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CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.

CALM Curve is a computerized method to assess progress during labor. Its algorithms calculate the patient's progress based on user-entered values for parity, dilatation, effacement, station, contraction frequency, and epidural use. Results of these calculations are displayed graphically and as percentile values derived from comparison to a database of women with similar characteristics who delivered vaginally. CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is > 35 weeks.

CALM Curve can function in a networked environment, as a standalone workstation, or as a web-based application. When connected to a fetal monitor, CALM Curve can use the monitor's uterine activity signal in lieu of user-entered values to calculate contraction counts.

The provided text describes the CALM Curve device but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device, not on presenting performance data against defined acceptance criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Information on standalone performance.
7. Type of ground truth used for a test set.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on:

• Device Description: CALM Curve is a computerized method to assess labor progress based on user-entered values (parity, dilatation, effacement, station, contraction frequency, epidural use) and displays results graphically and as percentile values compared to a database.
• Intended Use: To assess labor progress in singleton, cephalic presentation pregnancies with a gestational age > 35 weeks.
• Comparison to Predicate Device (LPM module of CALM software): The differences are operational (standalone product, web-based, manual contraction data entry) rather than algorithmic or related to core performance. The algorithm is stated to be the same as the predicate.
• Justification for Substantial Equivalence: The changes are described as minor modifications to the user interface and data input methods, not fundamental changes to the underlying algorithm for assessing labor progress.

The document states that the algorithm is the same as the predicate device (K980719). This implies that if any studies were done to establish the effectiveness or performance of the algorithm, they would have been associated with the predicate device's clearance. This 510(k) focuses on showing that the modifications to the predicate do not raise new questions of safety or effectiveness.

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CALM Patterns is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.

WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on CALM Patterns annotations.

CALM Patterns is a computerized method to detect, label and measure features in the fetal monitor recording. CALM Patterns uses fetal monitor data imported through an interface with an external source as described in a previous submission (K980719) or with a third-party clinical information system. CALM Patterns can function in a networked environment or as a standalone workstation.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the CALM Patterns device, discussing its substantial equivalence to a predicate device (OB TraceVue).

Therefore, I cannot provide the requested information. The document focuses on comparing the features of CALM Patterns to OB TraceVue for substantial equivalence, rather than presenting a performance study with acceptance criteria.

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CalMatrix Calcium Sulfate Bone Graft Binder, when mixed with allograft or other bone Gallwathx Calcium Oulfato Drives of maxillary and mandibular osseous and periodontal defects such as:

• Intrabony/infrabony defects .
• Furcation defects .
• Recession defects .
• Dehiscence/fenestration defects (natural teeth and prosthetic root form implants) ●
• Extraction socket (ridge preservation) defects .
• Ridge augmentation defects .
• Sinus lift defects .
• Endodontic bony defects .

Lifecore Biomedical Calcium Sulfate Bone Graft Binder (CalMatrix) is a calcium sulfate material that contains resorbable surgical grade plaster of paris with approximately 10% of a pharmaceutical grade sodium carboxymethylcellulose (CMC).

The Binder is a white, free-flowing powder. Calcium sulfate (CS) hemihydrate and PHARMACEUTICAL grade sodium carboxymethylcellulose are commercially available as raw materials for use in several orthopedic and dental devices. Calcium sulfate/CMC, when used in conjunction with demineralized bone matrix (DBM), controls the particles in the bony defect where bony walls may be insufficient to stabilize the graft. It increases the graft volume, and reduces particle migration during the early healing phase. CalMatrix remains pliable after mixing which allows the clinician an extended time period to complete the bone regeneration procedure.

The CalMatrix™ Calcium Sulfate Bone Graft Binder 510(k) submission (K041324) does not present acceptance criteria or a study directly proving the device meets specific performance criteria in the way typically seen for diagnostic or AI-driven medical devices. Instead, the submission focuses on establishing substantial equivalence to legally marketed predicate devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not define specific quantitative acceptance criteria or present a table of device performance against such criteria. The "performance data" section describes animal studies confirming biocompatibility and new bone growth, but these are not framed as meeting pre-defined acceptance criteria.

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

• Test Set Sample Size: Not applicable. There isn't a "test set" in the context of evaluating a diagnostic or AI device's performance metrics. The "animal studies" involved "animal models," but the specific number of animals or defects is not provided.
• Data Provenance: The animal studies were conducted using calcium sulfate/CMC with and without DBM. The country of origin is not specified, but the submission is to the US FDA. The studies appear to be prospective to evaluate the biocompatibility and bone growth response of the material. "Clinical use of this product was evaluated in animal and human studies," but details on the human studies are not provided in this summary.

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

Not applicable. There is no "ground truth" establishment in the context of diagnostic assessment for this type of device submission. The animal studies would likely have involved veterinary pathologists or orthopedic surgeons assessing findings.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic test set or adjudication method is described.

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

Not applicable. This type of study is relevant for evaluating human reader performance with and without AI, which is not the focus of this device submission.

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

Not applicable. This is not an AI/algorithm-driven device.

7. Type of Ground Truth Used

For the animal studies, the "ground truth" would implicitly be histopathology and radiographic assessment to confirm "new bone growth" and "no inflammatory or foreign body response."

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-driven device that requires a training set.

