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Classic is a Mandibular Advancement Device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.

Classic device is an intraoral device specially indicated for the treatment of snoring and obstructive sleep apnea syndrome. Its design makes it simple to use and comfortable to wear. It is intended for single-patient use by adults who are 18 years or older.

Classic device consists of two splints united to each other by a screw that allows controlled advancement of the mandible by the increase of the muscular tone at the airway level. Consequently, the flow of air through the upper airway is increased, and reducing snoring and apnea events.

The maximum protrusion of Classic arch form is 10 mm, measuring from patient's plate. This device needs an external controlling component such as screwdriver included in the kit. The device is according arches, maximizes tongue space and allow open, close and laterality movements during wear. These movements can be personalized by the doctor.

Each Classic device has the following components:

1. Upper splint
2. Lower splint
3. Activation key
4. Guide (Bar)
5. OrthoApnea screw

This document is an FDA 510(k) Premarket Notification for the "Classic" Mandibular Advancement Device (MAD). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a specific performance metric against a set of acceptance criteria derived from a novel clinical study.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth for demonstrating device performance are not applicable in the context of this 510(k) submission document. The submission relies heavily on non-clinical testing and comparison to predicates to assert safety and effectiveness.

Here's a breakdown of the requested information based solely on the provided document:

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

This document does not present acceptance criteria in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy) derived from a specific clinical study aimed at proving the device meets those criteria. Instead, the "acceptance criteria" for a 510(k) submission are fundamentally about demonstrating substantial equivalence to a predicate device.

The closest one gets to "performance" here is demonstrating adherence to established standards and similar characteristics to the predicate.

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

• Not Applicable. This submission is for a physical medical device (intraoral device) and relies on non-clinical (bench) testing and comparison to predicates, not a clinical test set of patient data with a defined sample size as would be used for an AI/software device.
• Data Provenance: The bench testing likely occurred at the manufacturer's facility or a certified lab. The document does not specify the country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No clinical test set with human data requiring expert ground truth establishment was used in this 510(k) submission.

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

• Not Applicable. No clinical test set with human data requiring adjudication was used.

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 a physical device, not an AI or software-as-a-medical-device (SaMD) product. No MRMC study was performed or required for this type of submission.

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

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

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

• Not Applicable. For the non-clinical testing performed, the "ground truth" would be the established physical and chemical properties of the materials and the performance specifications of the device components as defined by the international standards (e.g., ISO, ASTM). Biocompatibility is assessed against the absence of toxic reactions as per ISO standards. There is no patient-level "ground truth" for disease state or outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. It's not an AI/machine learning device.

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

• Not Applicable. As there is no training set, this question is not relevant.

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Howell D.A.S.H.® Sphincterotome with Dome Tip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy.

Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.

The sphincterotomes described in this submission are a sterile, single use devices compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. The active cords are accessories to sphincterotomes so that a sphincterotome can be connected to an electrosurgical unit.

This document is a 510(k) premarket notification for electrosurgical accessories, specifically sphincterotomes and active cords. It does not describe a study that uses acceptance criteria in the manner you've outlined for performance of an AI/ML device.

The document details the device's technical specifications and compares them to a predicate device (Zimmon® Papillotome K901443) to demonstrate substantial equivalence, a regulatory pathway for medical devices. The "Performance Data" section lists various engineering and biocompatibility tests conducted, but these are for the physical device components and their functionalities (e.g., sterilization, material strength, electrical safety standards) rather than for an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I cannot extract the information you requested about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document pertains to a traditional medical device.

To directly answer your request based on the provided document:

There is no information in this document regarding:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): Not applicable. The document lists performance tests for traditional device functionality (e.g., sterilization, joint strength), not performance metrics for an AI/ML algorithm.
2. Sample size used for the test set and the data provenance: Not applicable for AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for AI/ML.
4. Adjudication method: Not applicable for AI/ML.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for AI/ML.
6. Standalone (algorithm only) performance: Not applicable for AI/ML.
7. Type of ground truth used: Not applicable for AI/ML.
8. Sample size for the training set: Not applicable for AI/ML.
9. How the ground truth for the training set was established: Not applicable for AI/ML.

The "Performance Data" section (Page 6) lists a series of engineering and biocompatibility tests for the electrosurgical accessories (e.g., GLP Cytotoxicity, IEC 60601 standards for electrical safety, joint strength, packaging integrity). These tests are designed to ensure the physical and electrical safety and functionality of the device components, not the analytical performance of an AI/ML algorithm.

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This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.

