Indications: Any ENT, otorhinolaryngological, or head and neck surgery requiring the incision and removal of bone or tissue, including removal and shaping of bone during rhinoplasty procedures and removal of soft tissue during plastic, reconstructive, and/or athestic surgery of the head and neck.

Device Description

The XPS microdebrider system is composed of the Power Control unit, a footswitch and a handpiece combined with various accessory blades and burs. The XPS system and replaceable blades and burs are intended for use by health care professionals and are labeled as prescription devices. The disposable blades and burs are provided in styles and sizes to remove the various tissues and bone typically resected in ENT and Head and Neck surgery.

AI/ML Overview

This looks like a 510(k) premarket notification for a surgical device, not an AI/ML device. Therefore, the typical acceptance criteria and study designs relevant to AI/ML (like sensitivity, specificity, MRMC studies, ground truth establishment for training sets) do not directly apply in the same way.

However, I can extract information related to the device's intended use and the justification for substantial equivalence, which serves a similar purpose to demonstrating the device meets "acceptance criteria" for regulatory clearance based on a predicate device.

Here's an attempt to answer your questions based on the provided document, adapting where necessary for a non-AI/ML device.

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

For a traditional surgical device like this, the "acceptance criteria" are typically related to safety, effectiveness, and substantial equivalence to a predicate device for its intended use, rather than quantifiable performance metrics like sensitivity/specificity.

Acceptance Criteria (Implied from 510(k) Submission)	Reported Device Performance (as demonstrated for Substantial Equivalence)
Safety and Effectiveness for Rhinoplasty: The device can safely and effectively cut and remove bone and tissues during rhinoplasty procedures.	The XPS Microdebrider System for rhinoplasty is deemed equivalent to the TreBay Microplaner handpiece (K954715), which was cleared for "removal of bone and tissues in rhinoplasty, for such procedures including nasal dorsum surgery and nasal osteotomy, and surgery for rhinoplasty." No new safety or effectiveness issues were identified.
Safety and Effectiveness for Soft Tissue Removal in Plastic/Reconstructive/Aesthetic Surgery of the Head and Neck: The device can safely and effectively cut and remove soft tissues in these procedures.	The removal of soft tissue under these indications is considered equivalent to the removal of any other soft tissue of the head and neck, raising no new safety or effectiveness issues. A "multi-institutional experience" (article of Becker, et al.) found the use of powered cutting blades safe and effective for such tissue removal.
Substantial Equivalence: The modified indications for use (rhinoplasty and soft tissue removal) do not raise new questions of safety or effectiveness compared to legally marketed predicate devices.	The submission asserts that the specific procedures (rhinoplasty and soft tissue removal) are substantially equivalent to the currently broadly stated indications for use of the predicate device (XPS System) and the TreBay Microplaner.

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

This information is not provided in a way that aligns with an AI/ML device's test set. The submission refers to a "multi-institutional experience for these indications (article of Becker, et al.)" to support the safety and effectiveness for soft tissue removal. However, the specific sample size, study design, or data provenance (e.g., country of origin, retrospective/prospective) of this medical literature is not detailed in the 510(k) summary. This is typical for a 510(k) that relies on existing clinical experience and predicate device comparison rather than de novo clinical trials for new functionality.

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

This concept is not applicable in the context of this 510(k) submission. The "ground truth" for a surgical device is typically established through clinical practice, medical literature, and regulatory precedent. The "experts" would be the surgeons who published the "multi-institutional experience" or who are generally recognized in the field for performing these types of surgeries, but their specific qualifications or role in establishing a "ground truth" for a test set are not described here.

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

Not applicable. There is no mention of a "test set" requiring an adjudication method as would be relevant for an AI/ML performance study.

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 a surgical device, not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies and "human readers" are not relevant.

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

Not applicable. This is a physical surgical device intended for human use, not an algorithm.

