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Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

The Hanger Cranial Band 3D is a cranial remolding orthosis comprised of an additivemanufactured outer shell with a polyethylene foam inner lining.

The device is custom fabricated for individual patients by obtaining measurements via a handheld 3D laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The scan is then modified utilizing a CAD/CAM technology package—to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial orthosis. The 3D image is used to produce a positive mold using a routing machine, to which the foam liner is pulled onto. The 3D file is also used manufacture the outer shell, which is then attached to the foam-lined positive model.

The completed device applies gentle pressure to the elevated areas of the skull while leaving space for cranial growth in the depressed regions. It is open at one side and closed with a fastener to provide the selected fit and proper stability.

The provided document describes a 510(k) submission for the Hanger Cranial Band 3D, a cranial orthosis, and does not contain information about acceptance criteria and a study proving a device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study for this specific document.

Here's why and what information is available:

• No Acceptance Criteria or Study for Performance: The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The predicate device has been on the market for years with a proven safety and efficacy for the use of the device." This indicates that a study proving the device meets specific performance acceptance criteria was not conducted or presented in this submission because the device's performance is assumed to be substantially equivalent to the predicate.

• Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often achieved by showing similar intended use, technological characteristics, and principles of operation, rather than rigorous new performance testing against specific acceptance criteria.

What information is present in the document that somewhat relates to testing, even if not a formal performance study:

• Non-Clinical Performance Data (Section VII):
  • Biocompatibility: Both the outer shell and inner foam lining were tested and found to be biocompatible (reference Section 15, which is not provided).
  • Tensile Stress Testing: Conducted on the outer shell material of the subject device, showing average tensile strength was higher than the predicate device's outer shell material (copoly plastic). This is a comparative test, not a performance test against acceptance criteria.
  • Drop and Chemical Tests: Performed on the outer shell and "had passed the attribute acceptance criteria." However, what those acceptance criteria were (e.g., specific thresholds for impact or chemical resistance) is not detailed.
  • Validation of Manufacturing: "Validation activities were performed and demonstrated that the device can be reliably manufactured with the intended geometry and dimensional tolerances based upon patient-specific scan information." No specific metrics or acceptance criteria for these tolerances are provided.

In summary, based on the provided document, I cannot fill out the requested table and answer the study-related questions because a formal study proving the device meets specific performance acceptance criteria was explicitly not required or conducted for this 510(k) submission. The submission relies on establishing substantial equivalence to a predicate device that is already deemed safe and effective.

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Disposable device intended to recirculate, filtrate and perfuse physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The device is intended for use in a single procedure.

The Hang&Go PAC, just like the Hang&Go HT Basic, is a disposable, single use kit intended to circulate and filtrate physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The Hang&Go PAC is supplied sterile and packaged in a proprietary-design container and it is intended to be used only with the PERFORMER HT. The Hang&Go PAC, just like the Hang&Go HT Basic, includes all necessary tubing and components for the treatment execution: circulation tubing, heater bag, reservoir, table pack (Patient inlet and outlet tubing) with thermal protections. The Flow Reverse is a disposable, sterile component of the Hang&Go PAC. It is supplied sterile, individually packaged and included in the Hang&Go PAC carton box. The crossed layout of the 4 tubing segments allow to exchange the Patient's inlet and outlet flows by selectively opening / closing two segments at a time with the provided manual clamps.

I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification from the FDA regarding an infusion pump named "Hang&Go PAC." While it details the device's indications for use, comparison to a predicate device, and a list of non-clinical tests and applicable standards, it does not provide a table of acceptance criteria with reported device performance or information about sample sizes for test sets, expert involvement, adjudication methods, or specific details of standalone or MRMC studies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and compliance with recognized standards for general safety, biocompatibility, sterilization, and packaging. It mentions specific tests conducted (e.g., static priming volume, pressure drops, temperature probe qualification, physical integrity verification for the Flow Reverse component), but it does not present the acceptance criteria for these tests nor the detailed results in a format that would allow filling out the requested table.

