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The Intimina KegelSmart and Intimina KegelSmart Pearl are intended for independent use by women at home to strengthen pelvic floor muscles to treat stress and/or urge urinary incontinence.

The Intimina KegelSmart and KegelSmart Pearl are pelvic floor muscle exercise devices that provides biofeedback and exercise guidance. Each time the device is used it registers the user's pelvic floor muscle contraction strength and automatically sets a strength level, from 1 to 5, for the following session. Each level has a corresponding exercise routine that is communicated to the user with gentle vibrations.

The provided text is a 510(k) Summary for the Intimina KegelSmart and KegelSmart Pearl devices. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain a specific study proving the device meets acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or effect size for improvement in human readers with AI assistance.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the technological characteristics of the new device to a predicate device (The Reflex Treatment System).
• Safety and Performance Standards: Stating conformity with biological evaluation (ISO 10993) and electrical safety (IEC 60601) standards, and software guidance.
• Functional Performance Testing: A brief mention that functional performance testing was provided to demonstrate the device operates per its Instructions for Use, without detailing the results or acceptance criteria for this testing.
• Literature Review: A general statement about evidence in published literature regarding the effectiveness of pelvic floor muscle training for urinary incontinence.

Therefore, I cannot populate the requested table (1) or address points 2-7, 9 in detail based solely on the provided text, as this information is not present. The document describes a regulatory submission for substantial equivalence based on technological similarity and compliance with general safety/performance standards, not a clinical study demonstrating specific performance metrics against defined acceptance criteria for the new device.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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, as this is not an AI-assisted diagnostic device, and no MRMC study or AI component in that context is discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-only device in the diagnostic sense. The device itself (hardware and embedded software) provides guidance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any specific study of the device. The "ground truth" for the device's efficacy is largely derived from the existing medical literature on pelvic floor muscle training.
8. The sample size for the training set: Not applicable; this device is not a machine learning model that requires a training set in the typical sense for image analysis or diagnostics. Its "training" happens internally as it adapts to the user's strength.
9. How the ground truth for the training set was established: Not applicable for the reasons mentioned in point 8.

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The SOL Portable Diode Laser Unit (with wireless foot control) is intental intracral soft tissue general, only maxills-facial and cosmetic surgery. It is intended for ablating, vaportizing and coagulation of soft tissues using a fiber optic delivery system. Include excision and incision biopsies; hemostatic assissance; treatment of apthous ulcers; frenotomy; gingival incision and excision; gingivectory; gingivoplasty; incisiog and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty.

The SOL Portable Diode Laser, or SOL, is a battery operated counter top dental surgical and therapeutic diode laser. The SOL comprises five main assemblies; a housing, an optical fiber with hand piece, and optical fiber "tip", a foot switch and an auxiliary power supply. The housing contains the system PCBs with system display, battery, control panel with indicators, auxiliary power and footswitch jacks, safety key switch, system power On/Off switch, diode laser with 808 nm working beam and 405 nm aiming beam, heat dissipation assembly with over temperature thermistor and fiber storage wrap. The optical fiber with hand piece comprises a single glass core fiber contained inside an outer PVC jacket, connectors for diode and tip coupling and a hand piece for precise delivery of laser energy to the target tissue. The optical fiber tip is a single patient disposable glass core fiber for delivery of laser energy to the target that couples to the hand piece fiber. A wireless foot control can be used to activate the laser working beam. The auxiliary power supply connects to the housing and is used to charge the system battery and as a power source for the diode laser in the event of low battery capacity.

The provided text describes a 510(k) premarket notification for the SOL Portable Diode Laser Unit, claiming substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The study described is a comparative performance test against predicate devices.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated for a novel device performance. Instead, the study aims to show that the new device (SOL Portable Diode Laser Unit) performs as well as or better than the predicate devices, and that all devices (subject and predicates) meet a general standard.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "Measurements of the output of the subject devices' working beam range from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the unit's settings..." This implies a series of measurements across different power settings for both the subject device and two predicate devices, but the exact number of measurements or units tested is not provided.
• Data Provenance: The study was conducted for the purpose of a 510(k) submission, implied to be by the manufacturer (Den-Mat Holdings, LLC). The nature of the performance data (e.g., in-house testing) suggests it's prospective, but no specific country of origin for the data is mentioned beyond the manufacturer's location in Lompoc, CA, USA.

