation.

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AxyaFlex™ polyester suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

AxyaFlex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. AxyaFlex™ sutures are braided for optimal handling properties.

The provided text is a 510(k) summary for a surgical suture and does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML-based device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through physical and chemical properties and biocompatibility.

Therefore, many of the requested categories for AI/ML device evaluation are not applicable or cannot be extracted from this document.

Here's an attempt to answer the questions based on the provided text, while noting where information is missing or not relevant to AI/ML devices:

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

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

• Sample Size for Test Set: Not specified. The document mentions "summaries of studies" but does not detail the sample sizes for the tests conducted to evaluate suture diameter, length, and knot tensile strength.
• Data Provenance: Not specified.

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 is a medical device (suture), not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth for performance evaluation in the clinical sense. The "ground truth" here would be objective measurements against established standards (USP).

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

• Not applicable. (See #3)

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 not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• The "ground truth" implicitly used for the physical and mechanical properties (diameter, length, knot tensile strength) would be the United States Pharmacopeia (USP) standards and FDA Guidance Document entitled "Class II Special Controls Guidance Document: Surgical Sutures." For biocompatibility and chemical analyses, the ground truth would be established scientific and regulatory benchmarks for safety and equivalence to predicate materials.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device with a training set.

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

• Not applicable. This is not an AI/ML device.

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The AxyaLoop™ Nonabsorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The device described in this submission is designed with a corkscrew style thread and is available in 3.0mm, 5.0mm and 6.5mm diameters, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor is available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Nonabsorbable Bone Anchor is prethreaded with USP polypropylene monofilament, USP nydon, USP braided polyester and USP braided polyethylene suture materials.

The Nonabsorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

The provided document is a 510(k) summary for a medical device, the AxyaLoop™ Nonabsorbable Bone Anchor. It discusses substantial equivalence to predicate devices based on in vitro testing. However, it does not describe studies typically associated with AI/ML devices or diagnostic performance metrics often found in acceptance criteria for such devices (e.g., sensitivity, specificity, AUC).

Instead, the acceptance criteria relate to the mechanical performance of the bone anchor.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states: "The 510(k) Notice contains summaries of in vitro studies that were conducted to evaluate the anchor pull-out strength as specified in the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996)." and "The data presented demonstrate that the anchor pull-out force of the Axya AxyaLoop™ Nonabsorbable Bone Anchor was comparable to that of the predicate devices of similar corkscrew geometry. The failure mode observed for the Axya anchor was predominately the same as that of the predicate anchor."

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

• The document mentions "in vitro studies" but does not specify the sample size for these tests (e.g., number of anchors tested, number of simulated bone samples).
• Data provenance: "in vitro" implies laboratory testing, not human patient data. There is no information on country of origin.

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

• Not applicable. For mechanical performance tests like pull-out strength, "ground truth" is typically established by direct measurement using calibrated equipment, not expert consensus. The "FDA Guidance Document for Testing Bone Anchor Devices" likely outlines the methodology.

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

• Not applicable. This concept typically applies to human expert review of diagnostic images or clinical cases, not mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is a mechanical device, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.

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

• Not applicable. This device is a mechanical bone anchor, not an algorithm.

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

• For "anchor pull-out strength," the "ground truth" would be the measured force at which the anchor fails or pulls out from the simulated bone, as determined by mechanical testing according to established testing standards (likely referenced in the FDA Guidance Document).

8. The sample size for the training set:

• Not applicable. The device is a mechanical bone anchor, not an AI/ML algorithm that requires training data.

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

• Not applicable. As above, no training set for an algorithm is involved.

In summary:

This document describes a medical device clearance based on substantial equivalence to existing predicate devices, primarily through in vitro mechanical testing to demonstrate comparable performance in terms of pull-out strength and failure mode. The evaluation framework is entirely different from what would be expected for an AI/ML-driven diagnostic or assistive device.

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The Axya Model 6500 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 6.5 mm and 5 mm anchors may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.

The device is designed with a corkscrew style thread 6.5 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a bone punch and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 6500 Self-Tapping Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material. The Model 6500 Self-Tapping Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Axya Model 6500 AxyaLoop™ Self-Tapping Bone Anchor:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not explicitly state the sample size (number of anchors tested) for the in-vitro study evaluating anchor pull-out strength.
• Data Provenance: The study was conducted in-vitro. This suggests a laboratory setting rather than using human or animal biological samples for the primary evaluation of pull-out strength. The country of origin is not specified but is presumably the US, given the submission to the FDA.

