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The CO2 Pneumo-Dissector is used to dissect planes of soft tissue using pressure regulated, trigger-controlled pulses of medical grade CO2 gas. The device may be used in endoscopic, laparoscopic, and open procedures in which gentle blunt dissection of soft tissue planes is desired. Use the product only in accordance with the instructions provided.

The Pneumo Dissector Hook is a standard monopolar hook (based on design cleared under K140101) that can deliver CO2 flow on demand during general endoscopy and laparoscopic surgery. It is composed of two parts, a handle and an insert, which are linked using a nut-screw system. Also, the distal part of the instrument has the hook shape which is the monopolar electrode and the gas nozzle. It is a surgically invasive device intended for delivering pressurized CO2 gas to achieve separation of tissue layers prior to their dissection. The hook insert and tube are offered in lengths of 330mm and 200mm and diameters of 3.5mm and 5.0mm.
The handle has a connector for the CO2 as well as the banana plug or connector for electrosurgery. There is a push button to activate the CO2.
The nut-screw system is used to link the handle to the insert.
The insert consists of an insulated tube with a hook on the distal end.
The hook insert and tube are available in lengths of 330mm and 200mm and diameters of 3.5mm and 5.0mm.

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"POINT" Kinguide Agile Robotic Arm Surgical Stereotactic System (Kinguide RobotArm) is an accessory to the compatible "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments.

"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae (or T1-S1 vertebrae when used with the "POINT" Kinguide RobotArm), and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

"POINT" Kinguide Agile Robotic Arm Surgical Stereotactic System (Kinguide RobotArm) is an accessory to the compatible "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments.

Kinguide Agile system is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Kinguide Agile system is indicated for any medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to the digital markers of medical images (e.g. 3D C-arm) of the anatomy.

Kinguide RobotArm is compatible with Kinguide Agile Software version 15.0.0 or above.

Kinguide RobotArm consists of a RobotArm Station, a Guiding Tool Set and single use accessories.

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PhenoMATRIX is a WASPLab optional module intended for the automatic sorting of images of blood-based agar, chocolate agar, MacConkey agar, and CHROMagar Orientation culture media plates according to classification parameters based on Image Analysis Software results and clinical and demographic data.

Image Analysis Software performs semi-quantitative and/or qualitative analysis of culture media plates by detecting microbial growth, estimating colony counts and differentiating isolates based on phenotypic colony characteristics.

The system determines how the images should be sorted based on image analysis results in addition to patient data according to expert rules defined by the laboratory.

All images shall be evaluated by trained personnel for final assessment and result definition.

The PhenoMATRIX is an in vitro diagnostic software for automated classification of images of solid culture media plates streaked with microbiological samples derived from the human body.

The PhenoMATRIX comprises software modules intended for image analysis and automatic classification of high-resolution digital images captured by WASPLab device for semi-quantitative and qualitative assessment of microbial growth.

WLPostProcessing, its plugin and the Imaging Product SET perform microbial growth detection, colony counts estimations and isolates differentiation basing on phenotypic colony characteristics. The image analysis result is combined with LIS data (such as demographic data, clinical data and / or sample data) according to customizable logic rules defined by the laboratory, for image classification. The classification is used for image sorting into dedicated digital folders associated to suggested results.

The PhenoMATRIX requires the WASPLab in order to operate. WASPLab is an in vitro diagnostic device for handling, incubation, digital imaging and sorting of agar culture plates.

After PhenoMATRIX processing, the physical plates are left inside the WASPLab and images are available for digital inspection by the trained microbiologist through the WASPLab User Interface. The trained microbiologist shall assess the plate images in each digital classification folder. To each digital image a suggested result is assigned according to rules previously defined by the laboratory. The trained microbiologist reviews the plate images, folder by folder, and confirms (or changes) the assigned folder and result. After that, the plates follow the workflow that has been defined by the laboratory according to the assigned result.

The main functionalities of PhenoMATRIX are:

• Assignment of classification parameters to media plate images based on criteria defined by the user (e.g., LIS information, Image Analysis).
• Result assignment according to the classification folder.
• Visualization of media plate images in the WASPLab User Interface for digital inspection.

All plate images shall be reviewed by trained microbiologist before any result definition.

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The Pump In Style® Pro+ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment.

