DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE by HOWMEDICA CORP.

The Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable are intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fracture fixation when used with bone plates and screws and for the stabilization of bone graft material.

Device Description

The Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable described in this submission are modifications of the existing cable and beaded cable. The difference between the new stainless steel devices and the existing cables cleared in submissions K844068 and K961569 is the material (22-13-5 ESR vs. 316L) and the manner in which the cable is manufactured (Homogeneous strands vs. Non-Homogeneous). There are no other differences in the design, manufacturing method, or principles of operation between the two types of cables.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested in your bullet points regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Here's why and what information is available:

No Acceptance Criteria or Device Performance Table: The 510(k) pathway for medical devices does not typically involve defining and meeting specific quantitative performance acceptance criteria in the same way a drug trial or a novel high-risk device study would. Instead, substantial equivalence is established by comparing the new device's technological characteristics, intended use, and materials to a predicate device already on the market.
No "Study" as you've defined it: There isn't a clinical performance study described in the document to "prove the device meets the acceptance criteria." The submission is a regulatory filing demonstrating equivalence.
No Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, or Standalone Performance: These details are relevant to clinical performance studies, which are not detailed in this 510(k) summary.
No Ground Truth for Training Set: The concept of a "training set" and "ground truth" (as used in machine learning or diagnostic imaging) is not applicable here. This device is a surgical cable, not an AI/ML-driven diagnostic tool.

Information that is available from the document:

Device Name: Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable
Intended Use / Indications for Use: For spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Also for supplementary fracture fixation with bone plates and screws and stabilization of bone graft material.
Material Difference from Predicate: The new device uses 22-13-5 ESR stainless steel and homogeneous strands, compared to the predicate's 316L and non-homogeneous strands.
No Other Differences: "There are no other differences in the design, manufacturing method, or principles of operation between the two types of cables."
Predicate Devices: Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926); Dall-Miles Homogeneous Cable, Vitallium® (K945294); Dall-Miles Suture/Beaded Cable (K953818); and Dall-Miles Stainless Steel Beaded Cable, 316L (K961569).
Date of Summary: May 9, 1997
FDA Clearance Date: July 16, 1997
Regulatory Class: Class II
Product Code: JDQ

In summary, for this type of medical device clearance (510(k) for a surgical implant), the regulatory pathway focuses on demonstrating substantial equivalence to existing devices rather than a detailed performance study with specific acceptance criteria as you've outlined.

Summary

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K97 1721

JUL 16 1997

510(k) Summary

Proprietary Name: Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable

Common Name: Bone Fixation Cerclage

Classification Name and Reference: Bone Fixation Cerclage 21 CFR 888.3010

Proposed Regulatory Class: Class II

Device Product Code: OR(87) JDQ

。

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 5-9-97

The substantial equivalence of the Dall-Miles Cable and Beaded Cable is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926); Dall-Miles Homogeneous Cable, Vitallium® (K945294); Dall-Miles Suture/Beaded Cable (K953818); and Dall-Miles Stainless Steel Beaded Cable, 316L (K961569).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the shape of a person's head and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank Maas Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

JUL 16 1997

K971741 Re : Dall Mile Homogeneous Stainless Steel Cable and Beaded Cable Requlatory Class: II Product Code: JDQ May 9, 1997 Dated: Received: May 12, 1997

Dear Mr. Maas:

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 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ದ 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

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Paqe 2 - Mr. Frank Maas

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 requlations.

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.

If you desire specific advice for your device on our labeling requlation (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable Modification

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 Restorative Devices
510(k) Number	1697174

Prescription Use (Per 21 CFR 801.109)	X
OR	Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.