3. Number of Experts and Their Qualifications for Establishing Ground Truth (Test Set)

This information is not provided in the document. The study described is an in-vitro mechanical test. Ground truth in this context would likely be based on physical measurements and engineering standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As the study is an in-vitro mechanical test, there would be no need for expert adjudication in the traditional sense, which typically applies to subjective interpretations of medical images or clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The study described is an in-vitro mechanical test of device performance, not a study involving human readers or clinical cases.

6. Standalone (Algorithm Only) Performance Study

No, a standalone study was not done. This device is a mechanical bone anchor, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance (specifically pull-out strength) was based on physical measurements and engineering principles as specified in the "FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996)." This is a form of objective, quantitative data derived from a controlled laboratory setting.

8. Sample Size for the Training Set

This information is not applicable/provided. This device is a mechanical product, not a machine learning model, so there is no concept of a "training set" in the context of this submission. The "training" in manufacturing would relate to process validation and quality control, not data-driven model training.

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

This information is not applicable/provided for the reasons stated in point 8.

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The Axya Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The device is designed with a corkscrew style thread 3.0 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 3000 Bio-Absorbable Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material.

The Model 3000 Bio-Absorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

The provided 510(k) summary for the Axya Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor describes a medical device and its predicate devices, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the way a clinical or diagnostic performance study would.

This document focuses on establishing substantial equivalence to existing legally marketed devices, primarily through in vitro mechanical testing. The goal of this type of submission is to demonstrate that the new device is as safe and effective as a predicate device, not necessarily to meet pre-defined performance thresholds for diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as they are not relevant to a 510(k) submission based on substantial equivalence and in vitro testing.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to "summaries of in vitro studies" without providing specific numbers of anchors tested.
• Data Provenance: The studies were "in vitro," meaning conducted in a lab environment. The country of origin is not specified but is presumably where Axya Medical, Inc. (Beverly, MA, USA) conducted its research. The studies would be considered prospective in the sense that they were designed and executed to generate specific data for the submission, even if it's not a clinical trial.

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

• Not applicable. For in vitro mechanical testing, "ground truth" is established by the standardized methods of the test itself (e.g., precise measurement of force, observation of failure mode). There are no human "experts" establishing a diagnostic ground truth in this context.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data with subjective elements, which is not the case for material property testing.

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

• No. This type of study (MRMC) is for evaluating the impact of a diagnostic tool on human reader performance, typically in imaging or clinical decision-making. The Axya Bone Anchor is a surgical implant, not a diagnostic device.

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

• Yes, in spirit. The in vitro mechanical testing essentially represents "standalone" performance of the device's physical properties. It's the performance of the device itself under controlled conditions, not involving human interpretation in a clinical setting.

7. The Type of Ground Truth Used:

• Standardized Mechanical Measurements/Observations. The "ground truth" here is objective physical data (e.g., force in Newtons, precise description of fracture or pull-out). This is established by the methods outlined in the "FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996)."

8. The Sample Size for the Training Set:

• Not applicable. The concept of a "training set" is relevant to machine learning algorithms. This device is a physical implant, and its development does not involve training data in that sense. Its design and material choices are based on engineering principles and previous experience with similar devices, not a dataset for training an algorithm.

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

• Not applicable (as explained in point 8).

In summary: The provided document is a 510(k) summary for a medical device (a bone anchor) seeking market clearance based on substantial equivalence. It provides evidence of compliance with an FDA guidance document through in vitro mechanical testing to compare its performance (pull-out strength and failure mode) to predicate devices. It does not contain information about acceptance criteria or studies related to diagnostic accuracy, multi-reader performance, or algorithm training, as these concepts are not applicable to the nature of this device and its regulatory pathway.

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The Axya Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing in The Axya Model 0500 AxyaLoop - Blo Fissone in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular
Shoulder: Rotator curi, Bankart, and OEA: "Tocler." Total Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Uinar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The device is designed with a corkscrew style thread 6.5 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 6500 Bio-Absorbable Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material.

The Model 6500 Bio-Absorbable Bone Anchor is designed for use in both standard open
t the Model of the state the limited in (arthreasenia) surgical procedures The Model 6500 Blo-Absorbable Dono Anoner 16 access and in mical procedures.
surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

This is a 510(k) premarket notification for a medical device, the Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor, and therefore does not contain acceptance criteria or study results in the typical sense of an AI/ML device.

The document is a submission to the FDA demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving performance against specific quantitative acceptance criteria for a novel AI algorithm. The studies mentioned are in vitro studies comparing the device's physical properties to predicate devices, not clinical trials or performance evaluations of an AI model.

Therefore, the requested information elements related to AI/ML device performance (acceptance criteria table, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract the information that is present in the document which relates to the comparison to predicate devices:

1. Table of Acceptance Criteria and Reported Device Performance:

This document describes a comparison to predicate devices, not acceptance criteria for an AI/ML model. The "performance" being evaluated is related to physical properties of the bone anchor.

