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The Shoulder PacemakerTM electrotherapy device is intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for the Shoulder PacemakerTM device are:

• Prevention or retardation of disuse atrophy;
• Muscle re-education;
• Maintaining or increasing range of motion.

The device is intended for adults and adolescents age 14 and older.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies.

The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.

The subject device can be used in stand-alone mode or in wireless mode.

The Shoulder Pacemaker should be used in combination with:

• conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation;
• saver protection, interposed between the stimulator and the patient's arm. -

The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation.

The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

The provided text describes a 510(k) submission for the Shoulder PacemakerTM device, focusing on expanding its indications for use to include adolescents aged 14 and older. The submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (K210674), which is also the "Shoulder PacemakerTM" from the same manufacturer, NCS Lab Srl.

The core of the submission addresses the device's safety and effectiveness through non-clinical testing and leveraging existing clinical data through pediatric extrapolation, rather than conducting a new clinical study.

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

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

The document does not explicitly present a table of "acceptance criteria" in the traditional sense for a new clinical study comparing the device to a threshold or another device. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (K210674) and compliance with relevant medical device standards. The "reported device performance" is primarily the affirmation that the device meets these standards and is functionally identical to the predicate for all characteristics except the expanded age range.

The "performance data" section states: "All non-clinical, BLE module, battery, electrical safety, EMC and software testing was reviewed in K210674. No substantial changes have been made to the device since it was cleared by the FDA on August 24, 2021 that would affect prior testing results."

This implies that the device's performance aligns with the predicate device, which had already met the necessary performance criteria for its original clearance.

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

There was no new clinical "test set" or study conducted for this specific 510(k) submission in the traditional sense of prospectively enrolling patients for direct device performance testing. The clinical evaluation for the expanded age indication was based on pediatric extrapolation as per FDA guidance. This means:

• Sample Size: Not applicable for a new clinical test set. The submission relies on existing clinical literature and real-world use data.
• Data Provenance: The text mentions "Published literature and real-world use data." The specific countries or whether this data was retrospective or prospective from the original studies are not detailed within this summary, but it generally refers to existing, previously collected 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 new clinical test set was created, and thus no new ground truth was established by experts for this specific submission. The clinical evidence for pediatric extrapolation relied on published literature.

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

Not applicable. No new clinical test set requiring adjudication was conducted.

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 powered muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers, so an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical medical device (muscle stimulator), not an algorithm in the context of standalone diagnostic performance. The device does operate in a "stand-alone mode" (uncontrolled by a wireless tablet) but this refers to its operational mode, not a standalone algorithm performance test.

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

For the pediatric extrapolation, the "ground truth" would be considered the established clinical outcomes data from published literature and real-world use for NMES devices in both adult and pediatric populations, as well as the comparison of patient, disease, and device characteristics. This is a form of outcomes data and literature-based evidence analyzed to support equivalence in a younger population.

8. The sample size for the training set

Not applicable. This submission concerns a hardware device with an expanded indication for use, not an AI/ML algorithm requiring a training set in the typical sense. The software validation mentioned (IEC 62304) involves testing against design requirements, not training on a dataset.

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

Not applicable. There was no training set for an AI/ML algorithm.

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Shoulder PacemakerTM is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for Shoulder PacemakerTM are:

• Prevention or retardation of disuse atrophy;
• Muscle re-education;
• Maintaining or increasing range of motion.

The device is intended for adults only.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies.

The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.

The subject device can be used in stand-alone mode or in wireless mode.

The Shoulder Pacemaker should be used in combination with:

• conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation;
• saver protection, interposed between the stimulator and the patient's arm.

The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation.

The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

The provided text describes a 510(k) summary for a medical device called "Shoulder Pacemaker™," an electrotherapy device for neuromuscular electrical stimulation (NMES). It outlines the device's characteristics, indications for use, comparison to predicate devices, and performance data to support its substantial equivalence.

