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natural latex prophylactics to be sold and used solely as ultrasound probe covers. These probe covers are identical to those formerly (prior to August 1992) manufactured by Carter-Wallace, Inc. for CIVCO Medical Instruments Co., Inc.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device: "Kiltex ultrasound probe covers." It's important to note that this is a very old document (1996) and it pertains to an ultrasound probe cover, which is a far simpler device than what typically requires complex AI-driven performance studies today. Therefore, many of the requested categories related to AI performance, ground truth, and human-in-the-loop studies are not applicable to this device or its regulatory submission.

The core of this submission is demonstrating equivalence to a predicate device (natural latex condoms) and adherence to an existing standard for those predicate devices (ASTM D-3492).

Here's an attempt to fill in the requested information, understanding that many fields will be "Not Applicable" (N/A) given the nature of the device and the age of the document.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a non-AI device aiming for equivalence to a predicate, the "acceptance criteria" are effectively the standards met by the predicate device (latex condoms). The document states the Kiltex ultrasound probe covers "have been manufactured to meet the standards for latex condoms as set forth in ASTM D-3492."

There are no specific "performance metrics" for the probe cover's diagnostic ability as it is not a diagnostic device itself. Its performance relates to its physical integrity and barrier properties, which are covered by the ASTM standard.

Acceptance Criteria Category (Derived from ASTM D-3492 for latex condoms)	Reported Device Performance (Kiltex Probe Covers)	Notes
Physical Dimensions (e.g., length, width, thickness)	Manufactured to meet ASTM D-3492 standards	Specific values not provided in this summary, but are defined in ASTM D-3492.
Freedom from Holes and Defects (e.g., water leakage test)	Manufactured to meet ASTM D-3492 standards	This is a critical quality control for barrier devices.
Tensile Properties (e.g., tensile strength, elongation at break)	Manufactured to meet ASTM D-3492 standards	Ensures the material can withstand stretching without breaking.
Burst Properties (e.g., burst pressure, burst volume)	Manufactured to meet ASTM D-3492 standards	Relevant for devices exposed to internal pressure changes or stretching.
Packaging and Labeling Requirements	Implied to meet regulatory requirements for such devices	Not explicitly stated but expected for market release.
Biocompatibility	Implied (latex material)	Not explicitly stated as a test, but use of natural latex implies well-understood biocompatibility profile.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in this summary. The ASTM D-3492 standard would define sampling plans for lot release testing. The document only states the covers "have been manufactured to meet the standards."
- Data Provenance: Not specified. This would typically be internal manufacturing quality control data for the Kiltex Corporation. Given the nature of the device, it's about manufacturing conformity, not clinical data provenance.
- Retrospective or Prospective: N/A for this type of device and submission. This pertains to manufacturing adherence to a standard, not a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: N/A. Ground truth in this context is adherence to the physical and performance specifications outlined in ASTM D-3492, which are verified through objective testing (e.g., dimension measurements, water leak tests, tensile strength tests) by quality control personnel, not expert interpretation.
- Qualifications of Experts: N/A. Quality control technicians/engineers would perform the tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: N/A. This term typically refers to resolving discrepancies in expert interpretations in clinical studies. For manufacturing quality control, it's about meeting objective thresholds.
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:
- MRMC Study: No. This is a non-AI device.
- Effect Size: N/A.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a non-AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: "Ground truth" here is objective measurement against specified physical and performance limits defined by the ASTM D-3492 standard for latex condoms. This includes direct measurements of dimensions, results from standardized mechanical tests (e.g., tensile, burst), and absence of leaks.
The sample size for the training set:
- Sample Size for Training Set: N/A. There is no AI model to train.
How the ground truth for the training set was established:
- Ground Truth for Training Set: N/A. There is no AI model to train.

Summary of the K961029 Submission:

This 510(k) submission for Kiltex ultrasound probe covers relies on demonstrating substantial equivalence to legally marketed predicate devices (natural latex prophylactics/condoms without a reservoir end) and adherence to a recognized standard (ASTM D-3492) established for those predicate devices. The "study" referenced is the continuous manufacturing of these probe covers "to meet the standards" of ASTM D-3492, implying ongoing quality control and testing against these established norms. The document highlights the manufacturing history and the identity of the product to those previously marketed, signaling consistency and equivalence.

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