Therefore, I cannot provide the detailed information you requested based on the input text.

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The intended use of the PERFORMER HT is to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extra-corporeal circulation of warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.

The device must be used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The PERFORMER HT is a prescription electromechanical device intended to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extracorporeal circulation of warmed. physiologically compatible sterile solution.

The PERFORMER HT equipment is designed to:

• operate the treatment execution by means of a color touch-screen display .
• . control the temperature of solution perfused to the Patient through the extracorporeal circuit
• control the flow rates of roller pumps .
• control the volume in the extracorporeal circuit and Patient's body cavity .
• monitor Patient's body cavity temperatures .
• monitor the extracorporeal circuit pressures .
• . detect air in the circuit
• change the fluid path in the extracorporeal circuit by means of 2 two-ways pinch valves .

The Central Information Display (CID) enables the User to interact with the PERFORMER HT equipment. The touch-screen display allows the User to:

• inout Patient information .
• operate the various treatment phases
• display treatment parameters (e.g, flows, pressures, temperatures) .
• set treatment parameters .
• . set alarm limits
• display graphical trending of temperature probes connected to the HTS module
• · read alarm and alert messages

The PERFORMER HT is intended to be used with the HANG&GO HT BASIC, a disposable, single use kit intended to circulate and filtrate the clear solutions in the thoracic or abdominal cavity.

The HANG&GO HT BASIC includes all necessary lines and accessories for the treatment execution:

• · circulation line
• ·. heater bag
• · reservoir
• · table pack (Patient inlet and outlet lines) with thermal protections

The HANG&GO HT BASIC is supplied sterile, packaged in a proprietary-design container, and is intended to be used only with the PERFORMER HT.

The Performer HT is a prescription electromechanical device for isolated hyperthermic perfusion. It circulates warmed, physiologically compatible sterile solution in the thoracic or peritoneal cavity. It controls solution temperature and flow rates, monitors volumes/pressures/temperatures, and detects air. The device is intended for use by qualified medical professionals.

Here's an analysis of its acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

• Quality management (ISO 14971, EN ISO 13485, EN ISO 14971)
• Packaging and labeling (EN 980, EN 1041, ASTM D4169-04a)
• Biocompatibility (AAMI ANSI ISO 10993 series)
• Electrical safety (IEC 60601 series)
• Sterility (AAMI ANSI ISO 11135, ISO 11607 series, ASTM F1980-07, AAMI ANSI ISO 11737)
• Human Factors (IEC 62366, EN 62366)
• Software (IEC 62304, EN 62304) | The PERFORMER HT is designed to, complies with, and has been tested to, the FDA Recognized Consensus Standards listed in the table. |
  | Software ability to meet performance specifications. | Verified through described tests at unit, integration, and system level for all functions, actuators, and parameters. |
  | User interface optimization and mitigation of user- and patient-safety risks concerning human factors. | Demonstrated that task-risks and errors have been identified, addressed, and either eliminated or reduced in a simulated use environment. |

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

The document does not explicitly state a "sample size" for a specific test set in the context of clinical trials or retrospective studies on actual patient data. The testing primarily involved non-clinical tests conducted on the PERFORMER HT system (equipment and disposable).

Data Provenance: The tests were performed by the manufacturer, RanD S.r.l. in Italy, as part of their 510(k) submission. Therefore, the data provenance is from the manufacturer's testing environment and simulated use, and it is prospective in the sense that the tests were designed and executed to evaluate the device's performance against pre-defined specifications. It is not patient or clinical data.

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

Not applicable. The ground truth for this medical device primarily relates to its engineering specifications, safety standards, and functional performance as verified through non-clinical testing. There is no mention of a ground truth established by human experts in a diagnostic or clinical context. The "ground truth" is defined by the technical specifications and recognized consensus standards that the device is tested against.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers (e.g., radiologists) interpret medical images or data, and their interpretations are compared against a consensus ground truth.

