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Used for more accurate placement of pneumothorax decompression devices than the current standard of care auditory assessments. The Pneumothorax Decompression Indicator is a colorimetric capnography device indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with suspected tension physiology.

The Pneumeric Capnospot Pneumothorax Decompression Indicator is a capnography device that provides objective, real-time feedback during decompressive thoracostomy. Specifically, the device detects the presence of carbon dioxide in the gas from the decompressed pneumothorax, permitting more accurate placement of the needle or thoracostomy device compared to the current standard of care based upon auditory assessments.

The Pneumeric Capnospot is a therapeutic device intended to guide the placement of pneumothorax decompression needles and thoracostomy devices.

The product consists of a cylindrical polycarbonate tube containing a carbon dioxide detecting paper. The device has a male luer connector on the distal end of the device to connect to decompression needles and thoracostomy devices, a diaphragm to prevent backflow of gases, a color changing indicator and a female luer on the proximal end of the device that can be used to connect accessories.

The product is shipped non-sterile and labeled for single use only.

The provided text describes a medical device called the "CapnoSpot™ Pneumothorax Decompression Indicator" and its 510(k) submission to the FDA. However, the document does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy, particularly concerning an AI-driven component or human reader assistance.

The document discusses "Performance Data" in section 6.5, but this section focuses on design verification and shelf-life tests (visual inspection, dimensionals, backflow, cracking pressure, torque, luer leakage, animal data) to ensure the device meets specifications, rather than clinical performance metrics in humans or AI-driven acceptance criteria.

The 510(k) submission for this device is based on substantial equivalence to a predicate device (Turkel Pneumothorax Kit K923028), rather than demonstrating clinical efficacy or AI performance through a comparative study.

Therefore, based on the provided text, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them in the context of sensitivity, specificity, accuracy, or human reader improvement with AI. The document does not provide details on:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy.
2. Sample size used for a test set, its provenance, or how ground truth was established for such a test set.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Whether an MRMC comparative effectiveness study was done or its effect size.
6. Whether a standalone AI performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for diagnostic performance.
8. Training set sample size or how its ground truth was established.

The "Performance Data" refers to engineering and durability tests, and an "Animal Data" point is mentioned, but no details of a study with acceptance criteria for a diagnostic/AI performance are present.

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Mini-Lap Technologies RaviNeedle Aspiration Needle is indicated for use in endoscopic and open surgical procedures where it is appropriate to aspirate fluids and retain tissue during aspiration of fluids.

The RaviNeedle Aspiration Instrument is stainless steel needle approximately 12 inches in overall length. The proximal end of the device is fitted with a luer adapter which is fitted to a standard syringe (not supplied with the device). Using the standard syringe, the device is used to aspirate small volumes of fluid during either open or laparoscopic procedures. The device has a chisel-point tip to allow for percutaneous application. To maintain the position of the needle tip during multiple aspirations, the distal end of the needle is equipped with expandable wire cage/balloon which secures the needle to small structures being aspirated (e.g., the gallbladder). Use of the security feature is optional on the part of the user.

The provided text describes the K102274 510(k) submission for the RaviNeedle™ Aspiration Instrument. However, it does not contain a detailed study report with specific acceptance criteria, numerical performance data against those criteria, or a description of the methodology for establishing ground truth, sample sizes, or expert qualifications as typically found in a clinical study report.

The document states: "Testing showed the device meets all design criteria as well as the requirements of surgical users." and "In-vitro and in-vivo testing demonstrates that the device will perform as stated in the indications for use."

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided text):

• Specific quantitative acceptance criteria (e.g., "Flow rate must be > X mL/min").
• Specific quantitative performance results (e.g., "Achieved flow rate of Y mL/min").
• Details on how "requirements of surgical users" were quantified and assessed.

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

• Sample Size: Not specified. The document mentions "bench top or in-vivo testing" but does not give the number of samples, cases, or subjects used for any of the listed tests.
• Data Provenance: Not specified (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:

• Number of Experts: Not specified. The document mentions "requirements of surgical users" but does not detail the involvement of experts in establishing ground truth or evaluating performance.
• Qualifications of Experts: Not specified.

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

• Not specified.