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

• Sample Size: Not specified in terms of number of anchors or tests. The document refers to "in vitro studies."
• Data Provenance: Not specified, but "in vitro studies" implies laboratory testing rather than human clinical data.

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

Not applicable. This is not an AI/ML study requiring expert ground truth for image or data interpretation. The "ground truth" for bone anchor performance typically comes from validated mechanical testing procedures.

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

Not applicable. This is not an AI/ML study involving human adjudication of performance.

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 not an AI/ML study.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For anchor pull-out force: Mechanical testing results (physical measurements).
• For materials: Biocompatibility data conforming to FDA guidance.
• For sterilization: Manufacturing process and testing by the suture manufacturer.

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. This is not an AI/ML device.

In summary, this 510(k) document focuses on demonstrating substantial equivalence of a physical medical device (a bone anchor) to existing devices based on "in vitro studies" of its mechanical properties and materials, rather than presenting performance data for an AI/ML algorithm against predefined acceptance criteria.

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The Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The device described in this submission is designed with a corkscrew style thread and will be made available initially in a 5.0 mm nominal diameters, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axva Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 5000 Bio-Albsorbable Bone Anchor is prethreaded with USP polypropylene monofilament, USP nylon, JJSP braided polyester and USP braided polyethylene suture materials.

The Model 5000 Bio-Absorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

The Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor's acceptance criteria and the study proving it meets them are described below:

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. The document refers to "in vitro studies" and "the data presented" without specifying the exact number of anchors tested.
• Data Provenance: The studies were "in vitro studies" conducted to evaluate anchor pull-out strength. The country of origin is not specified, but the submission is to the FDA in the US, suggesting the testing was likely conducted by or for the manufacturer, Axya Medical, Inc. (located in Beverly, MA, USA). The studies were retrospective in the sense that they were performed to demonstrate substantial equivalence to already cleared predicate devices.

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

This information is not applicable as the study was an in vitro mechanical performance test, not a study involving human interpretation or clinical outcomes requiring expert ground truth.

4. Adjudication method for the test set:

This is not applicable as the study involved in vitro mechanical testing, not a process requiring adjudication of observations or interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This device is a bio-absorbable bone anchor, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.

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

This is not applicable. The device is a physical medical implant, not an algorithm. The testing focused on its physical mechanical properties.

7. The type of ground truth used:

The ground truth for the in vitro studies was the mechanical performance (specifically anchor pull-out strength and failure mode) of the predicate devices. The goal was to show that the Axya device performed comparably to these established devices.

8. The sample size for the training set:

This is not applicable. The device is a physical implant, not a machine learning model, so there is no "training set."

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

This is not applicable for the same reason as above.

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The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture in repairs of the extremities such as those shown below:

Foot and Ankle
1 Hallux Valgus repairs
2 Medial or lateral instability repairs/reconstructions
3 Achilles tendon repairs/reconstructions
4 Midfoot reconstructions
5 Metatarsal ligament/tendon repairs/reconstructions

Elbow wrist and Hand
1 Scapholunate ligament reconstructions
2 Ulnar and radial collateral ligament reconstructions
3 Lateral epicondylitis repair
4 Biceps tendon reattachment

The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm diameter specifically for use in ankle, foot, elbow, wrist and hand repairs and reconstructions. The Axya Bone Anchor is available as a system together with a drill bit, a delivery/extraction handle and a drill guide. These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 3000 Titanium Bone Anchor is prethreaded with size 2/0 USP non-absorbable monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers. The Model 3000 Titanium Bone Anchor is intended for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Axya Model 3000 AxyaLoop™ Titanium Bone Anchor:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document explicitly states an "in vitro study," but it does not specify the sample size (e.g., number of anchors tested, number of repetitions, or types of bone analogues used).
• Data Provenance: The study was an in vitro study. The country of origin for the data is not specified, but given the company's address (Beverly, MA, USA) and the FDA submission, it can be inferred the study was likely conducted in the USA or supervised under US regulatory standards.

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

This information is not applicable as the described study is an in vitro mechanical performance study, not a clinical study involving human expert assessment for ground truth. The "ground truth" here is the physical measurement of pull-out force.

4. Adjudication Method for the Test Set

This is not applicable as the described study is an in vitro mechanical performance study and does not involve human readers or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is a bone anchor, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or AI comparison was done.

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

This is not applicable. The device is a physical bone anchor, not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for the in vitro study was objective mechanical measurement (specifically, pull-out force) following an established FDA guidance document.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" mentioned or implied as this is a physical medical device undergoing mechanical testing, not a machine learning model.

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

This is not applicable for the same reasons as #8.

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