The subject devices consist of a catheter with a T-fitting, a Y-body connector, a hub, or a female luer lock on the proximal handle and 3 MM markings at the distal radiopaque tip.

The device distal tip configurations include stainless steel metal, tapered, dome and/or angled tips. ERCP catheters are available in single, double, or triple lumen configurations. All devices have an injection port/wire guide port. Some catheters include a stylet wire to facilitate advancement of the catheter, which is removed prior to wire guide insertion or contrast injection. ERCP catheters are used by passing the device through an endoscope. The injection port/wire guide port is then used to allow fluoroscopic visualization by injecting contrast and/or wire guide access to the desired duct.

This document describes the Cook Medical ERCP Catheters (ERCP, GT, FS-GT, HRC, and SUC) and their substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore no information relevant to the acceptance criteria of such a device can be extracted.

No information available for the requested sections:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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Classic™ intermittent catheters are intended for use in Mate, Female and Paediatic patients when regular assisted bladder drainage has been instructed by a physician. Classic™ intermittent catheters are indicated for use by individuals whose ablity to void the bladder fully by natural bodily functions is impaired.

Classic ™ Intermittent Catheter is a PVC plastic device that is intended to be inserted through urethra and into bladder of patient to allow drainage of urine. The Classic Intermittent catheter in pouch consists of a tube which is bonded onto a drainage funnel. Classic™ Intermittent Catheter has a round polished finish tip to provide maximum comfort for user. Each catheter features two large evelets in order to drain urine efficiently. Drainage eyelets cut-outs are smooth and rounded to minimize the risk of injury/discomfort when in use. Classic ™ Intermittent Catheters are available in: Adult Male. Available in coude tip or straight tip Adult Female. Available in straight tip Paediatic. Available in straight tip

Here's an analysis of the provided text regarding the acceptance criteria and study for the Classic™ Intermittent Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Classic™ Intermittent Catheter are defined by adherence to specific international and in-house standards, with the reported performance being that "All samples pass" for each test.

2. Sample Size for Test Set and Data Provenance

The document mentions "All samples pass" for each test, implying a test set was used for performance and physical characteristic evaluations. However, the exact sample size used for the test set is not explicitly stated in the provided text.

The data provenance is primarily from in-house testing conducted by Flexicare Medical Limited and evaluations against international standards (BS EN and ASTM). The country of origin of the data is the United Kingdom, where Flexicare Medical Limited is located. The nature of the testing (physical performance, material analysis, biocompatibility) indicates this is prospective data generated specifically for the device's evaluation.

3. Number of Experts and Qualifications for Ground Truth

This device is a physical medical device (intermittent catheter) and the evaluation is based on objective, measurable physical, chemical, and biological properties, not a subjective interpretation like medical imaging. Therefore, there is no concept of "experts establishing ground truth" in the way it applies to diagnostic AI systems. The ground truth is defined by the objective pass/fail criteria of the specified standards and in-house test methods.

4. Adjudication Method

Given the nature of the testing for a physical device, adjudication methods like 2+1 or 3+1 are not applicable. The tests performed have clearly defined pass/fail criteria based on objective measurements and adherence to standards. The "Outcome" column clearly states "All samples pass," indicating a direct evaluation against the established criteria.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for comparing the performance of different human readers (potentially with and without AI assistance) in tasks involving subjective interpretation, such as diagnostic imaging. The Classic™ Intermittent Catheter is a physical device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. The device is a physical catheter, not a software algorithm. Therefore, the concept of "algorithm only" performance is not applicable here.

7. Type of Ground Truth Used

The ground truth used for evaluating the Classic™ Intermittent Catheter is based on:

• Objective Measurement against Standards: Adherence to established international standards (e.g., BS EN 1616, ASTM F623-99, ISO 10993-7) for physical dimensions, flow rates, tensile strength, leak integrity, and biocompatibility.
• In-house Test Methods and Specifications: Specific internal tests developed by Flexicare Medical Limited for properties like tensile testing, tube hardness, and connection forces.

Essentially, the ground truth is defined by the pass/fail criteria stipulated within these standards and documented test methods.

8. Sample Size for Training Set

No "training set" is applicable or mentioned. This device does not use an AI algorithm that requires training data. The "samples" referenced in the "Summary of Testing" are test units of the manufactured catheter used for performance verification.

9. How Ground Truth for Training Set Was Established

Since there is no AI algorithm or training set, this question is not applicable.

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The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) and the mask NovaStar noninvasive ventilation (N); with standard elbow (SE) are intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The masks are intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment.

