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The X-ray Attenuating Cream has the same intended use, and indications for use as before, with the addition of indications for use with poly-isoprene surgeon's gloves as below:

The X-ray Attenuating Cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The X-ray Attenuating Cream is intended to be used during medical procedures where hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures.

NOTE: For use with natural rubber latex and latex-free poly-isoprene Surgeon's Gloves only.

The X-ray Attenuation Cream is a sterile cream intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The X-ray Attenuation Cream is intended for use during medical procedures in which hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 KVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. The X-ray Attenuation Cream is not intended to be used in the primary beam or the transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary x-ray beam.

Acceptance Criteria and Study for X-ray Attenuating Cream (K133684)

This submission (K133684) is a 510(k) for an X-ray Attenuating Cream (Ultrablox) seeking to expand its indications for use to include compatibility with latex-free poly-isoprene surgeon's gloves, in addition to its previously cleared use with natural rubber latex surgical gloves. The original device was cleared under De Novo 510(k) K123422.

Given that this 510(k) is for an expansion of use for an already cleared device, and the primary change is compatibility with a different type of glove, the performance testing focuses on demonstrating this compatibility. The document explicitly states: "The performance data presented in this 510(k) application demonstrate the X-ray Attenuating Cream can be used with latex-free poly-isoprene surgeon's gloves in addition to the previously cleared use with natural rubber latex surgeon's gloves."

Therefore, the acceptance criteria and study design are centered around confirming that this new compatibility does not negatively impact the device's function or safety, implicitly relying on the original clearance (K123422) for the core performance aspects (radiation attenuation and biocompatibility).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table for this 510(k) submission (K133684). This is because the device itself (its composition, radiation attenuation, and biocompatibility) has not changed from the predicate device (K123422). The "performance testing" described is to demonstrate compatibility with a new glove material.

However, based on the principle of substantial equivalence for this type of submission, the implicit acceptance criteria and reported performance are:

2. Sample Size Used for the Test Set and Data Provenance

The document for K133684 does not specify a separate "test set" with a sample size in the conventional sense (e.g., patient data, image dataset). The "performance testing" referenced appears to be focused on material compatibility testing rather than a clinical study. The details of the "performance data" are not provided in this summary but are stated to demonstrate compatibility.

Therefore, based on the provided document:

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. It is likely laboratory-based material compatibility testing rather than clinical data from a specific country.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of information is not applicable to this 510(k) submission. The "performance testing" detailed in this summary relates to material compatibility, not the assessment of imaging data or clinical outcomes that would require ground truth established by experts like radiologists or pathologists.

4. Adjudication Method for the Test Set

This information is not applicable to this 510(k) submission, as it does not involve assessment of imaging data or clinical scenarios requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This type of study would be relevant for evaluating the performance of an AI algorithm in an imaging context, which is not the subject of this medical device submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not done. This submission is for an X-ray attenuating cream, not a digital algorithm or AI-powered device.

7. Type of Ground Truth Used

This information is not applicable to this 510(k) submission. The "ground truth" for material compatibility would typically be based on established material science standards, physical testing, or chemical analysis, not expert consensus, pathology, or outcomes data in a clinical sense. The document implies that the "performance data" collected confirmed the physical and chemical compatibility of the cream with poly-isoprene gloves.

8. Sample Size for the Training Set

This information is not applicable to this 510(k) submission. There is no AI or machine learning component requiring a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable to this 510(k) submission, as there is no training set.

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The X-ray Attenuating Cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The X-ray Attenuating Cream is intended to be used during medical procedures where hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. X-ray Attenuating cream is not intended to be used in or adjacent to the primary x-ray beam or the transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary x-ray beam.

The subject device is an X-ray attenuating cream that utilizes bismuth oxide powder as the X-ray absorber material. The subject device is provided sterile in a tube for single use. The end user is to squeeze all of the cream out, either directly to the health care professional's hands or onto a surgical glove before donning a second glove. The device provides protection from X-rays and scatter radiation during procedures where the health care professional's hands are necessarily exposed to radiation.

The provided text describes the BloXR X-ray Attenuating Cream, its intended use, and the regulatory decision for its classification. However, the document does not contain the specific details about a study comprehensively proving the device meets acceptance criteria in the manner requested (i.e., comparing algorithmic performance to ground truth or human readers).

The document focuses on:

• Regulatory classification of the device (Class II, Product Code PDK).
• Indications for Use and Limitations.
• Device Description and Principle of Operation.
• Summary of Nonclinical/Bench Studies: These address biocompatibility, shelf-life/sterility, and performance testing related to X-ray attenuation.
• Labeling requirements and content: This includes information about % attenuation at different kVp levels.
• Identified Risks and Required Mitigation Measures: This details potential adverse tissue reactions, infection risk, and radiation exposure due to various factors, along with mitigation strategies.
• Special Controls: These outline the required testing (biocompatibility, sterilization, performance testing for glove compatibility, attenuation, and application) and labeling statements.
• Benefit/Risk Determination.

The key information requested regarding acceptance criteria and performance data in a structured study for an AI/ML medical device (e.g., sample sizes, data provenance, expert ground truth, MRMC studies, standalone performance) is not present in this document because the BloXR X-ray Attenuating Cream is a physical product (a cream), not an AI/ML algorithm or system.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML study design.

However, I can extract the acceptance criteria related to radiation attenuation and the reported performance from the labeling section as provided in the document.

1. Table of Acceptance Criteria (as per labeling) and Reported Device Performance (as presented in the document):

Note: The document explicitly states: "The labeling includes the table shown below of the % attenuation the end user can expect the device will provide if applied correctly." This implies these values from the "Performance Testing – Bench" section (of which the specific data is redacted, but summarized in the labeling) are the reported performance confirming the device meets what it claims to achieve.

Regarding the other requested information, as explained above, it is not applicable or not present in this document as it pertains to AI/ML device studies:

2. Sample size used for the test set and the data provenance: Not applicable for a physical cream; no "test set" in the context of an AI/ML algorithm. The performance data is from "Nonclinical/Bench Studies." The specific number of tests or samples for these bench studies is redacted (indicated by (b)(4)).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for radiation attenuation is based on physical measurement, not expert consensus.
4. Adjudication method for the test set: Not applicable.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: For attenuation, the ground truth is likely established through standardized physical measurements in a laboratory setting. For biocompatibility, it's toxicology/biological response data.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Evidence of Meeting Acceptance Criteria: The document explicitly states, "The labeling includes the table shown below of the % attenuation the end user can expect the device will provide if applied correctly." The percentages in this table match the "Manufacturer performance claims" (though the full table from the manufacturer is redacted). This indicates that the device's measured performance in bench testing aligned with the stated attenuation percentages provided to the user in the labeling, which serve as the practical acceptance criteria for its core function.
• Study Type: Nonclinical/Bench Studies (physical performance testing, biocompatibility, shelf-life, sterility).
• Ground Truth: For radiation attenuation, this would be objective physical measurements of X-ray transmission through the cream under controlled conditions. For biocompatibility, it's standardized biological assays (Cytotoxicity, Sensitization, Skin Irritation, Acute Systemic Toxicity).
• Limitations: This document is a regulatory decision summary and, by its nature, may redact specific proprietary information like detailed test reports, raw data, or exact sample sizes, indicated by "(b)(4)".

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