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SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.

Compression Sleeves are inflatable cuffs designed to apply intermittent pressure to the foot, calf or thigh in order to increase venous return and prevent pooling of blood associated with the formation of Deep Vein Thrombosis (DVT). The devices consist of inflatable vinyl bladder(s) lined with an outer non-woven fabric; the bladder is connected to pneumatic tubing for connection with a compatible pump system that controls the sleeve's pressure cycle. Hook-and-loop fasteners sewn into the fabric are used to secure the sleeve to the foot or leg. Models are available in a range of dimensions in order to fit varying foot, calf and thigh circumferences. Reprocessed sleeves have identical technological characteristics as the predicate devices, i.e. device materials, dimensions, operating principle and system compatibility are unchanged during reprocessing. SureTek sleeves are provided as sterile, while the manufacturer product is provided non-sterile.

The SureTek Reprocessed Compression Sleeve is a medical device intended to increase venous return as a prophylaxis to Deep Vein Thrombosis (DVT) by applying intermittent pressure to the lower extremities. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a reprocessed compression sleeve, and as such, its performance criteria are primarily focused on demonstrating equivalence to new, unused devices and compliance with relevant reprocessing and sterility standards.

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

• Sample Size for Bench Testing: The document states "maximum number of use and reprocessing cycles." A specific number of devices or cycles is not provided in the summary.
• Data Provenance: The studies described (bench testing, cleaning validation, packaging, sterility, and biocompatibility testing) are all prospective tests performed on the reprocessed devices themselves. The country of origin of the data is not specified, but it can be inferred that the testing was conducted to meet US regulatory requirements.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of device (a reprocessed compression sleeve) does not typically involve human expert interpretation for "ground truth" establishment in the same way an AI diagnostic algorithm would. The listed studies are technical validations against established standards. Therefore, information about the number or qualifications of "experts" to establish a diagnostic ground truth is not applicable or provided. The "truth" is determined by measurements against engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable. The studies conducted are not based on expert adjudication of cases, but rather on direct measurements and validations against standards.

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

Not applicable. This device is a reprocessed medical device, not an AI-assisted diagnostic tool. Therefore, a MRMC comparative effectiveness study involving human readers improving with AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device (a reprocessed compression sleeve), not a standalone algorithm.

7. Type of Ground Truth Used

The ground truth used for proving acceptance was based on a combination of:

• Performance Standards: Comparisons to the performance characteristics of new, unused predicate devices.
• Validated Test Methods and Industry Standards: Compliance with international standards such as ISO 11607, EN868-1, ASTM F88-00, F2906-04, D4169-04a, F1980-02, ISO 11135, and ISO 10993.
• Worst-Case Scenario Validation: Specific validation of cleaning efficacy under "worst case operational conditions."

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. As this is not an AI algorithm, there is no training set or associated ground truth establishment process in that context.

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Suretek Reprocessed Laparoscopic Instruments are intended for use during general and laparoscopic surgery for cutting, grasping, dissection and electrocautery of tissue.

Not Found

This document is a 510(k) clearance letter from the FDA for SureTek Medical's reprocessed laparoscopic instruments. It does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of an AI/ML medical device.

The letter confirms that the devices are substantially equivalent to legally marketed predicate devices. This means that the FDA has determined the reprocessed devices are as safe and effective as existing ones, based on documentation submitted by SureTek Medical.

Therefore, I cannot extract the requested information as it is not present in the provided text.

The information provided is:

• Device Name: Suretek Reprocessed Laparoscopic Instruments
• Indications For Use: Intended for use during general and laparoscopic surgery for cutting, grasping, dissection, and electrocautery of tissue.
• Regulatory Clearance: 510(k) K052690, cleared on May 12, 2006, with supplemental validation data reviewed on October 16, 2006.
• Predicate Devices: The enclosure (not fully provided here, but the list of specific devices like "AUTOSUTURE ENDO DISSECT 5mm" are implicitly the reprocessed versions that were found substantially equivalent to original devices).

This document is focused on regulatory clearance based on substantial equivalence, not a performance study against specific acceptance criteria in the way a new medical device would be evaluated for its efficacy or AI/ML algorithm's performance.

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SureTek Reprocessed Electrosurgical Electrodes are intended for use during general, arthroscopic and endoscopic surgery for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels.

