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The Bone Anchor System and Kit is indicated for securing soft tissue structures to bone anchors in surgical procedures where bone anchors are indicated. Examples of these procedures include:

The BAK is indicated for use in both traditional open surgery and endoscopic surgical procedures.

The Axya Bone Anchor System consists of an electronic control module and a reusable welding activator with an integral connector cable. The Kit (BAK) consists of a reusable suture welding sleeve packaged together with appropriate and currently approved bone anchors and USP polypropylene monofilament suture. The Kit is intended for use with the reusable system components in order to complete the suture welding process for the attachment of soft tissues to bone anchors in surgical procedures where bone anchors are indicated.

The provided text describes a medical device, the Axya Bone Anchor System and Kit (BAK), and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the format typically used for AI/ML device evaluations. Instead, it relies on demonstrating that the BAK's design and components are similar to existing approved devices and that the core technology (suture welding) has previously been shown to meet performance and safety standards.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain to a different type of evaluation (e.g., performance of an AI/ML algorithm).

Here's a breakdown of what can and cannot be answered based on the provided document:

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 explicitly stated as a separate "test set" in the context of an algorithm evaluation. The document refers to various tests conducted on the predicate devices or the core welding technology, such as "in vivo and in vitro studies" and "bench-test models." The specific number of sutures, animals, or tests performed is not detailed.
• Data Provenance:
  • In vivo studies: "New Zealand rabbits" were used for studies on the predicate ASLS system.
  • In vitro studies/bench-test models: Not specified.
  • Retrospective or Prospective: Not explicitly stated, though the animal studies would be prospective at the time they were conducted for the predicate device.

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)

This information is not provided. The "ground truth" here would relate to the assessment of suture strength, tissue reaction, etc., which would be determined by laboratory measurements and histopathological evaluations, likely by veterinary pathologists or engineers, but their number and specific qualifications are not mentioned.

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

Not applicable. This concept (adjudication of expert readings) is relevant for clinical studies involving human interpretation (e.g., radiology studies), not for mechanical or animal safety/efficacy testing described here.

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

Not applicable. This device is a surgical tool, not an AI-powered diagnostic or assistive system for human readers. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

Not applicable. This is not an AI/ML algorithm. The device is a surgical instrument.

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

The types of "ground truth" or evaluative methods used include:

• Laboratory measurements of suture knot strength (USP requirements).
• Bench-test models for suture fatigue and elongation.
• Histopathological evaluation of tissue reaction at suture implant sites in animal models.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, there is no training set for an AI/ML algorithm.

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The Bone Anchor System and Kit is indicated for securing soft tissue structures to bone anchors in surgical procedures where bone anchors are indicated. Examples of these procedures include:

The BAK is indicated for use in both traditional open surgery and endoscopic surgical procedures.

The Axya Bone Anchor System consists of an electronic control module and a reusable welding activator with an integral connector cable. The Kit (BAK) consists of a disposable suture welding sleeve packaged together with appropriate and currently approved bone anchors and USP polypropylene monofilament suture. The Kit is intended for use with the reusable system components in order to complete the suture welding process for the attachment of soft tissues to bone anchors in surgical procedures where bone anchors are indicated

The Axya Bone Anchor System and Kit (BAK) is a Class II device intended to secure soft tissues to bone anchors in surgical procedures. The device uses an ultrasonic suture welding process.

Here's an analysis of the acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it focuses on demonstrating that the BAK is substantially equivalent to predicate devices and that its performance (specifically suture strength and safety) meets established standards and is comparable to traditional methods.

The reported device performance is presented as:

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

The document describes two main types of studies:

• In Vitro (Bench-test) Studies:

  • Sample Size: Not explicitly stated with specific numbers for each test (e.g., number of sutures tested for knot strength, number of samples for fatigue). It generally refers to "data presented" and "tests" covering "respective sizes and types of suture materials" and "USP size 2 polypropylene monofilament sutures."
  • Data Provenance: Conducted "in vitro" and described as "bench-test models." No country of origin is specified, but it's implied to be part of the manufacturer's testing in the US. The data is retrospective in the sense that it refers back to studies conducted for prior 510(k) clearances (ASLS and SWK).

