ProSpore II is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1 ml glass ampule of growth media consisting of Tryptic Soy Broth and a pH indicator of phenol red. Also inside of the tube housing is a paper spore disc impregnated with a population of 105 Bacillus stearothermophilus spores (ATCC #7953).

AI/ML Overview

The provided text describes a self-contained biological indicator, ProSpore II, and its equivalence to a predicate device, ProofPlus, for monitoring 121°C steam sterilization cycles. However, the document does not contain a study that presents specific acceptance criteria and reported device performance in a format that can be extracted into the requested table.

Therefore, I cannot provide a direct answer to your request in the specified format. The document focuses on demonstrating substantial equivalence through descriptions of similarity in composition and function, and general statements about stability testing, rather than a detailed performance study with quantifiable acceptance criteria and results.

Here's a breakdown of what is and isn't available in the text:

Not Available in the Text:

A table of acceptance criteria and reported device performance: The document does not define specific quantitative acceptance criteria (e.g., "D-value must be X ± Y minutes") nor does it provide the exact reported performance values against such criteria. It states that "the stability of Resistance Characteristics, Spore Population, Media Recovery and overall effectiveness... has been demonstrated," but without specific numbers or benchmarks.
Sample size used for the test set and data provenance: No specific sample size for a "test set" (implying a performance evaluation against a gold standard) is mentioned. The testing described focuses on "Population Stability over an 18 month self-life" with "three separate lots of finished product ProSpore II ampules," but this isn't a performance test set in the traditional sense of evaluating efficacy against a specific outcome.
Number of experts used to establish ground truth and their qualifications: Not applicable, as the "ground truth" for a biological indicator is typically the documented D-value of the spore and its response to sterilization, not an expert consensus on interpreting an image or outcome.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this device does not involve human interpretation or reading in the same way as an imaging diagnostic device. Its output is a color change.
Standalone performance study (algorithm only): Not applicable, as this is a physical biological indicator, not a software algorithm.
Type of ground truth used: For stability testing, the ground truth would be the known resistance characteristics of the Bacillus stearothermophilus spores and their expected survival/kill rates under various sterilization conditions, measured through standard microbiological methods (e.g., spore enumeration, D-value determination). The document mentions "D-value stability."
Sample size for the training set: Not applicable, as this is a physical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

What is mentioned that is relevant, but not in the requested format:

Device name: ProSpore II® self-contained biological indicator
Intended Use: Determining the efficiency of a 121°C steam sterilization cycle.
Predicate Device: ProofPlus™ (AMSCO), K915275
Testing Information:
- Focus: Population Stability over an 18-month self-life.
- Included: D-value stability and Population stability.
- Lots tested: Three separate lots of finished product ProSpore II ampules.
- Additional testing: Recovery media tested for stability in recovering "low numbers" of "injured spores" over 18 months, and stability of color change when growth occurred.
- Outcome Summary: "For all lots tested, the stability of Resistance Characteristics, Spore Population, Media Recovery and overall effectiveness in monitoring routine steam sterilization cycles that has been demonstrated."

To answer your request, a different type of document, such as a detailed test report or a clinical study protocol, would be needed. This document serves to establish substantial equivalence for regulatory submission rather than providing specific performance metrics against defined acceptance criteria.

Summary

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AUG 1 6 1996

Image /page/0/Picture/1 description: The image shows a sequence of numbers and a letter. The sequence starts with the letter 'K', followed by the numbers '960790'. The numbers and letter are written in a bold, handwritten style, and they appear to be part of a code or identification number.

Summary of "ProSpore II Self-contained Biologic for steam sterilization at 121℃

Submitter:	Raven Biological Laboratories, Inc.
	5017 Leavenworth Street
	Omaha, Nebraska 68106
	(402) 556-6690
	(402) 556-4722 FAX
Contact:	Russ Nyberg
	Production Microbiologist
Prepared on:	29 May 1996
Device name:	ProSpore II® self-contained biological indicator
Classification:	Class II medical device, General hospital
Predicate Devices (legally marketed):	ProofPlus™ (AMSCO)
Predicate Device 510 (k) number	K915275

DESCRIPTION:

ProSporeII® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle. ProSpore II is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1 ml glass ampule of growth media consisting of Tryptic Soy Broth and a pH indicator of phenol red. Also inside of the tube housing is a paper spore disc impregnated with a population of 105 Bacillus stearothermophilus spores (ATCC #7953).

OPERATIONAL PRINCIPLES:

The plastic cap of the ProSpore II vial has short 'tines' along it's lower edge. When placed on the plastic tube body, the space between the tines allow for the passage of steam into the tube and thus reach the spore disc. A ProSpore II unit is placed inside of the sterilizer along with a load to be sterilized. If all parameters are met for the cycle (exposure time and temperature), the steam entering the ProSpore II capsule will be sufficient to deactivate or kill the spores on the paper disc. Once the cycle is finished, the ProSpore II vial is removed from the sterilizer and the cap is pressed down with ones thumb. This seals the vial. After allowing the unit to cool for 10 to 15

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minutes, the sides of the plastic tubes are squeezed which will result in crushing the glass of the media ampule. With this done, the spore disc is now in contact with the recovery media and the ProSpore II unit can be placed in an incubator and incubated at 55 to 60°C for a 7 day period of time. If the spores were killed in the sterilization cvcle, the recovery media will not change. If the cycle was 'failed cycle' and failed to kill the spores, the recovery media will change color from red to vellow indicating growth.

The change in color is the result of 'viable' spores germinating and consuming the nutrients provided in the growth media. This consumption process involves the release of nitrogen waste products which lower the pH of the media and increases the acidity which causes the color to change from red to vellow. Detection of failed steam sterilization cycles is facilitated by the use of ProSpore II. The outer label of the ProSpore II plastic tube body has a chemical indicator on the label which changes color when exposed to saturated steam ate 121ºC thus making it easy to distinguish processed from unprocessed vials.

STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE

ProSpore II is similar in composition and function to the 'Legally Marketed Predicate Device' ProofPlus.

both devices are intended for use in monitoring 'steam sterilization cycles at 121°C
both devices utilize a USP recommended strain of B. stearothermophilus bacterial spore as it's organism of choice for steam resistance characteristics.
both devices use a paper disc as the spore carrier.
- both devices utilize a plastic vial and cap to house the spore disc and media capsule.
- both devices contain a sealed recovery media ampule made of glass.
- both devices use a pH indicator in the recovery media which turns from red to yellow in color when growth is present.
both devices require that the recovery media ampule be activated after sterilization by breaking the glass ampule to release the media to come in contact with the spore disc.
both devices incorporate a 'chemical indicator' on the label which will change color when exposed to steam at 121°C so that exposed ampules or vials can be distinguished from unprocessed vials.

DESCRIPTION OF TESTING:

ﺴﻤﻌﺘﻌﻠﻬﺎ

ProSpore II has been tested for Population Stability over an 18 month self-life. This testing included both D-value stability and Population stability with three separate lots of finished product ProSpore II ampules. The recovery media has been tested to show stability in the recovery of "low numbers' of 'injured spores' over the 18 month shelf-life and the stability of the color change when growth occurred. For all lots tested, the stability of Resistance Characteristics, Spore Population, Media Recovery and overall effectiveness in monitoring routine steam sterilization cycles that has been demonstrated.

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CONCLUSION:

Raven's ProSpore II is substantially equivalent in composition and function to the legally marketed predicate device, AMSCO's ProofPlus, for monitoring steam sterilization cycles at 121°C, based on the testing results and analysis of 18 month self-life stability data.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).