The provided text is a summary for diagnostic ultrasound transducers and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It primarily focuses on:

Submitter Information: Company details and contact person.
Device Identification: Trade names, common names, and classification names.
Predicate Devices: Listing of previously cleared devices considered substantially equivalent.
Device Description: Technical specifications of the P10A, P12A, PT10A, and PA11-A transducers, including modes, frequencies, physical characteristics, and safety requirements.
Intended Uses: Specific applications for each transducer (Vascular, Transcranial, Cardiac).

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone performance study details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This document serves as a 510(k) summary, which is typically a high-level overview for regulatory submission, rather than a detailed report of performance studies or acceptance criteria.

Summary

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Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, PIOA, PIZA, PTI0A, PAH-A Biosound, Inc.

Image /page/0/Picture/1 description: The image shows the logo for BIOSOUND, which is written in all caps and in a bold, sans-serif font. Below the logo, it says "AN ISAIALI COMPANY". Above the logo, there is a handwritten number that appears to be K9535-30.

APR - 8 1996

Safety and Effectiveness Summary

The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR ¶807.92(a).

807.92(a)(1)

Submitter Information

Wayne Nethercutt Director, Regulatory Affairs

7990 Castleway Drive

Indianapolis, IN 46250

Phone: (317) 849-1793

Facsimile: (317) 841-8616

Contact Person: Wayne Nethercutt

Date: 07-18-95

807.92(a)(2)

Trade Name: P10A, P12A, PT10A, PA11-A

Common Name: Diagnostic Ultrasound Transducers

Classification Name(s): Transducer, Ultrasonic, Diagnostic 892.1570

FI 33

Biosound, Inc. - An I saure Gompany 7990 Gastleway Urive - Indianapoles. IN 46250 317 8491793 800 - 428 4374 - 1AX 217 - 841 8516

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Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, PIOA, PI2A, PT10A, PA11-A Brosound, Inc.

^^7 92(a)(3)

Predicate Device(s)

Esaote P10 Diagnotic Ultrasound Transducer K896356 .
Esaote P12 Diagnotic Ultrasound Transducer K896356 ●
Esaote SMA26 Diagnostic Ultrasound Transducer K944485/S3 ●
. Acuson S228 Diagnostic Ultrasound Transducer K902515

Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table.

807.92(a)(6)

SUBSTANTIAL EQUIVALENCE COMPARISON TABLE

ESAOTE AU4	Frequency MHz	Predicate Device	Frequency MHz	Application
		Esaote AU530510 (k): 896356
P12A	4.7	P12	5.0	Vascular
10A	2.3	P10	2.5	Cardiac

ESAOTE AU4	Frequency MHz	Predicate Device	Frequency MHz	Application
PT10A	2.0	Acuson ProbeS228Cleared viaK902515	2.0	Transcranial

ESAOTE AU4 Code	Frequency MHz	Predicate Device	Frequency MHz	Application
PA11-A	2.5 - 3.5 B-Mode2.3 - 2.8PW/CFM/CW	Esaote Probe: SMA26Cleared via K944485/S3	2.5 - 3.5	Cardiac
	2.5 - 3.5 B-Mode2.3 - 2.8PW/CFM/CW	Acuson Probe S228Cleared via K902515	2.0 - 2.5	Transcranial

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Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A Biosound, Inc.

807.92(a)(4)

Device Description

The subject devices are diagnostic ultrasound transducers described in the following tables..

MODES	CHARACTERISTICS
B mode	2.5/3.5 MHz
M mode	2.5/3.5 MHz
PW mode	2.3/2.8 MHz
CW mode	2.3/2.8 MHz
CFM mode	2.3/2.8 MHz
Power Color	2.3/2.8 MHz
Elevation & Focal Point	80 mm
Angle	30-90 deg.
Depth	$55.3 + 260$ mm
Connector	Both Electronical connectors
Cable length(meters)	2.00 mt.
Operating Temperature (deg.C)	from +10 to +40
Storing temperature (deg.C)	from -5 to +45
Weight (Kg)	500 G.
Safety Requirements	IEC 601-1(CEI62-5)
Application	CardiacTranscranial

PA11-A

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Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A Brosound, Inc.

P10A, P12A, PT10A

MODES	P10A	P12A
MODE	CW	CW
Frequency	2.5 MHz	5.0 MHz
Connector	Both Mechanical connectors	Both Mechanical connectors
Cable length (meters)	1850 mm	1850 mm
Operating Temperature(deg.C)	from +10 to +40	from +10 to +40
Storing temperature (deg.C)	from -5 to +45	from -5 to +45
Weight (Kg)	200 G.	200 G.
Safety Requirements	IEC 601-1(CEI62-5)	IEC 601-1(CEI62-5)
Application	Cardiac	Vascular

807.92(a)(5)

... .

Intended Use(s)

The intended use is specific for each transducer: P12A - Vascular

PT10A - Transcranial P10A - Cardiac PA11A - Cardiac/ Transcranial

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.