The PFS is a single use, non-toxic, disposable, sterile device. The PFS consists of the Cannulated Awl Assembly, the Implantable Pin Handle Assembly, and Exchange Guide and Bend Tube.

Prior to use, the implantable pin assembly is nested in the cannulated awl assembly. The cannulated awl assembly has a trocar point. The implantable pin has a blunt point that is positioned just behind the trocar point of the cannulated awl. The sharp point of the cannulated awl assembly is passed through a small incision. A hole is drilled into the Phalangeal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the cannulated awl handle is held stationary while the implantable pin is then advanced distally from the base of the phalangeal bone.

The awl handle is then withdrawn and removed for advancement of the implantable pin. Multiple pins, usually two, are implanted in the manner previously described. The pins are placed in a arrangement to minimize radial movement.

The implantable pin(s) is then cut at the taper near the proximal end of the pin. Using the bending tube end of the exchange guide the implantable pin is bent to 90° with the apex of the bend at the implantable pin insertion site. The pin is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable pin subsequent to healing. The implantable pin will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable pin is percutaneously removed.

AI/ML Overview

The provided text is a 510(k) summary for the Medcanica, Inc. Phalangeal Fixation System (PFS). It focuses on demonstrating substantial equivalence to a predicate device (MicroAire Surgical Equipment, Inc. K-wire) primarily through bench testing and comparison of technological characteristics, rather than clinical performance studies. Therefore, much of the requested information regarding acceptance criteria for device performance in clinical settings, human reader studies, and detailed ground truth establishment in a clinical context is not available in this document.

Here's an attempt to extract and infer the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from equivalence claim to K-wire)	Reported Device Performance (PFS vs. MicroAire K-wire)
Technological Characteristics: Substantial equivalence to predicate device across eleven specific characteristics.	"This has been demonstrated through comparison of eleven technological characteristics."
Performance Characteristics: Substantial equivalence to predicate device across five specific performance characteristics.	"Analysis of the data shows the products to be substantially equivalent."
Biocompatibility: Materials meet requirements of recognized consensus standards.	"The tissue/bone contact materials... meet the requirements of recognized consensus standards."
Safety and Effectiveness: Manufactured per specifications and good manufacturing practices.	"The PFS will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use."

Note: The document does not specify the exact eleven technological characteristics or five performance characteristics. It only states that comparisons were made and substantial equivalence was found.

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

Sample Size: Not explicitly stated. The document mentions "extensive bench testing of both devices." This implies a sample size adequate for the bench tests conducted, but no specific number is provided.
Data Provenance: The study was "bench testing." This means it was conducted in a laboratory setting, not on human subjects. Therefore, there's no country of origin or retrospective/prospective classification in a clinical sense.

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

Not Applicable. This was a bench testing study comparing the physical and mechanical properties of two medical devices. Ground truth, in this context, would be established by validated testing methods and measurements, not by expert clinical review of test data in the way it would be for diagnostic AI.

4. Adjudication Method for the Test Set

Not Applicable. As this was bench testing, there's no clinical adjudication process involving multiple human experts. The "adjudication" would be based on established engineering and materials science principles and validation of test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI device. It is a traditional medical device (K-wire for phalangeal fixation). Therefore, no MRMC study or AI-related comparative effectiveness was performed or would be applicable.

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

No. This is not an AI algorithm. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

Bench Test Results / Engineering Specifications / Material Standards. The "ground truth" for this study would be the scientifically validated results from the bench tests (e.g., measurements of strength, biocompatibility, dimensions, material composition) and the established performance characteristics and specifications of the predicate K-wire as a benchmark.

8. The Sample Size for the Training Set

Not Applicable. This is not a machine learning/AI device, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided device (Phalangeal Fixation System).

Summary

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14.29.1922

11994232

Summary of Safety and Effectiveness As Required by 807.92(c) for the Phalangeal Fixation System

MAR = 1 2000

Submitted by

Medcanica, Inc. 8308 NW 74th Avenue Miami, FL 33166 Phone: (305) 863-1603 Fax: (305) 863-1604

Contact Person: Sonia Jones Device Trade Name: Phalangeal Fixation System Common Name: K-Wire Classification Name: Smooth or threaded metallic bone fixation fastener, per § 888.3040

Identification of a Legally Marketed Predicate Device

The Medcanica. Inc. Phalangeal Fixation System (PFS) is substantially equivalent to the K-wire implantable pin that is manufactured and marketed by MicroAire Surgical Equipment, Inc.

Device Description

The PFS is a single use, non-toxic, disposable, sterile device. The PFS consists of the Cannulated Awl Assembly, the Implantable Pin Handle Assembly, and Exchange Guide and Bend Tube.

The implantable pin(s) is then cut at the taper near the proximal end of the pin. Using the bending tube end of the exchange guide the implantable pin is bent to 90° with the apex

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of the bend at the implantable pin insertion site. The pin is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable pin subsequent to healing. The implantable pin will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable pin is percutaneously removed.

Intended Use

The Phalangeal Fixation System is indicated for the fixation of transverse or short oblique fractures of proximal phalanx of the fingers.

Summary of Technological Characteristics

The PFS is substantially equivalent to the K-wire manufactured by MicroAire Surgical Equipment, Inc. This has been demonstrated through comparison of eleven technological characteristics.

Summary of Performance Data

Five performance characteristics of the PFS and K-wire manufactured by MicroAire Surgical Equipment, Inc. have been compared. Analysis of the data shows the products to be substantially equivalent.

Conclusion

The PFS has been demonstrated to be equivalent to the and K-wire manufactured by MicroAire Surgical Equipment, Inc. by extensive bench testing of both devices and comparison of technological characteristics.

The tissue/bone contact materials of the device have been carefully selected for their long history of biocompatibility. The materials meet the requirements of recognized consensus standards.

The PFS was designed utilizing design controls compliant with the Quality System Regulation. The PFS will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

MAR = 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Al Weisenborn MEDCANICA, Inc. 19526 East Lake Drive Miami, Florida 33015

Re: K994232 Trade Name: Phalangeal Fixation System Regulatory Class: II Product Code: HTY Dated: December 15, 1999 Received: December 16, 1999

Dear Mr. Weisenborn:

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 control provisions of the Act. The general control 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Mr. Al Weisenborn

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) 594-4659. 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell Sage

Sor James 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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Indications for Use

Page_1_of_1_

1994232 510(k) Number (if known):

Phalangeal Fixation System Device Name:

Indications for Use:

Fixation System is indicated for Phalangeal The the fixation of transverse or short oblique fractures of proximal phalanx of the fingers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nurnell V. Sager

(Division Sign-Off) on of General Restorative I 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.