• Animal Studies:

  • Sample Size: Not explicitly stated as a number of animals or implant sites. It mentions "New Zealand rabbits" for dorsal skin and bowel tissue studies. Without specific numbers, it's impossible to quantify the sample size.
  • Data Provenance: Animal models (New Zealand rabbits). The studies were previously conducted and referenced from a prior 510(k) (K980988), making them retrospective in the context of this current submission.

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

This information is not provided in the document.

• For the in vitro studies, "ground truth" would be objective measurements (e.g., force required for failure, cycle count to failure), not expert consensus.
• For the animal studies, the "investigators" concluded on safety and efficacy based on histopathology. However, the number of investigators/pathologists, their specific qualifications, or how their consensus was reached is not mentioned.

4. Adjudication Method

This information is not provided in the document. Given the nature of the studies (in vitro measurements and animal histopathology from earlier submissions), a formal human-reader adjudication method as often seen in imaging studies (e.g., 2+1) is unlikely to apply directly. The "investigators" formed conclusions, but the method of their consensus/adjudication is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

This type of study is primarily relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess changes in diagnostic accuracy or efficiency. The Axya Bone Anchor System is a surgical tool, not a diagnostic imaging device. The comparative effectiveness assessment focused on mechanical properties (suture strength) and biological safety (tissue reaction) compared to traditional methods, not human reader performance.

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

Yes, in essence, standalone performance was evaluated for the device's core function.

The in vitro studies on suture strength, fatigue, and elongation represent the standalone mechanical performance of the welded suture. The animal safety studies evaluated the biological response to the device's output (welded suture) without direct human intervention impacting the "welding" function itself during the test. The "algorithm" here isn't a software algorithm but rather the mechanical and ultrasonic welding process. The efficacy of this process was demonstrated independently of varied human surgical technique (e.g., how a human would tie a knot).

7. The Type of Ground Truth Used

• Quantitative Bench-Test Data: For suture strength and fatigue, the ground truth was derived from objective, measurable outcomes obtained from bench-tests (e.g., force measurements for knot strength, cycle counts for fatigue). These are "physical performance metrics."
• Histopathology: For the animal safety studies, the ground truth for tissue reaction and safety was established by detailed microscopic examination of tissue samples (histopathology) at the implant sites. This is a "pathology" based ground truth.

8. The Sample Size for the Training Set

Not applicable.

The Axya Bone Anchor System is a mechanical device, not a machine learning or AI-driven system that requires a "training set" in the conventional sense. The device's function is deterministic based on its design and physical principles. Its development would involve engineering design, prototyping, and testing, not statistical training on a dataset.

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

Not applicable.

As there is no training set as understood in AI/ML, there is no ground truth established for a training set. The device's performance is demonstrated through its inherent mechanical and biological properties, not learned patterns from data.

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The Suture Welding System and Kit is indicated for securing synthetic monofilament sutures in soft tissues and for securing ligatures of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The SWK is indicated for use in both traditional open surgery and endoscopic surgical procedures.

The Axya Suture Welding System and Kit (SWK) is substantially equivalent in design and function to the Axya Suturing and Ligating System (ASLS) and the Endo-Judge disposable suture placement system. Suture applicators and suture placement devices which may be used in both endoscopic or traditional open surgical procedures have been classified under 21 CFR 876.1500. These devices are indicated for the placement of sutures in soft tissue to close either traumatic or surgically produced wounds. The SWK is fabricated from materials with a substantial history of use in medical devices. Both the SWK and the predicate device secure the suture loop with an ultrasonic weld. The ultrasonic energy source used to weld and secure the suture loop is the same generator used for the Automatic Suturing and Ligating System and is similar to the energy source used in the UltraCision Harmonic Scalpel. The suture material is heated and welded by friction and the weld is formed by melting and fusing the polymer. No "flux" or "welding rod" is employed and no new chemical entities are introduced or produced in the welding process. The Axya Suture Welding System and Kit are sterilized by exposure to gamma irradiation at 2.5 Mrads which provides a sterility assurance level of at least 10° or, alternatively, by means of an ethylene oxide gas sterilization process which also provides a SAL of 10°.