Pump In Style Pro+ is a powered breast pump intended to be used in a home environment (or similar such as an office). It features 2-Phase Expression technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm.
Pump In Style Pro+ comprises a pump unit, which includes:

• User-adjustable controls: "On/Off" for powering on/off the device, "Let-down" for switching between pumping phases, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
• a port for connection of the tubing that channels the vacuum;
• a port for connection of the power supply;
• an internal, non-replaceable, rechargeable lithium-ion battery providing users the option to power the breast pump without reliance on a wall-connection or external power source;
• a LED battery status indicator which informs users of available charge;
• a pump phase LED status indicator which informs users of the active pump phase;
• vacuum level LED indicators (total of 16, one for each vacuum level).
  Pump In Style Pro+ is a double electric breast pump that can be used to extract breast milk from one breast at a time (i.e., single pumping) or from both breasts simultaneously (i.e., double pumping). A DC (direct current) motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk.
  The materials of the milk-contacting components are compliant with 21 CFR 177 and 21 CFR 178.

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The Perin Health Platform is a wireless remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in healthcare and home settings for long-term monitoring. The Perin Health Patch can monitor auscultation data of heart and lung sounds, photoplethysmography waveforms (PPG), oxygen saturation (%SpO2), heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity detection (including step count), and posture (body position relative to gravity including fall).

The Perin Health System is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. In home-use environments, the Perin Health Platform is able to integrate with optional third-party devices for blood pressure, and weight data collection via the mobile application. The mobile application transmits data from the Health Patch and third party devices to the cloud and web-based portal for storage, analysis, and review by healthcare professionals. The Perin Health Platform can include the ability to notify healthcare professionals when physiological data falls outside set limits or manual trigger by the patient.

The device is intended to provide physiological information for non-critical, adult population.

The Perin Health System is a wireless remote patient monitoring platform that enables healthcare professionals to perform spot-checking and retrospective monitoring of physiological data from adult patients. The Perin Health System is designed for use in hospitals, clinics, long-term care facilities, physician offices, and home environments.

The Perin Health System comprises the following components:

1. Perin Health Patch wearable device
2. Perin Health Patient Mobile Application
3. Perin Health Cloud
4. Perin Health Provider Portal
5. Perin Health Inpatient Application

1. The Perin Health Patch
The Perin Health Patch is a chest-worn wearable device that performs scheduled spot-check measurements of multiple physiological parameters. Unlike continuous monitoring systems, the Perin Health Patch captures measurements at predetermined intervals configured by healthcare providers based on clinical need.

The device integrates six primary sensing modalities:

• Auscultation (heart and lung sounds)
• Electrocardiography (1-channel ECG)
• Pulse oximetry via photoplethysmography (PPG)
• Bioimpedance (BioZ) for respiratory monitoring
• Temperature sensing (skin)
• Motion and orientation detection via accelerometer

The combination of these modalities in a small, low-power wearable form allows for the spot-checking of primary vital signs:

• Heart rate and R-R intervals
• Heart rate variability (HRV) parameters
• ECG waveform data
• Auscultation sound data (heart and lung sounds)
• Respiratory rate
• Pulse (PPG) waveform
• Oxygen saturation (SpO2%)
• Skin temperature
• Fall detection events
• Body posture
• Activity level and step count

The device adheres to the patient's upper left chest at the second intercostal space with a medical-grade long-term wear adhesive. The adhesive is placed on the patient-facing side of the wearable, with cutouts for the sensors to make direct contact with the skin. The wearable device is lightweight and semi-flexible, allowing for the device to conform to the natural curvature of the chest. It is water resistant, allowing for bathing and normal activities while the patient is wearing the system.

The wearable communicates to the receiving unit (mobile phone) via an encrypted Bluetooth Low Energy connection. Measurements, all notifications and control commands, and software updates are transmitted over the BLE connection. The wearable uses Near Field Communication (NFC) to facilitate the Bluetooth pairing process with the mobile phone by simply having to tap their phone to the device to initiate a Bluetooth connection. The wearable device also contains on-board memory that can store over two weeks of spot-check data. When measurements are taken and no receiving unit is present, the wearable can store recordings in the onboard memory. Recordings are stored in a stack, such that at the next connection possibility between the wearable and the receiving unit, the most recent data will be transmitted first followed by other measurements in reverse chronological order.

