A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
Avascular necrosis of the femoral head.
Non-union of femoral neck fractures.
Certain high subcapital and femoral neck fractures in the elderly.
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

HA coated stems of the Corail Hip System are indicated for cementless use only.

Device Description

The DePuy Corail AMT hip stems are manufactured from forged titanium alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail AMT stems are available with or without a collar, with various neck angles and with various neck offsets. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-arthroplasty and with modular femoral heads intended for total hip arthroplasty.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device, specifically the DePuy Corail AMT Hip Prosthesis. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a study. Therefore, the information requested (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training set information) is generally not applicable or available within this type of regulatory document.

The 510(k) submission focuses on comparing the new device to existing legally marketed devices to show that they are as safe and effective. The "Performance Data" section primarily lists non-clinical tests conducted to support substantial equivalence, rather than detailed studies with acceptance criteria and reported performance values in the way you've described for an AI/algorithm-based device.

Here's why each point is largely unaddressable and what information is available:

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

Not Applicable in this context. This document doesn't present acceptance criteria for an AI algorithm's performance. Instead, it describes physical and material characteristics of a hip prosthesis and confirms it meets standards typically through engineering tests.
Available Information: The document lists non-clinical tests performed, such as:
- Neck fatigue testing in accordance with ISO 7206-6:1992
- Distal fatigue testing in accordance with ISO 7206-4:2010
- Taper compatibility test
- Range of motion in accordance with ISO 21535:2009
- Reamer verification test
- Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST72:2011
- Hydroxyapatite coating process validations
However, specific acceptance criteria values (e.g., "fatigue strength must exceed X MPa") and the exact reported performance values from these tests are not provided in this summary document. The submission implicitly states these tests were conducted successfully to demonstrate substantial equivalence, meaning the results were comparable to the predicate device and met relevant industry standards.

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

Not Applicable. As this is for a physical orthopedic implant, there isn't a "test set" of data in the sense of a dataset for an AI algorithm. The tests mentioned are engineering and material science tests.

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. "Ground truth" in the context of an AI algorithm is not relevant here. The "ground truth" for the performance of a hip prosthesis would be defined by engineering standards, material properties, and clinical outcomes over time, rather than expert interpretation of a specific dataset.

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

Not Applicable. Adjudication methods are associated with reviewing and resolving discrepancies in expert labeling or diagnoses on data, which is not relevant for this device.

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. MRMC studies are used to evaluate diagnostic imaging systems, often in conjunction with AI. This document pertains to a physical hip implant, so such studies are not relevant.

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

Not Applicable. This is a physical device, not an algorithm.

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

Not Applicable. See point 3. "Ground truth" for this device would relate to validated engineering specifications, biomechanical properties, material analyses, and ultimately long-term clinical follow-up data (which is not part of a 510(k) submission for substantial equivalence).

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI algorithm. There is no "training set" of data.

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

Not Applicable. This is a physical device, not an AI algorithm. There is no "training set" of data or ground truth to be established for it.

In summary: The provided document is a 510(k) premarket notification for a physical medical device (hip prosthesis). It demonstrates substantial equivalence to predicate devices through comparisons of intended use, materials, design features, and by stating that non-clinical engineering and material tests were conducted in accordance with relevant standards. It explicitly states that "No clinical tests were conducted to demonstrate substantial equivalence." The questions posed are primarily relevant to the evaluation of AI/software as a medical device, which is not what this document addresses.

Summary

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November 1, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.

DePuy (Ireland) % Melissa Cook Regulatory Affairs Specialist III DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K190344

Trade/Device Name: DePuy Corail AMT Hip Prosthesis Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH, KWL, KWL, KWY Dated: October 3, 2019 Received: October 4, 2019

Dear Melissa Cook:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190344

Device Name

DePuy Corail AMT Hip Prosthesis

Indications for Use (Describe)

Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
1. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
1. Avascular necrosis of the femoral head.
1. Non-union of femoral neck fractures.
1. Certain high subcapital and femoral neck fractures in the elderly.
1. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
1. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.