However, the document does not contain the level of detail typically found in a clinical study report or a formal acceptance criteria document for an AI/ML medical device. Specifically, it lacks information regarding:

• Quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on electrical safety, EMC, and compliance with standards rather than clinical performance metrics for a specific diagnostic or therapeutic outcome.
• A "study" that proves the device meets acceptance criteria in the context of clinical effectiveness with quantitative results. The performance data section refers to non-clinical testing (electrical safety, EMC, software validation) and compliance with standards, not a clinical trial or performance study involving a test set, ground truth, or expert readers.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods as these pertain to clinical performance studies.
• MRMC studies or standalone algorithm performance as these are relevant for AI/ML devices analyzing complex data like images, which is not the primary function described for this NMES device.

Given that the device is a Powered Muscle Stimulator (Product Code IPF) intended for NMES, its performance evaluation focuses on electrical parameters, safety, and functional equivalence to predicate stimulators, rather than diagnostic accuracy as one might expect from an AI/ML imaging device.

Therefore, I cannot populate all sections of your requested outline based on the provided text. I will, however, extract the relevant information regarding acceptance criteria (as implied by the testing performed) and the "study" (non-clinical testing) that demonstrates compliance.

Acceptance Criteria and Device Performance for Shoulder Pacemaker™

Based on the provided 510(k) Summary, the acceptance criteria and performance are primarily related to electrical safety, electromagnetic compatibility (EMC), software validation, and general functional equivalence to predicate devices. There are no explicit quantitative performance metrics (e.g., sensitivity, specificity, or accuracy scores) for a clinical outcome mentioned for the Shoulder Pacemaker™, as it is a muscle stimulator focused on electrical stimulation parameters rather than a diagnostic AI/ML device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

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The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. It is intended to be implanted using the Compasso surgical instruments.

Compasso is a series of surgical instruments intended for use for the implantation of the Elite SPK or the Sharc-FT bone anchor.

The Elite SPK is an implantable bone anchor device designed to ensure the fixation of soft tissues (especially tendons) to bone, during the repair of injuries to the shoulder performed with open or arthroscopic technique. The implantable anchor is made of polyether ether ketone (PEEK), and allows the surgeon to attach the injured tendon to the humerus using a transosseous "double row" technique. The ELITE SPK anchor is suitable for a 3 mm in diameter hole, and is provided sterile for single use.

The Compasso is a series of manual surgical instruments to implant the Elite SPK. Instruments in contact with human body are made of Stainless Steel in conformity with ISO 5832-1, while other components not in contact with the patient are made of stainless steel, aluminum and laser sintering polyamide.

The Elite SPK may be provided in a kit form with sutures for physician convenience. The sutures are provided in their final, sterile form in the original packaging from the manufacturer. FDA has previously cleared the provided sutures in 510(k) application K100006; specifically, the kit includes the HS Fiber Sutures.

This document is a 510(k) Pre-market Notification for the Elite SPK, Compasso, and Elite SPK Kit, seeking clearance from the U.S. Food and Drug Administration (FDA). This notification declares the substantial equivalence of the new device to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Sterilization	The sterilization cycles have been validated following international standards. (Implied acceptance: device is terminally sterilized and meets sterility assurance level standards).
   Shelf Life	The shelf life of the devices has been established through stability studies. (Implied acceptance: device maintains its properties and safety over its declared shelf life).
   Biocompatibility	Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" have been taken into account. (Implied acceptance: materials are non-toxic, non-irritating, non-sensitizing, etc., as per ISO 10993 standards for medical devices in contact with tissue).
   Fixation Strength (Elite SPK)	Performance testing was performed to evaluate the fixation strength of the Elite SPK compared to the predicate device. These tests showed that the Elite SPK has adequate fixation strength and is comparable to the predicate devices. (Implied acceptance: fixation strength is non-inferior to or demonstrably equivalent to the predicate device, meeting clinically relevant biomechanical requirements for soft tissue to bone attachment).
   Functional Equivalence (Compasso instruments)	Implied (but not explicitly stated as a quantified acceptance criterion): The Compasso instruments are intended for use with the Elite SPK or Sharc-FT bone anchor, suggesting functionality and usability for their intended purpose. The substantial equivalence argument relies on their ability to implant the Elite SPK similar to how instruments implant the predicate.