The mask ClassicStar NV, with standard elbow is disposable and for single patient use.

The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH2O). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

Within the medical device family "Noninvasive Ventilation Masks" are devices to provide a patient interface for the application of noninvasive ventilation.

The masks ClassicStar and NovaStar are Full-Face masks which cover the mouth and the nose and are available with a standard elbow (SE) or an anti-asphyxia valve (AAV). Masks with a standard elbow (SE) may only be used on ventilation devices, which incorporate adequate alarm and safety systems for ventilation failure.

A mask with an anti-asphyxia valve (AAV) incorporates the anti-asphyxia valve in the mask elbow.

The ClassicStar Masks are disposable, while the NovaStar Masks are reusable up to 5 times for multiple patients. Further differences are the headgears, which are similar in materials but differ in means of connection to the mask. The headgears are generally provided with the masks, for the reusable masks further headgears are available as optional accessory.

All noninvasive ventilation masks are available in three different sizes (S, M, L),

The provided text is a 510(k) summary for non-invasive ventilation masks. It is a regulatory submission to the FDA for market clearance, not a scientific study reporting device performance against acceptance criteria in the way a research paper would. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth details) is not typically found in this type of summary.

Instead, a 510(k) summary focuses on demonstrating "substantial equivalence" to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate. The "acceptance criteria" here are essentially the regulatory requirements for substantial equivalence, and the "study" is the overall 510(k) submission process itself, where testing (e.g., biocompatibility, materials testing, performance under simulated conditions) is conducted to ensure the device meets recognized standards and performs similarly to its predicates.

Given this context, here's an attempt to answer your questions based on the provided text, recognizing the limitations:

Acceptance Criteria and Device Performance (Based on 510(k) Submission)

The "acceptance criteria" in a 510(k) context are primarily demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" is not quantified in the typical sense of a human-AI study but rather implied through comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Additional Requested Information:

Since this is a 510(k) summary for a physical medical device (masks) and not an AI/software device, many of your specific questions related to AI study design are not applicable.

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

   • Not applicable for this type of device and document. A 510(k) for a physical device like a mask does not typically involve "test sets" of data in the AI/machine learning sense. Performance is generally assessed through engineering testing (e.g., airflow resistance, dead space, seal integrity, materials biocompatibility, pressure drop) and clinical use data collection, if necessary, to demonstrate equivalence. Specific sample sizes for such tests are not detailed in this summary.
   • Data Provenance: The applicant is Dräger Medical AG & Co. KG from Lübeck, Germany. Any internal testing data would likely originate from their facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not applicable. Ground truth for a physical medical device like a mask is established through objective engineering measurements, adherence to recognized standards, and, if applicable, clinical validation (though not usually required for 510(k) unless a new significant performance claim is made or equivalence is challenged). There are no "experts establishing ground truth" in the diagnostic context.

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

   • Not applicable. This relates to diagnostic interpretation consensus, which is not relevant for a respiratory mask.

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 a physical medical device, not an AI or diagnostic tool. MRMC studies are not relevant.

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

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

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

   • Not applicable in the AI/diagnostic sense. The "ground truth" for a non-invasive ventilation mask would be derived from:
     • Engineering specifications and standards: Adherence to ISO, ASTM, or other recognized standards for breathing devices (e.g., dead space, flow resistance, pressure integrity).
     • Biocompatibility testing: Ensuring materials are safe for human contact.
     • Bench testing: Actual performance measurements in a laboratory setting.
     • Clinical experience/literature: Supporting the general safety and effectiveness of non-invasive ventilation masks of similar design.

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device.

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

   • Not applicable. This is not an AI/machine learning device.

In summary: The provided document is a regulatory submission aiming for market clearance based on substantial equivalence to existing devices. It demonstrates this equivalence through a comparison of intended use and technological characteristics, implicitly supported by internal testing and adherence to recognized standards by the manufacturer. It does not provide the detailed scientific study results typically found for AI/diagnostic devices.

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All Digital Clinical Thermometers are intended to precisely measure human body temperature. The Thermometers can be used in the measurement of oral, axillary and rectal temperature.

The Classic/Hypothermia Digital Clinical Thermometer consists of an electronically sensor which is located in a metal probe and is connected with a PCB and a Liquid Crystal Display all situated in a pen-like plastic housing. This structure is used for all kind of Thermometer mentioned in this description.

Hypothermia Thermometer have a greater measuring range so that they can be used as device for under cooled person temperature monitoring.