HA coated stems of the Corail Hip System are indicated for cementless use only.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

(As required by 21 CFR 807.92)

Submitter Information
Name	DePuy (Ireland)
Address	LoughbegRingaskiddyCo. Cork, Ireland
Phone number	574-371-4906
Establishment RegistrationNumber	9616671
Name of contact person	Melissa Cook
Date prepared	February 12, 2019
Name of device
Trade or proprietary name	DePuy Corail AMT Hip Prosthesis
Common or usual name	Uncemented hip prosthesis
Classification name	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesisHip joint femoral (hemi-hip) metallic cemented or uncemented prosthesisHip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3353, 888.3360, 888.3390
Product Code(s)	LZO, MEH, KWL, KWY
Legally marketed device(s) towhich equivalence is claimed	DePuy Corail AMT Hip Prosthesis (K173960, cleared September 21, 2018)DePuy Corail AMT Hip Prosthesis (K123991, cleared September 16, 2013)
Reason for 510(k) submission	Line extension – The subject devices represent hip stems with additionalsizes to allow surgeons more flexibility in the choice of stem sizes, neckangles, and neck offsets. The subject devices incorporate minormodifications to the plasma spray coating process and a labeling change.
Device description	The DePuy Corail AMT hip stems are manufactured from forged titaniumalloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating forbone fixation. The stem consists of a wide range of stem neck designs andsizes allowing an accurate anatomical match for each patient. Corail AMTstems are available with or without a collar, with various neck angles and
with various neck offsets. The stems are compatible with both unipolar andbipolar heads intended for hip hemi-arthroplasty and with modular femoralheads intended for total hip arthroplasty.
Intended use of the device	Total hip arthroplasty and hemi-hip arthroplasty
Indications for use	Total hip replacement or hip arthroplasty is indicated in the followingconditions:1. A severely painful and/or disabled joint from osteoarthritis,traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.2. Avascular necrosis of the femoral head.3. Acute traumatic fracture of the femoral head or neck.4. Failed previous hip surgery including joint reconstruction, internalfixation, arthrodesis, hemi-arthroplasty, surface replacementarthroplasty, or total hip replacement.5. Certain cases of ankyloses.Partial hip replacement or hip hemi-arthroplasty is indicated in thefollowing conditions:1. Acute fracture of the femoral head or neck that cannot beappropriately reduced and treated with internal fixation.2. Fracture dislocation of the hip that cannot be appropriately reducedand treated with internal fixation.3. Avascular necrosis of the femoral head.4. Non-union of femoral neck fractures.5. Certain high subcapital and femoral neck fractures in the elderly.6. Degenerative arthritis involving only the femoral head in which theacetabulum does not require replacement.7. Pathology involving only the femoral head/neck and/or proximalfemur that can be adequately treated by hip hemi-arthroplasty.HA coated stems of the Corail Hip system are indicated for cementless use only.

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Characteristics	Subject Device:DePuy Corail AMT HipProsthesis	Predicate Device:DePuy Corail AMTHip Prosthesis(K173960)	Predicate Device:DePuy Corail AMTHip Prosthesis(K123991)
Intended Use	Total Hip Arthroplasty,Hemi-Hip Arthroplasty	Same	Same
Material	Ti6Al4V with plasmasprayed HA coating	Same	Same
Fixation	Uncemented	Same	Same
Stem Size	8, 9, 10, 11, 12, 13, 14, 15,16, 18, 20	Same	Same
Neck Angle	125° and 135°	Same	Same
Neck Offset	Low, Standard, High	Same	Standard, High
Collar	Collared, Collarless	Same	Same
Sterile Method	Gamma	Same	Same
Packaging	Double PETG blister withTyvek peel lid	Same	Same
Shelf Life	5 years	Same	Same

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Neck fatigue testing in accordance with ISO 7206-6:1992 ●
Distal fatigue testing in accordance with ISO 7206-4:2010 .
Taper compatibility test .
Range of motion in accordance with ISO 21535:2009 .
Reamer verification test
. Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST72:2011
Hydroxyapatite coating process validations ●

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SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject DePuy Corail AMT hip stems are substantially equivalent to the predicate DePuy Corail AMT hip stems.

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.