Other key features of the wearable include:

• Customizable recording schedule set by the healthcare provider in their care program
• Replaceable battery
• Patient-triggered recordings via double-tap
• Signal quality indicators for measurement validation and identification of noisy measurements

2. The Patient Mobile Application
The Patient Mobile Application, available on iOS or Android platforms, is intended exclusively for use in home environments by patients under healthcare provider supervision. The application serves as a data relay and display interface, allowing the patient to complete key tasks, including onboarding, device setup, device communication, and patient-reported data.

The application serves as the primary interface between the Perin Health Patch and the cloud infrastructure, receiving spot-check measurements from the device and uploading them for provider review. The application establishes and manages secured BLE communication with the Health Patch. Given that the Health Patch operates on provider-configured recording schedules, the application manages data transfer in the background with minimal patient interaction required. When internet connectivity is unavailable, the application stores measurements locally until transmission becomes possible. The system also manages firmware updates for the Perin Health Patch.

The application integrates with FDA-cleared third-party blood pressure cuff and scale using BLE and transfers the data to the Cloud System. Healthcare providers determine which patients require the additional third-party device monitoring as part of their individualized care programs. The system also allows users to optionally enter manual data for blood pressure and weight if no third-party device is connected.

Patients are able to review their historical measurement data taken throughout their monitoring program and their goals and thresholds set by their providers. The patient can view metrics assigned within their care program:

• Heart Rate and Heart Rate Variability
• Respiratory Rate
• Oxygen Saturation
• Step Count
• Temperature
• Blood Pressure
• Weight

Patients can also select audio segments captured by the device for playback (no visualization).

The application provides comprehensive patient engagement features. Patients can complete customized questionnaires with up to 20 questions in various formats, review educational content delivered through their care programs, and submit non-critical medical reports to their care team. The reporting feature includes anatomical body mapping for location-specific symptoms, severity scaling, and photo attachment capabilities. The application supports secure messaging with care providers, virtual appointment attendance with waiting room functionality, and comprehensive offline operation with automatic synchronization upon connectivity restoration.

3. The Perin Health Cloud
The Perin Health Cloud infrastructure serves as the central hub for data management and processing. The cloud system receives encrypted spot-check data from relay systems and manages raw data processing (for Health Patch data only), storage, and retrieval of physiological measurements for retrospective clinical review. Algorithms are run in the cloud to process measurements from the Health Patch and generate Signal Quality Index, Heart Rate, Heart Rate Variability, Respiratory Rate, Oxygen Saturation, and Posture.

The alert and notification system enables healthcare professionals to configure multi-level alerts based on clinical parameters, technical issues, or manual patient triggers. Clinical alerts are based on provider-configured thresholds that are set in during the enrollment of a patient in a care program. The system supports complex notification rules including threshold exceedances, percentage changes, trending patterns, and consecutive violations. Alerts are displayed to providers for the purpose of highlighting data during their retrospective review and are not intended to support real-time patient monitoring or urgent care provider action.

The cloud infrastructure includes comprehensive audit logging of all user actions, data access, and system events. The system provides API access for integration with electronic health records with HL7 v2.x, HL7 FHIR R4, and other standard protocols, enabling bidirectional data exchange with major EHR systems.

4. The web-based Provider Portal
The web-based Provider Portal enables healthcare professionals to access and manage patient data and alert statuses remotely through any compatible web browser. Through the portal, providers can review spot-check measurements and historical trends, playback audio recordings of auscultation sounds captured by the Patch, configure individualized care programs, set measurement schedules and alert thresholds, and communicate with patients through various modalities.

Through the portal, providers can review spot-check measurements with customizable vital sign charts displaying trends over days, weeks, or months. Advanced visualization includes waveform analysis for ECG and PPG signals, audio playback for auscultation recordings, and comprehensive annotation tools. The portal displays signal quality indicators and out-of-range values with appropriate visual highlighting based on configured thresholds. The portal also displays patient severity levels (Low/Medium/High) based on the NEWS2 scoring methodology. Additional clinical measures, such blood pressure and weight, that are manually input into the EHR can be read into the Perin Health System and viewed in the Provider Portal using the EHR interface.

