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The ExtraXtender Film Processor is an automatic film processor used by dental offices to develop X-ray films. The Extra Xtender processes all film sizes of intra-oral and extra oral film. High quality archivable radiographs are delivered dry in 5 minutes. Films may be viewed wet after 2 1/2 minutes.

The Sprint Film Processor is an automatic film processor used by dental offices to develop xray films. The Sprint Film Processor processes all sizes of intra-oral film. Films may be viewed wet after 2 1/2 minutes.

Automatic Film processor

The provided text is a 510(k) summary for the Velopex ExtraXtender Film Processor and Sprint Film Processor. It focuses on establishing substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or specific studies proving a device meets
these criteria. This document is a regulatory submission, not a scientific study report.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets them based on the provided text. The document does not include information on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts used or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone (algorithm only) performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily provides:

• Device names and regulatory information.
• Contact details for the 510(k) holder.
• Predicate devices for demonstrating substantial equivalence.
• Indications for Use for both film processors.

To answer your questions, a different type of document, such as a validation study report or a different section of a regulatory submission (e.g., performance data), would be needed.

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The XTEND™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The XTEND™ Anterior Cervical Plate System consists of standard plates, Extender plates and Universal Extender plates. Extender plates may be used for revision surgery in which additional stabilization is required. Extender plates are attached to an adjacent XTEND™ plate, and Universal Extender plates are inserted adjacent to other plates. XTEND™ plates are available in various lengths to be used with either variable angle screws or fixed angle screws. Each XTEND™ plate is attached to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The XTEND™ Anterior Cervical Plate System implants are composed of titanium allov, as specified in ASTM F136 and F1295.

The provided text is a 510(k) summary for the XTEND™ Anterior Cervical Plate System. This document focuses on demonstrating substantial equivalence to previously approved devices through engineering and mechanical testing, rather than clinical studies involving human or animal subjects or AI/algorithm performance. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the XTEND™ Anterior Cervical Plate System are based on mechanical testing in accordance with FDA guidance. The "reported device performance" is the successful meeting of these criteria, which is implied by the 510(k) clearance.

The Study that Proves the Device Meets the Acceptance Criteria:

The submission explicitly states: "Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented."

This indicates that a series of in vitro mechanical tests were conducted on the XTEND™ Anterior Cervical Plate System. The purpose of these tests was to demonstrate that the device's performance characteristics (e.g., strength, durability, fatigue resistance) are equivalent to or better than those of the predicate devices. By meeting the benchmarks established in the FDA guidance and through comparison with predicate devices, the XTEND™ system was deemed substantially equivalent.

Non-Applicable Categories based on the provided text:

The following information is not present in the provided 510(k) summary because this type of premarket submission for a spinal implant device typically relies on engineering and material equivalence, rather than clinical trial data or AI performance metrics.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This refers to test samples for mechanical testing, not patient data. No human or animal data is detailed.
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" is not established by human experts in the context of mechanical testing for substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 physical spinal implant, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is established by standardized mechanical testing protocols and material specifications, as well as the performance of predicate devices.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of a 510(k) submission for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

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The XTEND-ST Nucleus Removal System is intended to resect damaged or diseased nucleus pulposus material found in the adult lumbar disc space.
The XTEND-ST Nucleus Removal System is indicated to resect damaged or diseased intervertebral nucleus pulposus material found in the adult lumbar disc space.

The CoreSpine XTEND-ST Nucleus Removal System is a soft tissue removal device that is comprised of a disposable, sterile handheid nucleus tissue cutting device, a table-top electronic control unit, and a foot pedal. The tip of the XTEND-ST cutting device can articulate and extend within the disc cavity providing an ability to reach areas of the disc that are otherwise unreachable with a rongeur. Cut tissue is continuously suctioned through a central lumen using a standard vacuum designed to minimize clogging. The XTEND-ST Nucleus Removal System is intended to effectively and efficiently prepare the disc space without damaging the annulus or endplates in preparation for a spinal implant or other therapy.
The XTEND-ST cutting device is made from a stainless steel rotary cutting mechanism with a motor housed in a plastic handle.

The XTEND-ST™ Nucleus Removal System is a medical device intended to resect damaged or diseased nucleus pulposus material in the adult lumbar disc space. The provided text, a 510(k) summary, outlines the non-clinical testing performed to demonstrate its safety and performance and establish substantial equivalence to predicate devices. However, it does not explicitly define acceptance criteria in a quantitative table or detail a specific study proving the device met these criteria in a structured manner often seen with AI/software medical devices.

Instead, the submission focuses on demonstrating general safety and performance through a series of tests, concluding that these studies showed substantial equivalence.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary for a mechanical device, explicit quantitative acceptance criteria for each test are not listed. Instead, the "reported device performance" is largely qualitative, asserting that the device met the requirements.

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

• Sample Sizes: The document does not specify exact sample sizes for any of the tests (e.g., number of units tested for electrical safety, number of cadavers used, number of human factor participants).
• Data Provenance: Not explicitly stated, but clinical data (if any) would typically be from surgical settings. The stated tests are "non-clinical," implying laboratory or simulated environments. "Cadaver testing" implies biological samples, likely from human donors, but the origin country is not mentioned.

