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The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.

The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viralbacterial filter protecting the patient from the internal components of the device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician's computer via the STS software/App.

The provided text is a 510(k) summary for the STS device, a pulmonary function data calculator. While it mentions a clinical study, the details provided are limited and do not fully address all requested points regarding acceptance criteria and study specifics for proving the device meets those criteria.

Based on the provided document, here's what can be extracted and what remains unknown:

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria values for performance. However, an implicit acceptance criterion is a "high correlation" and specific statistical thresholds mentioned in the clinical study summary.

2. Sample size used for the test set and the data provenance:

• Sample Size: 161 subjects (61 females, 100 males, implicitly). This test set was used for the clinical study comparing STS to Body Plethysmography.
• Data Provenance: Not explicitly stated (e.g., country of origin). It is a prospective study as subjects were "enrolled" and "tested by both STS and BP," suggesting data was collected specifically for this study.

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

• The document states that Body Plethysmography (BP) is considered the "gold standard" for measuring lung volumes. Therefore, the BP measurements served as the ground truth.
• It does not specify the number of experts or their qualifications involved in performing or interpreting the Body Plethysmography tests. It's implied that standard clinical practice for BP was followed, which would involve trained medical professionals, but this is not detailed.

4. Adjudication method for the test set:

• No information on adjudication methods is provided. The comparison is directly between the STS device measurements and the "gold standard" Body Plethysmography measurements.

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:

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported. This device is a pulmonary function data calculator and not an AI-assisted diagnostic imaging tool where human reader performance with and without AI assistance would typically be evaluated. The study focuses on the device's accuracy in measuring physiological parameters when compared to a gold standard.

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

• The clinical study described evaluates the "performance of STS technique in calculating resistance and compliance parameters" by comparing it with Body Plethysmography.
• The STS device itself is a "pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters." This implies a standalone performance evaluation of the device's measurements against the gold standard. However, the device "is to be used by either a physician, respiratory therapist, or technician" and its results are "displayed on the physician's computer via the STS software/App," indicating there's a human-in-the-loop for operation and interpretation. The study evaluates the measurement accuracy, which can be seen as a form of standalone performance for the measurement part of the device.

7. The type of ground truth used:

• The ground truth used was "gold standard" Body Plethysmography (BP) measurements of lung volumes. While BP is a clinical measurement, it serves as the established reference standard in this context.

8. The sample size for the training set:

• The document does not provide any information about the sample size used for the training set. This is a 510(k) submission, and often, proprietary training data details are not included in the public summary.

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

• The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.

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The Ortho-Pro STS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:

• Severely pronated foot
• Walking intemperance
• Calcaneal stance position greater than 5°
• Manually correctable deformities
• Mid-tarsal breech (arch pain)
• Forefoot varus greater than 10°

The Ortho-Pro STS Screw consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. External rounded threads increase ease of insertion. This device is manufactured from Ti-6A1-4V alloy and is available in six sizes, 06.5mm to Ø11.5mm in 1mm increments.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

The document is a 510(k) summary for the Ortho-Pro STS Screw, a bone screw. It describes the device, its intended use, and its technological characteristics compared to a predicate device. It also includes the FDA's clearance letter for the device.

Therefore, I cannot provide the requested table and information as it is not present in the given input.

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The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.

The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744). The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. The size and shape of these chambers are similar to the predicate device, as is the method of fitting to the patient's limb. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere. On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves. The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.

The provided text describes a 510(k) premarket notification for STS Compression Sleeves, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as would be found for an AI/ML-based device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets is not applicable in this context. The document describes a non-clinical equivalence testing rather than a clinical study or a study validating an AI/ML algorithm.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly defined with quantitative acceptance criteria and performance statistics as would be for an AI/ML device.

The determination of substantial equivalence for this device is based on non-clinical, inflation performance testing. The acceptance criterion implicitly is that the Huntleigh STS compression sleeves demonstrate similar inflation performance (pressure/time cycle) to the predicate device.

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

• Sample Size: Not specified quantitatively. The text states "The sleeves are tested by fitting to a subject's limbs," implying at least one subject, but no specific number is given.
• Data Provenance: The testing appears to be internal to Huntleigh Healthcare, Inc. The country of origin of the data is not specified, but the company is based in the USA (New Jersey). The testing is prospective for the purpose of this 510(k) submission, as it was performed to support the new device.

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

Not applicable. There is no "ground truth" in the sense of expert medical diagnosis or labeling for this type of device. The assessment is based on physical performance comparisons to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described for this non-clinical performance test. The comparison is objective (inflation metrics) against a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device, nor a diagnostic device that would typically involve human readers. Therefore, an MRMC study is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (compression sleeves), not an algorithm or AI/ML product.

7. The Type of Ground Truth Used

Predicate Device Performance Data. The "ground truth" (or more accurately, the comparator) for determining equivalence is the established performance characteristics (inflation pressure/time cycles) of the legally marketed predicate device, the Kendall SCD Therapeutic System (K890938).

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable. There is no training set for this device.

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