A flexible probe tip is provided by the Flexible Digital Clinical Thermometer that makes the measuring of the temperature more comfortable and safer.

With the patented 10-Second Digital Clinical Thermometer every user is able to receive the result of the measurement in a very quick time. The Express Models also operates with the vame efficient reliability and accuracy like the other Thermometer.

Due to a special integrated sensor in the Left-Right Handed Digital Clinical Thermometer display can easily be read whether the Thermometer is held in the right or the left hand. Especially for left-handed people it makes the measuring result read off more pleasant.

The Basal Digital Clinical Thermometer have a fourth digit on the display, because the measurement of this Thermometer is even more accurate compared with normal Thermometer. This precisely measuring method can be used to monitor and interpreting basal temperature changes.

The Lightweight-Probe Digital Clinical Thermometer consists of a flexible probe, connection cord and a display unit embedded in a round housing.

Variants Descriptions: "+" or Hypothermia, Express, Dual scale, Backlight, LR, following with the model numbers indicates different measuring range, different measuring time, scale switchable, with backlight with Left-Right Handed function.

For all Thermometers is essential, that they consist of a temperature sensor embedded in a special designed metal probe, which could be flexible or inelastic. This sensor is connected with the IC unit, which is connected with a Liquid Crystal Display (LCD) to display the measured temperature. All parts are situated in a pen-like plastic housing. During measuring, only the maximum measured value is displayed on LCD window and all devices are non-predictive.

All variant thermometers comply with referenced product standards of ATSM E1112-00, EN12470-3, IEC 60601-1, IEC 60601-1-2 and ISO 10993-1.

The provided text describes the submission for a 510(k) premarket notification for several models of digital clinical thermometers. It states that the new devices are substantially equivalent to previously cleared predicate devices and comply with relevant standards. However, the document does not contain a detailed study with specific acceptance criteria and performance results in the format requested.

The text focuses on demonstrating "substantial equivalence" to predicate devices rather than providing a standalone performance study with specific metrics like sensitivity, specificity, or accuracy derived from a new clinical trial.

Therefore, many of the requested items cannot be extracted directly from the provided text. I will provide the information that is available and indicate where the requested information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria (e.g., minimum accuracy levels in statistical terms) or detailed reported device performance (e.g., mean absolute deviation or confidence intervals from a clinical study). Instead, it states compliance with recognized standards.

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

This information is not provided in the document. The submission relies on compliance with standards and substantial equivalence, not a specific new test set with a reported sample size or data provenance from a prospective or retrospective study.

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. As no specific test set requiring expert ground truth is detailed, this does not apply.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided. As no specific test set requiring adjudication is detailed, this does not apply.

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

An MRMC study is not mentioned and is not applicable to a digital clinical thermometer, which is a standalone measurement device and not an AI-assisted diagnostic tool requiring human interpretation.

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

The devices are standalone devices (thermometers); their performance is inherently "algorithm only" in the sense that they provide a direct temperature reading. However, a dedicated study proving this standalone performance with specific metrics as if it were a complex diagnostic algorithm is not detailed in the submission. The submission states compliance with relevant standards which implicitly covers standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For clinical thermometers, the "ground truth" typically refers to traceability to a recognized temperature standard (e.g., by calibration against a primary temperature standard or a calibrated reference thermometer) and comparison to core body temperature measurements in clinical validation. The document does not explicitly state the specific type of ground truth used but implicitly relies on the methods required by the cited standards (ASTM E1112-00, EN 12470-3), which dictate how accuracy is to be determined and validated, including calibration and clinical performance testing against reference methods.

8. The Sample Size for the Training Set

This information is not applicable as these are not AI/machine learning devices that require a "training set."

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

This information is not applicable as these are not AI/machine learning devices.

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Futura Biomedical Classic Great Toe Implant is indicated for:

• Hallux limitus or hallux rigidus .
• . Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis ●
• Unstable or painful joint from previous surgery .

The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint srthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

The provided text is a 510(k) summary for a medical device called the "Classic Great Toe Implant." It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain any information regarding clinical studies, performance data, acceptance criteria, or ground truth establishment.

The document explicitly states that the device is substantially equivalent to a predicate device based on design characteristics and intended use, rather than clinical performance data from studies.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence, not performance evaluation through studies.

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The Classic NMS is recommended for use for the following conditions:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical simulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

A portable NMS device for pain control.

