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The accufit is indicated for use for Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen, and Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

The principle of operation of the accufit device is to provide direct electrical stimulation of muscles which produces muscle contractions in and around the area of the treatment electrodes. The accufit generates electrical stimulation to contract the muscles to achieve the desired intended use using unique IntelliPhase waveforms and IntelliSTIM electrodes. It offers two unique IntelliPhase waveforms, Biphasic and Interferential (4P), that are designed to optimize muscle re-education and activation for patients. The four IntelliPhase waveform protocols are twist, hold, grip, and tap. Each protocol may be used for 15, 30, or 45 minutes. Not only are there four IntelliPhase protocols, but there is also a fully automated protocol (IntelliCycle) that integrates all the above listed waveforms in a comprehensive, interlaced series. This engages all the targeted muscles in a continuous program to maximize muscle effects with the touch of a button. accufit is both the proprietary-trade name and generic name. accufit is a supplement to existing treatments and does not replace any traditional treatment or therapy. The system console is the heart of the accufit and contains the Touch LCD/GUI, electrodes, and power supply module. The main console also includes a key switch used to turn the power on and off, and an emergency stop push button that quickly de-energizes the system in emergency situations. There are 4 casters in the console base that can be used when moving the system.

The accufit device is a Powered Muscle Stimulator (Product Codes IPF, NGX) indicated for various muscle-related therapies, including:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

The device operates by providing direct electrical stimulation to muscles, causing contractions using unique IntelliPhase waveforms (Biphasic and Interferential (4P)) and IntelliSTIM electrodes. It offers four IntelliPhase waveform protocols (twist, hold, grip, and tap), each usable for 15, 30, or 45 minutes, as well as a fully automated IntelliCycle protocol.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a clinical study primarily focused on the improvement of muscle tone and firmness, specifically for strengthening muscles in the arms. While acceptance criteria in a quantitative sense (e.g., a specific percentage increase in strength) are not explicitly stated, the study's overall finding that "most patients saw improvement in muscle strength" serves as the reported device performance against an implied criterion of demonstrating clinical effectiveness for its new indication.

Given the available information, here is a summary related to the clinical study and its findings:

2. Sample Size and Data Provenance for Test Set

• Sample Size: 45 subjects were enrolled in the study.
• Data Provenance: Not explicitly stated regarding the country of origin. The study appears to be prospective as subjects were "enrolled" and "treated" with the device, and follow-up assessments were conducted.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This was a clinical study assessing the physiological effect of the device on muscle strength, not an AI/image-based diagnostic device requiring expert interpretation for ground truth. Muscle strength was measured objectively using a dynamometer.

4. Adjudication Method for Test Set

Not applicable. Muscle strength was measured using a dynamometer, which provides objective, quantitative data, thus negating the need for an adjudication method typically used for subjective assessments or interpretations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical trial assessing the direct effect of the device on muscle strength in human subjects.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a powered muscle stimulator for direct application to the human body, not an algorithm-only or AI-driven diagnostic tool. Its performance is intrinsically linked to human-device interaction.

7. Type of Ground Truth Used

The ground truth used in the clinical study was objective physiological measurement: muscle strength measured by a dynamometer at specified time points (baseline, final treatment, 30-day post-treatment, and 90-day post-treatment).

8. Sample Size for Training Set

Not applicable. This device is a physical therapeutic device, not an AI/machine learning model that requires a "training set" in the conventional sense of data-driven algorithm development. The "training" for the device would be its engineering and design based on established principles of electrical muscle stimulation.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no specific "training set" for the type of device described. The device's design and operational parameters would be based on scientific and engineering principles for powered muscle stimulators. Its effectiveness for specific indications is then demonstrated through clinical studies, as detailed above.

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

accufit (subject device) when using the Biphasic/Interferential (4P) waveforms is a noninvasive powered muscle stimulator used to provide an electrical stimulation of muscles for muscle re-education. The accufit is used on an outpatient basis under the supervision of a clinician.

The accufit is the result of a close collaboration between Lutronic Corporation and Mettler Electronics, Corporation. Mettler is the manufacturer of both the subject and predicate device. Using the Mettler Sys*Stim ME240 (K113017) as a starting point, the accufit utilizes two of the original and unchanged waveforms for muscle reeducation.

There are four preprogrammed treatment regimens that enable users to mimic common physical exercises. Each treatment regimen has recommended treatment electrode placement depicted in both the accufit operator's manual and on the accufit graphic user interface (GU). The IntelliSTIM treatment electrodes have been designed to support the accufit and are controlled by an intelligent real-time impedance feedback Mettler System. The IntelliSTIM are held in place with hydrogel adhesive strips and Velcro body wraps. The user may select the treatment duration of either 15, 30 or 45 minutes. The size, type of electrode and technical/performance characteristics.

This document is a marketing submission for a medical device (510(k)). It describes the "accufit" powered muscle stimulator and its associated electrodes ("IntelliSTIM" and "IntelliGEL"). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove acceptance criteria for a novel device with new performance claims.

