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This document is a 510(k) summary for the Single Lumen Embolectomy Catheter, submitted by American BioMed, Inc. in 1997. The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. It does not typically involve detailed studies proving that the device meets specific numerical "acceptance criteria" in the way one might see for digital health or AI/ML devices today.

Based on the provided text, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as defined in your request (with performance metrics, ground truth, expert opinions, etc.) is not present in this 1997 medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and intended use, rather than presenting a performance study with quantitative acceptance criteria against a defined ground truth.

Therefore, many of the requested details are not applicable or cannot be extracted from this type of regulatory submission from this era.

Here's an attempt to address your request based on the available information, noting where information is not present:

Acceptance Criteria and Device Performance for American BioMed's Single Lumen Embolectomy Catheter (K972572)

This 510(k) summary (K972572) for the Single Lumen Embolectomy Catheter does not present explicit, quantitative acceptance criteria or detailed performance study results in the manner requested (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly considered to be comparable to the predicate devices if the technological characteristics and intended use are similar, and safety is maintained.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria (e.g., "must achieve X% accuracy") are not stated, and no performance study with such metrics is reported, this section cannot be directly filled as requested. The "performance" is inferred from the comparison to predicate devices, focusing on design features and intended use.

Acceptance Criteria Category	Specific Criteria (Expected)	Reported Device Performance (Achieved)
Substantial Equivalence	Device is as safe and effective as predicate devices.	Conclusion: The modified American BioMed Single Lumen Embolectomy Catheters are equivalent in safety and efficacy to their predicate device (K881455, K905139, and Baxter Fogarty Arterial Embolectomy Catheter).
Material Compatibility	Materials used are safe and suitable for medical use.	Body Material: Silicone Compound. Balloon Material: Silicone Compound. (Implied to be safe as per predicate comparison.)
Functional Equivalence	Catheter dimensions and balloon inflation characteristics are comparable to predicate devices.	Catheter French Sizes: 2, 3, 4, 5, 6, and 7 (matches predicates). Catheter Length: 40, 60, 80, 100 cm (matches predicates). Inflated Balloon Diameter: Matches predicates for equivalent French sizes. Max Liquid Volume: Generally matches or is comparable to predicate K881455 & K905139. Differences from Baxter predicate are noted but not presented as affecting substantial equivalence.
Intended Use	Same intended use as predicate devices.	Intended Use: "Removing arterial emboli" (Same as predicates).
Design Modifications Effect	Modifications (number of balloons) do not negatively impact safety or efficacy, and potentially enhance safety (proximal safety balloon).	Changes from K881455 & K905139: three balloons (two at distal, one at proximal for safety) vs. one at distal. This modification is presented as maintaining or improving safety/efficacy.

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

This submission does not describe a clinical "test set" in the context of performance evaluation as it would be understood for, say, an AI/ML algorithm. The comparison is based on the technical specifications and intended use of the device against its named predicate devices. There is no mention of a patient-based test set or data provenance (country, retrospective/prospective).

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

Not applicable. This submission relies on a comparison of device specifications and intended use to predicate devices, not on expert consensus or adjudication of results from a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

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

Not applicable. This document is for a physical medical device (catheter) and does not involve human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is the established safety and efficacy of the predicate devices. The new device is deemed "substantially equivalent" if it can be shown to be as safe and effective as these predicates, typically through comparative analysis of design, materials, and intended use. There is no mention of pathology, outcomes data, or expert consensus on a test set for this specific submission.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of device development described in this submission.

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

Not applicable. As there is no training set, this information is not provided.

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