The device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.

The device is indicated for use by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids:

Device Description

The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable. The American Surgical Sponges (brand) product line is made from cotton, polyester, or rayon in various sizes and shapes and has been first marketed since 1985. The current cleared product line includes the Telfa® Sponges, which are cotton surgical sponges covered on both sides with polyethylene terephthalate. The Telfa® Sponges provide additional stiffness to the neurosurgical sponges. The new proposed addition to the product line includes neurosurgical sponges (cotton, polyester, or rayon) covered on one side with a thin single layer of polytetrafluoroethylene (PTFE) to enhance the material stiffness and non-adherence properties while maintaining flexibility of the sponge. The polytetrafluoroethylene (PTFE) layer will be provided in a choice of three thicknesses, 0.001", 0.003" or 0.005". The sponges range in size from 6mm × 76mm × 76mm.

AI/ML Overview

The presented text describes a 510(k) summary for the American Surgical Company's Neurosurgical Sponges, specifically focusing on the addition of a polytetrafluoroethylene (PTFE) layer to the sponges. The document details the product description, intended use, indications for use, and a comparison to a predicate device to establish substantial equivalence.

However, this document does not contain information about acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria in the way typically expected for an AI/ML medical device.

Here's why and what information is present:

Type of Device: The device described is a physical medical device (neurosurgical sponges), not a software or AI/ML algorithm. Therefore, the typical "acceptance criteria" and "performance study" inquiries relevant to AI/ML (like sensitivity, specificity, AUC, etc., and studies involving human reader performance or standalone algorithm performance) are not applicable in this context.
Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The primary evidence presented is that the modified device has the "same indications for use and intended use," "same principle of operation," "same basic design," "equivalent materials," "same shelf life," and "packaged and sterilized using the same materials and processes."

Given this, I cannot fulfill most of your request as the information is not present in the provided text. I will address the points that can be inferred or directly stated from the document, acknowledging where information is missing due to the nature of the device and submission.

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

Acceptance Criteria	Reported Device Performance
Biocompatibility: Absence of toxicity.	Biocompatibility Testing: Cytotoxicity, Sensitization, and Irritation testing conducted in accordance with FDA's Blue Book Guidance G95-1 (ISO-10993). Results "demonstrate the lack of toxicity of the device and its biocompatibility for use as a neurosurgical sponge." Studies were GLP compliant.
Material Adhesion/Stiffness: (Implicit: The PTFE layer is added to enhance stiffness and non-adherence while maintaining flexibility).	Peel Testing: Conducted to "quantify the amount of force necessary to pull apart the substrate and PTFE layers." (No specific quantitative results are provided in this summary, only that the test was performed).
Substantial Equivalence: (Implicit regulatory acceptance criteria)	The modified device is determined to be substantially equivalent to the predicate device (K962807) based on:
- Same indications for use	- Met
- Same intended use	- Met
- Same principle of operation	- Met
- Same basic design	- Met
- Equivalent materials	- Met (PTFE addition is considered an equivalent material for its intended purpose)
- Same shelf life	- Met
- Same packaging/sterilization	- Met

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable/not specified for the type of device. The biocompatibility tests would have involved specific animal models or in-vitro cell cultures, but these details are not provided. Peel testing would involve a sample of the sponges.
Data Provenance: The biocompatibility studies were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations, implying the testing was performed in the US or under US GLP standards. Details on retrospective/prospective are not applicable for material testing.

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)

Not applicable. This device is a physical sponge, not an AI/ML algorithm requiring expert opinion for ground truth. Biocompatibility and mechanical testing do not involve expert consensus on medical images or diagnoses.

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

Not applicable. This refers to adjudication of ground truth for AI/ML performance studies, which is not relevant here.

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

No. This is a physical medical device, not an AI/ML algorithm. An MRMC study is not relevant.

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

No. This is a physical medical device, not an AI/ML algorithm. A "standalone performance" study in the context of AI is not relevant.

