The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

Device Description

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is a combination of two FDAcleared Surgicraft Products, the Surgicraft LOCKDOWN Mesh (K072370) and the Surgicraft LOCKDOWN Screw (K080447). The new product for this indication is designated as the LOCKDOWN™ Acromioclavicular (AC) device and will have a new indication to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

It is not intended that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device be used as the sole means of reconstructing a chronic acromioclavicular joint dislocation.

The Surgicraft LOCKDOWN Mesh device is a woven mesh 11mm wide by 4 to 20 cm in length with loops at both ends. The Surgical Mesh is made from braided Polyethyleneterephthalate (Polyester) fibers (PET).

The Surgicraft LOCKDOWN Screw is manufactured from stainless steel and titanium alloy. The self-tapping 3.5 mm screws are available in lengths from 14- 40 mm in 1 mm increments. The washers have a hole with an inner diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments.

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is provided sterile.

AI/ML Overview

The provided document is a 510(k) summary for the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device. It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed. However, it explicitly states that no clinical testing was performed. Therefore, several sections of your request related to acceptance criteria proved by clinical studies, sample sizes for test sets, expert involvement, and ground truth for clinical outcomes cannot be addressed.

Here's a breakdown of the available information based on your request:

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

No explicit quantitative acceptance criteria or detailed reported device performance metrics were provided in the document in a way that would allow for a direct comparison table. The document states that "side-by-side testing was performed with the named predicate device in appropriate cadaver models and indicated that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is substantially equivalent to predicate device." This implies performance comparable to the predicate, but specific quantitative metrics comparing acceptance criteria to performance are not available.

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. The document mentions "appropriate cadaver models" were used for side-by-side testing. The number of cadaver models is not specified.
Data Provenance: The cadaveric testing would be considered prospective in the context of the study design; however, details on the origin of the cadaver models (e.g., country) are not provided.

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, as no clinical testing with human subjects or expert assessment of clinical outcomes was performed. The testing involved mechanical and cadaveric models.

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

Not applicable, as no clinical testing with human subjects or expert assessment of clinical outcomes was performed.

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 implant, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a medical device, not a software algorithm. The "standalone" performance would refer to the mechanical and biocompatibility testing of the device itself.

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

For the non-clinical testing:

Biocompatibility testing (per ISO 10993): Ground truth would be established by the ISO 10993 standards for material safety.
Screw pull-out testing, mesh burst strength, and suture attachment strength: Ground truth would be established by engineering specifications and benchmarks to ensure the device's mechanical integrity meets required safety and performance thresholds, likely compared against the predicate device's known performance.
Cadaveric model testing: Ground truth for substantial equivalence would be based on direct mechanical comparison of the device's performance (e.g., stability, fixation strength) against the predicate device in a simulated anatomical environment.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model that requires a training set.

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

Not applicable, as no training set was used.

Summary of Device Acceptance Criteria and Study:

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device gained regulatory clearance (K091207) based on demonstrating substantial equivalence to a predicate device, the Arthrex TightRope® Acromioclavicular device (K052776).

Acceptance Criteria (Implied by Substantial Equivalence):

The device must demonstrate similar:

Indications for use.
Function.
Materials (braided Polyethyleneterephthalate (Polyester) fibers (PET), stainless steel, and titanium).
Mechanical performance (screw pull-out strength, mesh burst strength, suture attachment strength).
Biocompatibility.
Performance in a cadaveric model, matching the predicate device's performance.

Study Proving Acceptance Criteria:

The study was a non-clinical comparative study against the predicate device.

