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Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and ethylene oxide sterilization.

Device Description

A 0.05mm thin, 50 GSM (Grams per Square Meter), translucent high strength polyurethane film tube shape, nominally 48" x 6" with heat sealed distal end to be applied over a transducer probe to provide a Transducer Cover that can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackager/relabeler/kit packers establishments for further packaging and ethylene oxide sterilization.

AI/ML Overview

The provided text describes the acceptance criteria and performance of the EMM Ultrasonic Transducer Cover, which is a medical device.

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

Test Performed & Description of test	Acceptance Criteria	Reported Device Performance / Result Summary	Conclusion
Water Resistance: Impact Penetration Test, Level 3	Blotter weight gain of no more than 1.0 g	Accept, 32 samples ≤ 1.0g (all samples = 0.0 g)	Ability of a protective product to resist the penetration of liquids and liquid-borne microorganisms according to AAMI PB70, Level 3. Substantially equivalent barrier property compared to the predicate device.
Water Resistance: Hydrostatic Pressure Level 3	Hydrostatic resistance of at least 50 cm	Accept, 32 samples > 50cm (all samples ≥ 180cm)	Ability of a protective product to resist the penetration of liquids and liquid-borne microorganisms according to AAMI PB70, Level 3. Substantially equivalent barrier property compared to the predicate device.
Flammability of Clothing Textiles (16CFR1610)	Burn Time ≥ 3.5 seconds	Accept, 5 samples DNI (Did Not Ignite)	Able to meet and claim flammability Class 1 rating in accordance with 16CFR1610. Exceeds predicate device based upon predicate device has not been tested for this attribute.
Tensile properties — Part 3: Test conditions for films and sheets (ISO 527-3)	Tensile strength minimum 40N in machine direction, minimum 34N in cross direction. Elongation 108 % minimum in machine direction, 119% minimum in cross direction.	Accept, all samples passed acceptance criteria in accordance with statistical sampling plan per ISO2859-1 (otherwise, material is rejected).	Specification confirmation of tensile and elongation properties of plastic films or sheets less than 1 mm thick to assure compliant device barrier performance. Substantially equivalent tensile and elongation property compared to material specification.
Lint and other particles generation in the dry state (ISO 9073-10)	IPM =/≤ 3.5 (Index for Particle Matter)	Accept, IPM 1.3 (outside), IPM 0.72 (inside)	Material does not significantly generate lint or particles that may shed during an ultrasonic scan procedure. Exceeds predicate device based upon predicate device has not been tested for this attribute.
Acoustic Output Measurement Standard for Diagnostic Ultrasound (NEMA UD 2-2004)	Negligible effect on the transmission of ultrasound signal and does not degrade signal or image.	Accept, Speed of sound = 1698 m/sec, Acoustic Attenuation = 0.51 dB, Acoustic Impedance = 1.63 MRayl.	Based on the acoustic testing results, it was concluded that EMM's transducer/probe cover has negligible effect on the transmission of ultrasound signal and that EMM's transducer/probe cover does not degrade signal or image. Exceeds predicate device based upon predicate device has not been tested for this attribute.
Compatibility of ultrasonic coupling gel with polyurethane (ASTM D543-20)	(Acceptance Criteria Not Defined)	Accept, Color N=9 Pass, Dimension N=9 Pass, Weight N=9 Pass, Coordinates N=9 Pass, Mechanical Properties N=9 Pass.	Confirmation that device polyurethane material is not negatively affected by the acoustic coupling gel during an ultrasonic scanning procedure. Exceeds predicate device based upon predicate device does not provide compatibility evaluation of acoustic coupling gel with their device.
Ethylene Oxide Residuals (ISO 10993-7:2008)	Tolerable contact limit (TCL) for EO at 10ug/cm2 and ECH at 5mg/cm2	Accept, Actual results for EO Residuals at Time 0 hours = 8.67ug/cm2. Actual results for ECH residuals at Time 0 hours = Not detected (within the limits of detection of 3.7ug/g).	Confirmation of maximum allowable residues for ethylene oxide (EO) within the submission device sterilized with EO and to ensure that the levels of residual EO, ethylene chlorohydrin (ECH), and ethylene glycol (EG) pose a minimal risk to the patient in normal product use. Substantially equivalent to predicate device based upon acceptable testing results that comply with testing standard.
In Vitro Cytotoxicity Test (ISO 10993-5;2009)	Viability is reduced <70% of the blank indicates cytotoxic potential. The Viab.% of 100% extract of the test article is the final result.	100% Test article extract 76.5% viability. No Test article extracts are <70% viability.	Study conclusion, "Under the conditions of this study, the test article extract did not show potential toxicity to L929 cells."
Closed patch Sensitization Study in Guinea Pigs (ISO 10993-10:2010)	No significant evidence of causing skin sensitization in the guinea pig.	No skin sensitization reaction was found in the Guinea pigs using extracts of the test article. The positive rate of sensitization was 0%. Dermal Reactions Challenge 24 Hour Score Ten test Guinea pigs, 0 (zero) reactions. 48 Hour Score Ten test Guinea pigs, 0 (zero) reactions.	Under the conditions of the study, the test article extracts showed no significant evidence of causing skin sensitization in the Guinea pigs. Substantially equivalent to the predicate device.
Intracutaneous Reactivity Test (ISO 10993-10:2010)	The requirements of the test are met if the final test article score is 1.0 or less.	All animals survived and no abnormal signs were observed. The skin reaction of polar and non-polar extract on testing side did not exceed that on the control side. Final test article score was calculated to be 0. Summary Analysis Test Results of Dermal Observations in Test Article Extract SC 24 hr = 0, 48 hr = 0, 72 hr = 0. Extract SO 24 hr = 0, 48 hr = 0, 72 hr = 0.	The test result showed that the polar and non-polar extract of the final test sample score is less 1.0, the requirements of the test are met. Substantially equivalent to the predicate device.