The system employs a structured care program architecture that ensures appropriate clinical oversight throughout the monitoring process. Healthcare organizations create standardized care program templates for common conditions. Individual providers can then select from these approved templates and customize them for specific patient needs, prescribing the specific devices needed, measurement frequencies appropriate to the condition, and recording schedules tailored to clinical requirements.

The portal includes comprehensive communication capabilities supporting both patient and care team interactions. Providers can conduct virtual appointments with integrated video calling, AI-powered real-time transcription using AWS HealthScribe, and automated clinical note generation structured into standard sections. The messaging system supports secure text communication with file attachments, while the task management system enables care coordination across team members. Providers can create and deploy customized questionnaires with various response types and scoring algorithms, manage educational content delivery, and review patient-submitted reports with collaborative response capabilities.

Additional portal features include appointment scheduling with EHR integration, comprehensive alert management with acknowledgment workflows, administrative functions for user and device management, and organization hierarchy configuration. The portal provides detailed audit trails, performance analytics, and compliance reporting to support quality improvement initiatives.

5. The Perin Health Inpatient Module
The Perin Health Inpatient Module provides a monitoring dashboard for monitoring capabilities in healthcare facility environments. The modules leverage the existing architectures for the Mobile Application and Provider Portal but offer unique interfaces for inpatient spot-check measurements.

The web-based monitoring dashboard, a page accessible through the Provider Portal, displays vital signs for up to 50 concurrent patients in a grid layout. Each patient card shows the latest values for heart rate, respiratory rate, oxygen saturation, temperature, and device status, with automatic sorting by alert priority and visual indicators for threshold violations. The dashboard refreshes every second, updating as new spot-check recordings are captured from patients across the unit.

The bedside Inpatient Application is built on top of the Android architecture of the Patient Mobile app and operates in kiosk mode. The Beside app only interfaces with the Perin Health Patch and relays information to the Cloud to provide clinicians with access to recent measurements in the Provider Portal Inpatient view. The application also maintains local data storage for backup operation and automatically synchronizes with the cloud upon connectivity restoration. Providers are unable to manually input clinical data (e.g., blood pressure measurements) directly into the bedside Inpatient Application but manual data input into the EHR can be read into and visualized in the Provider Portal over the EHR interface.

The Perin Health System supports monitoring in hospitals and out-of-hospital patient care settings where care is administered by healthcare professionals. Visual alarm indicators highlight parameter exceedances according to configured thresholds. High-priority alerts display prominently with appropriate color coding, though all clinical responses and acknowledgments must be performed through the Provider Portal to maintain proper documentation and workflow management.

The Perin Health System facilitates comprehensive spot-checking and retrospective monitoring across the continuum of care. Data flows from the wearable patch and third-party devices through the patient mobile application to the central cloud infrastructure, where processing algorithms derive clinical insights. Healthcare providers access this information through the web portal or inpatient displays for clinical review and analysis, enabling healthcare providers to track patient progress, adjust treatment plans based on measurements, and identify patients requiring intervention based on retrospective data trends.

Here's a breakdown of the acceptance criteria and the study details for the Perin Health System (PHD80060-2), based on the provided FDA 510(k) clearance documentation:

Acceptance Criteria and Device Performance Study (Perin Health System PHD80060-2)

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance for key physiological parameters are summarized below:

Note: For several parameters (Skin Temperature, Posture, Body Motion, Fall Detection, Step Count, Auscultation data), the document states they were "verified by using bench testing as per the acceptance criteria" or "in accordance with acceptance criteria," implying they met the specified thresholds without explicitly re-stating the achieved performance metrics.

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

• SpO2% (Induced Hypoxia Study):

  • Sample Size: 12 healthy adults (5 female, 7 male)
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be prospective clinical validation conducted for this submission.

• Respiratory Rate (Clinical Validation):

  • Sample Size: 35 participants (17 males, 18 females)
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be prospective clinical validation conducted for this submission.

• ECG, Heart Rate, R-R Interval, and Heart Rate Variability (Clinical Validation):

  • Sample Size: 243 participants
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be prospective clinical validation conducted for this submission.

• Wear-life Performance (Internal Clinical Wear Life Evaluation):

  • Sample Size: 26 participants
  • Data Provenance: Across 3 clinical sites. Implied to be prospective clinical evaluation.

