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:

Shoulder procedures	(e.g. Rotator cuff repair)
Knee procedures	(e.g. Patellar ligament / tendon avulsion repair)
Ankle procedures	(e.g. Achilles tendon reconstruction and repair)
Foot procedures	(e.g. Hallux valgus reconstruction)
Elbow procedures	(e.g. Biceps tendon reattachment)
Bladder neck suspension	(female urinary incontinence due to urethral hypermobility)

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

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Inferred from Predicate Device Statements)	Reported Device Performance (Axya BAK, or core technology)
Suture Knot Strength: Exhibit "knot strength" characteristics substantially above USP requirements for various USP suture materials.	Suture Knot Strength: "Data were presented which demonstrate that sutures placed by means of the suture welding process exhibit 'knot strength' characteristics substantially above the USP requirements for the various USP suture materials tested. These tests confirm that the polypropylene monofilament sutures placed with the ultrasonic suture welding technology are equivalent in holding strength (efficacy) to sutures placed with conventional knotting techniques." "Data presented in the original Notice for the Bone Anchor System and Kit confirm that USP size 2 polypropylene monofilament sutures secured by a weld formed with the AxyaWeld Tips exceed the USP knot strength requirements."
Strength vs. Angle of Applied Tension: Meet strength requirements regardless of the angle of applied tension between the suture and the bone anchor stem.	Strength vs. Angle of Applied Tension: "Data were presented that demonstrate that strength requirements are met regardless of the angle of applied tension between the suture and the bone anchor stem."
Suture Fatigue and Elongation: Meet suggested criteria following cyclic testing over the functional life.	Suture Fatigue and Elongation: "Suture fatigue and elongation over the functional life were evaluated in bench-test models and the welded sutures have been found to meet the suggested criteria following cyclic testing."
Safety - Histopathologic Change: No significant histopathologic change at suture implant sites.	Safety - Histopathologic Change: "In both animal models there was no histopathologic change seen at the suture implant sites where the suture was sealed with ultrasonic energy. The investigators concluded that there was no significant difference in safety of efficacy between the traditional method of suture placement and the technique which includes replacement of manual knot-tying with suture welding."
Safety - Thermal Injury: No risk of causing thermal injury to the patient.	Safety - Thermal Injury: "Because of design features of the BAK, no portion of the ultrasonic generator comes into contact with human tissues. Because of this, there is virtually no risk of causing a thermal injury to the patient. 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 design of the AxyaWeld Sleeve also prevents the heated area of suture from coming into direct contact with tissues."
Sterility: Components are appropriately sterilized and validated.	Sterility: "Axya Bone Anchor System and Kit with a reusable sleeve is provided non-sterile. The suture material and bone anchors are sterilized by the original manufacturer as dictated by the type of suture included with a given product configuration. The sterility processes, the manufacturing process, and the packaging process are validated by the manufacturer."

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.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

General Company Information

Axva Medical, Inc. Name: 100 Cummings Center Address: Suite 444C Beverly, MA 01915
(978) 232 9997 Telephone: (978) 232 - 9998 Fax:

General Device Information

Product Name: Bone Anchor System and Kit (BAK)
Classification: Accessory to an Endoscope - Class II

Predicate Devices

Axya Suturing and Ligating System (ASLS) [510(k) K980988]

Axya Suture Welding System and Kit (SWK) [510(k) K983108]

Description

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Intended Use

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:

Shoulder procedures	(e.g. Rotator cuff repair)
Knee procedures	(e.g. Patellar ligament / tendon avulsion repair)
Ankle procedures	(e.g. Achilles tendon reconstruction and repair)
Foot procedures	(e.g. Hallux valgus reconstruction)
Elbow procedures	(e.g. Biceps tendon reattachment)
Bladder neck suspension)	(female urinary incontinence due to urethral hypermobility)

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

Substantial Equivalence

This submission supports the position that the Axya Bone Anchor System and Kit (BAK) which includes USP size 2 polypropylene suture (manufactured by United States Surgical or Sharpoint) and a reusable welding sleeve is substantially equivalent to the original Bone Anchor System and Kit [501(k) K992405], and to the Axya Suturing and Ligating System (ASLS) [510(k) K980988], and the Axya Suture Welding System and Kit (SWK) [510(k) K983108); and that it is appropriate for its intended application. 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 to close either traumatic or surgically produced wounds. The BAK is fabricated from materials with a substantial history of use in medical devices. Both the BAK and the predicate devices secure the suture loop with an ultrasonic weld.