Therefore, the typical acceptance criteria and study design for performance claims (e.g., sensitivity, specificity, accuracy against a gold standard, or comparative effectiveness studies) are not applicable in the context of this 510(k) summary. The "acceptance criteria" here are essentially the demonstration that the new device is as safe and effective as the predicate device based on its design, technical specifications, and compliance with recognized standards.

However, I can extract the information on the technical specifications and performance testing that were conducted to support the claim of substantial equivalence.

Here's a breakdown of the requested information based on the provided text, adapted to the context of a 510(k) submission for substantial equivalence:

1. Table of Acceptance Criteria and the Reported Device Performance

As this is a 510(k) showing substantial equivalence, the "acceptance criteria" are not framed as specific performance metrics against a disease state or outcome. Instead, the criteria are the demonstration of comparable technical characteristics and compliance with relevant safety and performance standards to the predicate device. The "reported device performance" is the accufit's (and its electrodes') specifications and test results, which are shown to be identical or substantially equivalent to the predicate devices and compliant with standards.

Here's a summary of the key comparisons and performance aspects for the accufit powered muscle stimulator:

Here's a summary of the key comparisons and performance aspects for the IntelliSTIM and IntelliGEL electrodes:

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

This information is not provided in the document as it's not a clinical study with a "test set" in the traditional sense of evaluating a new performance claim against a ground truth dataset. The testing performed consists of:

• Bench Testing: To ensure compliance with electrical safety, EMC, and powered muscle stimulator standards. These are engineering verification tests, not clinical evaluations on patient data.
• Biocompatibility Testing: Conducted on the IntelliGel hydrogel adhesive strips according to ISO 10993 standards. These tests are typically performed in a lab on material samples and don't involve a "patient test set" or clinical data provenance.
• Software Verification and Validation Testing: Performed on the accufit's software. This is also an engineering/software quality assurance process, not a data-driven clinical performance study.

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. As described above, there was no clinical "test set" requiring ground truth established by experts for performance evaluation against a diagnostic or therapeutic outcome. The "ground truth" for the performed tests is adherence to recognized performance standards (e.g., the output voltage/current should be within a certain range as per engineering specifications, or a material should not cause cytotoxicity based on ISO 10993).

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

Not applicable. No clinical test set or adjudication process for clinical outcomes was 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

Not applicable. The device is a powered muscle stimulator, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or "AI assistance" in the sense of image interpretation or similar cognitive tasks.

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

Not applicable. This device is a powered muscle stimulator, not an algorithm. Its operation inherently involves human interaction (clinician supervision, patient interrupt switch).

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

Not applicable. For the purposes of this 510(k), the "ground truth" for the device's substantial equivalence is its compliance with internationally recognized safety and performance standards (e.g., IEC 60601 series, ISO 10993 for biocompatibility) and the demonstration that its technical specifications (e.g., output characteristics like voltage, current, pulse width) either match or are equivalent to those of the predicate device for the claimed indications.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed using a "training set" of data.

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

Not applicable. There was no training set for an algorithm.

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The AccuFit® Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiosy, scollosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The AccuFit® Lateral 2-Hole Plate consists of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) rigid plates and screws of varying sizes. The plate attaches by means of screws to the lateral portion of the vertebral body. The AccuFit® Lateral 2-Hole Plate (Subject Device) will be implanted using the instruments cleared with the AccuFit® Lateral Plate System (K162211), however a new inserter and tray will be introduced to the system that is to be used with the AccuFit® Lateral 2-Hole Plate (Subject Device). The AccuFit® Lateral 2-Hole Plate is to be provided non-sterile. They require sterilization prior to use.

The provided text describes a medical device (AccuFit® Lateral 2-Hole Plate) and its 510(k) clearance by the FDA based on substantial equivalence to predicate devices. It does not present information related to the performance of an AI/ML-enabled device, nor does it detail a study involving human readers or expert ground truth establishment for a diagnostic algorithm.

Therefore, I cannot extract the information required in your request about acceptance criteria, device performance, sample sizes, ground truth establishment, or human reader studies. The document pertains to a physical spinal implant, not an AI-based diagnostic tool.

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The AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The AccuFit Lateral Plate System consists of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates and bones screws of varying sizes and lengths. The plate attaches by means of screws to the lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The Lateral Plate System implants and instruments are provided non-sterile. Thev require sterilization prior to use.

This document is a 510(k) premarket notification decision letter from the FDA for the AccuFit™ Lateral Plate System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for specific performance metrics. Instead, it indicates that the device has undergone performance testing according to recognized ASTM standards and the results lead to a conclusion of substantial equivalence to predicate devices. This implies that the performance met the standards expected for such devices, which is to perform comparably to existing, legally marketed devices.

The performance testing mentioned are:

The overarching acceptance criterion is achieving substantial equivalence to the predicate devices based on these mechanical tests.