The provided text is a 510(k) summary for a neuromotor stimulator (NMS) device. It states that clinical testing was "Not applicable" because the device demonstrated substantial equivalence to a predicate device through bench testing of electrical output characteristics. Therefore, a study demonstrating the device meets specific acceptance criteria as you've requested was not performed, nor was it required for this 510(k) clearance.

This means I cannot provide the detailed information you've asked for regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth, as these elements were not part of the submission or FDA's review for this particular device based on the provided document.

Here's a summary based on the information available:

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

2. Sample sized used for the test set and the data provenance

• Sample Size: Not applicable, as no clinical test set was used. Bench testing was performed on the device itself.
• Data Provenance: Not applicable.

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

• Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication method for the test set

• Not applicable, as no clinical test set requiring adjudication was used.

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 MRMC comparative effectiveness study was done. This device is a neuromotor stimulator, not an AI-assisted diagnostic or imaging device, so "human readers" and "AI assistance" are not relevant in this context.

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

• Not applicable. This is a physical neuromotor stimulator, not an algorithm.

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

• Not applicable, as no clinical ground truth was established or used. The basis for clearance was substantial equivalence in electrical output characteristics to a predicate device.

8. The sample size for the training set

• Not applicable, as no clinical training set was used.

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

• Not applicable, as no clinical training set was used.

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TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

A portable TENS device for pain control.

The CLASSIC TENS™ device, a transcutaneous electrical nerve stimulator (TENS) for pain relief, did not require a study proving its performance against acceptance criteria in the traditional sense, as it was cleared through the 510(k) pathway based on substantial equivalence to a predicate device.

Instead of clinical performance testing, the submission focused on comparing the technological characteristics and labeling of the CLASSIC TENS™ to a legally marketed predicate device (Matrix I, K895473).

Here's a breakdown of the information based on the provided text, addressing your points as much as possible within the context of a 510(k) submission for a TENS device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The device relies on bench testing for technological comparison, not a "test set" of patient data in the typical sense.
• Data Provenance: Not applicable. The "testing" involved bench testing of the device itself against the predicate device's specifications, not clinical data from patients.

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

• Not applicable. Ground truth in this context refers to the characteristics and performance of the predicate device, established by previous FDA clearance and regulatory standards, not by individual experts assessing a test set.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" of cases requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No Multi-Reader Multi-Case (MRMC) study was done. This type of study is typically used for diagnostic or screening devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This TENS device is a therapeutic device, and its clearance was based on substantial equivalence through bench testing, not clinical performance studies involving human readers.

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

• Yes, in essence, a standalone evaluation was done, but not in the context of an "algorithm." The "Nonclinical Testing" section states "Bench testing demonstrated that the output characteristics or CLASSIC TENS™ are substantially equivalent to that of the predicate device." This means the device's electrical output and technological features were directly evaluated and compared to the predicate without human intervention in operating the device for patient therapy during the evaluation.

7. The Type of Ground Truth Used

• The ground truth used was the established performance and safety profile of the predicate device (Matrix I, K895473), as determined by its prior FDA clearance and existing regulatory standards for TENS devices. The "bench testing" served to confirm that the CLASSIC TENS™ adhered to these established parameters.

8. The Sample Size for the Training Set

• Not applicable. As a TENS device, there is no "training set" in the context of machine learning. The device's design and manufacturing are based on established engineering principles and regulatory standards for TENS units.

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

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

Summary of the Study (Bench Testing and Comparison):

The "study" in this context refers to the bench testing performed to demonstrate the substantial equivalence of the CLASSIC TENS™ to its predicate device, Matrix I (K895473).

• Objective: To show that the CLASSIC TENS™ has comparable technological characteristics, electrical output, and intended use as the predicate device, and that any differences do not raise new questions of safety or effectiveness.
• Methodology:
  • Technological Comparison: The physical design, components (specifically, the jacks and cables), and overall technological characteristics of the CLASSIC TENS™ were compared to the predicate. The only noted difference was the use of FDA-compliant jacks and cables.
  • Nonclinical Testing (Bench Testing): Specific tests were performed on the CLASSIC TENS™ to measure its electrical output characteristics (e.g., waveform, intensity, frequency) and these were compared directly to the known output characteristics of the predicate device.
  • Labeling Comparison: The proposed labeling for the CLASSIC TENS™ was reviewed and compared to the predicate device's labeling to ensure consistency in indications for use, warnings, and instructions.
• Results/Conclusion: The bench testing and comparisons demonstrated that the CLASSIC TENS™ is "substantially equivalent" to the predicate device. This equivalence formed the basis for the FDA's 510(k) clearance, allowing the device to be marketed.

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