The AUTOTAC System™ is intended to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue in the and normbloroonbable ituations that require membrane use/fixation.

The AUTOTAC System™ is intended to fixate or stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation.

Device Description

The AUTOTAC System™ consists of components and instruments designed to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation. The system provides an anchoring mechanism for the membranes to resident and adjacent bone or tissue at the surgical site. The Tissue Tack is fabricated from a well-known bioresorbable polymer and has a round, flat head, and two circular ribs on the shaft to prevent the implanted tack from slipping out. The tack is provided sterile by either gamma or ETO sterilization and is not intended to be re-sterilized by the user.

AI/ML Overview

Here's an analysis of the provided text regarding the AUTOTAC System™, focusing on acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device modification (K011675), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel device performance. As such, it does not contain all the typically requested information for a comprehensive study design demonstrating acceptance criteria.

Specifically, the document primarily addresses the mechanical performance and safety of the device through laboratory testing and clinical consultation, but it does not provide quantitative acceptance criteria or detailed study results in a format typically expected for demonstrating clinical effectiveness or accuracy in the way an AI/software device would.

However, I will extract and infer information where possible based on the provided text.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments / Context from Document
Sufficient pull-out strength to prevent premature movement of the periodontal membrane.	"Mechanical tests demonstrated that the pull-out... strength of the AUTOTAC System™ tissue tack is sufficient to prevent premature movement of the periodontal membrane."	The document states sufficiency but does not provide quantitative thresholds or measured values. This is an implicit functional acceptance criterion.
Sufficient shear strength to prevent premature movement of the periodontal membrane.	"...and shear strength of the AUTOTAC System™ tissue tack is sufficient to prevent premature movement of the periodontal membrane."	Similar to pull-out strength, this is an implicit functional acceptance criterion without quantified values.
Effectiveness for fixation of barrier membranes without new health risks.	"evaluated by consulting clinicians and laboratory studies and found to be effective for fixation of barrier membranes without new health risks"	This is a qualitative statement of effectiveness based on expert opinion and laboratory studies. No specific metrics for "effectiveness" are provided.
Predictable means to achieve clinical success in guided bone and/or tissue regeneration.	"...and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration."	Another qualitative statement based on expert opinion and laboratory studies, without defined metrics for "predictable" or "clinical success."
Substantial equivalence to predicate device (K993493) regarding safety or effectiveness based on tack design, material, and intended use.	"substantially equivalent to all features which could affect safety or effectiveness to the predicate tack (K993493) due to the similarities in tack design, material and intended use."	This is the primary regulatory "acceptance criterion" for a 510(k) submission. The FDA concurred with this finding.

Study Information (Based on available text)

Given the nature of this 510(k) for a physical device (a fixation tack), the study information requested is typically for software/AI devices or more complex clinical trials. The provided document details a regulatory submission for substantial equivalence of a physical medical device, not a performance study of an AI algorithm. Therefore, many of the requested fields are not applicable (N/A) or not detailed in this type of document.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "mechanical tests" and "laboratory studies" but does not give sample sizes for these tests.
- Data Provenance (country of origin, retrospective/prospective): Not specified. "Laboratory studies" generally imply controlled, prospective testing in a lab environment rather than clinical data from a specific country or population.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "consulting clinicians" (plural) were involved. The exact number is not stated.
- Qualifications of Experts: Not specified beyond being "clinicians." There is no mention of specialties or years of experience. For a physical device like this, these clinicians would likely be oral surgeons, periodontists, or related specialists.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/not specified. Clinical "adjudication" in the sense of resolving discrepancies in diagnostic reads (common for image analysis AI) is not relevant for the type of evaluation described here for a physical tack. The "consulting clinicians" likely provided a collective qualitative assessment.
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:
- MRMC Study: No, this type of study was not done. This is a physical device, not an AI system.
- Effect size of human readers with/without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the mechanical tests, the "ground truth" would be the measured physical properties (e.g., force required for pull-out/shear) against an implicitly accepted standard for "sufficiency." For the clinical evaluation, it appears to be a qualitative "expert consensus" from the "consulting clinicians" regarding effectiveness and predictability, likely based on their professional judgment and experience with membrane fixation.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a physical device, not a machine learning model. There is no "training set."
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, "K011675". The characters are written in a simple, clear style, with each digit and letter easily distinguishable. The text appears to be a code or identification number.

Special 510(k): Device Modification Summary of Safety and Effectiveness

Proprietary Name

JUN 2 2 2001

The AUTOTAC System™

Common Name

Screw, tack, membrane fixation pin

Classification Name Intraosseous fixation screw

Classification

Class II

Official Contact

BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 (205) 967-7880 Fax (205) 870-0304

Device Description

Product Evaluation

The AUTOTAC System™ tissue tack was evaluated by consulting clinicians and laboratory studies and found to be effective for fixation of barrier membranes without new health risks and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration.

Mechanical tests demonstrated that the pull-out and shear strength of the AUTOTAC System™ tissue tack is sufficient to prevent premature movement of the periodontal membrane.

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Indications for Use

Substantial Equivalence Information

The AUTOTAC System™ ETO-sterilized tissue tack is substantially equivalent to all features which could affect safety or effectiveness to the equivalorit to all foutures thk (K993493) due to the similarities in tack design, material and intended use.

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Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text is centered and there is no other text or graphics in the image.

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design in the center. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The seal is presented in black and white.

JUN 2 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald E. Dalton Director of Quality Assurance Biohorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230, South Birmingham, Alabama 35243

Re : K011675 The Autotac System Trade/Device Name: 872.4880 Requlation Number: Requlatory Class: II Product Code: DZL Dated: May 29 ,2001 Received: May 30, 2001

Dear Mr. Dalton:

We have reviewed your Section 510(k) notification of incent to we have reviewed your boosed above and we have determined the market the devisorially equivalent (for the indications for device is subscanciary orgal to legally marketed predicate use stated in the chorobase, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment date of chassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the reacrar tone, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provisions of the ing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II if your device is class III (Premarket Approval), it may (Special Concessional controls. Existing major be subject to Back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with bubbeancearly odaManufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Forch In the Qualition (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodic go mill verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. accron: "Illude device in the Eederal Register. Please note:

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Page 2 - Mr. Dalton

this response to your premarket notification submission does this response to your premarket have under sections 531
not affect any obligation you might have under the Flectronic not affect any obligation you mages under the Electronic through 542 of the Act for devices and 1requlations.

This letter will allow you to begin marketing your device as This lecter will affow your over of your dovice The FDA described in your 510(K) prematic normalice to a legally
finding of substantial equivalence of your device for your finding of substantial equivailies of yolassification for your marketed predicate device resures in a crabbed.
device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire specific advice rollibers the office of regulation (21 crk Farc ove anase contact the Office of
vitro diagnostic devices), please contact the for questi vitro diagnostic devices), preab otionally, for questions on
Compliance at (301) 594-4622. Additionally, plaase contact Compliance at (301) 554 inin. In your device, please contact
the promotion and advertising of your device, algo, please no the promotion and advertising of your actives in the office of the Office the orress on and the misbranding by reference to premarket notification" (21CFR 807.97) . Other general premarker notification (arch over the Act may be information on your responsible and Manufacturers Assistance obtained from the DIVISION OF Bildir Handsons.
at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

1ts Incernet addross
"http://www.fda.gov/cdrh/dsma/dsmamajn.html".

Sincerely yo

A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

(011675 510(k) Number (if known): _

The AUTOTAC System™ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runze

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use (per 21 CFR 801.109) Over-the-Counter Use

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.