The Secur-Fit™ Max and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

The subject Secur-Fit™ Max Hip and Secur-Fit™ Plus Max Hip Stems are titanium alloy hip stems. The hip stems have a Commercially Pure Titanium arc deposited circumferential coating with a PureFix™ HA hydroxylapatite surface treatment. The stems are intended for cementless fixation and are available in stem sizes 4-14 and neck lengths ranging from 25mm to 40mm. The stems are available with either a 127° or 132° neck angle. The Secur-Fit" Max Hip stems have a tapered distal geometry. The Secur-Fit" Plus Max Hip Stems have a fluted and slotted distal geometry.

AI/ML Overview

The provided text is a 510(k) Summary for a line extension to hip stems, not a study describing the acceptance criteria and performance of a device, especially not one that would involve AI or expert consensus. It describes a medical device (hip stems) and its intended use, rather than a diagnostic or AI-powered device. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not present in the provided document.

However, I can interpret what is available through the lens of a medical device submission, which uses "acceptance criteria" in the context of substantial equivalence to predicate devices and mechanical testing, rather than a diagnostic performance study.

Here's an attempt to answer the questions based only on the provided document, acknowledging that most questions cannot be fully answered.

Acceptance Criteria and Study to Prove Device Meets Criteria

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

Based on the provided 510(k) summary, the "acceptance criteria" are not explicitly stated in a quantitative table as one might find for sensitivity/specificity in a diagnostic device. Instead, the primary acceptance criterion for this 510(k) submission is substantial equivalence to predicate devices. The performance reported is in terms of this equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance (as stated in the document)
Substantial Equivalence in mechanical strength compared to predicate devices	"Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength."
Substantial Equivalence in intended use and design	"The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design."
Identity in manufacturing methods, packaging, and sterilization	"the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical."
Material consistency for the hip stems	"The material of the subject Secur-Fit™ Max and the Secur-Fit™ Plus Max Hip Stems remains unchanged."
Safety and efficacy for stated Indications for Use	(Inferred from FDA clearance) "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "mechanical testing" but does not detail the sample size (e.g., number of stems tested, number of cycles for fatigue testing) or the provenance of the data. This is typical for a 510(k) summary which focuses on demonstrating equivalence rather than providing full study protocols and results.

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 is not applicable and not provided. This document describes a hip stem, which is an implantable medical device, not a diagnostic device that requires expert ground truth establishment in the traditional sense of image interpretation or disease diagnosis. The "ground truth" for a mechanical device is its physical and mechanical properties, assessed through engineering tests.

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

This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for diagnostic interpretation, which is not relevant to the mechanical testing of a hip stem.

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

This is not applicable and not provided. This document is for a medical implant and does not involve AI or human readers for diagnostic tasks.

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

This is not applicable and not provided. This document is for a medical implant and does not involve an algorithm or AI.

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

The "ground truth" for this device would be its physical and mechanical properties as determined by standardized engineering tests (e.g., fatigue testing, static strength testing, material characterization). The document states "Mechanical testing demonstrates substantial equivalence," implying these types of engineering measurements were used. No other ground truth types (like pathology or outcomes data from clinical trials) are mentioned or implied for this 510(k) submission's scope.

8. The sample size for the training set

This is not applicable and not provided. This document describes a medical implant and does not involve machine learning models that require a training set.

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

This is not applicable and not provided. As above, there is no training set mentioned or implied for this medical device submission.

Summary

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K051738 P1/2
Special 510(k) Premarket Notification

Line Extension to the SecurFit" and Secur-Fit" Plus Max Hip Stem

JUL 19 2005

510(k) Summary of Safety and Effectiveness

Line Extension to the Secur-Fit™ Max and Secur-Fit™ Plus Max Hip Stem

Proprietary Name:	Secur-FitTM Max and Secur-FitTM Plus Max Hip Stems
Common Name:	Artificial Hip Components
Proposed Regulatory Class:	Class II
Classification:	Hip joint, metal/ceramic/polymer semi-constrained cemented or
	nonporous uncemented prostheses, 21 CFR §888.3353.
Device Product Code:	87 MEH, Prosthesis, Hip, Semi-Constrained, Uncemented,
	Metal/Polymer, Non-Porous, Calicum-Phosphate and
	87 LZO: Prosthesis, Hip, Semi-Constrained,
	Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
For Information contact:	Karen Ariemma, Senior Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	325 Corporate Drive
	Mahwah, NJ 07430
	Telephone: (201) 831-5718
	Fax: (201) 831-6038
	Email: karen.ariemma@stryker.com
Date Summary Prepared:	June 27, 2005

Device Description

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Device Modification

This Secur-Fit" Max and the Secur-Fit" Plus Max Hip Stems were cleared for use with metal and Alumina Ceramic Heads. This submission adds the use of a C-Taper Biolox® Delta Ceramic Femoral Head with the Secur-Fit™ Max and the Secur-Fit™ Plus Max Hip Stems.

Intended Use

The Secur-Fit" Max and the Secur-Fit" Plus Max Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.

Indications for Use

The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; t
Rheumatoid arthritis; ●
Correction of functional deformity; .
Revision procedures where other treatments or devices have failed; and .
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

Substantial Equivalence

The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design. Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical. The material of the subject Secur-Fit" Max and the Secur-Fit™ Plus Max Hip Stems remains unchanged. The subject ceramic femoral heads are fabricated from Zirconia toughened Alumina.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2005

Ms. Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. Mahwah, New Jersey 07430

Re: K051738

K051738
Trade/Device Name: SECUR-Fit™ Max and SECUR-FIT™ PLUS Max Hip Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, MEH Dated: June 27, 2005 Received: June 28, 2005

Dear Ms. Karen Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manced promoted provice Ameridae, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1776, the enations with the provisions of the Federal Food, Drug, devices that have been recided in accordance while proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosment Act (Act) that do not require approvide on trols provisions of the Act. The Act. The You may, therefore, thanker the device, basjon to the more in the manual registration, listing of general controls provisions of the free merchibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it ) If your device is classified (sec above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller in this and to 898. In addition, FDA may be found in the Code of Peacharing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backers on bevice complies with other requirements of the Act that FDA has made a decemmanon time your assess. A gencies. You must or any Federal statutes and regulations annuding, but not limited to: registration and issting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), falcing (21 CFR Part 820); go CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regalistin (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin maketing your avview of your device of your device to a legally
premarket notification. The FDA finding of substantial end the permits vo premarket notification. The PDA Inding of substantial equivalians 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), please
rst lead If you desire specific advice for your aconce on our and a gos ande the regulation entitled, the regulation entitled, the contact the Office of Collipiance at (2+0) 270 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by relerence to premarks. Iounted in (c) the Act from the Division of Small other general information on your responsible in toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at alled (demanain http://demanain.ht Manufacturers, International and Consumer Processars agov/cdrh/dsma/dsmamain.html
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html

Sincerely yours,

Signature

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ...........

Device Name: SECUR-FIT™ Max and SECUR-FIT™ PLUS Max Hip Stems

Indications For Use:

The Secur-Fit™ Max and Secur-Fit™ Plus Max Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.

The indications for use of the Secur-Fit™ Max and Secur-Fit™ Plus Max+Hip Stems as a Total Hip Replacement include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; .
Rheumatoid arthritis; .
Correction of functional deformity; .
Revision procedures where other treatments or devices have failed; and .
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter_Use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eun A. Oh

eneral, Restorative ical Devices

510(k) No. K0517

Page 1 of of l

(21 CFR 807 Sub

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.