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

Not applicable. This study does not involve expert evaluation for establishing "ground truth" in the clinical sense (e.g., disease diagnosis). It is a technical performance comparison based on physical measurements of laser output.

4. Adjudication Method

Not applicable. There is no adjudication method described as the study is a technical comparison of laser output measurements against a standard.

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

No. This is not an MRMC comparative effectiveness study. It's a technical performance comparison of a medical device against predicate devices, specifically focusing on laser output accuracy.

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

While the device (SOL Portable Diode Laser Unit) operates in a standalone manner for laser emission, the performance data presented is for the device itself (its laser output characteristics) rather than an "algorithm only" performance in the context of AI or diagnostic software. Therefore, this question, framed for AI/algorithm performance, is not directly applicable. The performance described is for the hardware's output.

7. The Type of Ground Truth Used

The "ground truth" for this study is the device's setting for laser output power, against which the actual measured output is compared. The acceptance criterion of "less than ± 20% of the setting" from IEC 60601-2-22 serves as the standard or benchmark.

8. The Sample Size for the Training Set

Not applicable. This is not a study involving machine learning or AI where a training set would be used. The performance data is derived from direct measurements of the physical device.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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To be used as a general purpose suction and/or irrigation device during open or laparoscopic surgical procedures; including general, gynecologic, thoracic, otolaryngologic, plastic and urologic.

Not Found

This FDA document is a 510(k) clearance letter for the VTI Suction Irrigation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document provided does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications. The letter is an administrative notification of clearance and refers to a premarket notification, but the content of that notification (which would contain the study details) is not included here.

Therefore, I cannot fulfill your request for the tables and study descriptions based solely on the provided text.

To answer your request, I would need access to the actual 510(k) premarket notification (K141323) submitted by Vascular Technology, Inc. to the FDA. This notification would typically include:

• A summary of the non-clinical and/or clinical performance data.
• A comparison to a predicate device, including performance data.
• The deemed acceptance criteria for performance.
• The details of any validation studies performed.

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Intense Pulsed Light (IPL-sq):

• Treatment mild to moderated inflammatory and pustular inflammatory acne vulgaris.
• The treatment of benign pigmented epidermal lesions including dyschromias, hyperpigmentation, melasma and ephelides (freckles).
• Lentigines, nevi, and café-au-lait macules.
• The treatment of cutaneous lesions including warts, scars and striae.
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, and venous malformations.
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction.

Infrared (Intense IR):
Topical heating for the purpose of elevating tissue's temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase of local circulation where applied, and the relaxation of muscles. In addition, may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Laser Nd:Yag 1064nm (1064 LongPulse):

• Coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of superficial and deep telangiectasias, reticular veins (0,1- 4 mm diameter) of the leg, rosacea, warts, venous lake, leg veins, poikiloderma of Civatte, angiomas, hemangiomas, and nevus;
• Non ablative treatment of facial wrinkles, scars and striae;
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction;
• Treatment of pseudofolliculitis barbae.

Not Found

The provided text is a 510(k) summary for a medical device called "Etherea," but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

A 510(k) submission typically demonstrates substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in the way a clinical trial might. The document lists the indications for use of the Etherea device, which uses Intense Pulsed Light (IPL-sq) and Laser Nd:Yag 1064nm (1064 LongPulse) technologies for various dermatological and cosmetic treatments.

To answer your request, I would need a document specifically detailing performance studies and acceptance criteria for this device. The current document is a regulatory clearance letter and an "Indications for Use" statement.

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The OnControl Bone Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and for bone biopsy. This system does not contain cement.

The OnControl Bone Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral (Access and) Biopsy Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the Vertebral Access System (cleared via K081713) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K081713.

Under fluoroscopic imaging guidance, activation of the driver assists the clinician to insert the vertebral needle set through the cortex of the bone, into the vertebral body. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn.

The driver is then separated from the needle assembly for specimen removal.

The provided text is a 510(k) summary for the Vidacare OnControl Bone Access System. This type of document is for premarket notification of a medical device to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. It typically doesn't contain a full study protocol with acceptance criteria and detailed device performance data in the way a clinical trial report would. Instead, it focuses on comparing the new device's technological characteristics, indications for use, and safety/effectiveness to existing, cleared devices.

Therefore, many of the requested items (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance details, and ground truth establishment) are not present in this type of document.