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

The document mentions "Performance Testing Summary" which includes mechanical tests (Static Axial Compression, Static Torsion, Dynamic Axial Compression). These are typically benchtop mechanical tests performed on physical device samples, not human or patient data. The document does not specify the sample size (number of devices tested) for these mechanical tests. It also does not provide information about the country of origin or whether "data provenance" (as in, patient data) is relevant for these types of tests, as they are not clinical studies.

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)

This question is not applicable to the information provided. The "test set" here refers to the physical devices undergoing mechanical stress tests, not clinical data requiring expert human interpretation or ground truth establishment in a medical context.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations of medical data. The tests described are mechanical engineering tests, not clinical evaluations.

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, an MRMC comparative effectiveness study was not done. The device is a spinal plate system, a physical implant, not an AI-assisted diagnostic or imaging device.

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

No, a standalone (algorithm only) performance study was not done. The device is a physical spinal implant.

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

The "ground truth" for the mechanical performance tests would be the established scientific and engineering principles and the performance benchmarks set by the ASTM F1717 standard for spinal implants, as well as the performance characteristics of the predicate devices. There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for these specific performance tests.

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for a mechanical device would involve engineering design, material selection, and manufacturing processes, not numerical data sets.

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

This question is not applicable for the reasons mentioned in point 8.

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AccuFit™ Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla.

AccuFit™ Screws are intended for securing a abutment onto an endosseous dental implant.

The AccuFit" Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes:

Table A. Compatible Commercial Implant Manufacturers

The AccuFit" Dental Abutments and Screws are designed for use with commercially available dental implant systems. The abutments will seat directly on implants and are secured by screws to become sub-structure of prosthesis. These abutments are offered in a straight body with a straight or scalloped prosthetic margin and are made of Titanium alloy Ti6AlV4.

A list of dental implant systems, which the AccuFit™ family of products is compatible with, is shown in tables within this document. The abutments and screws of the compatible systems are listed as the predicates for this filing.

The Accurit™ Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes:

Table A. Compatible Commercial Implant Manufacturers

This document is a 510(k) Premarket Notification for the AccuFit™ Dental Implant Abutments and Screws. It describes the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document describes the acceptance criteria implicitly through the comparison to predicate devices and the process of ensuring compatibility. The primary acceptance criterion is substantial equivalence to existing legally marketed dental implant abutments and screws.

The "reported device performance" is not quantified in terms of specific performance metrics (like wear resistance, fracture strength in controlled studies, etc.) in this submission. Instead, performance is demonstrated by adhering to material standards and ensuring a precision fit with compatible implant systems.

Study Information

The document describes a bench study/testing rather than a clinical trial or a study involving human subjects or AI performance.

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

   • Test Set Description: The "test set" consists of commercially available implant components from various manufacturers (Zimmer Dental, Nobel-Biocare, Biomet 3i, Lifecore Biomedical) that the AccuFit™ system is designed to be compatible with.
   • Sample Size: The document does not specify a numerical sample size (e.g., how many units of each compatible implant system were purchased for testing). It ambiguously states, "The commercially available implant components are purchased as samples."
   • Data Provenance: The data provenance is described as "commercially acquired samples" from various implant companies. This implies the data is retrospective in the sense that the compatible implants are pre-existing, but the testing performed by Berkeley Implant would be prospective for their device. The country of origin of these commercial implants is not specified, but they are recognized manufacturers in the dental implant market.

2. 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):

   • This submission does not involve medical image analysis or interpretation, and therefore, there are no "experts" in the sense of clinical specialists establishing a "ground truth" for a diagnostic task. The ground truth for device compatibility and performance is established through engineering measurements and material standards. The expertise involved would be in manufacturing, quality control, and metrology, but no specific number or qualifications of "experts" are listed in this context.

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

   • This is not applicable to the type of study described. There's no clinical "adjudication" of results in a diagnostic or therapeutic sense. The "adjudication" of fit is based on optical measurements and cross-assembly, which are objective engineering assessments.

4. 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. An MRMC study is relevant for evaluating diagnostic systems, especially those involving human interpretation (e.g., radiologists reading images with and without AI assistance). This submission is for a physical medical device (dental implant abutments and screws) and does not involve AI or human "readers" of any kind in a diagnostic capacity.

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

   • No. This is not an algorithm or AI-based device. It is a physical dental implant component.

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

   • The "ground truth" in this context is based on engineering specifications, material standards (ASTM F136-08e1), precise measurements (using high-precision optical equipment), and successful physical cross-assembly with predicate devices/compatible implant systems. The compatibility is determined by mating diameters, lead-in bevels, internal/external hex sizes, and internal threads.

7. The sample size for the training set:

   • This document describes the manufacture and testing of a physical medical device. It does not involve a "training set" in the context of machine learning or AI algorithms. The manufacturing process itself (machining, quality control) is analogous to "training" in that it produces the intended device, but it's not a data-driven training set.

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

   • As there is no "training set" in the AI/machine learning sense, this question is not applicable. The "ground truth" for the device's design and manufacturing is established by engineering design specifications derived from the compatible predicate devices and relevant material standards. The manufacturing process aims to meet these specifications.

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