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 device is a manual aspiration instrument, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

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

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

• The term "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. The performance data is based on "bench top or in-vivo testing" against "design criteria" and "requirements of surgical users." These would likely involve objective measurements for mechanical, flow, and leak tests, and potentially subjective assessments by surgical users for aspects like visualization and tissue interaction. However, the specific methodology for establishing these "ground truths" (i.e., the ideal or correct performance benchmark) is not detailed.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable.

Summary of Device and Study Type:

The K102274 submission is for a physical medical device, the RaviNeedle™ Aspiration Instrument. The performance data provided are for engineering and biocompatibility tests (benchtop and in-vivo testing) to demonstrate the device meets design specifications and user requirements. This is typical for a 510(k) submission for a Class I device and does not involve the kind of clinical study or AI performance evaluation details (like ground truth establishment, expert adjudication, or MRMC studies) that would be relevant for diagnostic software or AI-enabled devices. The level of detail you are asking for regarding "acceptance criteria" and "study" is generally not present in a 510(k) summary for this type of device, which focuses on substantial equivalence to a predicate.

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The GL Cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of sodium, potassium, glucose, and chloride in human whole blood. The GL Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.

The electrolyte measurements (Nat, K*, Cl ) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states, which use these measurements for diagnosis, are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.

The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.

The IRMA® SL Blood Analysis System GL Cartridge is for use with the IRMA Blood Analysis System. The GL cartidge is a single use, disposable carridge, for the in vitro measurement of any of the may on the may GL cartidge comprises the analytes sodium, potassium (K945240), chloride (K981270) and glucose. Oiz currently markets cartridges with sodium, potassium, (K945240) and chloride.

Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The glucose sensor uses an amperometric electrode along with a reference electrode that measures the glucose oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.

Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If abliotinal continuent a conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

The provided text describes the acceptance criteria and performance of the IRMA® SL Blood Analysis System GL Cartridge, specifically focusing on its glucose measurement capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for accuracy, precision, or linearity with numerical targets. Instead, it presents the performance data of the IRMA® device and claims substantial equivalence to the predicate device, the YSI Model 2300 Stat Plus. The implied acceptance is that the performance is comparable or within an acceptable range for clinical use, particularly when compared to a legally marketed predicate device.

Based on the "Summary of Performance Data" section:

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

• Accuracy (Glucose):

  • Sample Size: n = 37
  • Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). However, it's generally understood that such studies for medical devices are conducted on human samples, likely from clinical settings, and are typically prospective for regulatory submissions.

• Precision (Glucose):

  • Level 1: n = 59
  • Level 2: n = 58
  • Level 3: n = 60
  • Level 4: n = 59
  • Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). These types of studies often use control materials or pooled patient samples to evaluate reproducibility.

• Linearity (Glucose):

  • Sample Size: n = 20
  • Data Provenance: Not explicitly stated. Linearity studies typically involve prepared samples with known, varying concentrations.

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

This type of information (number of experts, qualifications) is not relevant for in vitro diagnostic devices like the IRMA® SL Blood Analysis System GL Cartridge. The "ground truth" for glucose measurement is established by reference methods or a predicate device, which are assumed to be accurate based on established analytical principles and prior validation. The study compares the IRMA® device's measurements to another measurement device (likely the predicate or a laboratory reference method), not to expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is for an in vitro diagnostic device measuring an analyte, not for subjective interpretation by experts. Ground truth is established by quantitative measurement, not expert consensus.

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 device is an automated blood analysis system, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study and AI assistance effect size are not relevant.

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

Yes, the performance data presented (accuracy, precision, linearity) reflects the standalone performance of the IRMA® SL Blood Analysis System GL Cartridge for glucose measurement. It is an automated system designed for direct measurement.

7. The Type of Ground Truth Used

The ground truth for the glucose measurements in the performance study would have been established by a reference method or a legally marketed predicate device (YSI Model 2300 Stat Plus, mentioned as the predicate in the substantial equivalence claim). This means the measurements from the IRMA® device were compared against measurements from a highly accurate and validated method or device.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" for the glucose measurement. In the context of this type of in vitro diagnostic device, the "training" for the device's internal algorithms and calibration parameters happens internally at the factory and during the initial calibration process described (using factory-derived parameters combined with measurements during daily calibration). There isn't typically a large external "training set" of patient data in the same way an AI/ML algorithm might have for image classification.