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

For this type of device, the "ground truth" for safety and effectiveness is established by:

Clinical experience/outcomes data: Referenced implicitly through the "multi-institutional experience (article of Becker, et al.)" which suggests safe and effective use of powered cutting blades for soft tissue removal.
Regulatory precedent and predicate device functionality: The device's substantial equivalence is based on its similarity to other legally marketed devices, whose safety and effectiveness have presumably been established through clinical use and regulatory review.
Medical literature and accepted surgical practices: The document refers to the commonality of the procedures and that the indications are "commonly carried out by the ENT/Head and Neck surgeon."

8. The sample size for the training set

Not applicable. This is a physical surgical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. (See answer to #8).

Summary

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K972453

Image /page/0/Picture/1 description: The image shows the logo for XOMED Surgical Products. The logo consists of the word "XOMED" in large, bold, sans-serif font, with the words "SURGICAL PRODUCTS" in a smaller font underneath. Below the words is a circular emblem with a four-pointed star inside. The logo is black and white.

Revised 8/25/97

510(k) Summary

1.0 Date Prepared June 27, 1997

SEP - 5 1997

2.0 Submitter (Contact)

David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532

3.0 Device Name

Proprietary Name:	XPS StraightShot Microresector System and/or SculptureSystem, and various descriptive tradenames for burs andblades as accessories for the system.)
Common Name(s):	Electrical surgical drill, microdebrider, or microresector,handpieces, burs and blades
Classification Name:	ENT Surgical Drill

5.0 Device Classification

ENT Surgical Drill	Procode: 77 ERL	Class II; 21CFR 874.4250	Tier 1
ENT Bur (Blade)	Procode: 77 EQJ	Class I; 21CFR 874.4140	Tier 1

6.0 Device Description

7.0 Intended Use

This device is intended for the cutting and removal of bone and tissues in ENT, otorhinolaryngology / head and neck surgical procedures.

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Substantial Equivalence 8.0

This submission is to obtain FDA concurrence that the specific procedures (rhinoplasty and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery of the head and neck) indicated in the proposed labeling are substantially equivalent to the current broadly stated indications for use. No other modifications or device changes are included.

The use of the XPS System for rhinoplasty is equivalent to the TreBay Microplaner handpiece, cleared via K954715, which is described as having a 4.4 mm cutting bur with a hooded tip and handpiece. Its cleared indications for use included "for removal of bone and tissues in rhinoplasty, for such procedures including nasal dorsum surgery and nasal osteotomy, and surgery for rhinoplasty".

The additional indication proposed for soft tissue removal during plastic, reconstructive, and/or aesthetic surgery of the head and neck is only identifying a specific soft tissue removal that is commonly carried out by the ENT/Head and Neck surgeon. The removal of this tissue is equivalent to the removal of any other soft tissue of the head and neck in that it raises no new issues of safety or effectiveness. In a multi-institutional experience for these indications (article of Becker, et al.), the use of powered cutting blades is found to be safe and effective for removal of such tissue.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name arranged in a circular fashion on the left side. To the right of the text is a symbol consisting of three stylized lines or strokes, which may represent a human figure or abstract design. The logo is presented in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David Timlin Manager, Regulatory Affairs XOMED Surgical Products 6743 Southpointe Drive, N. Jacksonville、FL 32216

SEP - 5 1997 Re: K972453 XPS Straight Shot Electronic or Pneumatic Surgical Drill Dated: June 27, 1997 Received: June 30, 1997 Regulatory Class: II 21 CFR 874.4250/Procode: 77 ERL

Dear Mr. Timlin:

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 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 (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. Tile 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 not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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.

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) 594-4613. 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,

William Yu, Ph.D.

Lilian Yin, Plu.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k): K972453

Device Name: Xomed (Trebay) Microdebrider / resector. XPS StraightShot. XPS Sculpture systems and accessory blades and burs

Indications for Use:

This device is intended for the cutting and removal of bone and tissues in ENT, otorhinolaryngology / head and neck surgical procedures.

(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)
Or

Over-the-Counter Use

(Optional Format 1-2-96)

David A. Bergman

Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.