The document states that the new device has "similar technological characteristics and to be equivalent" to its predicate devices in areas such as indications for use, target population, driver design, needle design, technique, sterility, biocompatibility, and anatomical sites. This "equivalence" is the primary "acceptance criterion" for a 510(k) submission, and the basis of the "study" (which is more accurately a comparison) presented.

Here's a breakdown of what can be extracted from the provided text, and where information is missing:

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

• Acceptance Criteria (Implied for 510(k) Equivalence):

  • Indications for Use: Equivalent to predicate devices.
  • Target Population: Equivalent to predicate devices.
  • Driver Design Features: Equivalent to predicate devices.
  • Needle Design: Equivalent to predicate devices (specifically, 11g, 152mm cannula of 304 stainless steel, beveled cutting tip and stylet, identical in gauge, length and materials).
  • Technique: Equivalent to predicate devices.
  • Sterility: Equivalent to predicate devices.
  • Biocompatibility: Equivalent to predicate devices.
  • Anatomical Sites: Equivalent to predicate devices.

• Reported Device Performance:

  • The document states that the new device was "found to have similar technological characteristics and to be equivalent" to the predicate devices across the criteria listed above.
  • Specifically, for the needle: "The Vertebral (Access and) Biopsy Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices..."
  • For the driver: "The powered driver is identical to the predicate driver cleared via K081713."
  • The system "assists the clinician to insert the vertebral needle set through the cortex of the bone, into the vertebral body."

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

• Not provided. This document does not detail a specific "test set" with a sample size as it's a comparative equivalence submission, not a new clinical study with performance endpoints. The "test" is the comparison to predicates.

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/Not provided. No explicit "ground truth" establishment process for a test set is described in this 510(k) summary. The ground for "equivalence" is based on comparing device specifications and intended use.

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

• Not applicable/Not provided. No adjudication method is described.

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. This device is a mechanical bone access system, not an AI software. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

• Not applicable/Not provided. This is a hardware device; the concept of "standalone algorithm performance" does not apply. The device description explicitly states it "assists the clinician."

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

• Not applicable/Not provided in the traditional sense. For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence lies in the established performance and safety of the predicate devices. The new device is simply shown to be functionally and materially similar, therefore inheriting the "truth" of the predicate's clearance.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device.

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

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

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The Well lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

The Well lead Tracheostomy Tubes and Disposable Inner Cannula includes an outer cannula, disposable inner cannula, introducer, neck strap and obturator. The disposable inner cannula acts as a removable liner for the outer tube; it can be withdrawn and changed after the airway has been cleaned, such as phlegm suction. The disposable inner cannula facilitates the airway management to make it easy to clean and prolong the use of the device. The device is used to provide an artificial airway in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by the means of the swivel neck plate/flange. When appropriately connected the device provides a secure artificial airway for spontaneous or mechanical ventilation.

The provided text describes a 510(k) summary for the Well Lead Tracheostomy Tubes and Disposable Inner Cannula. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new, innovative device.

Instead, the submission demonstrates that the new device has the same intended use and similar technological characteristics as the predicate device (K042684). Therefore, the "acceptance criteria" here refer to demonstrating this equivalence through adherence to relevant standards and a comparative analysis of features.

Here's a breakdown based on the provided text, addressing your questions where possible:

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

For this specific submission, the "acceptance criteria" are not quantitative performance metrics but rather qualitative conformity to established standards and similarity to a predicate device.

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

This document describes a substantial equivalence submission, not a clinical performance study with a test set of patient data. The "testing" mentioned refers to engineering and quality assurance tests demonstrating conformity to ISO standards, not tests on a clinical population. Therefore, there is no sample size for a test set or data provenance in terms of patient 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. This is not a study requiring expert readers to establish a ground truth for a test set. The evaluation is based on technical specifications and comparison to a predicate device.

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

Not applicable. As there is no test set in the clinical sense, there is no adjudication method.

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 not a study involving AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a medical instrument (tracheostomy tube), not an algorithm or AI-powered system.