The 510(k) Notice for the predicate ASLS system contains summaries of both in vivo and in vitro studies which were conducted to evaluate the safety, efficacy and appropriateness of the suture welding system. These data are applicable to the Bone Anchor System because the design and components of the welding mechanism are the same as those used in the BAK, ASLS and the SWK that were previously cleared for marketing. Data were presented which demonstrate that sutures placed by means of the suture welding process exhibit "knot strength" characteristics substantially above the USP requirements for the various USP suture materials tested. These tests confirm that the polypropylene monofilament sutures placed with the ultrasonic suture welding technology are equivalent in holding strength (efficacy) to sutures placed with conventional knotting techniques.

Data presented in the original Notice for the Bone Anchor System and Kit confirm that USP size 2 polypropylene monofilament sutures secured by a weld formed with the AxvaWeld Tips exceed the USP knot strength requirements. Data were presented that demonstrate that strength requirements are met regardless of the angle of applied tension between the suture

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and the bone anchor stem. Suture fatigue and elongation over the functional life were evaluated in bench-test models and the welded sutures have been found to meet the suggested criteria following cyclic testing.

The safety of the suture delivery system was previously evaluated by placing both welded sutures and manually knotted sutures in the dorsal skin and in bowel tissue of New Zealand rabbits [510(k) K980988]. Positive (electrocautery contact) and negative (normal tissue) controls were used in the bowel study. In both animal models there was no histopathologic change seen at the suture implant sites where the suture was sealed with ultrasonic energy. The investigators concluded that there was no significant difference in safety of efficacy between the traditional method of suture placement and the technique which includes replacement of manual knot-tying with suture welding. The design of the AxyaWeld Sleeve also prevents the heated area of suture from coming into direct contact with tissues.

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 that used for the Suture Welding System and Kit, and is similar to the energy source used in the UltraCision Harmonic Scalpel [510(k) K895252].

Because of design features of the BAK, no portion of the ultrasonic generator comes into contact with human tissues. Because of this, there is virtually no risk of causing a thermal injury to the patient. 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.

Axya Bone Anchor System and Kit with a reusable sleeve is provided non-sterile. The suture material and bone anchors are sterilized by the original manufacturer as dictated by the type of suture included with a given product configuration. The sterility processes, the manufacturing process, and the packaging process are validated by the manufacturer.

Axya Medical, Inc. believes that the information provided establishes that similar legally marketed and pre-enactment devices have been used for the same types of clinical applications as the Axya Bone Anchor System and Kit. The materials from which the Axya device is fabricated have an established history of use in medical applications, and the specific materials used by Axya have been thoroughly tested in accordance with applicable FDA guidelines.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

Mr. Howard L. Schrayer Axya Medical, Inc. 100 Cummings Center Suite 444C Beverly, Massachusetts 01915

Re: K994313 Trade Name: Axya Bone Anchor System and Kit (BAK) Regulatory Class: II Product Code: GAW and MBI Dated: December 21, 1999 Received: December 22, 1999

Dear Mr. Schrayer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a

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Page 2 - Mr. Howard L. Schrayer

legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Tunnell J. Vayor

Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K494313 510(k) Number (if known):

Device Name: Axya, Bone Anchor System and Kit, (BAK)

Indications For Use:

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:

Shoulder procedures	(e.g. Rotator cuff repair)
Knee procedures	(e.g. Patellar ligament / tendon avulsion repair)
Ankle procedures	(e.g. Achilles tendon reconstruction and repair)
Foot procedures	(e.g. Hallux valgus reconstruction)
Elbow procedures	(e.g. Biceps tendon reattachment)
Bladder neck suspension	(female urinary incontinence due to urethral hypermobility)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ressell L. Jogan

(Division Sign-Off) Dr. sion of Leneral Restorative Devices 16994313 STU(K) Number_

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.