In this case, the device's performance was evaluated against predefined engineering specifications and recognized standards. The "adjudication" would involve technical experts (engineers, quality assurance personnel) verifying that the test results met these objective criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This is not an AI/CAD (Computer-Aided Detection/Diagnosis) device, nor is it a device that is typically evaluated through MRMC studies. The PERFORMER HT is an electromechanical device for hyperthermic perfusion.

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

Yes, in essence. The performance tests described comprehensively evaluate the PERFORMER HT system (equipment and disposable) in its standalone capacity, to ensure it meets its functional and safety specifications. Even though it's an electromechanical device and not an algorithm, the tests assess its "standalone" operational capabilities without human intervention beyond initiating and monitoring the tests. The human factors study separately assessed user interaction, but the core performance tests were for the device itself.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests is based on pre-defined engineering specifications, recognized consensus standards, and established operational parameters. For example:

• Temperature control: The ability to heat and maintain fluid temperature within a specified range defines the ground truth for this function.
• Flow rate accuracy: The specified acceptable deviation from target flow rates serves as the ground truth.
• Alarm functionality: The system's response to simulated unsafe conditions (e.g., sensor failure) according to its design is the ground truth.
• Compliance with standards: The requirements outlined in international and European standards (e.g., ISO 14971, IEC 60601-1) form the ground truth for safety, quality, and electrical compatibility.

8. The Sample Size for the Training Set

Not applicable. This device is an electromechanical system, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The device's design and functionality are based on engineering principles and validated through testing, not learned from data.

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

Not applicable. As stated above, there is no "training set" for this type of device.

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Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

The Hanger Cranial Band™ is a thermoplastic helmet prepared with USP Class VI materials; a polypropylene or polypropylene-polyethylene copolymer outer shell. The Hanger Cranial Band™ was initially cleared on December 8, 2000, under 510(k) K001669. This submission provides for the use of a hand held 3-dimensional laser scanner to acquire accurate measurements and a CAD/CAM system to fabricate the orthosis. A medium density polyethylene foam inner lining is thermo-bonded to this shell. The device is custom fabricated for individual patients by obtaining accurate measurements via a hand held 3-dimensional laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The addition of digital imaging allows for increased clinical accuracy and objective clinical documentation. The scan is then modified utilizing a CAD/CAM technology package. The 3-dimensional cranial scan is modified utilizing computer aided design tools to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial band/orthosis. Modifications include but are not limited to: relief areas opposite of cranial bossing, circumference modifications for growth and remolding, suspension, and rotational modifications. The modified file is then emailed to the central manufacturing facility for fabrication and delivery. The modified file measurements are validated and a positive model carved for fabrication. The carved model is evaluated for clinical accuracy and used to fabricate the definitive orthosis. The definitive Hanger Cranial Orthosis is processed through a quality control check list to ensure clinical accuracy, appropriate fabrication techniques, and quality assurance. The Hanger Cranial Band is sent to the practitioner for patient fit and delivery. A digital record of each patient scan and modifications will be maintained on file at Hanger for each patient.

This 510(k) summary (K072566) describes a cranial orthosis, the Hanger Cranial Band™, and its manufacturing process, which now includes a 3D laser scanner and CAD/CAM system. The submission primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or quantitative reported device performance in the way a typical clinical study would for efficacy. The core of this 510(k) is to demonstrate substantial equivalence, which means showing that the device is as safe and effective as a legally marketed predicate device.

The "Performance Characteristic Summary" (K072566 pg 5 of 5) explicitly states: "There has been no change to the performance characteristics of the device system." This implies that the performance characteristics are considered to be the same as the originally cleared Hanger Cranial Band (K001669) and the predicate device (K014012).