Devices are monopolar and bipolar electrosurgical electrodes designed for ablation, resection and coagulation of soft tissue. Instruments consist of one or more distal electrodes, an insulated shaft, and a proximal handle with electrical connections to a compatible electrosurgical unit. Monopolar instruments require concurrent use of a compatible return electrode. Models have varying electrode configurations and tip angles. Some models are equipped with suction tubing for continuous cooling of the ablation site and aspiration of fluids/debris during use. Reprocessed electrodes have equivalent technological characteristics as the predicate devices, i.e. device design, dimensions, energy delivery and system compatibility are unchanged during reprocessing. Device materials are identical with the exception of shaft insulation, which may be replaced with a comparable heat shrink material.

The SureTek Medical 510(k) summary provided does not contain the specific type of acceptance criteria and associated study details that would typically be found for a medical imaging AI device. Instead, this document describes the reprocessed electrosurgical electrodes and focuses on demonstrating substantial equivalence to predicate devices for safety and performance in a manufacturing context.

Therefore, I cannot extract the information required concerning an AI device study. The provided text outlines:

1. Acceptance Criteria & Device Performance: The document states that "Simulated-use testing of instruments following maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices." This is a broad statement regarding functional equivalence but lacks specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would be expected for an AI device. The other listed testing (insulation, cleaning, packaging, sterility, biocompatibility) are related to manufacturing and safety standards, not AI performance.

2. Sample Size, Data Provenance: Not applicable in this context as no AI study is described. The "sample" here refers to reprocessed medical devices, not patient data.

3. Number of Experts, Qualifications: Not applicable.

4. Adjudication Method: Not applicable.

5. MRMC Comparative Effectiveness Study: Not applicable.

6. Standalone Performance: The closest analogous information is the "Simulated-use testing" which compares the reprocessed devices directly to new, unused devices. This is a standalone comparison for the physical device's function.

7. Type of Ground Truth: For the reprocessed electrosurgical electrodes, the "ground truth" seems to be the performance of new, unused devices as the benchmark for "substantial equivalence."

8. Sample Size for Training Set: Not applicable, as this is not an AI model.

9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided SureTek Medical 510(k) summary is for reprocessed electrosurgical electrodes and details performance testing related to manufacturing, safety, and functional equivalence to predicate devices, rather than an AI device's clinical performance study.

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SureTek Reprocessed Arthroscopic Blades and Burs are intended for use during arthroscopic and endoscopic procedures for cutting and resection of soft tissue, cartilage and bone. Endoscopic sinus surgery is limited to small diameter instruments (2 to 3.5mm).

Arthroscopic Shavers and Burs are powered instruments designed for cutting of soft tissue, cartilage and bone during arthroscopic/endoscopic surgeries. The stainless steel instrument consist of a hollow shaft with a distal blade or bur that rotates within an open-ended cannula with outer diameters ranging from 2 to 6 mm. Devices are designed for use only with compatible driver systems with continuous irrigation and aspiration of fluids through the inner shaft during use. Depending upon the aggressiveness required for cutting, shavers are designed with different serrated and non-serrated blades and angles, and burs have varying shapes (round, barrel, tapered) and number flutes (4 to 12). Reprocessed blades and burs have identical technological characteristics as the predicate devices, i.e. device component materials, dimensions and system compatibility are unchanged during reprocessing.

The SureTek Reprocessed Arthroscopic Shavers and Burs received 510(k) clearance based on substantial equivalence to predicate devices, without specific acceptance criteria or a dedicated study explicitly detailing device performance against such criteria in the provided summary. The information focuses on a comparison to new, unused devices through bench testing and compliance with various ISO and ASTM standards.

Here's an analysis of the provided information based on your requested categories:

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

The submission does not specify numerical acceptance criteria for performance metrics (like cutting efficiency, blade sharpness, or bur abrasion rate) or reporting device performance against specific targets. Instead, it states that "bench testing of devices following the maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the bench testing beyond "devices." It also doesn't specify the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided. The study appears to be a bench test comparison against new devices, rather than a clinical study requiring expert assessment for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the study described is bench testing and does not involve human adjudication of results in a clinical context.

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

This is not applicable. The device is a reprocessed arthroscopic shaver/bur, not an AI-assisted diagnostic or therapeutic tool that would involve human readers.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance evaluation, the "ground truth" was implicitly established by the performance characteristics of new, unused devices. For cleaning validation, the "ground truth" would be the absence of viable microorganisms and contaminants as per established standards and methods. For biocompatibility, it would be the absence of adverse biological responses as defined by ISO 10993.

8. The sample size for the training set

This is not applicable. The device is a reprocessed physical instrument and does not involve machine learning or a training set.

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

This is not applicable. There is no training set for this type of device.

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