2. Sample sized used for the test set and the data provenance:

Water Resistance (Impact Penetration & Hydrostatic Pressure): N=32 for each test, with C=0 (meaning zero failures allowed). The sample size exceeds the reference standard requirements (N=32, C=3 for AAMI PB70 AQL of 4%/RQL of 20%). The provenance is a laboratory test of the Final Finished Device (both heat seal and TPU film).
Flammability: 5 replicates (Polyurethane Film). The provenance is a laboratory test of the material.
Tensile and Elongation: Sample size per statistical sampling plan ISO2859-1, based upon lot population quantity (Polyurethane Film). The provenance is a laboratory test of the material.
Linting: N=10 (Polyurethane film). The provenance is a laboratory test of the material.
Acoustic Output: 3 samples for Speed of Sound, 3 samples for Acoustic Attenuation, 3 samples for Acoustic Impedance (Final Finished Device). The provenance is a laboratory test of the device.
Compatibility with Coupling Gel: N=45 (Polyurethane Probe Cover Samples). Tested by the manufacturer of the coupling gel. This is a laboratory test.
Ethylene Oxide Residuals: N=15 X 3 consecutive sterilization batches = 45 samples (Polyurethane film). The provenance is a laboratory test on sterilized material.
In Vitro Cytotoxicity Test: N=4 test article extracts (Probe Cover polyurethane, EO Exposed). The provenance is a laboratory test.
Closed patch Sensitization Study in Guinea Pigs: Ten test Guinea pigs. The provenance is a biological study (animal study).
Intracutaneous Reactivity Test: Not explicitly stated, but implies multiple animals (rabbits) based on the "all animals survived" phrase. The provenance is a biological study (animal study).

The data provenance is from bench testing and biological studies (animal studies) performed as part of the device submission. There is no indication of country of origin of the data beyond being part of a US FDA submission, nor is there information on whether the studies were retrospective or prospective, though bench and animal studies are typically prospective.

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

This device is not an AI/ML device that requires human expert interpretation to establish a ground truth. The ground truth for this device is based on objective measurements against established industry standards and biological endpoints. Therefore, no human experts were used to establish a ground truth in the context of diagnostic interpretation.

4. Adjudication method for the test set:

Not applicable. This device does not involve human interpretation or subjective assessments that would require an adjudication method like 2+1 or 3+1. The tests are objective and quantitative.

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:

Not applicable. This is not an AI-assisted diagnostic device, so no MRMC study was performed.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

The ground truth used for the various tests includes:

Objective measurement against established standards: E.g., blotter weight gain for water resistance, burn time for flammability, tensile strength values for mechanical properties, IPM for linting, speed of sound and acoustic attenuation for acoustic performance, and residual limits for EO residuals.
Biological endpoints: For biocompatibility tests (cytotoxicity, sensitization, intracutaneous reactivity), the ground truth is based on the observed biological response (e.g., cell viability, skin reactions) against defined criteria.

8. The sample size for the training set:

Not applicable. This device does not involve an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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