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

Given the explanation in point 8, the concept of "ground truth for the training set" as it applies to AI/ML is not directly applicable here. However, the accuracy of the device's measurements (and thus its "training" or calibration parameters) relies on the use of calibrants and control materials with known, highly accurate concentrations, which themselves are verified against reference methods. The device states: "The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry." This suggests the "ground truth" for its internal calibration is established through a combination of factory-set parameters and on-board calibration using precise, standardized solutions.

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The PercuTx - Injection /Aspiration Needle device is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures.

As with currently marketed endoscopic injection needles, the PercuTx Endoscopic Injection needle device may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic, and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic.

PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece

It appears the provided document is a 510(k) clearance letter from the FDA for a medical device called "PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece". This type of document does not typically include detailed information about acceptance criteria, study designs, or performance metrics in the way a clinical study report or a premarket approval (PMA) application would.

510(k) clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily on new clinical performance data that would involve detailed acceptance criteria and studies as requested in the prompt. While some 510(k) submissions might include performance testing, the provided letter itself does not contain that information.

Therefore, I cannot provide the requested information based on the given text. The text only states that the device is "substantially equivalent" to predicate devices and provides its intended use.

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The Injection/ Aspiration probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic and open surgical procedures designed for injection and aspiration of fluids and solutions in the tissue or body. This device is not intended for injection of drugs.

Injection/Aspiration Needles Probes/Devices

The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for "Injection/Aspiration Needle Probes/Devices." It states that the devices are substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance, sample sizes used for testing, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth used, or training set details.

Therefore, I cannot extract the requested information from the provided text. The document's purpose is to grant market clearance based on substantial equivalence, not to detail the performance study results.

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The Manan™ Accura needle is intended for use as a needle localization of breast lesions.

This needle is made in various gauges from 20 to 21 ga, and in various lengths from 3 to 15 cm. It is composed of an outer cannula essentially identical to the standard hypodermic needle and an inner stylet spring wire with an overbent tip.

The provided document is a 510(k) summary for the Manan™ Accura Needle, a spring hook localization needle. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about studies related to device performance or acceptance criteria in the context of a diagnostic AI device.

Therefore, I cannot provide the requested information, such as acceptance criteria, reported device performance, details of a study with sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size. This document describes a physical medical device (a needle) and not an AI or diagnostic software.

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The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill is indicated for use for biopsy of bone lesions.

The Bonopty Coaxial Bone Biopsy System with Eccentric Drill consists of a cannula with a sharp cutting edge and a drill bit (drill) that fits into the cannula. When the biopsy system is assembled, the tip of the drill protrudes beyond the cutting edge of the cannula. The distal tip of the drill has two cutters which do not align with the center line of the drill, as would a conventional drill. During drilling, the eccentric drill tip functions like a guide and forces the drill to wobble in the hole, with the drill tip as a center of rotation. Therefore, the hole created is larger than the outer diameter of the cannula of the needle assembly thus making it easy to advance the cannula over the drill until the cannula is anchored in the bone. Then the drill can be removed and the cannula left in the bone, mounted as a fixed guiding path to facilitate sampling with different biopsy needles or to allow further treatment, without the need to obtain localizing CT scans for each biopsy.

The Bonopty Coaxial Bone Biopsy System with Eccentric Drill consists of a Penetration Set, a Biopsy Set and an optional Extended Drill.

The Penetration Set consists of one Penetration Cannula with stylet (OD 14G, ID 15G, Length 95mm), one Drill (OD 15G, Length 122mm), one Depth Gauge (adjustable length) and one Reference Guide.

The Biopsy Set consists of one Biopsy Cannula with Stylet (OD 15G. ID 18G. Length 160mm), one Ejector Pin, one Depth Gauge (adjustable length) and one Reference Guide.

The Extended Drill (OD 15G, ID 18G, Length 160mm) is optional.

I am sorry, but the provided text does not contain the information required to answer your request. The document describes a bone biopsy system and its components but does not include any details on acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

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The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens.

Our company is presently authorized by the Food and Drug Administration to manufacture soft tissue biopsy needles, K944837 The bone biopsy needle is a variation of this needle.

The MD Tech Biopsy-Set Bone and Bone marrow is inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration), which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.

The provided text does not contain information about acceptance criteria, device performance metrics, or any study details that would allow for the completion of the requested table and subsequent questions. The document is a 510(k) summary for a bone and bone marrow biopsy needle, focusing on substantial equivalence to predicate devices and a description of the device's intended use and mechanism. It does not include data from performance studies.

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