Here's an analysis of the provided text regarding the Axya Suture Welding System and Kit (SWK):

Acceptance Criteria and Study Findings for Axya Suture Welding System and Kit (SWK)

The submission highlights the substantial equivalence of the Axya SWK to predicate devices and provides data to support its safety and effectiveness. The acceptance criteria are implicitly derived from the comparisons to established standards (USP requirements) and predicate devices (Axya Suturing and Ligating System (ASLS) and Endo-Judge).

1. Table of Acceptance Criteria and Reported Device Performance

• Synthetic monofilament sutures placed with the ultrasonic suture welding technology are equivalent in holding strength (efficacy) to sutures placed with conventional knotting techniques.
• Synthetic monofilament sutures secured by weld formed with the AxyaWeld Tips have equivalent knot strength to sutures welded with the predicate AxyaStitch Cartridge. |
  | Suture Degradation Profile | Strength Retention: No deleterious effect on the strength retention profile of synthetic absorbable sutures, following the profile described in the suture manufacturer's package insert and exceeding predicted USP requirements. | - Studies on synthetic absorbable sutures (Maxon™) showed strength loss curves following the manufacturer's profile and exceeding predicted USP strength retention requirements. This demonstrates no deleterious effect from the welding process. |
  | Safety - Tissue Reaction | Histopathologic Change: No significant difference in safety or efficacy in terms of tissue reaction between welded sutures and manually knotted sutures. No histopathologic change at implant sites. | - In animal models (New Zealand rabbits, dorsal skin and bowel tissue), there was no histopathologic change seen at the suture implant sites where the suture was sealed with ultrasonic energy.
• Investigators concluded no significant difference in safety or efficacy between traditional knotting and suture welding. |
  | Safety - Thermal Injury | Minimal to virtually no risk of thermal injury to the patient. | - No portion of the ultrasonic generator comes into contact with human tissues.
• The design of the AxyaWeld Sleeve prevents the heated area of suture from coming into direct contact with tissues. |
  | Sterility | Achievable sterility assurance level (SAL) of at least 10⁻⁶ via gamma irradiation or ethylene oxide gas sterilization. Sterility processes, manufacturing, and packaging are validated. | - Sterilized by exposure to gamma irradiation at 2.5 Mrads (SAL of at least 10⁻⁶) or ethylene oxide gas sterilization (SAL of 10⁻⁶).
• Sterility processes, manufacturing, and packaging processes are validated by the manufacturer. |
  | Biocompatibility | Fabricated from materials with a substantial history of use in medical devices and thoroughly tested in accordance with applicable FDA guidelines. No new chemical entities introduced or produced during welding. | - Fabricated from materials with a substantial history of use in medical devices.
• Specific materials used by Axya have been thoroughly tested in accordance with applicable FDA guidelines.
• No "flux" or "welding rod" is employed and no new chemical entities are introduced or produced in the welding process. |

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

The provided text describes the studies as "previously submitted efficacy studies" and "in vivo and in vitro studies." However, the exact sample sizes for the test sets (e.g., number of suture samples for strength, number of animals for in vivo studies) are not specified in this document.

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective or Prospective: Not explicitly stated, but the description of the studies (e.g., "Maxon™...tested for strength at baseline and at one-week intervals over seven weeks") suggests a prospective experimental design for the in vitro strength retention studies. The animal studies would also be prospective.

