The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during various arthroscopic surgical procedures.

Device Description

The CSS is an accessory device that is intended to be used in conjunction with currently marketed automated debrider systems and ESU's the same as the current MSI Bipolar Sheath. The CSS is designed to fit directly over various sizes of straight automated debrider system blades. The CSS will be available in a variety of diameters and in lengths. When the CSS is inserted over one of the debrider blades, the device may be used to cauterize tissue. The CSS can be utilized to provide spot coagulation or to coagulate tissue while the debrider blade is in operation.

AI/ML Overview

The provided text describes a 510(k) summary for the "CSS" (Coagulation Device) a modification to the MSI Bipolar Sheath. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and supporting data for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Substantial Equivalence in design, materials, construction, and intended use as predicate devices.	The CSS is stated to be "substantially equivalent in design, materials, construction and intended use" to the predicate devices (MSI Bipolar Sheath, K011202; Stryker Serfac K991960).
Does not raise new safety and efficacy concerns compared to similar legally marketed devices.	The document explicitly states, "the CSS does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices."
Functionality and conformance to design input requirements.	"Bench testing was conducted to determine device functionality and conformance to design input requirements." (No specific criteria or results are provided, only that testing was conducted.)
Differences in power are substantiated through applicable performance testing.	"The differences in power have been substantiated through applicable performance testing." (No specific criteria or results are provided.)

Missing Information:

Specific quantitative or qualitative acceptance criteria beyond "substantially equivalent" and "no new safety/efficacy concerns."
Detailed performance metrics (e.g., coagulation time, tissue effect, safety margins for specific power differences).
Actual data demonstrating how the device met these criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document only mentions "Bench testing."
Data Provenance: Not specified. It's bench testing, so likely conducted in a lab setting, but no country of origin is mentioned. The testing is retrospective, as it's for verification of a device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The study involved bench testing, not human interpretation or clinical data requiring expert ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set:

Not applicable. As this was bench testing, there's no mention of an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This device is an accessory for surgical procedures, and the testing described is bench testing, not a clinical study involving human readers interpreting cases.

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

Yes, in a way. The "bench testing" can be considered a standalone performance evaluation of the device itself (not an algorithm), without human-in-the-loop performance influencing the device's basic functionality. However, it's not "algorithm only" as there's no explicit algorithm described.

7. The Type of Ground Truth Used:

For the bench testing, the "ground truth" would be engineering specifications and design input requirements for functionality, materials, and power characteristics. This is based on engineering/design specifications for the device.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical device.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no training set is mentioned.

In summary, the provided document describes a 510(k) submission for a medical device accessory (CSS) that relies on demonstrating substantial equivalence through bench testing to established predicate devices. It does not provide the detailed study design, specific acceptance criteria, or quantitative results typical of studies for novel devices or AI/software as a medical device (SaMD).

Summary

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K031564

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Medical Scientific, Inc. 125 John Hancock Rd. Taunton, Ma. 02780 Tel: 508-880-7313 Fax: 508-880-7347

510K Summary of Safety and Effectiveness May 12, 2003 Case A Modification to the MSI Bipolar Sheath

1 . Sponsor Name

OCT = 7 2003

Medical Scientific, Inc. 125 John Hancock Rd. Taunton, Ma. 02780

2. Device Name

Proprietary Name: CSS Common Name: Coagulation Device Classification Name: Electrosurgical cutting and coagulation device and accessories

Identification of Legally Marketed Device 3. MSI Bipolar Sheath, K011202 Stryker Serfac K991960

4. Device Description

1. Intended Use
  The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during various arthroscopic surgical procedures.

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K031564 2 of 2

1. Comparison of Technological Characteristics
  The CSS is substantially equivalent in design, materials, construction and intended use as those of the predicates identified above. Since the CSS is the same in intended use and technological characteristics as the predicate devices, the CSS does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices. The differences in power have been substantiated through applicable performance testing.
1. Performance Testing
  Bench testing was conducted to determine device functionality and conformance to design input requirements.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "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 torso.

Public Health Service

OCT - 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul Nardella President Medical Scientific, Inc. 125 John Hancock Road Taunton, Massachusetts 02780

Re: K031564 Trade/Device Name: CSS Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 8, 2003 Received: September 12, 2003

Dear Mr. Nardella:

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. Paul Nardella

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,

b Mark N. Milken

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):

ଦିଆଯାଇଥିଲେ । ଏହା ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପ Device Name:

Indications For Use:

The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during arthroscopic surgical procedures.

K031564

(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 _________________________________________________________________________________________________________________________________________________________

for Mark N. Milliken

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

000009

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.