Mechanical Testing:
- Tests Performed: Biocompatibility testing (per ISO 10993), screw pull-out testing, mesh burst strength, and suture attachment strength.
- Methodology: These tests would involve standard engineering and biocompatibility protocols to assess the physical properties and material safety of the device and its components.
- Ground Truth: Established by adherence to ISO 10993 standards and engineering specifications for material strength and performance, likely benchmarked against the known performance of the predicate device.
- Sample Size: Not explicitly stated for each mechanical test, but typically these involve a statistically relevant number of samples for each component.
Cadaveric Model Testing:
- Methodology: "Side-by-side testing was performed against the predicate device in an appropriate cadaveric model." This would involve implanting both the Surgicraft device and the predicate device in cadaveric shoulder models and subjecting them to mechanical stress to compare their fixation capabilities and stability.
- Ground Truth for Comparison: The performance of the predicate device within the cadaveric model. The Surgicraft device was deemed equivalent if its performance matched that of the predicate.
- Sample Size: Not explicitly stated, but implies multiple applications and comparisons within these models.
- Data Provenance: Cadaver models, assumed to be prospective in nature.

Conclusion: The device met its acceptance criteria by demonstrating substantial equivalence to the predicate device through a series of non-clinical mechanical and cadaveric model tests. No clinical studies were deemed necessary for this 510(k) clearance.

Summary

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K091207

510(k) Summarv

Contact:	Donald W. GuthnerOrgenix, LLC111 Hill RoadDouglassville, PA 19518(646) 460-2984
Device Trade Name:	LOCKDOWNTM Acromioclavicular (AC) device.
Manufacturer:	Surgicraft (Trading Name of Mandaco 569 Limited)16 The OaksClews RoadRedditch, UKB98 7ST
Classification:	21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories
Class:	II
Product Code:	HTN

Indications For Use:

Device Description:

It is not intended that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device be used as the sole means of reconstructing a chronic acromioclavicular joint dislocation.

Manufactured by:

Surgicraft (Trading name of Mandaco 569) / 16 The Oaks / Clews Road / Redditch / Worcestershire / B98 7ST / UK T: +44 1527 512600 / F: +44 1527 512612 / E: info@surgicraft.co.uk / www.surgicraft.co.uk

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14091207

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is provided sterile.

Predicate Device(s):

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device was shown to be substantially equivalent to the Arthrex TightRope® Acromioclavicular device (K052776) and has the same indications for use, function and/or materials.

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device and the named predicate . device both use braided Polyethyleneterephthalate (Polyester) fibers (PET), stainless steel and titanium materials to fixate acromioclavicular separations.
Both devices contraindicate the use of the device as the sole means of reconstructing a . chronic acromioclavicular joint dislocation.
The indications for use statements for both devices are identical. .

Performance Standards:

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device. Side-by-side testing was performed with the named predicate device in appropriate cadaver models and indicated that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is substantially equivalent to predicate device.

Non-Clinical Testing

Mechanical testing was performed on the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device or its components prior to submission for approval. Testing performed included biocompatibility testing (per ISO 10993), screw pull-out testing, mesh burst strength and suture attachment strength. In addition, side-by-side testing was performed against the predicate device in an appropriate cadaveric model.

Clinical Testing

No clinical testing was performed nor was deemed necessary to demonstrate substantial equivalence.

Conclusions

Surgicraft considers the LOCKDOWN™ Acromioclavicular (AC) device to be equivalent to the predicate device listed above. This conclusion is based upon the devices similarities in function, materials and indications for use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted as a staff with two snakes coiled around it and wings at the top.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Surgicraft, Ltd. % Mr. Donald W. Guthner Orgenix, LLC l 1 l Hill Road Douglassville, Pennsylvania 19518

FEB 1 5 201

Re: K091207

Trade/Device Name: Surgicraft LOCKDOWN™ Acromioclavicular (AC) device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: January 5, 2010 Received: January 6, 2010

Dear Mr. Guthner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

. . . . . . . . . . . . . . . . . . . . . . . . . . .

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Page 2 - Mr. Donald W. Guthner

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K091207

Device Name: Surgicraft LOCKDOWN™ Acromioclavicular (AC) device

Over-The-Counter Use Prescription Use V AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

for W.M.Mulkern

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091207

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.