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

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the clinical test sets. However, it references:

• SpO2%: "arterial blood samples analyzed by a laboratory co-oximeter" as the gold standard. This implies specialized laboratory personnel for analysis, but their number and specific qualifications are not detailed.
• Respiratory Rate: "manually counted end-tidal CO2" as the gold standard. This would typically be performed by trained clinical staff, but their number and qualifications are not specified.
• ECG, HR, HRV: "standard Holter monitor" as the reference for comparison. Interpretation of Holter data would involve cardiologists or trained technicians, but the document doesn't specify if this was used as "ground truth" to establish the Holter reference itself or if it refers to the Holter output as the reference measurement.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test sets. The studies compare the device's measurements directly to a "gold standard" or "reference monitor" without mentioning a multi-reader adjudication process for discrepancies.

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

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done to evaluate how much human readers improve with AI vs. without AI assistance. The document focuses on the standalone performance of the device's measurements against established standards.

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

Yes, standalone performance was done for several key parameters. The clinical validation studies directly assess the Perin Health System's ability to measure physiological data (SpO2%, Respiratory Rate, ECG/HR/HRV) against a specified gold standard or reference device. These studies inherently evaluate the algorithm's performance without direct human interpretation influencing the measurement output. For example:

• SpO2% accuracy is measured against arterial blood samples.
• Respiratory rate accuracy is measured against manually counted end-tidal CO2.
• ECG, HR, HRV performance is validated against a standard Holter monitor.

7. Type of Ground Truth Used

The types of ground truth used for the clinical validation studies include:

• Laboratory Standard / Direct Measurement: For SpO2%, the ground truth was "arterial blood samples analyzed by a laboratory co-oximeter."
• Clinical Gold Standard: For Respiratory Rate, the ground truth was "manually counted end-tidal CO2."
• Reference Clinical Device: For ECG, Heart Rate, R-R Interval, and Heart Rate Variability, the ground truth/reference was a "standard Holter monitor."

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. This information is typically proprietary to the manufacturer and not usually disclosed in 510(k) summaries unless specifically relevant to a novel AI/ML algorithm requiring such details for FDA review.

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

Since no information about the training set or its sample size is provided, there is no information available on how the ground truth for the training set was established.

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Software

The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.

Hardware

The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection.

The Precision AI Guides and Biomodels are indicated for single use only.

The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only.

The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components:

Enovis:

• AltiVate Anatomic (K162024, K173073, K193226 (CS Edge))
• AltiVate Anatomic Augmented (K213387, K222592)
• Turon Shoulder System (K111629, K080402, K123982)
• Reverse Shoulder Prosthesis (K051075, K092873, K111629, K100741, K111061, K111735, K041066, K141006)
• AltiVate Reverse (K141990, K172351, K190290)
• AltiVate Reverse Glenoid (ARG) (K233481)

Lima:

• SMR Shoulder System (K161476, K100858, K101263)
• SMR Reverse Shoulder System (K110598)
• SMR 40MM Glenosphere (K142139)
• SMR 3-Pegs Glenoid (K153722, K130642)
• SMR Modular Glenoid (K113254, K143256)
• SMR TT Metal Back Glenoid (K133349)
• SMR Hybrid Glenoid System (K163397)
• SMR Stemless Anatomic (K221758)
• SMR 140° Reverse Humeral Body (K201905)
• SMR TT Augmented Glenoid System (K191746, K200171)
• SMR Lateralized Connectors with screws (K183042)
• SMR TT Augmented 360 Baseplate (K220792)
• SMR TT Hybrid Glenoid (K220792)
• PRIMA Humeral System and SMR Glenosphere Ø42 (K212800)
• PRIMA TT Glenoid (K222427)

The Precision AI Surgical Planning System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing patient-specific guides and models to transfer the plan to surgery. The subject device is a system composed of the following:

• The Precision AI Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operation preoperatively. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position to correct the measured deformity for that specific patient. The software will create patient-specific Guide CAD file(s) if requested by the surgeon.

• The Precision AI Guides, which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guides and models will be manufactured using 3D printing by selective laser sintering if the surgeon requests patient-specific guides to transfer the plan to surgery.

The PAI-SPS generates a pre-surgical plan based on medical imaging data using the PAI-SPS Software. The software allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data, which leads to the generation of a case planning report. The PAI-SPS Software allows for the creation of a glenoid and/or humeral pre-operative plan. If requested by the surgeon, PAI-SPS Guides and Models are designed and manufactured based on the approved pre-surgical plan. PAI-SPS Guide and Models are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively assisting the surgeon in positioning glenoid/humeral components used with total and reverse shoulder arthroplasty procedures.