The key "performance" aspect discussed is the accuracy of measurements obtained via the hand-held 3-dimensional laser scanner and the CAD/CAM system for fabricating the orthosis. However, no specific metrics (e.g., degree of accuracy, mean error) or acceptance criteria (e.g., "accuracy must be within X mm") are quantified or presented.

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

The document does not mention a specific test set, its sample size, or its data provenance (country of origin, retrospective/prospective). This 510(k) is about incorporating a new manufacturing technology (laser scanning and CAD/CAM) into an already cleared device, asserting that the change does not alter the fundamental performance. Therefore, a separate "test set" for a new clinical performance study is not described.

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

This information is not applicable and not provided in the document. As no specific test set and ground truth establishment study are described, there are no details on experts or their qualifications for this purpose.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as no specific test set requiring adjudication is described.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device in question is a cranial orthosis, not an imaging interpretation or diagnostic AI device that would typically involve human readers.

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

A standalone performance study of the algorithm (e.g., for the laser scanner's accuracy or the CAD/CAM's precise fabrication) was not explicitly described or reported in terms of specific performance metrics or studies in this 510(k). The document highlights that the "addition of digital imaging allows for increased clinical accuracy and objective clinical documentation," but it doesn't quantify or prove this with a standalone study. The focus is on the process change and its substantial equivalence to an existing device.

7. Type of Ground Truth Used

The document does not describe a specific "ground truth" (expert consensus, pathology, outcomes data) for a new performance study. The ground truth for the device's efficacy is implicitly linked to the existing understanding and clinical outcomes of cranial orthoses, particularly the predicate devices that have established their effectiveness for treating cranial deformities. The new technology (laser scanning and CAD/CAM) is presented as an improvement to the manufacturing process leading to increased accuracy in fabrication based on clinical measurements, rather than a new diagnostic or prognostic tool requiring distinct ground truth establishment.

8. Sample Size for the Training Set

There is no mention of a training set or its sample size. The CAD/CAM system uses design tools to modify a 3D cranial scan. It's a design and manufacturing process, not a machine learning algorithm that typically requires a "training set" in the conventional sense. The "training" would be more akin to engineering and design validation of the CAD/CAM system itself, which is not detailed in this 510(k) for public consumption.

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

Since there is no described "training set" in the context of an AI/ML algorithm, the method for establishing its ground truth is not applicable and not provided.

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Ask a specific question about this device

Ask a specific question about this device

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Hang Ups InvertAlign is intended to be used for inversion, a method of gravity-assisted traction that utilizes the user's own body weight. Inversion is indicated of gray intervertebral dimentions, decrease pressure on the intervetebral discs, stretch and relax muscles, and temporarily relieve back pain associated with the listed contitions.

The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The user straddles the main shaft of the InvertAlign and while resting his seat on the base of the table frame, the user places each foot on the foot platform. The user's ankles slide between the foam padded ankle clamps. In the InvertAlign's full upright position, the user will be reclined in the supine position at approximately 10 degrees off vertical. By pulling the locking pin and locking the clamps securely to the ankles, the user or supervisor is able to manually adjust the foam clamps to form a secure but comfortable fit. The user or supervisor may then use the tilt control button to increase / decrease the angle of inversion. The InvertAlign can be stopped at any angle and is able to tilt beyond ninety degrees from horizontal to allow the user to hang and move freely at full inversion.

The provided text is a 510(k) summary for a medical device called "Hang Ups InvertAlign." This document primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device's technological characteristics and intended use. It does not contain information on acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document because it does not exist within the provided text. Similarly, I cannot answer the other questions about study specifics (sample size, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details) as this information is not present.

The document's "Summary of Safety and Effectiveness" section focuses on the historical use of inversion and the features of the device that contribute to safety and effectiveness, rather than a formal study with acceptance criteria and measured performance.

In summary, the requested information about acceptance criteria and a study proving their fulfillment is not available in the provided 510(k) summary.

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