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

   The document does not specify the sample size used for any of the performance tests (sterilization, shelf life, biocompatibility, or fixation strength). The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned. These details would typically be found in the technical reports for each test, which are summarized here.

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

   This type of information is not applicable to the performance tests described for this device. The tests are primarily engineering, materials science, and biological safety evaluations, not diagnostic accuracy studies that require expert-established ground truth.

4. Adjudication Method for the Test Set

   Not applicable for the engineering and biological safety tests performed.

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

   No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. The Elite SPK and Compasso are surgical implants and instruments, respectively, and thus do not involve human readers interpreting cases.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

   Not applicable. This device is not an algorithm or AI-driven system. Its performance is related to its physical and material properties and its function in a surgical context, with a human surgeon always in the loop.

7. Type of Ground Truth Used

   The "ground truth" for the tests mentioned would be based on:

   • Sterilization: Established international standards (e.g., ISO 11137 series for radiation sterilization, ISO 17665 series for moist heat sterilization).
   • Shelf Life: Real-time or accelerated aging studies with defined acceptance criteria for physical, chemical, and functional properties over time.
   • Biocompatibility: In vitro and in vivo testing endpoints defined by ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation effects).
   • Fixation Strength: Biomechanical testing protocols (e.g., cyclic loading, pull-out strength, stiffness) with acceptance criteria often established relative to predicate devices or clinically accepted performance benchmarks.

8. Sample Size for the Training Set

   Not applicable. This is not a machine learning or AI device that requires a training set.

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

   Not applicable. As mentioned above, this is not an AI/ML device.

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The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).

NCS Fish-Fit MD System is an implantable anchor made from Titanium grade 4. Sutures are not pre-assembled with bone anchor. The system includes an instrumentation package, Compass MD. The instrument package is intended to facilitate implantation of the anchor.

The provided 510(k) summary for the NCS Fish-Fit MD System is for a medical device (an implantable suture anchor) and not for a software or AI/ML-based device. Therefore, the questions related to clinical studies, ground truth, expert adjudication, MRMC studies, and training sets are not applicable to this submission.

The acceptance criteria and supporting study described are for the mechanical performance of the device, comparing it to predicate devices.

Here's the information that can be extracted from the provided text, adapted for the nature of this device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set: The document refers to "non-clinical testing" and "data have been provided," but does not explicitly state the sample size (e.g., number of anchors tested) or the provenance (e.g., in vitro, ex vivo). It implies laboratory-based mechanical testing.
• Data Provenance: Non-clinical (likely in-vitro mechanical testing).

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

• Not applicable. This is a mechanical device, and the "ground truth" is measured physical properties like strength, not a diagnostic interpretation. The testing likely conformed to engineering standards.

4. Adjudication method for the test set

• Not applicable. This is a non-clinical, mechanical testing study, not a study involving human interpretation or adjudication.

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 an AI/ML device or a diagnostic imaging device.

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

• Not applicable. This is a hardware medical device.

7. The type of ground truth used

• The "ground truth" for this device's performance measurement would be quantitative mechanical measurements (e.g., force in Newtons, displacement in millimeters) obtained from standardized engineering tests (e.g., universal testing machine results).

8. The sample size for the training set

• Not applicable. This is a hardware medical device; there is no "training set."

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 Proving Acceptance Criteria:

The study was a non-clinical testing program conducted to assess the mechanical properties of the NCS Fish-Fit MD System, specifically its fixation strength and pull-out strength. The testing was performed in accordance with the FDA guidance document "Guidance Document for Testing Bone Anchor Devices" dated April 20, 1996. The purpose was to demonstrate that the device performs as well as (i.e., is substantially equivalent to) the identified predicate devices in these critical mechanical parameters. While specific numerical results or sample sizes are not provided in this summary, the conclusion states that the testing verified adequate performance, demonstrating substantial equivalence.

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