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

Not applicable. The "ground truth" here is the established safety and effectiveness of the existing predicate device and the accepted international standards for such devices. The new device demonstrates conformance to these standards and equivalence to the predicate.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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

Not applicable. See point 8.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Opthalmic, Fetal, Abdominal, Intra-Operative (Specify), Intra-Operative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Trans-Rectal, Trans-Vaginal, Trans-Urethral, Intra-Vascular, Peripheral -Vascular, Laparascopic, Muscular-Skeletal Conventional, Muscular-Skeletal Superficial, Others (Specify)
Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (B - M), Other (Specify)
Note 1: Abdominal, Solid organs, aneurysms,
Note 2: Small Organ: breast, thyroid, testes.
Note 3: Includes imaging for guidance of biopsy

The Interson USB Ultrasound Probe System is a self contained portable, multiple-mode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection eight transducers to be offered with the system permits a wide range of clinical applications including fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, cardiac, neonatal cephalic, urology, ophthalmology. With these general areas of intended use, the various transducers adapt the system for the specific imaging tasks. Eight different models of the USB Ultrasound Probe System are available and any two may be connected at the same time to a USB 2.0 port. In addition to the initial operational settings for each USB Ultrasound Probe System are preprogrammed in the system. User-customized parameter settings for each USB Ultrasound Probe System may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function. The Interson USB Ultrasound Probe System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz. These probes can be applied to a variety of fields such as fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, neonatal cephalic, cardiac, ophthalmology, and urology. The Interson USB Ultrasound Probe System provides various measuring functions. It can measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), and LMP (last menstral period). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of Interson USB Ultrasound Probe System is B-Mode, The Interson USB Ultrasound Probe System supports the Cine function (capable of storing up to 32 to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

This 510(k) Premarket Notification for the INTERSON USB Ultrasound Probe System does not contain any studies proving the device meets specific acceptance criteria.

Instead, it asserts substantial equivalence to a predicate device (Terason 2000, K992505) and lists the device's technological characteristics and proposed indications for use. The documentation focuses on demonstrating that the new device has similar intended uses and technological features to an already legally marketed device, which is the basis for a 510(k) clearance, rather than presenting a performance study with acceptance criteria.

The "acceptance criteria" and "device performance" in this context would generally refer to safety and effectiveness, which are implicitly covered by demonstrating substantial equivalence to the predicate device. The document does mention acoustic output limits as a safety characteristic.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as no such study is provided in the given text.

The document provides the following information:

• 1. A table of acceptance criteria and the reported device performance: This information is not provided in a performance study format. The document states acoustic output limits for all applications:

  • ISPTA.3: 94 mW/cm2 (Maximum)
  • MI: 1.9 (Maximum)
    It explicitly states these limits are "the same as predicate Track 1 devices." This indicates a comparison to the predicate rather than a new performance study against defined acceptance criteria for the new device.

• 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, as no performance study data is presented.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study data is presented.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no performance study data is presented.

• 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 document predates widespread AI in medical imaging and focuses on a hardware device's substantial equivalence to a predicate, not an AI efficacy study.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hardware device submission, not an algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study data is presented.

• 8. The sample size for the training set: Not applicable, as no algorithm training data is presented.

• 9. How the ground truth for the training set was established: Not applicable, as no algorithm training data is presented.

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The SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 and SL 801 Mechanical Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.

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This is a 510(k) clearance letter for a series of wheelchairs, not a study report for an AI/ML powered device. The document does not contain information about acceptance criteria or a study proving that a device meets such criteria because it pertains to a different type of medical device and regulatory process.

Therefore, I cannot provide the requested information based on the given input.

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The EN 600-658, EN 600-666, EN 600-664, EN 600-664, EN 600-690, EN 600-6 151, EN 600-663, EN 600-665 and EN 600-670 Mechanical Wheelchats are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a line of wheelchairs, indicating that they have been found substantially equivalent to predicate devices. It does not contain any details about performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

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The RetinaDx Angiography System is intended for use by trained medical professionals (physicians, ophthalmic technicians, ophthalmic photographers or others with similar training) in a medical office, hospital or other medical setting. It is indicated when a medical professional suspects a patient could have damage or disease of the retina. It is used to take photographs of the patient's retina, which are then studied by the medical professional to get additional information about the retina to consider in his or her efforts to decide on a diagnosis and treatment plan.

RetinaDx Digital Angiography System (Camera Ophthalmic)

This FDA document is a 510(k) clearance letter for the RetinaDx Digital Angiography System and does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on substantial equivalence to a predicate device, not necessarily on a new clinical study demonstrating specific performance against predefined acceptance criteria for a novel technology. Therefore, most of the information you requested would not be present in this type of FDA document.

To answer your questions, one would typically need access to the actual 510(k) submission, which is not publicly available in this detail, or a peer-reviewed publication of a clinical study for the device, which is not provided here.

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