The instrument is used for measuring the corneal thickness of the eye.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, A-mode (P=previously cleared by FDA).

Device Description

The PachPen device is designed as an ultrasound pachymeter which uses pulsed echo ultrasound to measure the corneal thickness of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a numeric display of returning pulse echoes to indicate the thickness of the cornea.

AI/ML Overview

This document is a 510(k) summary for the PachPen Pachymeter, an ultrasound device for measuring corneal thickness. As such, it is a submission for regulatory clearance and does not contain a detailed study report with acceptance criteria and device performance data in the structured format requested.

The document confirms the device's substantial equivalence to a predicate device (AccuPach V Pachymeter K042752), which is the basis for its regulatory clearance. However, it does not provide the specific performance data from a clinical or technical study proving the device meets an explicit set of acceptance criteria.

Therefore, many of the requested fields cannot be directly populated from the provided text.

Here's an attempt to answer based on the available information and highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Hypothesized based on device type)	Reported Device Performance (Not explicitly stated in this document)
Accuracy of corneal thickness measurement (e.g., ± X microns)	Not provided (The document states substantial equivalence to a predicate device, implying similar performance, but specific values are not listed)
Precision/Reproducibility of measurements (e.g., within Y microns)	Not provided
Measurement Range (e.g., Z to W microns)	Not provided
Biocompatibility of eye-contact probe	Implicitly met by substantial equivalence to predicate device with similar materials.
Electrical Safety (IEC 60601-1 compliance)	Implicitly met by substantial equivalence and general controls.
Electromagnetic Compatibility (EMC)	Implicitly met by substantial equivalence and general controls.

Self-correction: The document does not explicitly state acceptance criteria or report specific performance metrics for the PachPen device. Its clearance is based on substantial equivalence to a predicate device. For a full study report, these details would be necessary.

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

Sample Size: Not specified.
Data Provenance: Not specified. Since it's a 510(k) summary for substantial equivalence, the data likely relates to the technical specifications and comparison with the predicate device, rather than a large clinical study directly evaluating the new device's performance against ground truth in human subjects.

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

Not applicable/Not specified in this document. The submission is for substantial equivalence to an existing device, rather than a de novo clinical validation requiring expert-established ground truth for a new diagnostic claim.

4. Adjudication method for the test set

Not applicable/Not specified.

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 device is an ultrasound pachymeter, a measurement tool, not an AI-assisted diagnostic imaging system for human interpretation. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.

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

Yes, in a sense. The PachPen Pachymeter is a standalone device designed to provide a numeric measurement. Its performance would be evaluated as a standalone instrument, but not in the context of an "algorithm only" in the way AI or image processing algorithms are typically described.

7. The type of ground truth used

Not explicitly stated for the PachPen device. For a pachymeter, ground truth for accuracy studies would typically involve:
- Phantom measurements: Using phantoms with precisely known thicknesses.
- Comparative measurements: Against a highly accurate reference standard pachymeter or other established measurement method.
- Histology/Pathology (less common for in-vivo devices): Ex-vivo tissue measurements.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary of what the document does provide:

Device Description: The PachPen is an ultrasound pachymeter that uses pulsed echo ultrasound with an eye-contact probe to measure corneal thickness.
Indications for Use: Measuring the corneal thickness of the eye.
Predicate Device: AccuPach V Pachymeter (K042752).
Regulatory Clearance Basis: Substantial equivalence to the predicate device.
Transducer: A-mode 10.5 MHz, which is the same as used in the predicate device.
Regulatory Class: Class II, under "Ultrasonic pulsed echo imaging system" (21 CFR 892.1650).

Key Takeaway: This 510(k) summary is a regulatory filing demonstrating substantial equivalence, not a detailed technical or clinical study report. It relies on the predicate device's established performance, rather than presenting new, detailed performance data for the PachPen itself.

Summary

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K05055 2

MAR 2 8 2005

510(k) SUMMARY

Applicant:	Accutome Inc.
Address:	263 Great Valley ParkwayMalvem, PA 19355
Contact Person:	Jeffrey L. WrightManager, Engineering, Manufacturing & QC
Telephone:	(610) 889-0200(610) 889-3233 fax
Preparation Date:	February 28, 2005
Device Name:	PachPen Pachymeter
Common Name:	Ultrasound Pachymeter
Classification:	System, Imaging, Pulsed Echo, Ultrasonic(see: 21 CFR 892.1560) Product Code: IYO Panel: 90
Legally MarketedPredicate Devices:	AccuPach V Pachymeter (K042752)
Description of the Device:	The PachPen device is designed as an ultrasoundpachymeter which uses pulsed echo ultrasound to measurethe corneal thickness of the eye. It utilizes an eye-contactprobe to generate and receive the ultrasound pulses, andprovides a numeric display of returning pulse echoes toindicate the thickness of the cornea.
Indications for Use:	The instrument is used for measuring the corneal thicknessof the eye.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers.

MAR 2 8 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey L. Wright Manager, Engineering, Manufacturing & QC Accutome, Inc. 263 Great Valley Parkway MALVERN PA 19355

Re: K050552

Trade Name: PachPen Pachymeter Regulation Number: 21 CFR 892.1650 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: February 28, 2005 Received: March 7, 2005

Dear Mr. Wright:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Booken or resped the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the Merror, 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 Cosmone Act (110). "The general controls provisions of the Act include requirements for annual provision, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the PachPen Pachymeter, as described in your premarket notification:

Transducer Model Number

A-mode 10.5 MHz

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);

{2}------------------------------------------------

Page 2 - Mr. Wright

labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality labeling (21 OF R Part 807), good mart 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in nnonmation, meraling working works September 30, 1997 "Information for Manufacturers Seeking Appendix O; (enerobed) oversic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancyc Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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PachPen 510(k) Notification

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic	P
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:_

Transducer used is the one used in AccuPach V K042752.

(PLE ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Nancy C Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number _

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.