The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthordesis.

Device Description

The IP-XS Compression Nail system is for bones with small comes in diameters of 3.5mm and 4.5mm. They have a circular cross section with multiple transverse holes for interlocking components. The two proximal transverse holes are elongated to allow the interlocking component to move axially and apply compression to the bone fragments. The proximal end has an internal axial threaded hole to receive a compression screw. Threaded Kirschner wires 02.0mm and 01.6mm are used as the interlocking components.

AI/ML Overview

The provided text describes a medical device, the IP-XS Compression Nail System, and its clearance through the FDA 510(k) process. This process focuses on establishing substantial equivalence to existing legally marketed devices, rather than conducting new clinical trials or detailed performance studies with acceptance criteria in the way a novel device might.

Therefore, the requested information elements such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment are not applicable in the context of this 510(k) submission.

Here's why and what information can be extracted:

Acceptance Criteria and Reported Device Performance: No explicit acceptance criteria or numerical performance data (like sensitivity, specificity, accuracy) are reported for the IP-XS Compression Nail System. The 510(k) process for this type of device relies on demonstrating equivalence to predicate devices and generally involves non-clinical testing to ensure safety and function.
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): These concepts are typically relevant for studies evaluating the diagnostic or predictive performance of a device (e.g., AI-powered diagnostic tools, imaging systems). The IP-XS Compression Nail System is an intramedullary fixation rod, a mechanical orthopedic implant. Its evaluation is based on mechanical testing and comparison to similar devices, not on data analysis or expert adjudication.

Information that can be extracted from the provided text:

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

Acceptance Criteria	Reported Device Performance
Not Applicable	Cantilever testing and validated FEA analysis indicate the device will support in-vivo loads expected for its application.

Explanation: The document does not specify formal acceptance criteria in a quantitative manner as one might see for a diagnostic device (e.g., "sensitivity must be >90%"). Instead, the "performance" is described in terms of non-clinical testing demonstrating structural integrity.

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

Sample Size: Not applicable. The "testing" mentioned is mechanical (cantilever testing, FEA analysis), not clinical or using a "test set" of patient data.
Data Provenance: Not applicable. The data is from non-clinical laboratory testing.

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)

Number of Experts & Qualifications: Not applicable. Ground truth as typically understood for diagnostic performance is not relevant for this mechanical device's evaluation in the 510(k) submission. Mechanical testing results are based on engineering principles and measurements.

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

Adjudication Method: Not applicable. This is a mechanical device, not one requiring diagnostic interpretation or adjudication.

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

MRMC Study & Effect Size: Not applicable. This is not a diagnostic device involving human readers or AI assistance.

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

Standalone Performance: Not applicable. This is a mechanical implant, not an algorithm.

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

Type of Ground Truth: Not applicable in the conventional sense. The "ground truth" for evaluating this device's performance would be the physical properties and mechanical behavior under simulated loads, as measured by engineering tests.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is not AI/ML-based; there is no "training set."

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

Ground Truth Establishment for Training Set: Not applicable. There is no training set for this type of device.

Summary of Device Evaluation in 510(k):

The evaluation of the IP-XS Compression Nail System for its 510(k) clearance focused on demonstrating substantial equivalence to predicate devices (Small Bone Nail - Accumed K031438 and SST Small Bone Locking Nail - Biomet) in terms of materials, design, and indications for use. The "study" mentioned, non-clinical testing (cantilever testing and validated FEA analysis), served to confirm that the device would support in-vivo loads, thereby supporting its safety and effectiveness relative to its predicates. This is a common approach for mechanical devices in the 510(k) pathway, which does not typically involve the extensive clinical performance studies, ground truth establishment, or expert evaluations associated with novel diagnostic technologies.

Summary

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Date August 14, 2003

Submitter

PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121

Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Common name Intramedullary nail

Classification name

Rod, Fixation, Intramedullary and Accessories per 21 CFR section 888.3020.

Equivalent Device

The IP-XS Compression Nail is similar in materials, design and indications as the Small Bone Nail (Accumed K031438) and SST Small Bone Locking Nail (Biomet).

Device Description

Intended Use

Summary Nonclinical Tests

Cantilever testing, simulating loading that might be seen when this device is used for ankle fractures, was performed as well as validated FEA analysis. This testing indicates that the IP-XS Compression Nail will support the in-vivo loads expected to be seen for this application.

SEP 1 0 2003

K032548
page 1 of 1

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2003

Mr. J.D. Webb PLUS Orthopedics 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K032548

Trade/Device Name: IP-XS Compression Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 14, 2003 Received: August 18, 2003

Dear Mr. Webb:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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510(k) number (if known): K0 305 4 8

Device Name:

Indications for Use:

IP-XS Compression Nail System Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of General, Neurological and Restorative Devices

510(k) Number

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use

(Optional format 1-2-96)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number_KO32548

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.