The provided text describes a 510(k) summary for the A.M. Surgical Mountable Endoscopic Blade. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one might expect for a novel AI/software device.

Here's an analysis based on the provided text for a manual surgical instrument, not an AI or software device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use	The device is indicated for use in minimally invasive ligament or fascia release: Carpal tunnel release, Plantar fasciotomy, Lateral release of the knee, Forearm fasciotomy, Morton's neuroma, Gastrocnemius release.
Material Composition	Manufactured from stainless steel. (No change from predicate)
Design Features	Mounts to a 4mm 30° endoscope. (Substantially equivalent to predicate)
Safety and Effectiveness	Adequately supported by substantial equivalence to the predicate device (K982142).

Explanation:
For this type of device (a manual surgical instrument), the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity for algorithms. Instead, acceptance is based on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device. This equivalence is established by comparing intended use, material composition, and design features, and then asserting that this similarity ensures comparable safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) relies on substantial equivalence to a predicate device (K982142), not on a new clinical study with a specific test set of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No "ground truth" for a test set was established in the context of a new clinical study for this device.

4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not applicable. This is a 510(k) for a manual surgical instrument, not an AI/software device that would typically undergo MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used
Not applicable. The basis for clearance is substantial equivalence to a predicate device, not empirical ground truth data from a new study.

8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires training data.

9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device.

Summary of the Study and Conclusion:

The "study" or justification for the A.M. Surgical Mountable Endoscopic Blade is a Substantial Equivalence (SE) determination under the 510(k) pathway.

Acceptance Criteria Met: The device met the regulatory acceptance criteria by demonstrating substantial equivalence to a previously cleared predicate device, the Mountable Endoscopic Blade (K982142). This means its intended use, material composition (stainless steel), and design features (mounts to a 4mm 30° endoscope) were found to be sufficiently similar to the predicate to ensure equivalent safety and effectiveness.
Proof: The entire 510(k) submission, specifically section D ("Substantial Equivalence Information"), serves as the "study" or proof. It asserts that "The safety and effectiveness of Mountable Endoscopic Blade is adequately supported by the substantial equivalence information provided within this Premarket Notification." The FDA's letter concurs with this finding, stating that the device is "substantially equivalent."

In essence, for this medical device, the "study" is a regulatory comparison rather than a clinical trial or performance evaluation against specific numerical targets.

Summary

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K080133

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of AM Surgical's Mountable Endoscopic Blade.

Submitted By:	A.M. Surgical, Inc.
Date:	January 14, 2008
Contact Person:	Vincent PascalePhone: 800-437-9653Fax: 631-980-4369
Proprietary Name:	Mountable Endoscopic Blade
Common Name:	Surgical Knife
Classification Name and Reference:	21 CFR 878.4800, Manual Surgical Instrumentfor General Use
Device Product Code and Panel Code:	General and Plastic Surgery/EMF

DEVICE INFORMATION

INTENDED USES/ INDICATIONS A.

The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release.

Carpal tunnel release for carpal tunnel syndrome .
Plantar fasciotomy for plantar fasciitis .
Lateral release of the knee for extensor mechanism malalignment .
Forearm fasciotomy for compartment syndrome
. Morton's neuroma for interdigital neuroma
Gastrocnemius release for heel cord contracture (equinus) .

DEVICE DESCRIPTION B.

The Mountable Endoscopic Blade is a device that mounts to a 4mm 30° endoscope.

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Ko 80133

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C. MATERIALS

The blade is manufactured from stainless steel. There is no change in material for the Mountable Endoscopic Blade.

SUBSTANTIAL EQUIVALENCE INFORMATION D.

The intended use, material composition, and design features of the Mountable Endoscopic Blade are substantially equivalent to previously cleared 510(k) Mountable Endoscopic Blade (K982142). The safety and effectiveness of Mountable Endoscopic Blade is adequately supported by the substantial equivalence information provided within this Premarket Notification.

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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

A.M. Surgical, Inc. % Mr. Vincent Pascale 290 East Main Street, Suite 200 Smithtown, New York 11787

Re: K080133

Trade/Device Name: Mountable Endoscopic Blade Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: II Product Code: EMF Dated: March 5, 2008 Received: March 5, 2008

Dear Mr. Pascale:

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. Vincent Pascale

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko80133

Indications for Use Statement

510(k) Number: Not yet assigned.

Device Name: Mountable Endoscopic Blade

Indications For Use:

The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release.

· Carpal tunnel release for carpal tunnel syndrome
· Plantar fasciotomy for plantar fasciitis
· Lateral release of the knee for extensor mechanism malalignment
· Forearm fasciotomy for compartment syndrome
· Morton's neuroma for interdigital neuroma
· Gastrocnemius release for heel cord contracture (equinus)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number

Prescription Use _

Over-The Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative. and Neurological Devices

510(k) Number. K080133

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.