The provided 510(k) clearance letter for the PAI-SPS does not contain specific acceptance criteria or details of a study proving the device meets said criteria in the format requested. The document primarily focuses on the regulatory clearance process, device description, and comparison to predicate devices, stating that clinical testing was not required to demonstrate substantial equivalence.

However, based on the information provided, we can infer some aspects and highlight what is missing.

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

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of measurable thresholds (e.g., minimum accuracy percentages, error margins). The document implies that the acceptance criteria relate to demonstrating "substantial equivalence" in safety and effectiveness compared to predicate devices.
• Reported Device Performance: No specific numerical performance metrics are reported. The document states that "Software verification and validation" and "Usability validation" were completed to demonstrate substantial equivalence.

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

• Sample Size: Not specified. The document does not mention a specific "test set" in the context of clinical or performance data using patient-specific samples.
• Data Provenance: Not specified. As clinical testing was not required for substantial equivalence, there's no mention of country of origin or whether data was retrospective or prospective.

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

• Not applicable/Not specified. The document does not describe a study involving expert-established ground truth for a test set. The validation efforts mentioned (software V&V, usability validation) do not typically involve this type of ground truth establishment.

4. Adjudication method for the test set

• Not applicable/Not specified. Since no expert-established ground truth test set is described, an adjudication method is 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

• No. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." Therefore, an MRMC comparative effectiveness study was not performed or submitted for this clearance.

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

• Yes, implicitly. The "Software verification and validation" would have involved testing the algorithm's performance in generating the 3D construct and patient-specific guide files. While specific metrics are not provided, this validation inherently assesses the algorithm's standalone capabilities. The software "auto segments via a locked, or static, artificial intelligence algorithm."

7. The type of ground truth used

• For the AI algorithm (segmentation): Implicitly, the ground truth for the segmentation algorithm would have been expert-annotated CT images or established anatomical landmarks against which the AI's segmentation accuracy is measured during its development and internal validation. The document does not specify how this ground truth was established, only that the AI algorithm is "locked, or static."
• For the overall system: The ground truth for the planning software and guides would be the "optimal position" for implant placement as determined by a qualified surgeon. The system's goal is to assist in achieving this optimal position.

8. The sample size for the training set

• Not specified. The document mentions that the AI algorithm for auto-segmentation is "locked, or static," implying it was trained on a dataset, but the size of this training set is not provided.

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

• Not specified. While it's implied that the AI for auto-segmentation was trained using data with established ground truth (likely expert-defined anatomical structures on CT images), the methodology for establishing this ground truth is not detailed in the clearance letter.

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PuraStat is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.

PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a mucoadhesive hydrogel that provides a protective barrier over rectal mucosa. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel-filled syringe via the polypropylene adapter also commercially available.

PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume.

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Pen Needles are sterile, single use needles intended for using with pen injector devices for the injection of drug.

The Pen Needle is a sterile, single use device intended for use with pen injector devices for the subcutaneous injection of drug. The device is available in ordinary and safety configurations.

The following are the types of needles:

• Ordinary Type I, Ordinary Type IB, Ordinary Type VIA, Ordinary Type VIB, and Ordinary Type VIC needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, and seal paper.

• Safety Type IIA, Safety Type IIB, and Safety Type IIIA needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, spring, and seal paper.

• Safety Type IIIB, Safety Type VII, Safety Type VIII, and Safety Type IX needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, spring, and seal paper.

• Safety Type IV needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear inner core, spring, and seal paper.

• Safety Type V and Safety Type X needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, spring, rear spring and seal paper.

• Ordinary Type XI needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, adjusting sleeve and seal paper.

• Safety Type XII needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, adjusting sleeve, spring, rear spring and seal paper.

The needle shield and rear needle shield provide physical protection to the needle tube before and after use. The needle container together with seal paper forms the primary sterile barrier system and protects the needle hub. The hub is designed to be securely screwed onto the needle-based injection system (e.g. pen injector) for the subcutaneous injection of drug.

The product is individually packaged and sterilized by irradiation to achieve a sterility assurance level (SAL) of 10⁻⁶. It is intended for single use only.

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