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

The "ground truth" for the biocompatibility testing would be the established biological responses to the materials (e.g., absence of cytotoxicity, irritation, sensitization) as defined by ISO 10993 standards.
For the peel testing, the "ground truth" would be the measured force required to delaminate the layers.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm involved, so there is no training set.

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

Not applicable. There is no AI/ML algorithm involved, so there is no training set or ground truth for one.

Summary

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KI12598

2.0 510(k) Summary

JUN 2 0 2013

510(K) Owner:

American Surgical Company, LLC (formerly American Surgical Sponges, LLC and American Silk Sutures Inc) 82 Sanderson Avenue, Suite 212 Lynn, MA 01902 781-592-7200 Owner/Operator Number: 10030544

Submitter:

Contact:

Erik Piasio Managing Director Tel: 781-592-7200 Fax: 781-595-5460 Email: Erik.Piasio@americansurgical.com

Email: lkahler@rcinsightgroup.com

Manufacturer:

American Surgical Company, LLC 82 Sanderson Avenue, Suite 212 Lynn, MA 01902 781-592-7200 Registration Number: 1221144

Date Prepared: 01 September 2011

Trade name: American Surgical Sponges (brand) Neurosurgical Sponges

Lori Kahler

The RC Insight Group 461 Main Street, Suite 217 Pawtucket, RI 02860 Tel/Fax: 401-722-1811

Common name: Neurosurgical Paddie or Sponge

Classification name: 21 CFR § 882.4700

Product Code(s): HBA (neurosurgical paddie)

Classification: Class II

Current Legally Marketed Device:

American Surgical Company Special 510(k)

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American Surgical Sponges (brand) Neurosurgical Sponges K962807

Summary Description of the Device:

Intended Use:

The device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.

Indications for Use:

The device is indicated for use by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids:

Substantial Equivalence:

The modified American Surgical Sponges (brand) Neurosurgical Sponges is equivalent to the previously cleared 510(k) (K962807, May 2, 1997) as these devices:

have the same indications for use and intended use, .
use the same principle of operation, .
. incorporate the same basic design,
incorporate equivalent materials, .
have the same shelf life, and .
. are packaged and sterilized using the same materials and processes.

In summary, the modification to the American Surgical Sponges (brand) Neurosurgical Sponges described in this submission is substantially equivalent to the predicate device.

American Surgical Company Special 510(k)

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Biocompatibility Testing:

PTFE is widely used in medical devices. Biocompatibility testing conducted included Cytotoxicity, Sensitization and Irritation testing. Testing was completed in accordance with FDA's Blue Book Guidance G95-1 ("Use of International Standard ISO-10993, 'Biological' Evaluation of Medical Devices Part 1: Evaluation and Testing' "). The results of the studies demonstrate the lack of toxicity of the device and its biocompatibility for use as a neurosurgical sponge. All studies were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR part 58.

Performance Standards:

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, American Surgical Company conducted peel testing to quantify the amount of force necessary to pull apart the substrate and PTFE layers.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with flowing lines representing movement or connection.

June 20, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

American Surgical Company, LLC c/o Mr. Michael Alouane LSSBB Director of Quality 82 Sanderson Ave., Suite 212 Lynn, MA 01902

Re: K112598

Trade/Device Name: American Surgical Company Neurosurgical Sponges Regulation Number: 21 CFR 882.4700 Regulation Name: Neurosurgical Paddie Regulatory Class: Class II Product Code: HBA Dated: June 5, 2013 Received: June 6, 2013

Dear Mr. Alouane:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. Michael Alouane

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K112598

Device Name: American Surgical Sponges (brand) Neurosurgical Sponges

Indications For Use:

The device is indicated for use by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer -S 2013.06.20 16:48:38 -04'00'

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number

Page 1 of 1

Regulation Number and Section

§ 882.4700 Neurosurgical paddie.

(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).