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

• Not Applicable / Not Stated Directly: For this type of mechanical device submission, "ground truth" as it pertains to expert consensus on diagnostic imaging or clinical outcomes (as implied by the question) is not directly applicable in the same way it would be for an AI algorithm.
• The human factor analysis likely involved experts in human factors engineering and user experience, but their number and specific qualifications are not detailed.
• Cadaver testing would have involved medical professionals (e.g., orthopedic surgeons, anatomists) to assess the device's performance, but their number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

• Not Applicable / Not Stated: The concept of an adjudication method (like 2+1 or 3+1 consensus) is typically used when establishing a ground truth from expert opinions, often for diagnostic accuracy studies. This is not described for the non-clinical testing of this mechanical device. The "conclusion" of each test (e.g., "met the test limits," "demonstrated appropriate levels") implies an evaluation against predefined benchmarks, but a multi-expert adjudication process is not mentioned.

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

• No: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. These studies are typically used for evaluating the impact of diagnostic aids (like AI) on physician performance. This device is a surgical tool, not a diagnostic aid.

6. Standalone (Algorithm Only) Performance Study

• No: This is a mechanical surgical device, not a software algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable. The device's performance was assessed during "bench testing" and "cadaver testing," which are "standalone" in the sense that the device was evaluated without human-in-the-loop diagnostic assistance, but always with a human operating the device as it's a surgical tool.

7. Type of Ground Truth Used

• For Biocompatibility: Material specifications and ISO standards for biocompatibility (implied).
• For Electrical Safety/EMC: IEC 60601-1 standards and associated test limits.
• For Human Factors: Principles of human-device interaction, usability criteria (implied by "acceptable human factors features").
• For Performance (Bench/Cadaver Testing): Engineering specifications, anatomical integrity (e.g., not damaging annulus or endplates), effectiveness of tissue removal (implied by "effectively and efficiently prepare the disc space"), and comparison to predicate device performance. Direct "pathology" or "outcomes data" in the typical clinical trial sense are not described for these non-clinical tests.

8. Sample Size for the Training Set

• Not Applicable: This is a mechanical device, not an AI algorithm, so there is no "training set."

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

• Not Applicable: As there is no training set for an AI algorithm, this question is not applicable.

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The Xtend ring is used to maintain engorgement of the penis for men that are having difficulty with organic or psychological erectile dysfunction.

The Xtend rings are used by men with erectile dysfunction to improve their ability to have sexual intercourse. When they have a sufficient erection for intercourse a Xtend constriction ring (K980752) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The Xtend ring kit consists of a set of 4 rings. The rings are elastic pharmaceutical quality material which come with an applicator and ring removal hooks. The ring safety removal loops were performance tested for strength. All warnings and precautions from the FDA internet address, www.fda.gov/cdch/ode/oxponrig.html, are included in the premarket notification.

The provided text describes a medical device called the "Xtend Ring Kit" and its 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. The core of this submission is about regulatory approval based on equivalence, rather than a clinical study demonstrating performance against specific medical criteria.

Therefore, the specific quantitative details regarding acceptance criteria, study design parameters (like sample size for test/training sets, expert qualifications, adjudication methods), and statistical outcomes (like effect size for MRMC studies or standalone algorithm performance) are not present in the provided document. The document focuses on regulatory compliance and mechanical performance testing, not diagnostic or therapeutic efficacy studies with clinical endpoints.

However, based on the information available, we can infer some "acceptance criteria" from a regulatory/engineering perspective and the "study" that proves these criteria were met, though it's not a clinical effectiveness study in the typical sense for AI/diagnostic devices.

Here's an analysis based on the provided text:

Acceptance Criteria and device performance

Study that proves the device meets the acceptance criteria:

The "study" in this context is primarily the 510(k) premarket notification process itself, which relies on demonstrating substantial equivalence to a predicate device and fulfilling general control provisions, rather than a prospective clinical trial.

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

   • Test Set: Not applicable in the traditional sense of a clinical test set. The performance testing mentioned ("ring safety removal loops were performance tested for strength") would have involved a sample of the manufactured rings. The specific sample size for this mechanical strength test is not mentioned.
   • Data Provenance: Not applicable. This is not a study using patient data but rather documentation and mechanical testing of the device itself.

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

   • Not applicable. The ground truth for this device's "performance" is based on mechanical properties (strength of loops), material specifications (pharmaceutical quality), and compliance with FDA regulations and labeling requirements, not expert interpretation of clinical data.

3. Adjudication method for the test set:

   • Not applicable. There was no human interpretation of data requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This type of study is typically done for diagnostic imaging or AI-assisted diagnostic devices to assess the impact on human reader performance. The Xtend Ring Kit is a physical medical device (an external penile rigidity device ring), not an imaging or AI diagnostic tool.

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

   • No. This is not an algorithmic device. Mechanical performance tests were conducted on the device components (e.g., ring safety removal loops).

6. The type of ground truth used:

   • The "ground truth" here is primarily engineering specifications for material quality and strength, and regulatory compliance (e.g., inclusion of required warnings, substantial equivalence to a predicate device). For the strength of the removal loops, the ground truth would be a defined force or stress threshold that the loop must withstand.

7. The sample size for the training set:

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

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

   • Not applicable.

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