Humeral staples are intended for fixation of two-part proximal humerus fractures and three-part proximal humerus fractures in conjunction with limited internal fixation such as suture wire. The device is intended for single use.

Device Description

Humeral staples are manufactured from either Stainless Steel (ASTM F 138) or Titanium (ASTM F 1472). The staple features two trocar point ends and suture holes. The staple is designed for intramedullary implantation in the proximal humerus.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called a "Humeral Staple." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary like this one is not a clinical study report. It does not typically contain information about acceptance criteria, detailed device performance metrics, sample sizes for test sets, ground truth establishment, or multi-reader multi-case studies.

Instead, it focuses on demonstrating equivalence to existing devices through comparisons of:

Intended Use: What the device is designed to treat.
Device Description: Physical characteristics and materials.
Technological Characteristics: How it achieves its function.
Materials: What it's made from.
Performance Data: (If applicable, usually refers to non-clinical bench testing or engineering analysis for equivalence, not detailed clinical outcomes as would be found in a clinical trial).

Therefore, based solely on the provided text, I cannot extract the information required for your request. The document discusses "substantial equivalence" as the primary "acceptance criteria" for regulatory clearance, not specific performance metrics in a clinical study context.

Here's how I can answer your questions based on what is and is not in the document:

Acceptance Criteria and Study for Humeral Staple (Based on 510(k) Summary)

The primary "acceptance criterion" for the Humeral Staple, as detailed in this 510(k) summary, is Substantial Equivalence to legally marketed predicate devices. This means the new device must be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

The "study" demonstrating this is a comparison to predicate devices based on technological characteristics, intended use, and materials. This is a regulatory pathway, not a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Regulatory)	Reported Device Performance (Comparison for Substantial Equivalence)
Substantial Equivalence to Predicate Devices	Material equivalence (Stainless Steel/Titanium), similar indications for use (long bone/extremity fractures), similar diameters and lengths (for predicate nail-type devices).
Safe and Effective (implied by Substantial Equivalence)	No detailed performance metrics are provided in this summary. The device's safety and effectiveness are inferred by its similarity to already cleared devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This document does not describe a clinical test set or human subject data. It's a regulatory submission comparing the device to existing predicate devices.
Data Provenance: Not applicable. The comparison is based on the characteristics of the Humeral Staple itself and information about the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no test set in the clinical sense, and no ground truth established by experts for human studies described in this summary. Regulatory review involves FDA experts.

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

Not applicable. No test set described.

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. This is not an AI/medical imaging device. It is a surgical implant.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable in the context of clinical "ground truth." The "ground truth" for regulatory clearance is the established safety and effectiveness of the legally marketed predicate devices that the Humeral Staple is compared against.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable.

In summary, this 510(k) document is a regulatory submission focused on demonstrating equivalence to existing devices, not a report of a clinical performance study with defined acceptance criteria and detailed device metrics.

Summary

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JUL 3 0 2004

510(K) SUMMARY HUMERAL STAPLE

Koy/1355
page 1 of 1

SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: COMMON OR USUAL NAME: CLASSIFICATION NAME: DEVICE CLASS: PANEL CODE:

Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-6670 John Reabe March 8, 2004 Humeral Staple Intramedullary fixation fastener Smooth or threaded metallic bone fixation fastener Class II Orthopedic/87

DEVICE INFORMATION:

INTENDED USE:

Humeral stables are manufactured from either Stainless Steel (ASTM F 138) or Titanium (ASTM F 1472). The staple features two trocar point ends and suture holes. The staple is designed for intramedullary implantation in the proximal humerus.

DEVICE DESCRIPTION:

SUBSTANTIAL EQUIVALENCE INFORMATION:

The humeral staple is similar to the DePuy ACE, Inc., The Nancy Nail (K032687); Synthes, Elastic Intramedullary Nail (K971783); Smith & Nephew, Inc., Ender Nail (K811002); and Smith & Nephew. Inc., Steinman Pin (preamendment device) in that all the devices are made of stainless steel or titanium, offered in similar diameters and lengths, and have similar indications related to long bone or extremity fractures.

The humeral staple is substantially equivalent to the other predicate devices. The difference between the humeral staple and predicate devices is the humeral staple is U-shaped and the other products are not U-shaped, but are used in multiples.

SUMMARY OF TECHNOLOGICAL COMPARISON:

The humeral staple is substantially equivalent to the predicate devices listed in the previous section in terms of material, indications for use and design.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

Mr. John Reabe Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K041355

Trade/Device Name: Humeral Staple Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HTY Dated: May19, 2004 Received: May 20, 2004

Dear Mr. Reabe:

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. John Reabe

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter maification. The FDA finding of substantial equivalence of your device to a legally prematted 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 other Ectorers, 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,

Mark N. Milliken

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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Kodi 35 > 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Humeral Staple

Indications for Use:

Humeral staples are intended for fixation of two-part proximal humerus fractures and Humoral blapios are internes in conjunction with limited internal fixation such as suture wires. The device is intended for single use.

(Please Do NoT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Mark N. Millerson

Sion-(Division Division of General, Restorative, and Neurological Devices

510(k) Number K041353

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.