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

The text mentions "The investigators concluded that there was no significant difference in safety of efficacy..." in the context of the animal studies. However, the number of experts (investigators) involved in establishing the ground truth (e.g., assessing histopathologic change) is not specified. Their specific qualifications (e.g., board-certified veterinary pathologists, surgeons with X years of experience) are also not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in ground truth establishment for the test sets. The mention of "investigators concluded" suggests a consensus or lead investigator's finding, but the process is not elaborated.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The studies focus on comparing the device's performance to predicate devices and conventional techniques, but not specifically on how human readers/surgeons' effectiveness might improve with or without AI assistance (as this is not an AI device).

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

This device is not an AI algorithm. It is a surgical tool. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable. The device inherently requires a human operator for its function.

7. The Type of Ground Truth Used

The ground truth used in the studies appears to be a combination of:

• Performance Benchmarks/Standards: USP requirements for knot strength and strength retention.
• Direct Comparison to Predicate Devices: E.g., AxyaStitch Cartridge for knot strength.
• Direct Comparison to Conventional Techniques: Conventional knotting techniques for holding strength and manual knotting for safety/efficacy in animal models.
• Histopathology: In the animal studies, histopathologic examination of tissue samples at implant sites, likely interpreted by pathologists.

8. The Sample Size for the Training Set

The devices described are not AI/ML algorithms that utilize a "training set" in the conventional sense. Therefore, the concept of a "training set sample size" is not applicable. The studies described are validation studies for a physical medical device.

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

As explained above, the concept of a "training set" and its associated ground truth establishment is not applicable to this type of medical device submission.

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The ASLS is indicated for the placement of synthetic monofilament sutures in soft tissues and for the ligation of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The ASLS is indicated for use in both traditional open surgery and ondoscopic surgical procedures.

The Axya Automatic Suturing and Ligating System (ASLS) is a device for the placement of sutures in soft tissue to close either traumatic or surgically produced wounds. It uses curved, hollow needles to place the suture through soft tissue structures and secures the suture loop with an ultrasonic weld. The ultrasonic energy source used to weld and secure the suture loop is similar to the energy source used in the UltraCision Harmonic Scalpel. The device is sterilized by exposure to gamma irradiation.

Here's an analysis of the provided text regarding the Axya Automatic Suturing and Ligating System (ASLS), broken down into the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test sets in either the in vivo or in vitro studies. It mentions:

• In Vitro Studies: "respective sizes and types of suture materials tested" and "one-week intervals over seven weeks."
• In Vivo Studies: "dorsal skin and in bowel tissue of New Zealand rabbits." This indicates rabbit models were used.
• Data Provenance: The studies were conducted by Axya Medical, Incorporated. The location is not specified, but the submission is to the U.S. FDA, implying the data would be expected to adhere to U.S. regulatory standards. The studies described are prospective as they were conducted specifically to evaluate the ASLS.

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

The document mentions "investigators" who concluded on the safety and efficacy of the in vivo studies. However, it does not specify the number of experts, their qualifications, or how they established the ground truth beyond their conclusions based on histopathologic analysis.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "investigators" reached conclusions, implying a collegiate or consensus-based approach, but no specific process is detailed.

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

No, an MRMC comparative effectiveness study involving human readers is not described. The study compared the device's performance to conventional knotting or to USP standards.

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

Yes, the studies described are standalone in the sense that they evaluate the performance of the ASLS device itself (suture strength, strength retention, tissue reaction) without a human operator's diagnostic or interpretative input being part of the primary outcome measure. The device replaces manual knot-tying, so its performance is measured against the output of that manual process.

7. The Type of Ground Truth Used

• Suture Strength: Based on USP requirements and comparisons to "conventional knotting techniques."
• Strength Retention: Based on the suture manufacturer's package insert profile and USP requirements.
• Biocompatibility/Tissue Reaction: Established through histopathologic examination of tissue samples from the animal models, with "investigators" providing the conclusions.
• Thermal Injury: Implied from the design features of the device (no tissue contact) and possibly verified by temperature monitoring, though not explicitly detailed.

8. The Sample Size for the Training Set

The document does not mention a training set because this device is a mechanical/energy-based surgical instrument, not an AI/algorithm-based diagnostic system that requires machine learning training.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

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