SL-PLUS AND SLR-PLUS STEMS by PLUS ORTHOPEDICS

The SL-PLUS® Stem primary component is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SLR-PLUS® Stem, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Device Description

The SL-PLUS® and SLR-PLUS® Femoral Stems are of a double taper design and are manufactured from Ti-6AI-7Nb titanium alloy according to ASTM F136-98. The primary stem SL-PLUS® is available in 14 sizes ranging from size 01 through 12. The SLR-PLUS® revision stem is available in 11 sizes ranging from size 1 through 11. The femoral ball heads are manufactured from CoCrMo alloy according to ASTM F799-99. They are available in 22 mm, 28 mm, and 32 mm diameters and five different lengths, namely small (S), medium (M), long (L), extra long (XL) and extra-extra long (XXL). In addition, the INTRAPLANT ceramic ball heads with 28 mm and 32 mm diameter may be used with the SL-PLUS® and SLR-PLUS® stems.

AI/ML Overview

The provided document is a 510(k) Summary for the SL-PLUS® and SLR-PLUS® Stems, a medical device for total hip arthroplasty. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed data from clinical trials or performance studies with acceptance criteria in the same way an AI/ML device would. Instead, it relies on demonstrating that the new device is as safe and effective as a previously approved device.

Therefore, the specific information requested about acceptance criteria, study design, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance, as one would find for an AI/ML diagnostic or assistive device, is not present in this document.

The relevant section regarding performance is:

Performance data: "Biomechanical Testing has been done. All test results are sufficient for in vivo loading."

This statement is very general and does not provide quantitative acceptance criteria or detailed study results. The FDA's 510(k) process for mechanical devices often relies on bench testing (biomechanical testing) and comparisons to predicate devices based on design, materials, and established performance standards, rather than clinical efficacy studies with human subjects that generate metrics like sensitivity/specificity or human reader improvement with AI.

To directly address your request given the provided document:

Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in provided document, likely based on internal engineering specifications and relevant ASTM standards for hip implants.	"Biomechanical Testing has been done. All test results are sufficient for in vivo loading."

Sample size used for the test set and the data provenance: Not applicable. Biomechanical testing typically involves physical samples of the device and testing under simulated physiological loads, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biomechanical testing is typically established by engineering standards and measurement equipment, not expert opinion.
Adjudication method for the test set: Not applicable.
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 is a mechanical implant, not an AI/ML diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For biomechanical testing, ground truth refers to the accuracy of the measurements against known physical properties or against established standards for mechanical failure/performance.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

In summary, this document pertains to a medical device (hip stem) seeking 510(k) clearance based on substantial equivalence and biomechanical testing, not an AI/ML medical device requiring clinical performance metrics often associated with AI studies.

Summary

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Koo1942

K001942 Special 510(k) SL-PLUS® and SLR-PLUS® Stems July 10, 2000

510(k) Summary of Safety and Effectiveness

JUL 2 5 2000

Hartmut Loch, C.E.O. Contact: PLUS ORTHOPEDICS 3550 General Atomics Ct., Bldg. 15-100 San Diego, CA 92121 Tel: 858-455-2400
SL-PLUS® and SLR-PLUS® Stems Trade name:

Total Hip Joint, Femoral Component, Cementless Common name:

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Classification 21 CFR 888.3350 (87 LWJ) name:

SL-PLUS® and SLR-PLUS® Stems, K932481, S/E 06/08/94 Equivalence:

The SL-PLUS® and SLR-PLUS® Femoral Stems are of a double taper Characteristics: design and are manufactured from Ti-6AI-7Nb titanium alloy according to ASTM F136-98. The primary stem SL-PLUS® is available in 14 sizes ranging from size 01 through 12. The SLR-PLUS® revision stem is available in 11 sizes ranging from size 1 through 11. The femoral ball heads are manufactured from CoCrMo alloy according to ASTM F799-99. They are available in 22 mm, 28 mm, and 32 mm diameters and five different lengths, namely small (S), medium (M), long (L), extra long (XL) and extra-extra long (XXL). In addition, the INTRAPLANT ceramic ball heads with 28 mm and 32 mm diameter may be used with the SL-PLUS® and SLR-PLUS® stems. PLUS Unipolar CoCrMo, K990309, S/E/ 3/15/99 PLUS Bipolar CoCrMo, K982447, S/E/ 11/25/98

INTRAPLANT Ceramic Head Prosthesis, K990261, S/E 8/27/99.

The SL-PLUS® Stem primary component is intended for treating patients Indications: who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SLR-PLUS® Stem, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Contraindications include acute or chronic infections (local or systemic), Contraindications: serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.

Biomechanical Testing has been done. All test results are sufficient for in Performance data: vivo loading.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2000

Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics Building 15-100 3550 General Atomics Court San Diego, California 92121-1122

Re: K001942

Trade Name: SL-Plus® and SLR-Plus® Stems Regulatory Class: II Product Code: LWJ and JDI Dated: June 23, 2000 Received: June 26, 2000

Dear Mr. Loch:

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. Hartmut Loch

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,

Donna R. Lochner

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K001942 Special 510(k) SL-PLUS® and SLR-PLUS® Stems July 10, 2000

Page 1 of 1

510(k) Number (if known): K001942

Device Name: SL-PLUS® and SLR-PLUS® Stems

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Duane R. Vochines.

Ivision Sign-Off-Off-Off-Off-Clices 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

NO Over-The-Counter-Use (Optional Format 1-2-96)

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.