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

Not applicable.

Summary of the Device's "Proof" of Meeting "Acceptance Criteria" (Substantial Equivalence Approach):

The "acceptance criteria" for the CalMatrix™ Calcium Sulfate Bone Graft Binder are implicit in the substantial equivalence pathway for FDA 510(k) clearance. The manufacturer's proof that the device meets these (unwritten) criteria is based on:

• Technological Characteristics Comparison: CalMatrix is composed of calcium sulfate hemihydrate with carboxymethylcellulose (CMC). It is compared to:
  • CAPSET Calcium Sulfate Bone Graft Barrier (K955096): Also composed of calcium sulfate hemihydrate.
  • ALLOMATRIX® Putty (K020895): Utilizes the same calcium sulfate (CS)/CMC blend.
    The primary difference is that ALLOMATRIX comes pre-mixed with DBM, while CalMatrix is mixed by the clinician. The submission argues they are substantially equivalent in "mechanical characteristics, product configuration, anatomical site, safety characteristics, and sterilization."
• Intended Use Comparison: The indications for use for CalMatrix are explicitly stated as "the same as CAPSET" and are for treating multiple types of maxillary and mandibular osseous and periodontal defects.
• Performance Data (Biocompatibility and Bone Growth):
  • Animal Studies: These studies demonstrated that the materials (calcium sulfate/CMC, with and without DBM) were well tolerated, showing "no inflammatory or foreign body response," and "substantial new bone growth" in filled defects. While not providing specific quantitative acceptance thresholds, these findings support the material's safety and efficacy for its intended use, aligning with the expected performance of predicate devices.
  • Historical Use: The submission heavily relies on the "well-documented" historical use and established biocompatibility of calcium sulfate (Plaster of Paris) and the widespread use and known biocompatibility of sodium carboxymethylcellulose (CMC) in medical devices. This serves as a significant part of the "proof" for safety and general expected performance.
• Conclusion of Equivalence: The manufacturer concludes that the data supports substantial equivalence based on indications for use, product design and configuration, and materials used, directly comparing it to the specified predicate devices.

In essence, the "study" demonstrating that CalMatrix meets its "acceptance criteria" is the presentation of comparative analysis, biocompatibility data from animal studies, and reliance on the long-standing safety and efficacy profile of its constituent materials (calcium sulfate and CMC) in comparison to predicate devices, rather than a prospective study against novel, quantitatively defined performance metrics.

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The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

CALM is an easy-to-use system consisting of personal computers, data acquisition modules, and a system server. Interfaced with standard fetal and maternal monitors, CALM helps an Obstetrics Labor and Delivery department with fetal surveillance, charting, and archiving of patient data.

Here's an analysis of the provided text regarding the CALM system's acceptance criteria and study information, formatted as requested:

Acceptance Criteria and Study Information for CALM System (K980719)

It's important to note that the provided 510(k) summary for the CALM system is a substantial equivalence determination rather than a report on a clinical study designed to meet specific performance acceptance criteria. The document's purpose is to demonstrate that the CALM system is as safe and effective as a legally marketed predicate device (Birthnet™ Perinatal Patient Data Management System), based on a comparison of features, intended use, and technical specifications. Therefore, direct "acceptance criteria" and "reported device performance" in the traditional sense of a performance study are not explicitly detailed in the provided text. Instead, substantial equivalence is established by comparing functionalities.

The table below reflects the comparison of features between the CALM system and its predicate device, which implicitly serve as the basis for the FDA's substantial equivalence determination.

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) summary for substantial equivalence, the "acceptance criteria" are implicitly defined by the functionalities and specifications of the predicate device. The "reported device performance" is a statement of the CALM system's ability to match or perform similarly to these functionalities.

Detailed Study Information:

The provided document is a 510(k) summary for the CALM system, and it primarily focuses on demonstrating substantial equivalence to a predicate device (Birthnet™ Perinatal Patient Data Management System, K965008). It does not describe a clinical performance study designed to establish new acceptance criteria or to show performance against such criteria. Instead, it compares the features and intended use of the CALM system to a previously cleared device. Therefore, many of the requested details about performance studies, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, and standalone performance evaluations, are not applicable or not provided in this type of submission.

Here's an attempt to address your points based on the available information:

1. Sample sizes used for the test set and the data provenance: Not applicable. The document describes a comparison of device features and intended use for substantial equivalence, not a performance test with a distinct test dataset.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment by experts is described in this substantial equivalence summary.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
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: Not applicable. This document predates widespread AI integration in medical devices and describes a data management system, not an AI-assisted diagnostic or interpretation tool. No MRMC study is mentioned.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The CALM system is a "Computer-based information management system" and a "central monitoring system with signal analysis and display functions." Its function is to interface with existing fetal and maternal monitors and process/display their data, along with caregiver input. It is not an "algorithm only" device in the sense of an AI performing diagnosis without human oversight. Its performance is intrinsically linked to the input from monitors and human interaction.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" here is the established functionality and performance of the predicate device for comparison.
7. The sample size for the training set: Not applicable. As this is a data management system being cleared via substantial equivalence, there is no mention of a "training set" in the context of machine learning or algorithm development.
8. How the ground truth for the training set was established: Not applicable, for the reasons stated above.

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