The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomies. The system consists of plates and screws for treatment of the phalanges, and metatarsals.

Device Description

The Nexa Orthopedics bone plate and screw system of plates and screws made of Stainless Steel (316L) and Titanium (6AL-4V ELI) intended to be implanted into the bones of the foot, ankle, hand, wrist, ulna and radius. The plates are provided in 4 sizes, right and left configuration. The screws are provided in 2 diameters 2.7 and 3.2 and lengths from 12-28 mm. The plates and screws are used for fracture fixation, fusion, and osteotomy of the bones of the foot.

AI/ML Overview

This document is a 510(k) premarket notification for the Nexa bone plate and screw system, dated December 22, 2005. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance criteria or a comprehensive clinical study report. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria cannot be directly extracted from this document in the typical sense of a modern medical device clinical study report.

However, I can extract and infer information relevant to the context of a 510(k) submission at that time, focusing on how the device demonstrates substantial equivalence rather than meeting specific quantifiable performance targets like sensitivity/specificity for an AI algorithm.

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

In the context of the 2005 510(k) for this device, "acceptance criteria" and "reported device performance" are primarily about demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing design characteristics, material, and intended use. The "acceptance criteria" are implied to be that the new device is as safe and effective as the predicate based on these comparisons.

Item	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Nexa Orthopedics System)
Product Name	Must function as a bone plate and screw system.	Nexa bone plate and screw system
Use	Single use.	Single use.
Fixation	Method of fixation should be screw-based.	Screw.
Material	Industry standard materials used for bone plates and screws (e.g., Stainless Steel, Titanium). No new materials introduced.	Stainless Steel (316L) and Titanium (6AL-4V ELI). Acknowledged as "industry standard materials."
Sizes	Must be available in appropriate sizes for intended application (phalanges, metatarsals). Sizes within the expected range for predicate devices or with justification.	Plates: 4 sizes, right and left. Screws: dia 2.7mm, 3.2mm, length 12-28mm. (Predicate: Plates 2 sizes, Screws length 8-24mm - Nexa offers more sizes, which is noted but not considered a deviation from equivalence for this type of device).
Indications for Use	Intended for fixation during fractures, fusions, and osteotomies of the phalanges and metatarsals, similar to predicate. The scope of indications must be substantially equivalent.	"The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomies. The system consists of plates and screws for treatment of the phalanges, and metatarsals." (This aligns with the predicate's general intent for foot bones).
Biocompatibility (Implied)	Must be biocompatible, as expected for implantable devices made of standard materials.	Not explicitly stated in this summary, but implied by the use of "industry standard materials" (316L Stainless Steel and Ti 6AL-4V ELI), which are well-established for biocompatibility in implantable devices.
Mechanical Strength (Implied for Fixation)	Must provide adequate mechanical strength for fracture fixation, fusions, and osteotomies, comparable to predicate devices.	Not explicitly detailed in this summary, but "similar design characteristics" and "fixation" suggest comparable mechanical properties derived from similar materials and design principles to the predicate.

Study that proves the device meets the acceptance criteria:

The document describes a comparison to a predicate device as the "study" demonstrating that the device meets the implied acceptance criteria for substantial equivalence.

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 for Test Set: Not applicable in the context of this 510(k) submission. This is not a study assessing clinical performance with a "test set" of patient data or images in the way an AI/software device would. The "test" here is the comparison of device specifications and intended use against a legally marketed predicate device.
Data Provenance: Not applicable. The "data" consists of device specifications, materials, and intended use as described by the manufacturer in comparison to public information about the predicate device.

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: Not applicable. There is no "ground truth" establishment by external experts for a test set in this type of submission. The "ground truth" for substantial equivalence is the information presented by the applicant and evaluated by the FDA reviewer.
Qualifications of Experts: FDA reviewers (e.g., in the Orthopedic Reviewing Panel, Office of Device Evaluation) would analyze the information, but they are not establishing a clinical "ground truth" for a dataset.

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

Adjudication Method: Not applicable. There is no test set requiring expert 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: No, absolutely not. This is a 510(k) for a physical orthopedic implant (bone plate and screw system), filed in 2005. MRMC studies, especially those involving AI assistance, are relevant to diagnostic imaging algorithms or CAD systems, which are completely different device types.

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

Standalone Performance Study: No. This is a physical implant. There is no "algorithm" to evaluate.

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

Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate device (Wright Medical Charlotte Small MTP Fusion Plate), and the demonstration that the new device is substantially equivalent to it based on shared technological characteristics, materials, and intended use. There is no clinical "ground truth" dataset in the sense of patient outcomes or pathology.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.

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

Ground Truth for Training Set Establishment: Not applicable.

Summary for the context of this 2005 510(k) for an orthopedic implant:

The "acceptance criteria" here implicitly revolve around demonstrating that the Nexa bone plate and screw system is substantially equivalent to its predicate device (Wright Medical Charlotte Small MTP Fusion Plate) in terms of:

Intended use
Device materials
Design characteristics
Principles of operation

The "study" that proves the device meets these acceptance criteria is the comparative analysis presented in the 510(k) submission, specifically the "Comparison to Predicate Device" section. This comparison highlights similarities in all critical aspects (use, fixation, material, general indications for use, and manufacturing standards) between the proposed device and the predicate. The FDA's issuance of the 510(k) clearance (DEC 22 2005) serves as the "proof" that the device met these implicit acceptance criteria for substantial equivalence.

Summary

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DEC 2 2 2005

510 (k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

Prepared:	December 6, 2005
Applicant:	Nexa Orthopedics, Inc., (dba Futura Biomedical, LLC)10675 Sorrento Valley Road, Suite 100San Diego, CA 92121
Telephone:	858-866-0660
Fax:	858-866-0661
Contact:	Louise M. Focht
Device Name:	Nexa bone plate and screw system
Device Trade Name:	Nexa bone plate and screw system
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Regulation Number	888.3030
Product Code:	87 HRS
Predicate Device:	K051884 Wright Medical Charlotte SmallMTP Fusion PlateK033639 Acumed Lower ExtremityCongruent Plate System
Registration Number:	2030833
Owner Operator Number:	9028319

Device Description:

Indications for Use:

The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomics. The system consists of plates and screws for treatment of the phalanges, and metatarsals.

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Comparison to Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical Charlotte Small MTP Fusion Plate

Regulatory Class: II 87 HRS Product Code:

Table 1 summarizes similarities and differences between the Nexa Orthopedics and the Wright Medical Charlotte Small MTP fusion plate system.

Item	Nexa Orthopedics System	Wright Medical Plate System
Product Name	Nexa bone plate and screw system	Wright Medical Charlotte Small MTP FusionPlate
Use	Single use	Single use
Fixation	Screw	Screw
Material	Stainless Steel	Stainless Steel
Sizes	Plates 4 sizes, right and leftScrews dia 2.7mm, 3.2mm ,length 12-28mm	Plates 2 sizes, right and leftScrews dia 2.7mm, 3.2mm ,length 8-24mm
Indications for use	The bone plate and screw system is intendedfor use in providing fixation during fractures,fusions and osteotomies. The systemconsists of plates and screws for treatment ofthe phalanges, and metatarsals.	The Charlotte Small MTP Fusion Plate isintended to help increase the rate of bonyunion, and to maintain the position of the toeduring fusion. Once the joint has fused, theplate is secondary in the transmission of gaitforces.• Fractures, osteotomies orarthrodesis of the first metarsal-phalangeal joint• Deformity due to hallus valgus• Deformity due to arthritis in the firstmetatarsal-phalangeal joint• Loss of motion-hallux rigidus• Pain associated with osteoarthritisor rheumatoid arthritis in the firstmetatarsal-phalangeal joint• Revision procedures where othertreatments or devices have failed;and• Chronic instability in the firstmetatarsal-phalangeal joint

Similarities of the Nexa Orthopedies bone plate and serew system and Charlotte small MTP Fusion Plate system include:

Both devices are: intended for single use only, intended for surgical implantation longer than 30 days; both devices are a system of plates and screws used for fixation of fracture, fusion, ostcotomics, of the metatarsal and phalangeal bones; both devices are made of

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industry standard materials, no new materials are introduced in either product; Both madely bunnuard many sized; both devices have the same indications for use.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2005

Ms. Louise Focht Vice President of Research and Development Nexa Orthopedics, Inc. 10675 Sorrento Valley Road, Suite 100 San Diego, California 92121

Re: K053408

Trade/Device Name: Nexa Bone Plate and Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: December 6, 2005 Received: December 7, 2005

Dear Ms. Focht:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) premained is substantially equivalent (for the indications felerenced above and nave user.imired by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device Amendments, or 10 commerce price to May 20, 1978, the ensordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The I ou may, mercrore, market the act include requirements for annual registration, listing of general controls proficious of wactice, 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 If your device is olabilition (600 a00 rols. Existing major regulations affecting your device can may be subject to sach additions, 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 nean I lease be devisou has i brinnation that your device complies with other requirements of the Act that I DA has Intact a and regulations administered by other Federal agencies. You must or any I catal suttates and regaranents, including, but not limited to: registration and listing (21

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Page 2 - Ms. Louise Focht

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT at 607); adomig (Dr CFR Part 820); and if applicable, the electronic forul in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product lastianon only of begin marketing your device as described in your Section 510(k) This iciter will anow you to ough maing of substantial equivalence of your device to a legally premarket notification: The PDF intemsgssification 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 If you desire specific acriously 3 at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html.

Sincerely yours,

M. J. McFee

Mark N. Melkerson 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):__K053408 910 (K) Names: (Nexa bone plate and screw system

Indications for Use:

The bone plate and screw system is intended for use in providing fixation during I he bolle plate and screw system is intentive a consists of plates and screws for fractures, rasible phalanges, and metatarsals bones.

Over-The-Counter Use Prescription Use _ >> AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K053408

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.